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Computer-Based Patient Record: An Essential Technology for Health Care (1991)

Chapter: THE ROAD TO CPR IMPLEMENTATION

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Suggested Citation:"THE ROAD TO CPR IMPLEMENTATION." Institute of Medicine. 1991. Computer-Based Patient Record: An Essential Technology for Health Care. Washington, DC: The National Academies Press. doi: 10.17226/18459.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

The Road to CPR Implementation Technological change is a complex process that is influenced by a multi- tude of factors, including the attributes of a technology, the users of the technology, and the environment in which the technology is used. Success- ful implementation of computer-based patient record systems depends on "more than the transmission of technical details and the availability of sys- tems" (Anderson and Jay, 1987:4). It requires an understanding of the factors that influence the development and adoption of computer technolo- gies in health care. This chapter first identifies the factors that could enhance or impede CPR development and use. It then presents the committee's plan for ad- dressing these factors. The plan includes a discussion of the various organi- zations that have a role to play in CPR development and diffusion, the types of activities that would facilitate patient record development, how such activities might be implemented, and when such activities should take place. Chapter 5 presents the committee's formal recommendations for achieving the primary goals of the plan. DEVELOPMENT AND DIFFUSION FACTORS The process of technological change involves two general stages: devel- opment and diffusion. Development is the production of new capabilities or the alteration of characteristics of existing technologies; diffusion is the application of a new technology in the provision of services. These two stages do not necessarily occur in chronological sequence. User application can reveal that a technology needs further development. Alternatively, 94

THE ROAD TO CPR IMPLEMENTATION 95 diffusion sometimes parallels the development of a new technology (NAS, 1979). Moreover, as discussed below, the factors affecting development and diffusion are interrelated: development is unlikely to occur if the condi- tions for diffusion are unfavorable. Barriers to Development Patient Record Definition A basic impediment to the development of CPRs and CPR systems has been the lack of a clear definition of what a CPR could and should be. An intellectual understanding of what a CPR needs to do, the range of individu- als for whom it needs to function, and the expectations and performance demands of its users is an essential prerequisite to successful design of a CPR system (Teach and Shortliffe, 1981). Many computer-based informa- tion management systems are currently in place and generate and use pa- tient data for various purposes (e.g., billing, laboratory, radiology); what is lacking is a unified concept of what constitutes a computer-based patient record system. A fully articulated definition of a CPR and CPR system should describe attributes of the record and system (i.e., content, format, and function) as a guide for system developers and users.1 It should not, however, prescribe how those attributes are to be achieved. Resolution of that question is best left to CPR system developers and vendors. Chapter 2 identifies basic CPR system requirements, but system design- ers require more detailed specification in certain areas. Among these are the level of performance (e.g., speed and convenience) the system must provide to achieve health care provider acceptance; the kinds of new system functions needed to justify a change in current routines of record use and the costs of implementation; the frequency with which multiple users would view the record simultaneously; the level of system security, confidential- ity, and reliability required; and the level of institutional, regional, national, or international interconnectivity demanded of the system. In particular, patient record system developers require specific informa- tion about system functionality and performance to design systems that meet user needs. Understanding the diverse set of CPR user needs requires that representatives of all users be involved in a process of setting priorities for system functionality and performance. 1As discussed in Chapter 1, the committee's definition of a CPR is an electronic patient record that resides in a system specifically designed to support users through the availability of complete, accurate patient data, alerts, reminders, clinical decision support systems, links to medical knowledge, and other aids.

96 THE COMPUTER-BASED PATIENT RECORD Content and Format Standards As discussed in Chapter 3, CPR development has been, and continues to be, impeded by the lack of standards for the content and format of CPR data (McDonald and Hammond, 1989; Bradbury, 1990; Gabrieli and Murphy, 1990; Lindberg and Humphreys, 1990; Masys, 1990). To exploit the poten- tial benefits of linking CPRs across specialties and institutions, developers must ensure the following. (1) The content of CPRs must be defined; that is, each CPR should contain a uniform core set of data elements. (2) Data elements must be named consistently; that is, some form of vocabulary control must be in place. (3) Format standards for data exchange must be developed and used. Defining a core set of data elements requires participation by representa- tives of all patient record user groups. (Exclusion of any group could diminish the efficiency to be gained from implementing CPR systems if, as a result, key data elements are excluded from the core data set.) However, the uniform core data set should not be so large that it requires health care professionals to collect information that does not derive directly from rou- tine service provision. Moreover, because providers are likely to require data elements in addition to those in the uniform core data set, CPR systems should be flexible and not be limited to core data elements. Vocabulary control efforts have already led to substantial progress in developing standardized vocabularies. The use of existing controlled vo- cabularies in combination could cover the basic name of each patient prob- lem and of each procedure performed by a practitioner (Lindberg and Humphreys, 1990). Inadequate support for the timely update of clinical vocabularies, however, remains an obstacle to developing better vocabulary control for the CPR. Another obstacle is user resistance: users generally have not considered the benefits of a reasonably specific, controlled vocabulary as warranting a switch to a new system—especially if that system entails higher costs for record creation and maintenance (Lindberg and Humphreys, 1990). Existing format standards focus on particular portions of the record; no single format standard exists that could be used for the entire CPR. Nor is there at present a means for establishing one standard for use by the entire health care industry. In short, format standards for data exchange need further development and a means of achieving credibility. To date, such efforts have been carried out primarily by volunteer organizations. Greater support (i.e., funding and recognition) of these efforts would help to accel- erate standards development. Costs and Risks Venture capital is unlikely to be forthcoming for large-scale technologi- cal systems that require sizable investments before yielding a return in a

THE ROAD TO CPR IMPLEMENTATION 97 highly uncertain market (NAS, 1979). Consequently, development of a technology may require subsidization of development costs or creation of a more certain market, or both (NAS, 1979). Both of these factors apply to CPR systems: they require significant investment for development, and a high degree of uncertainty exists regarding the willingness of health care providers to purchase the systems. As discussed in Chapter 3, the committee found no comprehensive CPR systems in existence in 1990. Furthermore, no cost data are available on the monetary investment that might be required to implement such a sys- tem; evaluations of cost data related to computer applications tend to have focused on medical information systems (MISs) rather than on CPR sys- tems. MIS development costs and time estimates, however, do convey a sense of the magnitude of CPR development costs and time. A survey of automated ambulatory care systems found that development costs ranged from $100,000 to $10 million and that development time ranged from 1 to 7 years (Henley and Wiederhold, 1975). Congress's Office of Technology Assessment (OTA) has estimated the development cost for a commercial inpatient MIS to be $25 million and the time to develop such a system to be 10 years (OTA, 1977). Costs related to the acquisition of a technology are discussed later in this chapter. A General Accounting Office (GAO) study on the use of information technology in hospitals found that commercial hospital information systems currently in use were not as comprehensive as those planned by the Depart- ment of Defense and the Department of Veterans Affairs (GAO, 1988). The GAO cited two factors that could account for the less extensive development of commercial information systems—which may itself reflect an uncertain market. The first is the potentially small market for such systems.2 The second is the low level of spending for automation in the hospital industry. The causes of this low level are uncertain, but GAO offers several possibili- ties: the historical lack of incentives for hospitals to minimize costs (a situa- tion that has changed since the implementation of the prospective payment system by Medicare); the difficulties hospitals face in trying to raise initial funds for information systems; the cost savings in early systems were attributed to reductions in the work of clerical rather than clinical staff; the difficulties involved in achieving or quantifying savings (time sav- ings in particular are likely to be fragmented); and resistance by medical personnel to the introduction of information management technology (GAO, 1987). 2Some experts believe hospitals must have 200 or more operating beds to make optimal use of hospital information systems. According to the GAO report (1988), nearly 70 percent of community hospitals have fewer than 200 operating beds.

98 THE COMPUTER-BASED PATIENT RECORD The CPR market may also be uncertain because computer applications are generally not well understood by health care practitioners (Anderson and Jay, 1987). This lack of understanding limits the demand for such products and, as a result, reduces commercial interest in developing new products. Few sources exist to help practitioners learn what a computer technology can do for them, and there is little likelihood such help will be forthcoming in the near future, given the costs associated with producing such resources. Barriers to Diffusion Technological diffusion has been analyzed in greater depth than techno- logical development. Rogers (1987) presents five characteristics of a tech- nology that influence its adoption: • relative advantage over existing technologies (the degree to which an innovation is perceived as better than the practice it supersedes); • compatibility (the degree to which an innovation is perceived to be consistent with values, experiences, and needs of potential adopters, as well as with the structure of adopting organizations); • complexity (the degree to which an innovation is perceived as difficult to understand and use); • feasibility3 (the degree to which one can experiment with an innovation on a limited basis); and • observability (the degree to which the results of an innovation are ob- servable to others). Other factors also affect CPR adoption and use, including the environment of the health care system; leadership; user behavior, education, and train- ing; costs; social and legal issues; and network needs. Major concerns in these areas are briefly noted below. Environment of the Health Care System The U.S. health care system has been characterized as comprising "thou- sands of relatively autonomous units, centering on large hospitals, which are themselves made up of relatively autonomous divisions and depart- ments" (Lindberg, 1979:215). Maintaining CPRs, however, "imposes re- quirements for greater coordination among separate ancillary services, par- ticularly with regard to terminology" (McDonald and Tierney, 1988:3438). 3Rogers (1987) uses the term trialability to reflect the degree to which an innovation can be experimented with on a limited basis.

THE ROAD TO CPR IMPLEMENTATION 99 By extension, the use of patient records that are linkable requires coordina- tion among the institutions that are likely to contribute to or use such records. Thus, autonomy within and among provider institutions must be addressed when planning and implementing CPR systems. Disaggregation of care (i.e., the delivery of medical care by many small providers who operate independently of and in competition with one an- other) has significant implications for the adoption of a coordinative, systemwide technology. Such technology is often subject to nonadditive benefits—that is, the benefits of collaboration among multiple providers outweigh the benefits of individual adoption. As a result, providers have fewer incen- tives to acquire such technology (NAS, 1979). The reimbursement policies that are applied to providers influence their willingness and ability to acquire CPR technology. For instance, under cost-based reimbursement schemes, providers have more incentive to ac- quire technologies that are reimbursable than technologies that are not reim- bursable. In contrast, prospective payment systems create incentives for institutions to reduce costs—and thus to acquire potentially cost-reducing technologies such as CPR systems. Under current reimbursement policies, any potential acquisition of new technology must contribute to the improve- ment of a provider's financial status or at least be budget neutral. It should also substantially improve patient care processes, for example, by providing clinical decision support or by giving complete record access to authorized personnel. Leadership Given the fragmented environment of the U.S. health care system, it is not surprising that at present no one organization or agency is leading the effort to establish the necessary infrastructure for national implementation of CPRs and CPR systems. National and regional organizations may be knowledgeable about the issues, but they are not consistently soliciting information from or educating their members about CPRs. Thus, despite the many aspects of CPRs that are in need of coordination, no organization has the operational responsibility and funds to establish programs and projects to set the direction for the health care industry. Overcoming this problem could be the key requirement for progress, and the committee devoted con- siderable attention to discussing and formulating its primary recommenda- tion in this area (see Chapter 5). User Behavior, Education, and Training Users are more likely to accept a technology if several conditions are met: they have a stake in the system; they can use it at minimum cost; the

700 THE COMPUTER-BASED PATIENT RECORD technology produces information leading to improved clinical services; that information is almost immediately available; and the technology increases their status (Young, 1987). Computing applications that do not signifi- cantly change the routines associated with the practice of medicine are also more likely to be accepted by users (Kaplan, 1987). An individual's propensity to use a technology has been attributed to specialization, fear of malpractice suits, industry promotion, a specific form of medical practice, and payment methods (Banta, 1987). An encounter with a peer who is already using a technology can also influence an individual's use (Anderson et al., 1987). Young (1987:9) suggests that problems with the acceptance of clinical computing systems relate to the way a physician organizes his or her thought processes and interacts with written aids. [U]se of the medical records is not properly appreciated. The written record is not just a repository of information; it often forms part of the doctor's thought process, so that the style of writing, the position on the paper of particular items, abbreviations, the sequence of information, use of margins, may all have an important significance for the indi- vidual practitioner—a significance which goes beyond the actual facts recorded, and which is impossible to capture in an orderly typed record or video display unit. It is the loss of these individual aspects of the medical record which causes most problems. The advantages of struc- tured, typewritten reports commonly do not outweigh the loss of the extra information which is conveyed to the individual practitioner by the above features. Some individuals in the health care community are skeptical that com- puter systems can be designed to meet user performance and functional requirements. They may also doubt that a CPR system will improve an institution's ability to manage its information. Previous negative experi- ences with computer systems or inaccurate data generated by a system may cause some providers to actively resist the acquisition and implementation of CPRs. Whether or not an individual clinician is skeptical about a CPR system, using it will require behavioral changes. Thus, as noted earlier, some natural resistance to the CPR is to be expected. Individual institutions will need educational programs to support these changes. Educational curricula for health care professionals must also be modified to reflect the role of the CPR in the provision of health care services. Who will develop, implement, and pay for such materials (e.g., vendors or professional groups) is an area of considerable uncertainty. CPR implementation requires experts who can support CPR users, but at present only a relatively small number of individuals have the necessary expertise in medical informatics (Clepper, 1991). More people must be encouraged to enter this field and a variety of educational and training

THE ROAD TO CPR IMPLEMENTATION 101 programs tailored to different types of health care professionals must be developed. The committee considered the educational barrier to CPR de- velopment sufficiently important to formulate a specific recommendation to address it, as discussed in Chapter 5. In addition to education, practitioners need incentives to use CPRs to enter data and maintain patient records. Perhaps the greatest motivation for practitioners to use CPRs would be to produce evidence that CPRs can help to improve the quality of patient care and reduce the administrative burdens they currently face. As discussed in Chapter 3, at least one institution has experimented with a fee-for-data arrangement for physicians who input their own discharge summaries into an automated system. Other arrangements to encourage the use of CPRs are also feasible. For example, third-party pay- ers could provide incentives for health care providers (including physicians) to submit claims electronically or in a computer-compatible format (e.g., diskette). Alternatively, third-party payers may reject reimbursement claims that do not contain standard data. A regulatory approach is another possi- bility for use in place of or in addition to an incentive structure. However, the potential side effects and costs of both incentives and constrictive regu- lations must be understood and carefully weighed. Costs A major factor influencing a firm's adoption of a technology is the size of the investment required relative to the size of the firm. Acquisition costs for CPR systems are likely to be substantial but are difficult to esti- mate.4 This difficulty arises because the purchase or lease price of a system does not reflect the total implementation cost; it excludes the cost of train- ing and potential losses of productivity during transition to the system. Studies that have attempted to estimate total costs have tended to focus on MISs rather than CPR systems. Further, purchase or lease prices for CPR systems vary significantly, depending on the scope of functions a system offers, the size of an institution, and an institution's previous level of auto- mation. One cost analysis of the implementation and operation of an automated ambulatory care medical record system found that the cost per patient en- counter of a computer-based system was 26 percent greater than the direct costs associated with operation of a manual system. However, the manual system failed to access 18 percent of the records requested within the de- 4A confidential survey of CPR vendors conducted by the Technology Subcommittee of this IOM study committee revealed that purchase or lease costs for a CPR system range from $2 million to $6 million for a medium-sized hospital (see the appendix to Chapter 3).

702 THE COMPUTER-BASED PATIENT RECORD mand time, whereas the automated system provided access to 100 percent of the records requested. Quantification of the access benefit reduced the dif- ference in costs between the two systems (Koster et al., 1987). This cost analysis illustrates another major difficulty faced by health care provider institutions deciding on acquisition of a CPR system. Deci- sions about whether to acquire technology are based in part on information about the benefits of the technology; once again, data on CPR system ben- efits are sparse. Few recent studies have analyzed actual costs and ben- efits. The studies that have been conducted address MISs rather than CPR systems; they also focus on projected rather than actual experience or in- clude only those benefits that can be measured in terms of dollars and ex- clude such benefits as improved quality of care or reduced waiting time for patients. The costs of acquiring and operating CPRs and CPR systems will be borne primarily by practitioners and health care provider institutions. Yet the benefits of these systems will accrue to patients, practitioners, health care provider institutions, third-party payers, researchers, policymakers, and the public. These cumulative benefits of CPR systems should exceed the benefits individual practitioners and health care providers might be ex- pected to gain. As such, CPR systems in certain respects represent a public good. Given today's strict budget constraints, health care provider institutions (including physicians' offices) must choose among alternative technologies when allocating resources. Compared with a CPR system, other technologies could offer greater monetary benefits to an individual institution, albeit lower combined or social (public good) benefits. When this situation prevails, provider institutions have fewer incentives to invest in CPRs and CPR systems. Nonclinical data users (e.g., third-party payers and researchers) could also incur costs from CPR implementation. They may need to modify existing systems or acquire new ones to be compatible with CPR standards; they may also need to revise procedures for handling computer-based data and develop training programs for personnel. The cost of CPR technology, like the cost of computer technology in general, may well decrease over time. Moreover, CPRs may reduce the costs of care enough to offset the expense of acquiring and operating CPR systems, although this remains to be proved. The committee was quite concerned about the immediate barriers to CPR implementation raised by potentially substantial costs for full acquisition, installation, and operation of CPR systems across the nation; it was also concerned about the distribu- tion of these costs. Consequently, it formulated a specific recommendation to address these matters, which is presented in Chapter 5.

THE ROAD TO CPR IMPLEMENTATION 103 Legal and Social Issues The legal and social issues involved in implementing CPRs and CPR systems are formidable. State licensure requirements for hospital medical records are obsolete, ambiguous, and nonuniform (Waller, in this volume). The wide variation among states in hospital licensure requirements for medical records makes it difficult to develop CPR systems that comply with licensure laws in all 50 states; this factor in turn hinders the development of CPR formats that can be used nationally. Failure by a vendor to establish a CPR system's compliance with one or more state licensure require- ments may adversely affect the system's marketability. The differences across states could be so great as to make national implementation impossible. Hospital licensure laws and regulations in some states still assume a paper patient record, which makes the legal status of CPR systems unclear. Other state laws and regulations appear to permit use of some forms of automation but not others, or the use of automation for some, but not all, patient record functions. It is not clear whether regulations requiring that records be kept in ink or be typewritten permit the creation of records electronically or the use of lasers. Further, the regulations in many states require that medical records be signed but are silent on whether a computer key or code can be substituted for a signature. Issues of record ownership, responsibility, and control must also be ad- dressed. The physical records are the property of the provider institution at which they were created. In addition, provider institutions currently are responsible for ensuring the accuracy and completeness of record contents (Amatayakul and Wogan, 1989). As data are transmitted and shared among institutions, all with the ability to add and update information from a vari- ety of settings, the principles of ownership become blurred. It is not clear who would maintain records for routine use and maintain the structure of the record to accommodate new terminology and data elements for new diseases, treatments, tests, and approaches to health care. The locus of control of access to patient data is another unanswered question. Current laws concerning disclosure of and access to patient record information vary from state to state, further complicating the transfer of patient information across state lines. Perhaps the impediment to CPRs that is of greatest concern is the issue of privacy. The computerization of most types of record keeping, as well as the recent well-publicized cases of inappropriate access by computer hack- ers, has increased concerns about the misuse of personal information (Westin, 1976; Privacy Protection Study Commission, 1977; Peck, 1984; Agranoff, 1989). A system in which patient data, including sensitive information (e.g., human immunodeficiency virus test results, data on psychiatric treat-

104 THE COMPUTER-BASED PATIENT RECORD ment), can be accessed more easily may be strongly resisted in some quar- ters.5 There are several aspects to concerns about confidentiality of informa- tion and patient privacy. Ultimate responsibility for protecting the privacy of patient data that are shared among multiple users has not been defined; in addition, generally accepted standards for the protection of computer-based data do not exist (Agranoff, 1989; NRC, 1991). The consequences for breaches of confidentiality vary by state and in some cases need to be stronger than they are at present (Waller, in this volume). The National Conference of Commissioners on Uniform State Laws drafted the Uniform Health-Care Information Act to address issues of patient privacy, patient access, disclosure of patient information to third parties, and transfer of such information across state lines (National Conference of Commission- ers on Uniform State Laws, 1986). As of this writing, however, only one state had adopted this act (Waller, in this volume). Concerns about patient privacy affect more than the security features of CPR systems and legal remedies. A consistent personal identification number (PIN) in all patient records would facilitate record linkage across time and provider institutions (National Center for Health Statistics, 1990; Washington Business Group on Health, 1989). Nevertheless, despite its operational attractiveness to researchers and other patient record users, the PIN raises concerns about the increased potential to invade patient privacy (Washington Business Group on Health, 1989). Currently, the Food and Drug Administration (FDA) device regulations and authorities do not apply to computer products intended only for use 5Westin's 1976 study of the impact on citizen rights of computers in the health care field found that "most cases of actual harm involving individuals were still arising from manual records" and concluded that the main problem with the use of computer-based patient records involved "potential harm—the creation of health data systems that many health professionals, citizen groups, and individuals directly affected by such systems consider to be threats to basic rights" (Westin, 1976:xvi, emphasis in original). As noted by Lindberg (1970), however, the public and its elected legislators must have their anxieties allayed about potential misuses of data. Some observers have suggested that computer-based patient record systems will offer greater confidentiality for patient information because they can limit the information that various users can see. For example, administrative or financial personnel could be prevented from seeing sensitive diagnostic or treatment data. Further, CPR systems could provide an audit trail listing those personnel who accessed a particular record (Hard, 1990). As discussed in Chapter 3. however, existing security technology frequently has been not applied to current CPR systems. Moreover, a recent National Research Council (NRC) study on computer system security concerns concluded that several trends reflected a growing potential for system abuse. Among these trends are the proliferation of networking and embedded systems, the widespread use of databases containing personal information, and the widespread ability to use and abuse computers (NRC, 1991).

THE ROAD TO CPR IMPLEMENTATION 105 in such traditional library functions as storage, retrieval, and dissemination of medical information (Food and Drug Administration, 1989). As of this writing, however, the FDA's policy on the regulation of computer products had not been finalized; this situation creates uncertainty for vendors about potential regulation and its effects on system development costs and time. Liability for system defects is also a concern of vendors, particularly given the still-developing field of medical computer liability (Brannigan and Dayhoff, 1986; Willick, 1986; Metzger, 1988; Denis and Poullet, 1990). It has been asserted that a strict liability is likely to be applied to system vendors in cases in which the computer produces output on which a physi- cian relies without further checking, for example, patient record systems (Brannigan and Dayhoff, 1986; Bronzino et al., 1990). Liability for defects in clinical decision support systems is less clearly defined. System developers (i.e., health care specialists and computer pro- grammers), manufacturers, purchasers, and users are all involved in bring- ing a computer system to the patient. In cases in which harm is caused, liability could be assigned if negligence (i.e., lack of due care) can be proved and if the patient can prove that the negligent party owed a duty of care to the patient. (Physicians already have an established duty of care to patients.) Practitioners are expected to use such systems to supplement the medical library or to act in place of a consultant; they can ignore informa- tion provided by such systems and are expected to evaluate its accuracy. Thus, liability for negligence in the use of clinical decision support systems could apply to practitioners.6 The nature and obduracy of the legal barriers to CPR implementation must be understood, underscored, and addressed. For that reason, Appendix B discusses legal aspects of computer-based patient records and record sys- tems. Among the more critical legal aspects addressed there are regulatory and accreditation issues, evidentiary issues, patient privacy and record ac- cess concerns, record ownership questions, legal risks attached to specific CPR systems, and computer contracting issues. The committee regarded these issues as significant obstacles and formulated a specific recommenda- tion to address legal barriers (see Chapter 5). Network Needs To transmit and link records presumes the existence of an infrastructure, that is, a network and standards for data communication on the network. 6There has also been some discussion about the potential for practitioners to be found negligent if they do not use clinical decision support systems once the systems become widely available in the future (Willick, 1986; Metzger, 1988).

706 THE COMPUTER-BASED PATIENT RECORD Both communications technology and a management structure to coordinate participants are necessary elements of a network. Currently, the necessary coordinative mechanisms and the resources to establish and operate a health care computer network are not available. Those in the health care field must, as a result, look to other established networks for data transmission. Internet is a loosely organized confederation of federal, regional, and local networks that are used by researchers and educators for electronic mail, software and data file transfer, graphics and image file transfer, re- mote computer access to supercomputers and other specialized research instruments, and remote access to computerized databases.7 An estimated 1 million researchers are active users of the academic networks that are con- nected to Internet. It does not, however, provide users with uniformity in the type and quality of service; furthermore, despite its size, Internet does not yet reach the entire research and education community (Gould, 1990a). Federal sponsors and academic participants envision continued evo- lution of Internet until it becomes a user-friendly, unified high-speed re- search network with nationwide coverage. The Federal Networking Coun- cil8 plans to transform Internet into a full-fledged National Research and Education Network (NREN) in three phases. The final phase calls for an operational national network with gigabit-capacity trunks and for tran- sition of the network from government to commercial operation (Gould, 1990b). The NREN is being built to support "communication and resource shar- ing among institutions and individuals engaged in unclassified research and scholarly pursuit" (Gould, 1990b:l). As such, it is a model for the kind of infrastructure needed to transmit patient record data routinely. Given the 7In 1969 the Defense Advanced Research Projects Agency (DARPA) established an experimental network to demonstrate the potential of computer networking based on packet-switching technology, which allows many users to share a common communications channel. During the 1970s, DARPA sponsored several additional networks and supported the development of a set of rules and procedures (called the Internet protocols) for addressing and routing messages across separate networks. In the 1980s, DARPA sought to separate the operational traffic and administrative burden of military research and development (MILNET) from that of general academic research needs (Internet). Since 1985, the National Science Foundation has been responsible for coordinating the development of Internet. Funding for operations comes from five federal agencies involved in operating research networks and from universities, states, and private companies that operate and participate in local and regional networks (Gould, 1990a). 8The Federal Networking Council includes representatives from DARPA, the Departments of Energy and Health and Human Services, the National Aeronautics and Space Administration, and the National Science Foundation (Gould, 1990a). 9Senate Bill S. 1067 (High-Performance Computing Act of 1990) authorized the expenditure of $95 million over three years by the National Science Foundation for research, development, and support of the National Research and Education Network (National Science Foundation, 1990).

THE ROAD TO CPR IMPLEMENTATION 107 magnitude of the resources required to establish a national network,9 the committee recognized the utility of using the NREN to accommodate the data transmission needs of health care beyond simply research and educa- tion. The committee viewed planning for health care's high-speed network needs to be a key factor in CPR diffusion and proposes a specific approach for future efforts later in this chapter. ELEMENTS OF AN IMPLEMENTATION STRATEGY The remainder of this chapter outlines the elements of a strategy to foster nationwide implementation of CPRs and CPR systems within a decade. The discussion focuses first on change agents and stakeholders, moving on to resources and finally organizational structures. Specific committee rec- ommendations directed toward particular aspects of this strategy are devel- oped more fully in Chapter 5. Change Agents and Stakeholders The committee distinguished between potential change agents and stake- holders in the process of developing and implementing CPR systems. Change agents are individuals or organizations who have, first, a mandate related to or significant interest in CPR implementation and, second, the resources or means for effecting a change (e.g., leadership position, regulation, fund- ing). Change agents are in a position to initiate and facilitate the change process. Stakeholders are individuals or organizations who are affected positively or negatively (or both) by the change and who thus may support or oppose it accordingly. Potential impacts faced by stakeholders include, for example, financial gain or loss, a threat to professional autonomy, and an increased risk of loss of privacy. Although stakeholders may not initiate a change process or have the potential to advance a desired change, they may have the ability to thwart it. Table 4-1 identifies the main organizations and groups of individuals who are potential change agents or stakeholders with respect to developing and implementing CPR systems. They are grouped by sector—public or private—and are further designated according to the scope of their primary influence (i.e., national, regional, local, or individual). To engage the support of change agents in the change process, it is necessary to understand their interest level and available resources. To manage the change process, it is necessary to identify the potential impact of a change on stakeholders. The interests and resources of major CPR change agents and the potential impact on CPR stakeholders of the changes they might effect are discussed below.

108 THE COMPUTER-BASED PATIENT RECORD TABLE 4-1 Change Agents and Stakeholders Important to the Implementation of Computer-based Patient Record Systems Organization Change Agent/Scope of Influence Stakeholder Public Sector Agency for Health Care Policy and Research Centers for Disease Control Congress Department of Defense Department of Veterans Affairs Food and Drug Administration Health Resources and Services Administration Health Care Financing Administration National Institutes of Health National Library of Medicine" State health agencies State legislatures Private Sector Computer standards organizations Computer-based patient record vendors Health care professionals Joint Commission for Accreditation of Healthcare Organizations Patients Patient groups Professional associations Professional schools Provider institutions Researchers Third-party payers Universities Yes/national No Yes/national Yes/national Yes/national No Yes/national Yes/national No Yes/national Yes/regional Yes/regional Yes/national Yes/national Yes/individual Yes/national No Yes/local to national Yes/national Yes/regional to national Yes/local No Yes/local to national Yes/regional to national Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes No Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes °A specific agency of the National Institutes of Health. Health Care Professionals and Professional Associations Health care professionals bear a dual burden: they must learn to use a new technology, and they must change their behavior. Some professionals may view the CPR as a threat to their professional roles and resist imple- mentation of CPR systems through attempts at circumvention or even system sabotage (Dowling, 1987). Alternatively, professionals can support

THE ROAD TO CPR IMPLEMENTATION 109 development and implementation by participating in planning and by influencing their peers. Professional associations for physicians, nurses, dentists, social workers, physical therapists, and similar kinds of health care practitioners are all vehicles by which to provide ongoing education to their members about the benefits and liabilities of CPRs. Associations such as the American College of Physicians, American College of Surgeons, American Dental Associa- tion, American Hospital Association, American Medical Association, American Medical Record Association, American Nurses Association, and Group Health Association of America are among the societies that could implement for- mal CPR education and awareness programs as part of their membership mailings and annual meetings. Many already have active committees to deal with medical informatics issues. These and similar associations are likely to voice the concerns of their members, but they are also in a position to influence their members. De- pending on how they weigh the advantages and disadvantages of CPR ac- tivities, they can lobby for or against them. To the extent that professional organizations see more benefits than liabilities in CPR implementation, they can be valuable participants in future consensus-building activities. Patients and Representatives of Patients As discussed earlier, the question of ensuring privacy and confidentiality has been identified as one of the crucial hurdles to effective CPR imple- mentation. Given patient concerns about privacy and the potential for CPR systems to increase information flow within and outside of health care pro- vider settings, patients may distrust CPR systems. Furthermore, patients are no more likely than health care professionals to use or understand com- puters, let alone computer-based record systems. Survey data suggest that Americans view the nation's health care system as poorly organized and inefficient; most believe that rising health care costs can be reduced without cutting the quality of care (Blendon, 1988). As noted elsewhere in this report, CPRs and CPR systems offer many ad- vantages (compared with current paper records) for overcoming some of these inefficiencies and improving health care quality. Hence, patients may have some basis for supporting the implementation of CPR systems. Any influence of individual patients on CPR efforts is likely to be indi- rect at best. Patients might, for example, select providers on the basis of the provider's use of a CPR system. Greater influence can be exerted by the various voluntary membership organizations that represent the concerns of particular patient groups (e.g., the American Diabetes Association) or those of specific population groups (e.g., the American Association of Re- tired Persons). These organizations have the capacity to acquire a broad

110 THE COMPUTER-BASED PATIENT RECORD understanding of the strengths and limitations of CPRs and CPR systems and to offer substantial support or opposition to CPR activities. Provider Institutions Health care provider institutions are likely to be interested in CPR sys- tems in response to concerns about quality and costs and to internal and external demands for information. By purchasing a CPR system, provider institutions can influence CPR development and implementation in three ways. First, such action signals the market that demand for CPR systems exists. Second, it directly affects the staff who must use the system. Third, it can help to create an understanding on the part of both providers and patients that such systems are the emerging standard of practice. Third-party Payers Third-party payers include both insurers and employers. For insurers, CPR systems offer an opportunity to streamline operations. To realize the gains in efficiency and productivity offered by CPR systems, however, in- surers may have to incur short-term costs to make their systems compatible with CPR formats. Long-term improvements in efficiency may also be realized; for instance, redundant data entry can be eliminated through elec- tronic claims submission and payment. Insurers have a major stake in improving the knowledge base for quality and cost management (e.g., clinical practice guidelines and utilization man- agement), as well as for coverage and reimbursement decisions (e.g., tech- nology assessment and outcomes research). As change agents, insurers could offer incentives—for example, faster payment of claims when they are submitted in electronic form. Alternatively, because third-party payers should value improved data, they could increase reimbursement rates to reflect the costs of implementing and operating CPR systems. Employers are likely to be interested in CPRs as a means of improving the quality and reducing the costs of care received by their employees and related beneficiaries. Groups such as the U.S. Chamber of Commerce, the Washington Business Group on Health, and regional health care business coalitions have devoted considerable resources to finding ways to manage the utilization and cost of health care services, which are ultimately re- flected in the health care insurance premiums employers pay. The potential for CPRs to improve information management at the micro (patient) and macro (population) levels is likely to be of interest to employers. Health care business coalitions, chambers of commerce, and major employers could all contribute to CPR development and implementation efforts by finan- cially supporting research and pilot demonstrations and by developing rela-

THE ROAD TO CPR IMPLEMENTATION 111 tionships with insurers and health care provider institutions that use or support CPR systems. Federal Government EXECUTIVE AGENCIES Federal agencies have varying degrees of interest in and authority to influence CPR development and implementation. Certain agencies can provide substantial funding for research and development; oth- ers may be able to finance the acquisition of CPR technology. Federal agencies can support standards development through funding or regulatory mandate. For instance, they can direct major federal providers of health care to use CPR equipment that meets certain standards, or they can require the use of CPR technology for hospital accreditation or Medicare participa- tion. The remainder of this section outlines the change agent and stake- holder roles of selected federal departments and agencies. Within the Department of Health and Human Services (DHHS), the Pub- lic Health Service agencies10 would benefit greatly from efficient access to complete, accurate patient care data; therefore, their interest in CPRs is likely to be high. For example, the Agency for Health Care Policy and Research (AHCPR) is charged to develop uniform definitions of data to be collected and used in describing a patient's clinical and functional status; it also supports the development of common reporting formats and linkages for such data and of standards to ensure data security, confidentiality, accu- racy, and maintenance (U.S. Congress, 1989). These activities support or would be supported by CPR implementation. The research institutes of the National Institutes of Health (NIH) are viewed as stakeholders who would benefit from improved patient data. Within NIH, the National Library of Medicine (NLM) is in a strong position to support CPR development directly through its medical informatics pro- gram and its work on the Uniform Medical Language System (UMLS). Further, MEDLINE, HEALTH, and other on-line databases of the NLM's MEDLARS (Medical Literature and Retrieval Systems) are valuable re- sources for health care professionals that could be made available through CPR workstations. The Centers for Disease Control (CDC) and the FDA could each benefit from the implementation of CPR systems in two ways. First, CPR imple- mentation would likely improve patient data for epidemiological research. 10These agencies include the Agency for Health Care Policy and Research, the Centers for Disease Control (including the National Center for Health Statistics), the Food and Drug Administration, the Health Resources and Services Administration, the Indian Health Service, and the National Institutes of Health (including the National Library of Medicine).

772 THE COMPUTER-BASED PATIENT RECORD Second, direct (i.e., electronic) reporting of events in which these agencies are interested could improve their public health and regulatory activities. Examples of crucial data include occurrences of tracked diseases and infor- mation about adverse events related to Pharmaceuticals and medical de- vices. The Health Resources and Services Administration (HRSA) administers federal support of maternal and child health (MCH) services amounting to more than $525 million a year." MCH programs offer demonstrably more difficult technical and practical barriers to successful implementation of CPRs and CPR systems than do, for instance, traditional hospital inpatient services or physician office-based practices. These obstacles must be recog- nized, understood, and planned for in the service of improved MCH care. The appendix to this chapter describes how CPRs and CPR systems could support HRSA in meeting its mandate. The challenges to CPR implementation that are found in MCH programs are by no means unique. For CPRs to be productively and effectively developed and diffused throughout the U.S. health care system, implementers must confront and overcome precisely these kinds of barriers, especially as health care delivery moves more and more into outpatient and nontraditional settings and as it confronts complex "socioclinical" issues related to disad- vantaged and underserved populations. Thus, the MCH arena should be seen as a particularly fruitful area in which to design, test, and implement practical computer-based systems for the 1990s. The Health Care Financing Administration (HCFA) is responsible for administering the Medicare program and the federal portion of Medicaid. Because of the magnitude, scope, and complexity of these programs, HCFA has considerable motivation to improve the efficiency of claims processing, to assess the effectiveness and appropriateness of medical interventions, and to monitor the quality of care rendered. The agency is currently devel- oping a computer-based patient record abstracting system, the Uniform Clinical 1 1HRSA uses two main types of funding. The majority of support is awarded to state health agencies through MCH block grants that are intended to enable states to ensure access to maternal and child health services for low-income individuals and individuals who live in areas of limited health resources. The purposes to which these funds can be put are quite broad—ranging from reducing infant mortality and the incidence of preventable diseases to improving the rates of use of diagnostic and therapeutic services. Most of the remainder of MCH appropriations is disbursed through awards called special projects of regional and national significance (SPRANS). These programs can involve MCH research, training, and projects related to genetic disease testing and counseling and to diagnosis and treatment of hemophilia. More recently, amendments to Title V of the Social Security Act have directed that some funds be used specifically for newborn screening and for child health demonstration projects.

THE ROAD TO CPR IMPLEMENTATION 113 Data Set (UCDS), to improve the efficiency of the Medicare peer review organizations (PROs; Krakauer, 1990). At present, the UCDS must be ab- stracted manually from hospital charts of Medicare patients; CPR systems would improve the efficiency of collecting these necessary data. The HCFA Bureau of Program Operations engages in three activities that would benefit from widespread CPR technology. First, the bureau is trying to promote submission of claims by electronic media. Second, it is devel- oping a so-called Common Working File, in which all claims for all kinds of services will be located and accessible upon inquiry. Third, it is seeking to develop a capability for real-time cooperation with PROs that will allow on-line authorization of services. The Omnibus Budget Reconciliation Act of 1990 (Public Law 101-508) provides for the development of prospective and retrospective drug utiliza- tion review (DUR) programs by states participating in Medicaid.12 The act also includes provisions to conduct demonstration projects to evaluate the efficiency and cost-effectiveness of prospective DURs in patient counseling and reducing costs. Such demonstration projects, which would be overseen by HCFA, are likely to address issues of interest to CPR developers and could support CPR development efforts. As noted in Chapter 3, the Departments of Defense (DoD) and Veterans Affairs (VA) have installed integrated medical information systems in nu- merous hospitals (GAO, 1988) and are actively engaged in developing and implementing components of a CPR. Widespread use of CPR systems can be expected to benefit both departments by expanding the availability of technology to meet patient care, research, and education needs. For ex- ample, with the CPR, the VA can improve its ability to coordinate health care services provided to veterans in both VA and non-VA settings. The 12Drug utilization review (DUR) is a formal program for comparing data on drug use against explicit, prospective standards and, as necessary, introducing remedial strategies to achieve some desired end. Three primary objectives of DUR are (1) improving quality of care, (2) conserving drug funding resources and controlling individual expenditures, and (3) maintaining program integrity (i.e., controlling fraud and benefit abuse). Retrospective DUR is a systematic process that involves selection, review, analysis, and interpretation of drug use data that are collected and analyzed after events occur. Retrospective DUR is used to identify drug utilization trends that warrant further education of practitioners and patients; it also highlights areas of system abuse that might call for more extensive peer-level review and provides mechanisms for evaluation and modification of program criteria and standards. Prospective DUR refers to systems that are designed to influence drug prescribing, dispensing, or use in a real-time environment. Implementation of such a system requires that a health care professional with patient care responsibilities have sufficiently detailed information regarding a patient's medical condition, drug use profile, and history to make an informed decision regarding new or renewed drug use (Norris, 1991).

114 THE COMPUTER-BASED PATIENT RECORD affiliation of VA medical systems with academic medical centers can be enhanced by providing consistency and flexibility for health care profes- sionals at these dispersed sites, thus facilitating collaboration among affili- ated institutions. Although these departments have accomplished a great deal with respect to components of CPR systems, their primary mandate is not patient care. Thus, they cannot be expected to assume primary responsibility for leading CPR development throughout the health care field. Such large health care provider systems, however, can have a great deal of influence on what is developed and produced by vendors. CONGRESS The potential for Congress to foster CPR development and implementation is great, but its present level of interest in such a course is unclear. Certainly, as evident from the IOM studies on quality assurance in Medicare (IOM, 1990a) and clinical practice guidelines (IOM, 1990b), Congress has expressed a desire to improve the quality of health care.13 Managing costs remains a critical issue, as is well illustrated by the work of the Physician Payment Review Commission (Lee et al., 1989) and the Prospective Payment Assessment Commission (ProPAC, 1990). Congress is also concerned about improving the quality and availability of health care data for research, a concern reflected in the establishment of AHCPR in late 1989. Despite Congress's activities on behalf of improved health care, some obstacles to strong congressional support of CPR development may arise. For example, having allocated new monies to some of the efforts noted above, particularly certain parts of the AHCPR mandate, Congress may not see a need for additional specific support to improve patient records. That is, it may believe these problems are being addressed through existing mechanisms. Further, Congress may be especially concerned about the issue of privacy. In the committee's judgment, better patient records are essential to achiev- ing Congress's health care objectives. Consequently, the central role of the CPR in improving patient records and enhancing quality of care, in man- aging costs, in facilitating Medicare claims processing, and in improving available data for clinical and health services research must be made clear. Further, CPR advocates must seek to convince key members of Congress that through technological capabilities and legal remedies, CPR systems will bring about a net gain in protecting privacy compared with current record- keeping systems. 13More recent evidence of Congress's interest in the quality of health care appears in the form of H.R. 1565, which was introduced in the House of Representatives on March 21, 1991. This bill is intended to increase access to health care and to affordable health insurance, as well as to improve health care quality and contain costs.

THE ROAD TO CPR IMPLEMENTATION 115 States State governments face issues similar to those of the federal government in that they devote significant percentages of their budgets to health care and are concerned about health care quality, cost, and access for their citi- zens. States have also been fertile grounds for progressive policymaking and legislation. They have played important roles in developing regional databases to monitor quality, manage costs, and assess clinical effective- ness.14 State governments, cabinet-level health officers, and groups such as the National Conference of State Legislators, Council of State Governments, Association of State and Territorial Health Officials, and National Assoc- iation of Health Data Organizations could provide a regional perspective in national CPR efforts. In addition, states would be likely candidates for pilot regional studies or experimental prototypes. Universities and Professional Schools CPR systems offer several advantages to universities. For example, uni- versities whose professional schools (i.e., schools of medicine, nursing, and dentistry) are involved in clinical research can benefit from the improved data likely to be available for analysis. Furthermore, CPR systems may give the schools a means of disseminating their results for application in clinical practice. (These benefits are likely to accrue to independent re- search centers as well.) The interest of health professions schools in CPRs may be mixed, how- ever. On the one hand, faculty members' concerns about threats to their expertise and professional roles might prompt negative reactions to the CPR. On the other hand, individuals in academic or research settings might be 14The following descriptions are examples of the types of state activities already in progress (National Association of Health Data Organizations, 1988). In 1977 New York established the Statewide Planning and Research Cooperative System (SPARCS), a public-private effort that provides a unified data system to gather information throughout the state regarding all hospital stays. SPARCS is a major management tool for assisting hospitals, agencies, and other organizations with decision making regarding the financ- ing, planning, and monitoring of inpatient hospital services. In 1985 the General Assembly of Colorado established the Colorado Health Data Commission to collect, analyze, and disseminate data as a way to encourage competition and informed decision making. In 1986 the Pennsylvania Health Care Cost Containment Council was established through an act that mandates health care utilization and cost data collection and dissemination. Its central purpose is to increase purchaser and consumer knowledge of health care costs and quality.

776 THE COMPUTER-BASED PATIENT RECORD more innovative and more receptive to change than health care profession- als in other types of settings. Through the training of health care professionals (including continuing education), professional schools can both shape attitudes toward and pro- vide the skills for using CPRs. Moreover, to the extent that professional schools influence the agenda of researchers (by providing space and sup- port), they can foster the development of CPR systems. Some schools also now serve as centers of medical informatics training and of continuing research in medical informatics. The NLM supports 11 institutions in efforts to develop prototypes of an Integrated Academic Information Management System (IAIMS). The ob- jective of these projects is to "develop the institutional information infra- structure that permits individuals to access information they need for their clinical or research work from any computer terminal wherever and when- ever it is needed" (NAS, 1989). These projects may become models for linking the many departments of academic health and medical centers, including other departments in parent universities (e.g., economics, law, sociology) that have a role to play in clinical and health services research. IAIMS sites may also provide an infrastructure on which to base selected pilot CPR demonstration projects. Standard-setting Organizations Two kinds of standard-setting organizations are potential CPR change agents. The first is those groups that are developing standards for health care information systems, primarily in the areas of communication proto- cols and the characteristics of information collection and use. Among these organizations are the Institute of Electrical and Electronics Engineers (IEEE), the American Society for Testing Materials (ASTM), and the Inter- national Standards Organization (ISO). The second kind of standard-setting group comprises various health care accreditation organizations, such as the Joint Commission on Accreditation of Healthcare Organizations, the National Committee on Quality Assurance, and the National League of Nursing. Their role may be to foster CPR development, acquisition, and use by setting standards for accreditation that are most effectively met through CPR systems. Vendors CPR system vendors are likely to support development if the projected demand for CPR technology seems sufficient to recoup investment and mar- keting costs. As discussed earlier, however, vendors are uncertain about the willingness of health care providers to purchase CPR systems. Users or

THE ROAD TO CPR IMPLEMENTATION 117 other change agents (such as Congress) may need to provide incentives for a greater or more certain CPR market before vendors can be expected to invest major sums for research, development, or marketing. Activities and Resources Critical to CPR Development In light of the various barriers to CPR development, the interest and resources of change agents, and the concerns of stakeholders, the committee identified eight critical activities that will help to advance CPR develop- ment: (1) identification and understanding of CPR design requirements; (2) development of standards; (3) CPR and CPR systems research and develop- ment; (4) demonstrations of effectiveness, costs, and benefits of CPR sys- tems; (5) reduction of legal constraints for CPR uses as well as enhance- ment of legal protection for patients; (6) coordination of resources and support for CPR development and diffusion; (7) coordination of information and resources for secondary patient record databases; and (8) education and training of developers and users. Dedicated resources and improved organization must be provided to ac- complish these activities. Resources can take the form of funding, exper- tise, and equipment. Without adequate funding, however, the other kinds of resources are unlikely to be available. Funding is required to support stan- dard setting, research, demonstrations, review of legal issues, information coordination, education, and a user-developer forum. Potential sources of funding include federal and state governments, ven- dors of CPR systems, and private foundations. The committee believes that funding for CPR development should be a governmental priority because the CPR is essential to achieving a variety of ends desired by government (e.g., improved patient care and research). The budget deficits faced by federal and state governments, however, may make the infusion of signifi- cant new funds difficult. CPR vendors may be willing to contribute some funds but probably not enough to support all needed activities. Vendors may be more likely to contribute when uncertainty regarding the market for CPR systems has been reduced. Foundations and other groups in the pri- vate sector that support health-related research and educational activities may also be an important, indeed, necessary source of funding; again, how- ever, the sums available from this source will not be sufficient to support the entire task envisioned by the committee. Purchasers of systems are unlikely to provide funding for development efforts. They may be willing, however, to contribute in-kind support, for instance, through their participa- tion in demonstration projects. Substantial levels of resources are already devoted to CPR system devel- opment, and this suggests that a major effort should be made to avoid duplication of effort and to build on expertise that has already been devel-

/78 THE COMPUTER-BASED PATIENT RECORD oped. The need is great to coordinate CPR-related activities, enhance col- laboration, and eliminate potential inefficiencies in the development pro- cess. Experience gained from working with currently available data is likely to benefit CPR development. The needs of secondary patient record users may be better met in the interim (i.e., until CPR systems are widely used) through enhancements to existing databases—similar to the approach AHCPR is currently pursuing for research. Organizational Structure Health care providers spend large amounts of money on computer and software systems that may not meet their needs today and that will not meet their needs tomorrow.15 Complete, accurate, accessible patient care data are needed now for clinical care and research. The current combination of private sector, public, and voluntary efforts cannot adequately address the many issues that affect and are related to CPR development and diffusion. Progress is essential on several fronts: coordinating existing and new activi- ties; maximizing public funding; strengthening voluntary efforts (e.g., stan- dard setting); developing a national consensus; and establishing a frame- work for local efforts. No one organization currently has the mandate and resources necessary to provide leadership for the CPR effort. Further, the committee concluded that the complexity and importance of the task required an organization dedicated to the CPR mission—such an arrangement would be more likely to foster progress than ad hoc efforts by a number of organizations. There- fore, an initiative should be mounted to create the necessary organizational apparatus, identify and accumulate resources, and pursue the activities noted earlier. This initiative could involve either a new organization created for this purpose or an existing organization that could be given an expanded mission. The organization's fundamental goal would be to facilitate endeavors that improve the flow of information and reduce uncertainty so that a true market for CPRs and CPR systems could function. Some of these activities are under way, but they are not coordinated with other CPR or CPR-related ventures. Moreover, existing efforts lack author- ity and national attention. There is also no established mechanism for setting priorities for CPR development or for representing CPR interests on an ongoing basis. The committee believes that the establishment of a for- mal leadership role is essential for CPR implementation success. The committee further believes that this leadership role should be estab- lished in an organization with the following mission: 15Nonfederal hospitals in the United States spend more than $5 billion per year on computing- related products and services (Booz-Allen and Hamilton, 1990).

THE ROAD TO CPR IMPLEMENTATION 119 • Support the effective, efficient use of computer-based patient informa- tion in patient care, health care policymaking, clinical research, health care financing, and continuous quality improvement. • Educate change agents and stakeholders (including the general public and health care professionals) about the value of computer-based patient data in improving patient care. • Foster the CPR as the primary vehicle for collecting patient data. • Promote the development and use of standards for CPR security and data content, structures, and vocabulary. Specific steps the organization should take to achieve this mission in- clude the following: • Establish a forum for CPR users and developers to address such issues as definition of CPR functions and content. • Facilitate data and security standards setting and endorse such standards. • Promote CPR data transmission through national high-speed networks by representing the biomedical community in planning for such networks. • Address legal issues related to CPRs and CPR systems. • Develop mechanisms for sharing the costs of acquiring and operating CPR systems among all users of CPR data. • Define priorities and criteria for CPR demonstration projects that could be used by federal agencies, private foundations, and health care provider institutions. • Conduct workshops and conferences to educate health care profession- als and policymakers. • Explore the need for a clearinghouse or data center for secondary CPR information. Given the mission and objectives outlined above, the committee con- cluded that any organization leading the effort to advance the implementa- tion of CPRs should have several key attributes. First, it should be national in scope. Second, it should have authority to make and implement deci- sions. Third, it should represent all CPR users, as well as CPR developers. Fourth, it must have sufficient visibility and influence to be able to achieve measurable progress within a relatively short time. Three to five years was seen as a reasonable time frame for initial headway to be made. The committee had particular concerns about the feasibility of establish- ing and operating such an organization. To clarify the issues further, it examined several organizational models in terms of the need for and ability to secure funding, receive a mandate, and gain acceptance. The three main options explored by the committee were a purely governmental (federal) effort, a purely private sector entity, and some form of a public-private

720 THE COMPUTER-BASED PATIENT RECORD commission, consortium, council, or institute. The advantages and disad- vantages of these options are discussed below.16 Federal Agency There are several advantages to a federally based CPR development effort. In general, a federal initiative associated with an existing agency has implied authority and power, as well as lower start-up and operating costs than would be incurred for a newly created, freestanding organization. Moreover, con- gressional support is likely to be stronger if the CPR effort is closely linked to federal efforts that are already under way. In addition, staff would not need to spend time raising funds as would be necessary for a private sector effort. A federal agency would have less independence than a private sector organization, however, and would face possible limitations from bureau- cratic policies and procedures. Thus, greater potential for innovation might exist in the private sector. Another disadvantage to locating leadership for CPR development within the federal government is the potential for health care providers to see such efforts as too closely aligned with government and therefore open to excessive regulation and intrusiveness. Finally, such an approach must rely on receiving a mandate and funding, which could make start-up time for federal efforts longer than for a private organization. Within DHHS, several agencies might be considered. First, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) might be able to bridge the gaps among various agencies and programs in DHHS. It would be unlikely, however, to gather the resources and expertise required to mount an effort of the magnitude envisioned by this report. AHCPR has functions quite consistent with the objectives of the leader- ship entity proposed by the committee, although these functions are not its primary responsibilities. Currently, AHCPR does not have the resources to undertake a CPR implementation project, but if such funding were forth- coming it could, over time, assume a more significant role. One drawback, however, is that such an effort might be seen as possibly undermining the agency's main mission—that is, support of health services, outcomes, and effectiveness research and the development of clinical practice guidelines. HCFA has a substantial interest in the CPR for both operational and quality improvement reasons. Although HCFA would be a key beneficiary of widespread CPR implementation and hence likely to want to provide 16To address this issue fully, the committee organized a one-day workshop in September 1990 to evaluate the feasibility and desirability of alternative organizational models for a CPR organization; AHCPR provided separate funding for the meeting. Workshop participants in- cluded representatives of health care professionals, provider institutions, federal agencies, in- surers, employers, and private foundations.

THE ROAD TO CPR IMPLEMENTATION 121 critical resources, it may not be the ideal agency to champion patient record development. If HCFA were to lead the CPR effort, health care providers might not be able to separate it from HCFA's other activities, particularly regulation of the Medicare program, cost containment, and related efforts. Providers might resist the CPR development initiative because of a percep- tion that it was intended as a cost-containment mechanism rather than as a way to improve health care delivery. The Departments of Defense (DoD) and Veterans Affairs (VA) are both making significant investments in comprehensive medical information sys- tems.17 As a result, they have a great deal of expertise in designing and imple- menting such systems. These departments do not seem likely candidates for leading a CPR initiative, however, because of their restricted populations and other non-health care responsibilities. In short, no existing federal organization simultaneously has the mandate, mission, credibility, and re- sources to take on this responsibility. Private Sector Sponsorship The committee also considered a private sector, not-for-profit member- ship organization, similar to the Joint Commission on the Accreditation of Healthcare Organizations, to lead the CPR development effort. A decided advantage to a purely private approach is that the conversion to computer- based records would become something championed by, rather than imposed on, these organizations and their constituents. The active involvement of such organizations might prompt them to provide core funding, and the efforts to secure funding from others might then be more effective. In addition, staff recruitment for a private organization would be facilitated by the broad-based support the organization would receive from national health care groups. This strategy has its limitations, however. Most important is that such an organization would lack the power and authority implicit in a governmental entity. Further, federal funding could be difficult to obtain unless key agen- cies played a major role in the organization's activities. Public-Private Commission or Consortium In theory, a public-private organization would offer the advantage of involving and being able to draw on funding and personnel resources from "DoD is acquiring the Composite Health Care System for installation in its 167 hospitals and nearly 600 clinics. The costs for full deployment of this system are expected to be $1.6 billion. The VA is installing the Decentralized Hospital Computer System to support its 172 hospitals and 358 outpatient facilities. The VA estimates that this system as currently defined will cost $925 million (GAO, 1988, 1990).

722 THE COMPUTER-BASED PATIENT RECORD both sectors. Furthermore, because the problems with patient records affect both public and private organizations, acceptance of a solution would be more likely if both sectors were involved in the decision-making process. The drawbacks of a public-private entity should not be underestimated, however. Managing the diverse interests that would be represented in such an organization presents a major challenge. Certain federal agencies al- ready have charters that would overlap the charge to such an organization. In addition, a purely private sector organization might offer more entrepre- neurial agility than a hybrid group. Perhaps the biggest drawback of a public-private organization is the inherent instability of such an approach. Lacking a federal mandate and given the less-than-immediate contribution to the profitability of private sector participants concerned with CPR de- velopment, a public-private organization may not command sufficient resources and attention to address effectively the barriers to CPRs and CPR systems. Preferred Approach The committee recognizes that the federal sector has considerable re- sources (including authority and knowledge) to influence CPR develop- ment. For example, HCFA can establish reimbursement mechanisms that reward providers who submit insurance claims generated by CPR systems. AHCPR is expressly mandated to improve patient data for research. The VA and DoD have gained considerable experience in CPR development and implementation. NLM has made significant contributions to the manage- ment of medical knowledge for practitioners. Nevertheless, several factors militate against a purely federal approach. First, the resources, potential change agents, and stakeholders that must be coordinated or engaged in CPR development are present in both the public and private sectors. Thus, a structure is needed that can draw from both sectors. Second, the committee believes that routine use of the CPR can be achieved most efficiently through a collaborative process that develops con- sensus on key issues (e.g., data and security standards, the minimum con- tent of CPR systems) yet allows flexibility at the local level to foster inno- vation in the development and use of CPRs. Third, the committee believes that patient care should be the primary focus of CPR development and implementation. Practitioner use of CPR systems requires that the systems meet practitioner needs, and only if prac- titioners are willing to use CPR systems to capture data and to secure assis- tance in clinical decision making can the benefits of CPRs for moderating costs and conducting research be realized. It is essential that practitioners view the CPR as a valuable resource for improving patient care. Thus, CPR efforts must involve health care providers as well as federal agencies.

THE ROAD TO CPR IMPLEMENTATION 123 CPR design should not be driven solely by governmental objectives—for example, those embodied in the cost-containment and health outcomes re- search missions of HCFA and AHCPR, respectively. Although those agen- cies are likely to have significant interest in CPR development, their pri- mary mission is not patient care. The committee concluded that a public-private approach would be opti- mal in the long run and, as elaborated in Chapter 5, proposes the establish- ment of a Computer-based Patient Record Institute (CPRI). It was also of the view that the potential base of funding in the private sector is not sufficiently solid to provide adequate support for a new organization at this time. This judgment was founded on its review of the history of CPR development and on a poll of the participants at the workshop noted earlier. As a result, the committee also concluded that a federally initiated and funded approach would be most appropriate for necessary interim activities. Immediate action is needed to advance CPR efforts and to lay the ground- work for an organization such as the CPRI that would ultimately coordinate the necessary infrastructure for a national CPR system. Many of the barri- ers to CPR implementation relate to lack of information; part of the interim effort thus should focus on education and evaluation. Standards devel- opment and representation of the interests of health care in the national high-speed computer network discussed earlier should also be given high- priority attention. The overall goal of such efforts would be, within five years, to turn over operational issues to a public-private organization that is supported mainly by its members. The committee noted that if the private sector failed to support CPR efforts adequately, the federal government might still be sufficiently moti- vated to advance the CPR unilaterally. Long-term dominance by the federal government in this area could result in an approach that was more regula- tory and bureaucratic than collaborative and innovative. To preclude such an eventuality, the committee placed special importance on joint public and private sector progress. This approach is consistent with the recent General Accounting Office report on automated medical records (GAO, 1991), which made two recom- mendations to the secretary of Health and Human Services. First, as part of DHHS's mandate to conduct research on outcomes of health care ser- vices, the secretary should "direct the Public Health Service, through its Agency for Health Care Policy and Research, to support the exploration of ways in which automated medical records can be used to more effec- tively and efficiently provide data for outcomes research" (GAO, 1991:26). Second, as part of the effort to support outcomes research, the secretary should "develop a plan and budget for consideration by the Congress, to bring about the greater use of automated medical records" (GAO, 1991:26). Specific elements of such a plan could include "a national forum that

124 THE COMPUTER-BASED PATIENT RECORD sets goals for automating medical information, addresses individual and organizational concerns with automated records, and identifies incentives to induce health care organizations to increase their use of automation" (GAO, 1991:26). Specific Steps for Change Agents The challenges of developing affordable CPR systems that are acceptable to users and of achieving widespread use of such systems within a decade should not be underestimated or understated. Much of the progress toward these goals is likely to occur incrementally over time and across the coun- try. The CPRI can play an important role in tracking progress and directing future efforts, but significant contributions to CPR development and imple- mentation can and must be made by individuals and groups other than the CPRI. A great deal of work can be accomplished at the regional, local, and institutional levels in preparation for CPR implementation. • As discussed earlier in this chapter, health care professionals could support development and implementation by helping to plan and conduct research or demonstrations of CPR systems. Involvement of all kinds of CPR users is needed—especially practitioners as the primary source of data— to design systems that will meet their requirements. • Professional societies could implement formal education and awareness programs as part of their membership mailings and annual meetings. They could also support conferences at which CPR users could share experiences, report on useful experiments in various settings, and meet with other pro- fessional disciplines to discuss data and function needs. • Purchasers of CPR systems could actively seek systems that are able to meet basic data-exchange and security standards and offer sufficient capac- ity to evolve over time. • Insurers could offer incentives (e.g., faster payment of claims) for data that are provided in electronic form. • Health care business coalitions, chambers of commerce, and major em- ployers could all support CPR development and implementation efforts by supporting research and pilot demonstrations as well as by developing rela- tionships with insurers and health care provider institutions that use or support CPR systems. • Federal agencies could provide substantial funding for research and development and support standards development through funding or regula- tory mandate. • States could serve as candidates for pilot regional studies or experi- mental prototypes. • Health care accreditation organizations could foster CPR development,

THE ROAD TO CPR IMPLEMENTATION 125 acquisition, and use by setting standards for accreditation that are most effectively met through CPR systems. • In their training of health care professionals (including continuing edu- cation), professional schools could both shape attitudes toward and provide the skills for using CPRs. They could also foster the development of CPR systems to the extent that the agenda of researchers is influenced by the schools' provision of space and support. • Researchers could study the costs and benefits of CPR systems, at both micro and macro levels, including the impact of CPR systems on the quality and costs of care. • State agencies, hospital associations, and local professional groups could establish working groups to develop a common understanding and vision of how CPRs could support their health care environment and to identify the elements of local and regional infrastructure needed to support future CPRs. Working groups could study the relationships among referring physicians and among other providers to understand their entire system of health care. They could also define needed data elements, educate local health care professionals on health care information management issues, and monitor progress in the development of standards for security and data exchange. SUMMARY In addition to technological advances, successful implementation of CPR systems requires elimination of the barriers to development and diffusion. It also requires that the concerns of stakeholders be addressed and that potential change agents be engaged. Many impediments to the CPR arise from a lack of awareness and under- standing of CPRs and their capabilities. System purchasers and users lack adequate information about the benefits and costs of CPRs. In particular, developers and vendors require more specific information about what users want from systems and what price providers would be willing to pay for systems that meet their needs. Activities aimed at improving (e.g., demon- stration projects) and disseminating (e.g., education programs) available information about CPR systems constitute an important step for CPR imple- mentation. Other impediments arise from the lack of an infrastructure to support CPR development and diffusion. Such an infrastructure comprises stan- dards for communication of data (i.e., vocabulary control and data format standards); laws and regulations that protect patient privacy but do not inhibit transfer of information to legitimate users of data outside the clinical setting; experts trained in the development and use of CPR systems; institu- tional, local, regional, and national networks for transmitting CPR data; reimbursement mechanisms that pay for the costs of producing improved

726 THE COMPUTER-BASED PATIENT RECORD patient care information; and a management structure (i.e., an organization) for setting priorities, garnering and allocating resources, and coordinating activities. Removal of these impediments is essential to the timely develop- ment and implementation of CPR systems. REFERENCES Agranoff, M. H. 1989. Curb on technology: Liability for failure to protect comput- erized data against unauthorized access. Computer and High Technology Law Journal 5:263-320. Amatayakul, M., and M. J. Wogan. 1989. Fundamental considerations related to the Institute of Medicine Patient Record Project. Paper prepared for the Institute of Medicine Committee on Improving Patient Records in Response to Increasing Functional Requirements and Technological Advances. Anderson, J. G., and S. J. Jay. 1987. The diffusion of computer applications in medical settings. Pp. 3-7 in Use and Impact of Computers in Clinical Medicine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. Anderson, J. G., S. J. Jay, H. M. Schweer, M. A. Anderson, and D. Kassing. 1987. Physician communication networks and the adoption and utilization of computer applications in medicine. Pp. 185-199 in Use and Impact of Computers in Clini- cal Medicine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. Banta, H. D. 1987. Embracing or rejecting innovations: Clinical diffusion of health care technology. Pp. 132-160 in Use and Impact of Computers in Clinical Medi- cine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. Blendon, R. J. 1988. The public's view of the future of health care. Journal of the American Medical Association 250:3587-3593. Booz-Allen and Hamilton. 1990. Response to the Strategy and Implementation Sub- committee Report to the Institute of Medicine Committee on Improving the Pa- tient Record. Bethesda, Md. Bradbury, A. 1990. Computerized medical records: The need for a standard. Jour- nal of the American Medical Association 61:25-35. Brannigan, V. M., and R. E. Dayhoff. 1986. Medical informatics: The revolution in law, technology, and medicine. Journal of Legal Medicine 7:1-53. Bronzino, J. D., V. H. Smith, and M. L. Wade. 1990. Medical Technology and Society: An Interdisciplinary Perspective. New York: McGraw-Hill Publishing Company. Clepper, P. 1991. Communication to committee. National Library of Medicine, Bethesda, Md. Denis, S., and Y. Poullet. 1990. Questions of liability in the provision of informa- tion services. Online Review 14:21-32. Dowling, A. F. 1987. Do hospital staff interfere with computer system implementa- tion? Pp. 302-317 in Use and Impact of Computers in Clinical Medicine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. Food and Drug Administration. 1989. Draft Policy for the Regulation of Computer Products (photocopy). Washington, D.C. Gabrieli, E. R., and G. Murphy. 1990. Computerized medical records. Journal of the American Medical Association 61:26-31.

THE ROAD TO CPR IMPLEMENTATION 127 GAO (General Accounting Office). 1987. ADP Systems: Examinations of Non-fed- eral Hospital Information Systems. IMTEX-87-21. Washington, D.C. June. GAO. 1988. Use of Information Technology in Hospitals. Statement of Melroy D. Quasney, Associate Director, Information Management and Technology Divi- sion, before the Subcommittee on Education and Health, Joint Economic Committee. T-IMTEC-88-4. Washington, D.C. May 24. GAO. 1990. Defense's Acquisition of the Composite Health Care System. State- ment of Daniel C. White, Special Assistant to the Assistant Comptroller General, before the Subcommittee on Military Personnel and Compensation, Committee on Armed Services, U.S. House of Representatives. T-IMTEC-90-04. March 15. GAO. 1991. Medical ADP Systems: Automated Medical Records Hold Promise to Improve Patient Care. Washington, D.C. Gould, S. 1990a. CRS Issue Brief: Building the National Research and Education Network. Washington, D.C.: Library of Congress. Gould, S. 1990b. CRS Report for Congress: The Federal Research Internet and the National Research and Education Network. Prospects for the 1990s. Washing- ton, D.C.: Library of Congress. Hard, R. 1990. Computers help keep patient files confidential. Hospitals 179:49-50. Henley, R. R., and G. Wiederhold. 1975. An Analysis of Automated Ambulatory Care Medical Record Systems [AARMS]: Findings. AARMS Study Group, University of California, San Francisco. June. IOM (Institute of Medicine). 1990a. Clinical Practice Guidelines: Directions for a New Program, ed. M. J. Field and K. N. Lohr. Washington, D.C.: National Academy Press. IOM. 1990b. Medicare: A Strategy for Quality Assurance, vols. 1 and 2, ed. K. N. Lohr. Washington, D.C.: National Academy Press. Kaplan, B. 1987. The influence of medical values and practices on medical com- puter applications. Pp. 39-50 in Use and Impact of Computers in Clinical Medi- cine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. Koster, A., F. L. Waterstraat, and N. Sondak. 1987. Automated and ambulatory record systems: A comparative costs analysis. Journal of the American Medical Record Association 58:26-31. Krakauer, H. 1990. The uniform clinical data set. Pp. 120-133 in Effectiveness and Outcomes in Health Care, ed. K. A. Heithoff and K. N. Lohr. Washington, D.C.: National Academy Press. Lee, P. R., P. B. Ginsburg, L. R. LeRoy, and G. T. Hammons. 1989. The Physician Payment Review Commission report to Congress. Journal of the American Medical Association 261:2382-2388. Lindberg, D. A. B. 1970. A statewide medical information system. Computers and Biomedical Research 3:453-463. Lindberg, D. A. B. 1979. The development and diffusion of a medical technology: Medical information systems. Pp. 201-239 in Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology. Washington, D.C.: National Academy of Sciences. Lindberg, D. A. B., and B. L. Humphreys. 1990. The Unified Medical Language System and the Automated Patient Record. Paper prepared for the Institute of

128 THE COMPUTER-BASED PATIENT RECORD Medicine Committee on Improving Patient Records in Response to Increasing Functional Requirements and Technological Advances. Masys, D. R. 1990. Of codes and keywords: Standards for biomedical nomencla- ture. Academic Medicine 65:627-629. McDonald, C. J., and W. E. Hammond. 1989. Standard format for electronic transfer of clinical data. Annals of Internal Medicine 110:333-335. McDonald, C. J., and W. M. Tierney. 1988. Computer-stored medical records: Their future role in medical practice. Journal of the American Medical Association 259:3433-3440. Metzger, M. C. 1988. Legal implications of computer-aided medical diagnosis. Journal of Legal Medicine 9:313-328. NAS (National Academy of Sciences). 1979. Medical Technology and the Health Care System: A Study of the Diffusion of Equipment-Embodied Technology. Washington, D.C.: National Academy of Sciences. NAS. 1989. Information Technology and the Conduct of Research: The Users' View. Washington, D.C.: National Academy Press. National Association of Health Data Organizations (NAHDO). 1988. NAHDO Resource Manual. Washington, D.C. March. National Center for Health Statistics. 1990. The National Committee on Vital and Health Statistics, 1989. Hyattsville, Md. National Conference of Commissioners on Uniform State Laws. 1986. Uniform Health-Care Information Act. Chicago, 11l. National Science Foundation. 1990. Report on Selected Congressional Activities. 101st Cong., 2d sess. NSB-90-117. Washington, D.C.: Office of Legislative and Public Affairs. December. Norris, J. 1991. Communication to committee. Drug Utilization Review and Point of Sale Systems. Hill and Knowlton, Waltham, Mass. March. NRC (National Research Council). 1991. Computers at Risk: Safe Computing in the Information Age. Washington, D.C.: National Academy Press. OTA (Office of Technology Assessment). 1977. Policy Implications of Medical Infor- mation Systems. OTA-H-56. Washington, D.C.: U.S. Government Printing Office. Peck, R. S. 1984. Extending the constitutional right to privacy in the new techno- logical age. Hofstra Law Review 12:893-912. Privacy Protection Study Commission. 1977. Personal Privacy in an Information Society. Washington, D.C.: U.S. Government Printing Office. ProPAC (Prospective Payment Assessment Commission). 1990. Medicare Prospec- tive Payment and the American Health Care System: Report to Congress. Washingon, D.C. June. Rogers, E. M. 1987. Diffusion of innovations: An overview. Pp. 113-131 in Use and Impact of Computers in Clinical Medicine, ed. J. G. Anderson and S. G. Jay. New York: Springer-Verlag. Teach, R. L., and E. H. Shortliffe. 1981. An analysis of physician attitudes regard- ing computer-based clinical consultation systems. Computers and Biomedical Research 14:542-558. U.S. Congress. 1989. Congressional Record, vol. 135, no. 165, pt. 3. November 21. Washington Business Group on Health. 1989. Fostering Uniformity for Health Care Assessment Data Gathering. Washington, D.C.

THE ROAD TO CPR IMPLEMENTATION 129 Westin, A. F. 1976. Computers, Health Records and Citizen Rights. National Bureau of Standards Monograph 157. Washington, D.C.: U.S. Government Printing Of- fice. Willick, M. S. 1986. Professional malpractice and the unauthorized practice of pro- fessions: Some legal and ethical aspects of the use of computers as decision- aids. Rutgers Computer and Technology Law Journal 12:1-32. Young, D. W. 1987. What makes doctors use computers? Discussion paper. Pp. 8- 14 in Use and Impact of Computers in Clinical Medicine, ed. J. G. Anderson and S. J. Jay. New York: Springer-Verlag. APPENDIX: MATERNAL AND CHILD HEALTH CARE AND COMPUTER-BASED PATIENT RECORDS As discussed in Chapter 3, much of the progress to date in implementing CPRs and CPR systems has occurred in hospitals and large multispecialty practices, particularly in health maintenance organizations. To be successful, however, CPRs and the larger computer-based systems in which they function must be useful and practical for many other types of providers, including, for instance, community-based clinics and other outpatient facilities serving either primary care or special health care needs. In this category might fall services to disadvantaged populations such as those eligible for maternal and child health care through Title V of the Social Security Act. The area of maternal and child health (MCH), both generally and as administered by the Health Resources and Services Administration (HRSA) in support of the Title V mandate, poses particularly interesting challenges and opportunities for CPRs and CPR systems. Five topics are briefly dis- cussed here as examples. First, the challenges involve, among other matters, the capability to track populations that typically do not have regular providers of care; that move in and out of eligibility for the services; that move in and out of geographic areas (e.g., states, underserved regions) where the services are provided; and that are in many ways socially, economically, and demographically disadvan- taged. In such circumstances, ease of data entry, storage, and transmission of clinical and sociodemographic information takes on special importance. CPRs can maximize these attributes, especially in comparison to traditional paper records that are often institution-specific, fragmented, illegible, and lacking in information related to social support, health education, and similar nonclinical issues. Another important factor in reaching these populations is coordination of care across many different sites. Computer-based systems will facilitate timely, accurate movement of necessary information and collaboration among those delivering both clinical and social services. Second, MCH programs are expected to reach out to obstetricians, gyne- cologists, and pediatricians throughout the states, to develop integrated

130 THE COMPUTER-BASED PATIENT RECORD MCH service delivery programs, to improve home visit programs (including those concerned with case management), to collaborate with inpatient insti- tutions delivering care to children with special health care needs, and to improve services to rural populations. CPR systems should make it easier to achieve these objectives by making clinical and sociodemographic data more readily available even in relatively nontraditional settings. Certainly the expectation of CPR developers and innovators is that their technologies, when broadly implemented, will offer capabilities far beyond what can be achieved with today's paper medical charts, particularly in terms of longi- tudinal records in which, for instance, information about immunizations and screening services must be maintained over a considerable period of time. A third major challenge facing HRSA and its MCH bureau is the re- quired implementation of relatively recent mandates of Title V that call for development and maintenance of a data and information system. Part of this system presumably would involve the acquisition of pertinent epide- miological data that can be used by the bureau and others to improve and promote health and prevent disease among mothers, infants, children, and others eligible for MCH block grant services. To the extent that CPRs and CPR systems allow institutional providers and practitioners (e.g., physi- cians, visiting nurses, clinic staff) to enter data once (and only once) for both clinical and administrative purposes, they will considerably simplify the reporting requirements of these programs. Moreover, the expectation is that CPR systems ultimately will communicate with each other with the aid of a composite clinical data dictionary (CCDD); this means that states, and the providers and clinicians who operate in them, will not need to conform rigidly to a single federal data system in meeting HRSA's report- ing requirements (because the federal system itself would be a party to the CCDD). A fourth way in which the movement toward CPRs and CPR systems may be important for MCH activities concerns the support of research. As a general proposition, researchers are more accustomed to the use of com- puters for data gathering and analysis than are clinicians, so movement toward the implementation of such systems presumably would be regarded as welcome progress by those involved in MCH research. Indeed, one specific aim of research grants in this area is to use automated systems to facilitate the management and delivery of health care for target populations. One special aspect of the research effort involves infant mortality and Medicaid (Title XIX) services. The secretary of Health and Human Services is expected to develop a national data system for linking vital statistics (birth and death) records with information on Medicaid insurance claims forms. This task clearly lies within the realm of CPR development. In a related vein, special projects may be mounted to enhance family- centered and community-based health care, both within and across states.

THE ROAD TO CPR IMPLEMENTATION 131 These projects could benefit greatly from a capacity to acquire large amounts of information, locate those data securely in a single site (for analysis and archival purposes), and make them available to properly authorized users for analysis (and perhaps for clinical purposes as well). The collection, storage, maintenance, and use of such information through computer-based systems, rather than through paper records (or paper records secondarily data-entered into computer files), can be expected over the long run to promote more comprehensive and more productive special projects on this and other complex topics (e.g., services to children with serious impair- ments and handicaps such as spina bifida, debilitating chronic illnesses, or cleft lip and palate). The fifth point relates more specifically to the potential value of commu- nication and collaboration across federal agencies. Several federal depart- ments have already taken steps to design and implement one or more com- ponents of a CPR system. Notable among these are the Departments of Defense (DoD) and Veterans Affairs (VA). Both departments have health care delivery responsibilities for distinct, and sometimes quite dispersed, populations that have both traditional primary care needs (e.g., for screen- ing and prevention) and health care problems at least equivalent in com- plexity and severity to those facing disadvantaged MCH populations. Both departments also have considerable health research programs. Lessons from their efforts to date may prove helpful in planning computer-based systems to serve MCH needs; conversely, issues that arise in planning for and delivering services to disadvantaged MCH populations might be posed to DoD and the VA as a means of bringing difficult technical questions to their attention. In addition, the Health Care Financing Administration (HCFA) has mounted an interesting effort to develop a "uniform clinical data set"; although it is oriented toward hospital care (and care for the elderly), its development- al history to date offers useful and perhaps cautionary lessons for others attempting to develop clinical data sets and data dictionaries. Certainly it would be important for HCFA developers to understand the special needs and perspectives of a computer-based data set oriented more toward Medicaid than toward Medicare. Finally, the Agency for Health Care Policy and Research (AHCPR) has a specific congressional mandate to work toward the development of com- puter databases that will serve broad clinical evaluation purposes. Part of AHCPR's interest has been specifically in computer-based record systems, including the potential for a public, or public-private, entity to undertake many technical, legal, and other tasks related to the establishment of CPRs and CPR systems nationally over the next decade. Because the MCH com- ponent of HRSA will have wide concerns about quality of care, outcomes of care, and similar issues, it would seem prudent for HRSA to work together from the outset with a sister Public Health Service agency on many of these subjects.

Improving Patient Records: Conclusions and Recommendations Computer-based patient records and the systems in which they function are becoming an essential technology for health care in part because the information management challenges faced by health care professionals are increasing daily. Technological progress makes it possible for CPRs and CPR systems to provide total, cost-effective access to more complete, accu- rate patient care data and to offer improved performance and enhanced functions that can be used to meet those information management chal- lenges. CPRs can play an important role in improving the quality of patient care and strengthening the scientific basis of clinical practice; they can also contribute to the management and moderation of health care costs. The Institute of Medicine (TOM) study committee believes that the time is right for a major initiative to make CPRs a standard technology in health care within a decade. Achieving this goal within 10 years will require a nationwide effort and a great deal of work. More research and development are needed in several critical areas to ensure that systems meet the needs of patients, practitioners, administrators, third-party payers, researchers, and policymakers. For example, the need to protect patient privacy must be balanced by the need for timely access to data at multiple sites. Systems must offer both considerable flexibility for users and standards required for data transfer and exchange. CPR implementation will necessitate both organizational and behavioral changes. Organizationally, it will require substantial coordination across the many elements of the pluralistic U.S. health care system. Behaviorally, it will demand that users develop new skills to use CPR systems and to change their documentation behaviors. 732

CONCLUSIONS AND RECOMMENDATIONS 133 BOX 5-1 SUMMARY OF THE RECOMMENDATIONS OF THE INSTITUTE OF MEDICINE COMMITTEE ON IMPROVING THE PATIENT RECORD The committee recommends the following: 1. Health care professionals and organizations should adopt the computer- based patient record (CPR) as the standard for medical and all other records related to patient care. 2. To accomplish Recommendation 1, the public and private sec- tors should join in establishing a Computer-based Patient Record In- stitute (CPRI) to promote and facilitate development, implementation, and dissemination of the CPR. 3. Both the public and private sectors should expand support for the CPR and CPR system implementation through research, development, and demonstration projects. Specifically, the committee recommends that Congress authorize and appropriate funds to implement the re- search and development agenda outlined herein. The committee fur- ther recommends that private foundations and vendors fund programs that support and facilitate this research and development agenda. 4. The CPRI should promulgate uniform national standards for data and security to facilitate implementation of the CPR and its secondary databases. 5. The CPRI should review federal and state laws and regulations for the purpose of proposing and promulgating model legislation and regulations to facilitate the implementation and dissemination of the CPR and its secondary databases and to streamline the CPR and CPR systems. 6. The costs of CPR systems should be shared by those who benefit from the value of the CPR. Specifically, the full costs of implement- ing and operating CPRs and CPR systems should be factored into reimbursement levels or payment schedules of both public and pri- vate sector third-party payers. In addition, users of secondary data- bases should support the costs of creating such databases. 7. Health care professional schools and organizations should en- hance educational programs for students and practitioners in the use of computers, CPRs, and CPR systems for patient care, education, and research. This chapter summarizes the committee's principal conclusions and pre- sents recommendations for improving patient records (see Box 5-1). These recommendations, to which committee members gave unanimous approval, outline a course to facilitate the transition of health care away from the current paper patient record and toward routine use of the CPR and its

134 THE COMPUTER-BASED PATIENT RECORD supporting CPR system. Specifically, the committee's recommendations recognize the CPR as the standard patient record of the future, provide an organizational framework for overcoming barriers to CPR development and implementation, and identify steps that will advance the use of CPRs and CPR systems. CONCLUSIONS Patient records are the primary repository of data in the information- intensive health care industry. Although clinical information is increas- ingly likely to be computerized, the current, predominant mode for record- ing patient care data remains the paper record. Paper records have the advantages of being familiar to users and portable; when they are not too large, users can readily browse through them. Paper records, however, have serious, overriding limitations that frequently frustrate users and perpetuate inefficiencies in the health care system. Further, the impact of these limita- tions is growing as the health care system becomes more complex. Modern patient care requirements have outgrown the paper record. Quality improvement and cost containment continue to be major con- cerns for the health care industry. Quality assurance; utilization management; appropriateness, effectiveness, and outcomes assessment; clinical practice guidelines; and value purchasing are all prominent responses to the quality or cost challenges faced by present-day health care. Each of these initia- tives increases the legitimate demand for complete, accurate, readily acces- sible patient data. Health care professionals today face an unprecedented information ex- plosion as the quantity and complexity of patient data and medical knowl- edge increase practically daily. Current patient records cannot adequately manage all the information needed for patient care. Paper patient records have not kept and cannot keep pace with the rapidly changing health care system. As a result, they increasingly impede effective decision making throughout the health care sector—from the bedside to the formulation of national health care policy. Some health care institutions are already applying computer technol- ogies to this information management challenge. In general, however, the diffusion of information management technologies has been slower in health care than in other information-intensive industries. Moreover, the majority of information management applications in the health care sector have fo- cused on financial and administrative rather than clinical data. In its study, the committee reviewed the needs of patient record users, as well as existing and emerging computer technologies. It concluded that better CPR systems—systems that meet user needs more fully—can be achieved within 10 years. Nevertheless, the committee cautions that merely automat-

CONCLUSIONS AND RECOMMENDATIONS 135 ing current patient records will perpetuate their deficiencies and will not be sufficient to satisfy emerging user demands. If future patient records are to be an asset in patient care, they must offer broader functions than those provided by the record systems of today. The future patient record will be a computer-based, multimedia record capable of including free text, high-resolution images, sound (e.g., ausculta- tions), full-motion video, and elaborate coding schemes. CPR systems will offer access (availability, convenience, speed, reliability, and ease of use), quality, security, flexibility, connectivity, and efficiency. In addition, fu- ture patient records will provide new functions through links to other data- bases and decision support tools. No contemporary clinical information systems are sufficiently compre- hensive to be considered full CPR systems. Several existing systems, how- ever, offer prototypes of components of CPR systems. The committee considers nine technological capabilities to be essential to CPR systems: (1) databases and database management systems, (2) work- stations, (3) data acquisition and retrieval, (4) text processing, (5) image processing and storage, (6) data-exchange and vocabulary standards, (7) system communications and network infrastructure, (8) system reliability and security, and (9) linkages to secondary databases. No new technological breakthroughs are needed to develop robust CPR systems, but some emerging technologies are crucial. Low-cost yet power- ful clinical workstations and improved human interface technologies are needed. Voice-recognition systems, high-capacity networks (e.g., fiber- optic), and open-architecture systems will be required to achieve broad adoption of CPR systems. Emerging clipboard-sized computers that accept input through a hand-held stylus may also prove to be a critical development. In addition, CPR diffusion requires development of standards for health care data and greater emphasis on protecting the integrity and confidentiality of CPR data. Technology is not the only potentially limiting factor in advancing CPR systems; informational, organizational, and behavioral barriers must also be addressed. Barriers to CPR development include development costs and lack of consensus on CPR content. CPR diffusion is adversely affected by the disaggregated health care environment, the complex characteristics of CPR technology, unpredictable user behavior, the high costs of acquiring CPR systems, a lack of adequate networks for transmitting data, a lack of leadership for resolving CPR issues, a lack of training for CPR developers and users, and a variety of legal and social issues. The committee developed a plan for advancing the development and implementation of CPRs and CPR systems that identifies a broad group of stakeholders who would be affected (both positively and negatively) by CPR system implementation. It also identifies a group of organizations

756 THE COMPUTER-BASED PATIENT RECORD that, in the committee's view, could contribute significantly to such devel- opment and implementation. Finally, the plan identifies a series of activi- ties that would advance CPR efforts. Carrying out these activities will require adequate funding and effective organization. The committee reviewed organizational structures that could be used to provide the necessary framework for coordinating CPR activi- ties. It concluded that no existing organization has the mandate and re- sources necessary to lead this effort. Thus, the committee believes that a new organization is needed to support CPR development and implementa- tion. The committee proposes a framework for the establishment of such an organization, but it also emphasizes that securing adequate resources for and engaging the appropriate parties in CPR development efforts are more important than the precise structure of the recommended organiza- tion. RECOMMENDATIONS RECOMMENDATION 1. The committee recommends that health care professionals and organizations adopt the computer-based patient record (CPR) as the standard for medical and all other records related to patient care. The committee believes that future patient records must be more than a way to store patient data—they must also support the clinical decision pro- cess and help improve the quality of patient care. Achieving widespread use of CPRs is a major component of building a national health care infor- mation system that can support the provision of integrated health care ser- vices across settings and providers of care. Further, widespread use of CPRs would contribute to the collection of patient care data as a national health care resource. Achieving these objectives requires that CPRs be more than automated paper records. The committee defined the CPR as an electronic patient record (i.e., a repository of health care information about a single patient) that resides in a system specifically designed to support users through availability of com- plete and accurate data, alerts, reminders, clinical decision support systems, links to medical knowledge, and other aids. Further, the committee identi- fied 12 attributes that comprehensive CPRs and CPR systems possess. 1. The CPR contains a problem list that clearly delineates the patient's clinical problems and the current status of each (e.g., the primary illness is worsening, stable, or improving). 2. The CPR encourages and supports the systematic measurement and recording of the patient's health status and functional level to promote more precise and routine assessment of the outcomes of patient care.

CONCLUSIONS AND RECOMMENDATIONS 137 3. The CPR states the logical basis for all diagnoses or conclusions as a means of documenting the clinical rationale for decisions about the manage- ment of the patient's care. (This documentation should enhance use of a scientific approach in clinical practice and assist the evolution of a firmer foundation for clinical knowledge.) 4. The CPR can be linked with other clinical records of a patient—from various settings and time periods—to provide a longitudinal (i.e., lifelong) record of events that may have influenced a person's health. 5. The CPR system addresses patient data confidentiality comprehen- sively—in particular, ensuring that the CPR is accessible only to authorized individuals. (Although absolute confidentiality cannot be guaranteed in any system, every possible practical and cost-effective measure should be taken to secure CPRs and CPR systems from unauthorized access or abuse.) 6. The CPR is accessible for use in a timely way at any and all times by authorized individuals involved in direct patient care. Simultaneous and remote access to the CPR is possible. 7. The CPR system allows selective retrieval and formatting of informa- tion by users. It can present custom-tailored "views" of the same information. 8. The CPR system can be linked to both local and remote knowledge, literature, bibliographic, or administrative databases and systems (including those containing clinical practice guidelines or clinical decision support capabilities) so that such information is readily available to assist practitio- ners in decision making. 9. The CPR can assist and, in some instances, guide the process of clinical problem solving by providing clinicians with decision analysis tools, clinical reminders, prognostic risk assessment, and other clinical aids. 10. The CPR supports structured data collection and stores information using a defined vocabulary. It adequately supports direct data entry by practitioners. 11. The CPR can help individual practitioners and health care provider institutions manage and evaluate the quality and costs of care. 12. The CPR is sufficiently flexible and expandable to support not only today's basic information needs but also the evolving needs of each clinical specialty and subspecialty. The committee believes that the CPR can be well established within a decade in the majority of offices of physicians, dentists, and other health care professionals and in clinics, hospitals, and multifacility provider insti- tutions. Achieving such widespread use in only 10 years is an ambitious goal, but it can be accomplished if two conditions are met. First, a concen- trated effort—with appropriate leadership, resources, coordination, and in- centives—must be mounted. Second, CPR systems must be affordable and at least minimally acceptable to users.

138 THE COMPUTER-BASED PATIENT RECORD The committee considers it essential to maintain and exploit the interest in CPRs that has been building over the past several years. A less aggres- sive target (e.g., 20 years) for implementation of CPRs as standard patient records could result in a loss of momentum. In contrast, a well-coordinated effort could help to accelerate progress and secure CPR implementation within the 10-year target set by the committee. The committee's remaining recommendations outline how such a concentrated effort might be orga- nized and identify specific strategies for addressing CPR system affordability and acceptability to users. RECOMMENDATION 2. To accomplish Recommendation 1, the com- mittee recommends that the public and private sectors join in establish- ing a Computer-based Patient Record Institute (CPRI) to promote and facilitate development, implementation, and dissemination of the CPR. The committee identified a series of activities to facilitate CPR develop- ment and implementation: (1) identification and understanding of CPR design requirements; (2) standards development; (3) research and develop- ment of CPRs and CPR systems (including networking infrastructure); (4) demonstrations of effectiveness, costs, and benefits of CPR systems; (5) review of legal constraints and needed legal protection; (6) coordination of information and resources for CPR development and diffusion; (7) co- ordination of information and resources for databases of secondary re- cords; and (8) education and training of developers and users. Some of these activities are already under way, but they are fragmented and hampered by inadequate resources and coordination. The committee believes that securing adequate resources and managing them effectively are essential to development and widespread implementation of CPR sys- tems. To facilitate these tasks, some portion of the research devoted to CPRs should focus on the value of CPR systems. These efforts could provide potential funders of future research and development and purchas- ers of systems with credible evidence on which to base CPR investment decisions. Both funding and evaluation expertise from the public and pri- vate sectors should be channeled into a coordinated effort to amass this evidence. In addition, priorities should be established so that resources can be directed toward activities that promise the greatest contribution to devel- opment of CPRs and CPR systems. Many organizations and individuals could play a role in advancing CPRs and CPR systems, but these actors are dispersed throughout the health care field and have different kinds and levels of interest in CPR development. There is no one focal point for CPR efforts and no spokesperson or organi- zation to speak for CPR interests. Further, the nation at present has no means of developing consensus on CPR-related issues or of setting priori- ties among alternative uses of CPR development resources.

CONCLUSIONS AND RECOMMENDATIONS 139 No existing organization has the mandate or resources for ongoing coor- dination of CPR resources and activities. Consequently, the committee recommends either the creation of a new organization or the extension of an existing organization's charter to achieve such coordination. For the pur- poses of this report, the committee has called this new or expanded compo- nent of an existing organization the Computer-based Patient Record Insti- tute (CPRI).1 The CPRI has a four-part mission: • Support the effective, efficient use of computer-based patient informa- tion in patient care, health care policymaking, clinical research, health care financing, and continuous quality improvement. • Educate change agents and stakeholders (including the general public and health care professionals) about the value of computer-based patient records in improving patient care. • Foster the CPR as the primary vehicle for collecting patient data. • Promote the development and use of standards for CPR security and data content, structures, and vocabulary. The CPRI should take several specific steps to achieve this mission: • Establish a forum for CPR users and developers to address such issues as definition of CPR functions and content. • Facilitate data and security standards setting and endorse such stan- dards. • Promote CPR data transmission through national high-speed networks by representing the biomedical community in planning for such networks. • Address legal issues related to CPRs and CPR systems. • Develop mechanisms for sharing the costs of acquiring and operating CPR systems among all users of CPR data. • Define priorities and criteria for CPR demonstration projects that could be used by federal agencies, private foundations, and health care provider institutions. • Conduct workshops and conferences to educate health care profession- als and policymakers. • Explore the need for a clearinghouse for secondary CPR information. One of the first tasks of the CPRI should be to develop a detailed plan for achieving CPRs in terms of incremental steps that can be completed by the many individuals and organizations interested in CPR development. Such 1The name Computer-based Patient Record Institute is descriptive and not intended to limit the concept of the organization or its potential responsibility for related infrastructural issues (such as a national biomedical communications network).

140 THE COMPUTER-BASED PATIENT RECORD a plan would establish priorities for CPR development within and among activities (e.g., define where data standards are most needed or where they could be applied most quickly). By defining and coordinating the roles of key change agents, the CPR can help focus attention on the most important tasks and avoid redundancy of effort. Moreover, by tracking and reporting concrete progress toward CPR development, the CPRI can help maintain and perhaps continue to increase interest in and resources for CPR develop- ment. It is essential that the CPRI and all organizations and individuals associated with CPR development build on existing efforts. For example, CPRI can work with the Agency for Health Care Policy and Research (AHCPR) to identify needed progress for existing databases so that secondary user needs can be better met during the transition to CPRs. The committee, for several reasons, concluded that in the long run an independent public-private organization would be the optimal structure for the CPRI. No one federal agency would have the prestige, funding, or per- sonnel to pursue a complete CPR agenda successfully; in addition, suspicion or skepticism on the part of the private sector (both the business and the health care communities) regarding a purely governmental effort would be difficult to overcome. The committee emphasizes that if the CPRI is to be successful, it must represent all patient record users, particularly practitioners. A purely private sector effort also has little likelihood of success: past history shows that private sector CPR development has been fragmented, unique to particular institutions, and generally underfunded. Indeed, the base of funding in the private sector is not sufficiently solid to support a new organization at this time. In addition, it is unlikely that private sector activities can overcome intentional and unintentional governmental barriers, such as the myriad state laws and regulations that hamper progress in this area. Furthermore, certain government agencies (notably the Departments of Defense and Veterans Affairs) have made more progress in this area than the private sector, and that work should be incorporated into any national effort. Ultimately, the committee concluded that a federally initiated and funded approach would be most appropriate for inaugurating the necessary activi- ties. The goal of such an interim effort would be to turn over, within five years, CPR coordination efforts to a public-private organization supported by its members. The committee thus recommends a two-phase strategy for the establishment of the CPRI. In the first phase, the secretary of the Department of Health and Human Services should establish an office or program to organize specific activities aimed at reducing the barriers to computer-based patient record development. In the second phase, the CPRI should be established as a public-private organization dedicated to coordi- nating the many activities needed to facilitate widespread use of the CPR. The main goals of the initial federal program should be to respond to immediate needs to advance CPR efforts and to lay the groundwork for the

CONCLUSIONS AND RECOMMENDATIONS 141 CPRI. In particular, because many of the barriers to implementation relate to lack of information, the interim effort should emphasize education and evaluation of the value of CPR systems. This effort should also focus on coordinating standards development and representing the health care field's interests in the emerging national high-speed computer network. Ideally, the interim office should be run by a small professional staff headed by a recognized expert in CPR development. An advisory board with representation from both the private and public sectors should also be established. Program staff would support standards activities, conduct edu- cational programs, serve as liaisons to professional organizations and com- missions, represent the health care community in National Science Founda- tion network discussions, advise AHCPR and other extramural funders of research and demonstration projects, and plan for the second phase of CPR development and implementation. This program should be funded initially by the DHHS agencies that have a fundamental interest in patient data; these include AHCPR and other Pub- lic Health Service agencies such as the Food and Drug Administration (FDA), the Centers for Disease Control (CDC), the Health Resources and Services Administration (HRSA), and the Health Care Financing Administration (HCFA). Approximately $2 million to $5 million per year would be re- quired for the first two years; more substantial funding would be needed for the next three years. The program should be closely aligned with AHCPR, but consideration should be given to contracting with a private sector or- ganization to run the program. (Private sector management would allow greater flexibility and facilitate the eventual anticipated transition to a public-private entity.) The committee urges that the private sector actively support immediate CPR activities through participation and funding (e.g., of demonstration projects) and that it be prepared to support the CPRI financially within five years. Failure of the private sector to support CPR efforts adequately could result in federal government control or dominance of CPR develop- ment and implementation efforts. RECOMMENDATION 3. Both the public and private sectors should expand support for the CPR and CPR system implementation through research, development, and demonstration projects. Specifically, the com- mittee recommends that Congress authorize and appropriate funds to implement the research and development agenda outlined below. The committee further recommends that private foundations and vendors fund programs to support and facilitate this research and development agenda. Over the past several decades, impressive technological innovations in computer-based information storage, retrieval, and communication have al- lowed U.S. industry and research organizations to revolutionize the man-

142 THE COMPUTER-BASED PATIENT RECORD agement of information throughout society. Yet in terms of the rapidly expanding information needs of health care, the public and private sectors have mounted only relatively limited, fragmented efforts to take advantage of these technological innovations. Most computer systems in the health care sector have evolved either from automated systems in single departments (such as the laboratory or pharmacy) or from administrative systems that support patient registration, scheduling, or financial needs. Although such systems must share data with a CPR, they cannot be used as the beginning point for its development. Major tasks in system design, computer program- ming, and technical integration must be completed before current technology can be exploited to speed development of the CPR. In addition, much must be learned about how the CPR can be integrated and effectively used by different health care professionals and organizations to meet their needs. The committee strongly urges that a major research and development (R&D) effort be supported and that several demonstration prototypes of the CPR be developed, implemented, and evaluated in a variety of health care environments. Specifically, major long-term financial and organizational support for R&D and for prototype demonstration projects in implementing the CPR is greatly needed in at least six major areas: (1) data acquisition, (2) data and security standards, (3) networking support, (4) cost-benefit analysis of CPR systems, (5) CPR and quality assurance, and (6) structure and format of the patient record. Data Acquisition The single greatest challenge in implementing the CPR is to develop a technology that is sufficiently powerful and appropriate to the needs and preferences of health care professionals so that they can—and will—enter medical and other health care data directly into the computer. Significant new technologies (e.g., graphical user interface, voice-recognition technol- ogy, high-resolution computer displays, high-speed communication net- works, and hand-held data-entry devices) can now support data entry by practitioners. These technologies hold great promise for CPR systems that will be acceptable for direct professional use. Much work, however, re- mains to be done to translate the potential benefits of these technologies into functioning CPR systems. Data and Security Standards Data Standards Three kinds of standards apply to health data: content, data-exchange, and vocabulary. Nationally accepted standards for CPR data are of prime

CONCLUSIONS AND RECOMMENDATIONS 143 importance to the CPR: they are necessary for transmitting complete or partial patient records, and they are essential to the aggregation of informa- tion from many sources, either for longitudinal records of individual pa- tients or for databases of secondary records to be used for research or epidemiological purposes. Significant efforts are under way to support standards development for CPR data dictionaries, uniform coding, vocabu- lary, and data formatting. More needs to be accomplished, however, before the CPR can be shared across institutions or even by different clinical infor- mation systems within institutions. CONTENT STANDARDS Two main kinds of standards must be developed for the content of CPRs. The first requirement is a minimum data set that applies to all CPRs; the second is content standards for specific kinds of CPR records (e.g., hospital, dentist office). The lack of either of these kinds of standards will impede effective use of CPR data by clinical and nonclinical users because record content will continue to vary among prac- titioners and provider institutions. A further requirement is to establish a specific meaning for data elements; that is, data elements should be used to collect the same piece of information in all record systems. Efforts by various federal agencies (e.g., HCFA, DoD, VA) and health data standards groups to develop clinical data dictionaries should be coordinated to ensure a reasonable level of consistency and compatibility. The committee sug- gests that the CPRI foster efforts to establish a composite clinical data dictionary that would enable users to translate data from different systems to equivalent meanings. DATA-EXCHANGE STANDARDS It is likely that patient record data will con- tinue to be diverse because they are produced using a variety of technolo- gies from different vendors and by a complex mix of institutions, service bureaus, reimbursement agencies, and government agencies. A major prior- ity should be to develop and promote standards for data representation and data exchange. Without such standards, it will be impossible to support the necessary exchange of patient medical, financial, and administrative infor- mation among the different interested organizations and institutions. In 1991, no nationally or internationally recognized format standard ex- ists for transferring a complete patient record between disparate clinical information systems. At present, only one health data format standard (Medix, from the Institute of Electronic and Electrical Engineers) even has the ob- jective of transferring the entire patient record, and it is not yet operational. Therefore, the CPRI should coordinate efforts to develop, test, and demon- strate a health data format standard capable of transmitting all or any por- tion of the CPR between different clinical systems. The committee urges that special care be taken to include input from and coordination with inter-

144 THE COMPUTER-BASED PATIENT RECORD national standards efforts (especially those in Europe) to ensure that the format standard complies with the International Standards Organization's Open Systems Interconnect. CLINICAL VOCABULARY STANDARDS Effective retrieval and use of health care information in the CPR depend in large part on the consistency with which a CPR content names and describes clinical findings, clinical prob- lems, procedures, and treatments. The development and widespread dis- semination of the content and techniques of effective vocabulary control of high-priority data elements are major intellectual, technical, and organiza- tional challenges. Standardized vocabulary efforts such as the Unified Medical Language System (UMLS) of the National Library of Medicine (NLM) are needed to establish a common vocabulary base for clinical systems. The committee believes that funding for development of standards for clinical vocabulary systems should be expanded and, because of the technical difficulties in- volved, sustained for at least a decade. The committee urges that the NLM be granted increased funding over the same period to refine the UMLS further, particularly the vocabulary involved in patient care and access to clinical knowledge bases. The NLM is the appropriate organization to educate the health care community concerning UMLS and other clinical vocabulary activities, and it is well positioned to do so effectively. The CPRI could work closely with the NLM to ensure efficient, nonredundant efforts in this area. Security Standards PATIENT DATA CONFIDENTIALITY Among the highest priorities in the com- ing decade will be the enhancement and application of methods to ensure the privacy and confidentiality of patient data in the CPR. Much of the technology to make the CPR more secure already exists, but for greatest effectiveness these technologies must be better deployed or embedded in CPR systems. Today, no standards define the limits and scope of privacy and confiden- tiality for sensitive data in clinical information or CPR systems. Thus, the committee suggests that the CPRI coordinate development of such stan- dards for health care, which will include minimal procedures with which systems must comply to ensure privacy and confidentiality in CPR systems. The institute should also address similar issues for computer systems con- taining secondary records (derived from data in the CPR) and establish standards for these systems as well. In particular, standards are needed to address the limits and procedures for removing (or scrambling) patient and provider identifiers in secondary records.

CONCLUSIONS AND RECOMMENDATIONS 145 DATA AND SYSTEM SECURITY Standards are needed to ensure the integrity of the data in CPR systems. The committee suggests that the CPRI actively participate in developing such standards and that it coordinate and cooper- ate with the FDA and the Information Security Foundation proposed in the National Research Council's 1991 report, Computers at Risk: Safe Comput- ing in the Information Age (published by the National Academy Press). Considerable attention was focused in the late 1980s on broad security measures for computer systems; now, the special requirements of the CPR need to be articulated and infused into the deliberations about these evolv- ing industry standards. The committee therefore recommends that the CPRI coordinate efforts with organizations that are already active in establish- ing standards for secure systems and for the transmission of sensitive data over standard communications networks. Networking Support The information-intensive nature of health care mandates a strong em- phasis on communication and transmission of information to many different organizations in diverse places. Electronic mail, file transfer, and image communication will become increasingly important support services, not only within a given hospital or health care institution but also across cities and states, and nationwide. Strong federal support will be critical for pro- viding networking opportunities for health care information transfer at all organizational levels. Current federal initiatives to develop high-performance national com- puter networks largely address the key relevant issues (enhanced transmis- sion speeds, logistics of routing, standards for connectivity, and transmis- sion protocols). The overall focus to date, however, has been on communications support for the research community; recognition of the role of such net- works in supporting the clinical enterprise in general and the CPR in par- ticular has been limited. To remedy this inadequacy, the CPRI should become an active participant in discussions by the Federal Networking Coun- cil regarding the National Research and Education Network. Cost-Benefit Analysis In view of the substantial direct costs of CPR development and imple- mentation, issues of cost-effectiveness are important from both institutional and societal perspectives. It is not reasonable to imagine wholesale invest- ment in and development of CPRs and CPR systems without some reliable sense of what will be gained, and at what cost. Given study time and staffing constraints, the committee did not systematically inquire into evi- dence regarding the cost-effectiveness of CPRs or conduct a cost-benefit

146 THE COMPUTER-BASED PATIENT RECORD analysis. Nevertheless, it recognizes the significance of economic consider- ations and, as is appropriate for any new medical technology, calls ex- pressly for an examination of the cost-effectiveness of various features of the CPR before any widespread deployment occurs. Major questions remain regarding the costs and benefits of the as yet incomplete and untried technology of a comprehensive CPR and CPR sys- tem. Accurate estimates have been extremely difficult to obtain because only incremental parts of the CPR system have been operational at any one time. To obtain a more accurate picture of costs and benefits will require major R&D efforts—for instance, extensive modeling and simula- tion projects or community-based demonstrations that could later be gen- eralized beyond the community sites. An especially important step will be for investigators to develop sound models of total costs and benefits because it is likely that the CPR will range into areas of function and value far beyond those of current patient records. These R&D projects should address at least three issues related to the benefits of CPRs and CPR systems. First, the nature and magnitude of benefits to individual patients, practitioners, provider institutions, and soci- ety generally should be evaluated. Second, short-term versus long-term ben- efits must be examined. Third, monetary and nonmonetary benefits should be estimated and compared. In addition, a methodological issue must be addressed because researchers are unlikely to be able to determine benefits in dollar terms with any precision. Thus, sophisticated approaches for char- acterizing benefits must be employed, such as is done for complex technol- ogy assessments. R&D efforts must also address at least two issues concerning the costs of CPRs and CPR systems. First are the costs of acquisition, implementation, and operation; included in these should be the costs of the R&D itself. Second, short- and long-term costs must be appropriately identified. Cost determinations will depend on calculation of direct costs, indirect costs, and amortization of capitalized equipment. Quality Assurance The CPR can and should become a resource (with a capability far beyond that of paper patient records) for the systematic evaluation of health care practices and policies. The committee was unanimous in its view that, at least on a trial basis, linking CPR information with health status assessment provides an unprecedented opportunity to study the effectiveness and out- comes of health care procedures. Similarly, the CPR offers a vehicle for dissemination of clinical practice guidelines. Both individual practitioners and health care provider institutions can use the CPR for their own purposes in evaluating and comparing patterns and

CONCLUSIONS AND RECOMMENDATIONS 147 outcomes of care, and they can do so more efficiently than with a paper- based patient record system. In addition, those organizations whose respon- sibilities include the accreditation, regulation, and improvement of health care can, with appropriate safeguards, accumulate and analyze the data they need using the CPR rather than the paper record. Quality of care has taken on greater salience in recent years, and public and private programs of quality assurance and continuous quality improve- ment have multiplied. Many of these rely (or intend to rely) on information residing in computer databases, including administrative or insurance claims files. At present, these kinds of databases are rather primitive foundations for reliable quality assurance efforts, and they have at best sparse informa- tion on important aspects of the processes and outcomes of care. Moreover, emerging efforts to develop uniform clinical data sets based on information in paper records are hampered by various drawbacks in using those records (e.g., long manual abstraction times). Thus, CPRs and CPR systems offer great promise for furthering the nation's movement toward improving the quality of health care. Many questions, however, remain to be investigated. These include definition of minimum clinical data sets for different types and settings of care, development of appropriate real-time clinical reminders and alerts, and mechanisms for ap- plying the statistical tools and methods of modern continuous quality im- provement approaches. Although other public and private sector agencies and organizations will undoubtedly take primary responsibility for R&D in this area, the CPRI should be empowered to work directly with those groups to support these activities. Structure and Format of the Patient Record The technological capabilities of CPR systems offer new possibilities for improved design of patient record structure and format. To use these capa- bilities most effectively, the committee believes the relationship between the structure of patient records and the quality of patient care should be explored further. For example, specific elements of patient records that contribute to patient care outcomes need to be identified for incorporation into CPR systems. The committee declined to endorse a particular patient record format at this time; rather, it strongly urges rigorous evaluation of the value of vari- ous attributes of different patient record structures. RECOMMENDATION 4. The CPRI should promulgate uniform na- tional standards for data and security to facilitate implementation of the CPR and its secondary databases. As discussed earlier, major financial and organizational support is needed

148 THE COMPUTER-BASED PATIENT RECORD to promote the development of uniform national standards for data and security. Once agreed upon, these standards must be incorporated into the design and use of CPR systems; they must also be continually reviewed and revised to keep up with technological advances. Mechanisms must be developed to communicate standards to the parties affected by them. For example, system developers and vendors should be notified when uniform national standards have been established so they can design systems with up-to-date features. System purchasers, for their part, must be educated about the value of these voluntary standards to ensure that they will buy systems that offer features that meet the standards. System users (e.g., clinicians) who may be one step removed from purchase deci- sions also need to be educated about standards so they can demand such features in the systems that are acquired by their institutions. Furthermore, institutions should adopt and enforce organizational policies and procedures that support standard security practices. The CPRI is an appropriate body to develop mechanisms for endorsing and communicating health care stan- dards to affected parties. RECOMMENDATION 5. The CPRI should review federal and state laws and regulations for the purpose of proposing and promulgating model legislation and regulations to facilitate implementation and dis- semination of the CPR and its secondary databases and to streamline the CPR and CPR systems. The committee identified at least four ways in which legal issues affect CPR development and use. First, the inconsistency of licensure laws—for instance, for hospitals across the states—can impede development and dif- fusion of new systems. Second, regulations can force inefficiencies on record keeping (e.g., redundant collection of data). Third, laws concerning owner- ship, responsibility, and control of patient records and data may be ambigu- ous or inconsistent, or both, and thus hinder the electronic transfer of CPR data. Fourth, laws protecting confidentiality of computer-based patient data need to be strengthened to address concerns about patient privacy. The committee concluded that a comprehensive review of pertinent laws and regulations, especially state laws and regulations, is needed to remove potential legal barriers and to ensure adequate protection of patient privacy. Following this review, guidelines should be developed and disseminated to appropriate audiences. The committee noted that the Uniform Health-Care Information Act should be included in this review and that efforts should focus on why it has not been widely adopted. The committee also deter- mined that the review process should include an assessment of and recom- mendations regarding penalties for violation of the privacy of patients or providers through unauthorized access or misuse of patient data in the CPR or other patient records.

CONCLUSIONS AND RECOMMENDATIONS 149 The committee assigns high priority to these legal and regulatory issues because they pose major obstacles for steady progress toward the CPR and may take a long time to resolve. For this reason, the committee suggests that the CPRI convene a panel of experts to conduct such a review and prepare a report, including guidelines for state and congressional consider- ation. The committee also suggests that the CPRI disseminate the findings of the report through educational conferences and other means. RECOMMENDATION 6. The costs of CPR systems should be shared by those who benefit from them. Specifically, the full costs of imple- menting and operating CPRs and CPR systems should be factored into reimbursement levels or payment schedules of both public and private sector third-party payers. In addition, users of secondary databases should support the costs of creating such databases. The committee believes that capturing complete and accurate clinical data is an essential element of the patient care process; it sees the CPR as an essential tool for improving and evaluating the quality of patient care and for decreasing its costs. Short-run benefits of CPRs and CPR systems should include (1) improved patient care resulting from increased availabil- ity of patient data, medical knowledge, and clinical aids (e.g., decision support); (2) increased productivity of health care professionals from im- proved access to patient data and reduction of redundant data recording; and (3) reduction in administrative costs. Long-run benefits should include the ability to increase and improve medical knowledge through research using patient data derived from CPR systems. As discussed in Chapter 4, the current distribution of costs and benefits of CPR systems may not provide adequate investment incentives for health care provider institutions. To overcome this problem, the committee be- lieves that a better understanding of the costs and benefits of CPR systems (as discussed earlier in this chapter) and some sharing of CPR costs will be needed. Cost sharing would encourage health providers to invest in CPR systems and thus move the nation toward an optimal level of CPR system use. Further, the existence of cost-sharing mechanisms would send a signal to CPR developers regarding the strength of the CPR market and should increase the willingness of developers to invest in additional R&D. The costs associated with CPR systems go beyond one-time procurement expenses, entailing expenditures for installation, training, maintenance, and other activities that must be planned for and appropriately budgeted. The committee therefore suggests that reimbursement mechanisms address three kinds of CPR system costs for all health care providers: (1) costs associated with procurement or leasing, (2) costs associated with installation and imple- mentation (including training), and (3) costs associated with operation and maintenance.

150 THE COMPUTER-BASED PATIENT RECORD The CPRI should take the lead in coordinating efforts to develop and implement reimbursement mechanisms that incorporate the costs of CPR systems. This process, which will require collaboration with representa- tives of practitioners, health care provider institutions, business, third-party payers, Congress, and federal and state government agencies (especially HCFA), could explore several CPR reimbursement mechanisms: incentives for data that are provided in electronic form, enhanced capital pass-through for CPR system acquisition, recognition of the costs of CPR operation in reimbursement rates, or a combination of the above. The committee urges organizations concerned with developing reimbursement levels or schedules (e.g., the Health Insurance Association of America, the Physician Payment Review Commission, the Prospective Payment Assessment Commission, and individual third-party payers) to make the establishment of acceptable CPR reimbursement mechanisms a high priority in the early 1990s. CPR systems will greatly facilitate the creation of secondary databases for claims payment, health care policy, and clinical research by eliminating the need for manual data abstraction from records. In some cases, these databases can be constructed at a cost lower than that associated with cur- rent patient record systems; in other cases, desirable databases simply would not have been possible with current record systems. (The ability to select, retrieve, and aggregate desired data from CPRs will be of particular benefit to researchers.) Thus, users of such secondary databases should support the costs of data capture, processing, storage, and retrieval by CPR systems. The CPRI should develop an equitable plan to divide some of the costs of CPR systems that contribute to secondary databases among all such data- base users. RECOMMENDATION 7. The committee recommends that health care professional schools and organizations enhance their educational pro- grams for students and practitioners in the use of computers, CPRs, and CPR systems for patient care, education, and research. An essential requirement for optimal functioning of CPR systems is effi- cient user operation of computers, CPRs, and CPR systems, including asso- ciated decision support, bibliographic retrieval, and other clinical aids. Be- cause students and practitioners alike have educational needs in these areas, health care professional schools, programs, societies, and organizations all have a role to play in CPR education. Such training will require curriculum modification, development of con- tinuing postgraduate education programs, and preparation of faculty. In addition to formal training, professional schools, programs, societies, and organizations can reinforce computer skills by using computers to conduct routine business. (For example, professional societies could administer li- censing examinations by computer.) The CPRI should facilitate this evolu-

CONCLUSIONS AND RECOMMENDATIONS 151 tion of education programs by serving as a resource for curriculum and continuing education development. The number of health care professionals who can design, develop, sup- port, and train others in the use of state-of-the-art CPR systems is far fewer than the number needed. Therefore, the committee suggests that the CPRI support training programs in health care to address these personnel short- ages. The committee notes the special training needs of registered record ad- ministrators (RRAs) with respect to CPRs. As the CPR becomes more commonplace, the role of RRAs should evolve to keep pace with the changes in patient records. The RRA of the future is likely to require greater knowl- edge of computing technologies (including database systems and software), quality control procedures, and the needs of all patient record users. Future RRA roles may also emphasize maintaining the quality and consistency of CPRs to support patient care and facilitate research using patient data. SUMMARY The Institute of Medicine study committee set out to develop a plan for improving computer-based patient records and the systems in which they reside. As its first step, the committee examined why previous attempts had not resulted in wide acceptance of CPRs and asked if and how another effort might be successful. It identified five conditions in the current health care environment that it believes increase the likelihood of success: (1) ever-increasing uses of and legitimate demands for patient data, (2) avail- ability of more powerful and more affordable technologies to support CPRs and CPR systems, (3) widespread acceptance of computers as a tool to increase efficiency in virtually all facets of everyday life, (4) an aging, mobile population, and (5) a widely held belief that needed reform in health care will not be easily achieved without routine use of CPRs. To accomplish its task, the committee identified both the strengths and weaknesses of current patient record systems, detailed the users and uses of patient records, and defined user requirements for patient records and pa- tient record systems. It reviewed available and emerging technologies and highlighted crucial emerging technologies whose development should be encouraged. Further, it identified nontechnological barriers to the develop- ment and diffusion of CPRs. The committee believes its recommendations effectively address these potential barriers to routine CPR use. The first recommendation defines the CPR as the standard for future patient records. The second proposes an organizational framework within which CPR barriers can be systematically addressed and overcome. The committee's remaining recommendations then focus on specific barriers: needed research and development, promulgation

752 THE COMPUTER-BASED PATIENT RECORD of standards for CPR data and security, review of legal constraints and remedies, distribution of costs for CPR systems, and education of health care professionals. The committee recognizes that considerable work must be accomplished and practical difficulties resolved before CPRs become the standard mode of documenting and communicating patient information and before they are perceived and used as a vital resource for improving patient care. The challenge of coordinating CPR development efforts in the pluralistic health care environment is great. Resources are limited and must be used wisely. Further, achieving maximum benefit from CPR systems will require that they be linked to an information infrastructure (i.e., network) that allows patient data, medical knowledge, and other information to be transmitted and accessed when and where needed, subject to appropriate security and confidentiality measures. The committee is convinced that with proper coordination and appropri- ate resources the goal of widespread CPR utilization within a decade can be achieved. The desire to improve the quality of and access to patient data is shared by patients, practitioners, administrators, third-party payers, researchers, and policymakers across the nation. CPRs and CPR systems can respond effectively to the health care system's need for a "central nervous system" to manage the complexities of modern medicine. The CPR, in short, is an essential technology for health care.

Appendix A Subcommittees USERS AND USES SUBCOMMITTEE MEMBERS Donald M. Berwick,* Chair, Harvard Medical School and Harvard School of Public Health, Boston, Massachusetts Carmi Margolis, Assistant Chair, Ben Gurion University of the Negev, Beer-Sheva, Israel G. Octo Barnett,* Massachusetts General Hospital, Boston William H. Buckley, Massachusetts General Hospital, Boston Harold D. Cross, Practitioner of Internal Medicine, Hampden, Maine Allyson Ross Davies, New England Medical Center Hospitals, Boston, Massachusetts Nicholas E. Davies,* Practitioner of Internal Medicine, Atlanta, Georgia David H. Gustafson, University of Wisconsin, Madison Clement J. McDonald, Regenstrief Institute for Health Care, Indianapolis, Indiana Mary L. McHugh, St. Francis Regional Medical Center, Wichita, Kansas John A. Norris,* Hill and Knowlton, Inc., Waltham, Massachusetts, and Harvard School of Public Health, Boston, Massachusetts James S. Roberts, Joint Commission for Accreditation of Healthcare Organizations, Oakbrook Terrace, Illinois Stephen Schoenbaum, Harvard Community Health Plan, Brookline, Massachusetts Gary Sennett, AETNA Life Insurance Company, Hartford, Connecticut Barclay M. Shepard, Department of Veterans Affairs, Washington, D.C. Elaine Ullian, Faulkner Hospital, Boston, Massachusetts Mary Joan Wogan, American Medical Record Association, Washington, D.C. *Member, Committee on Improving the Patient Record. 153

754 APPENDIX A TECHNOLOGY SUBCOMMITTEE MEMBERS Morris F. Collen,* Chair, Kaiser Permanente Medical Care Program, Oakland, California Marion J. Ball,* Assistant Chair, University of Maryland at Baltimore G. Octo Barnett,* Massachusetts General Hospital, Boston Robert J. Beck, Oregon Health Sciences University, Portland Paul D. Clayton, Columbia Presbyterian Medical Center, New York, New York Jerome R. Cox, Washington University, St. Louis, Missouri Betsy L. Humphreys, National Library of Medicine, Bethesda, Maryland Allan H. Levy, University of Illinois Medical Center, Urbana Gretchen Murphy, Group Health Cooperative of Puget Sound, Seattle, Washington John A. Norris,* Hill and Knowlton, Ine., Waltham, Massachusetts, and Harvard School of Public Health, Boston, Massachusetts Helmuth F. Orthner, George Washington University, Washington, D.C. Allan T. Pryor, University of Utah, Salt Lake City William W. Stead, Duke University Medical Center, Durham, North Carolina *Member, Committee on Improving the Patient Record.

APPENDIX A 155 STRATEGY AND IMPLEMENTATION SUBCOMMITTEE Edward H. Shortliffe,* Chair, Stanford University School of Medicine, Palo Alto, California Paul C. Tang, Assistant Chair, Hewlett-Packard Laboratories, Palo Alto, California Margret Amatayakul, American Medical Record Association, Chicago, Illinois Jeffrey F. Blair, International Business Machines Corporation, Atlanta, Georgia Peter A. Bouxsein, American College of Physicians, Philadelphia, Pennsylvania Nicholas E. Davies,* Practitioner of Internal Medicine, Atlanta, Georgia Paul M. Ellwood, Interstudy, Excelsior, Minnesota J. Michael Fitzmaurice, Agency for Health Care Policy and Research, Rockville, Maryland Ruth E. Garry,* CNA Insurance Companies, Chicago, Illinois Stephen F. Jencks, Health Care Financing Administration, Baltimore, Maryland Charles N. Kahn III, U.S. House of Representatives, Committee on Ways and Means, Washington, D.C. Bruce McPherson, American Hospital Association, Chicago, Illinois Thomas Q. Morris,* Columbia Presbyterian Hospital, New York, New York Jeremy Nobel, Harvard School of Public Health, Boston, Massachusetts John A. Norris,* Hill and Knowlton, Inc., Waltham, Massachusetts, and Harvard School of Public Health, Boston, Massachusetts Barclay M. Shepard, Department of Veterans Affairs, Washington, D.C. *Member, Committee on Improving the Patient Record.

Appendix B Legal Aspects of Computer-based Patient Records and Record Systems Adele A. Waller Computer-based patient records and record systems may bring into play laws of many kinds. For example, system hardware may be patented and sys- tem software copyrighted. If a computer-based patient record system fails and the failure results in harm to a patient, tort liability can result to the vendor or to the provider using the system, or to both. Tort liability can also arise if a system is not protected from unauthorized access and breaches of patient confidence result or records are destroyed or altered. A computer hack- er gaining unauthorized access to a computerized patient record system faces possible criminal liability. Various privacy laws limit permitted dis- closure or redisclosure of information stored in computer-based patient re- cord systems. Other laws must also be taken into account. Licensure laws applicable to health care providers, as well as reimbursement and insurance laws, all impinge on computer-based patient records, as do public health laws that require reporting of vital statistics and of various injuries and diseases. Contract law and the Uniform Commercial Code come into play in con- tracts for computer-based record systems. The availability of specific per- formance as a remedy for a vendor's breach of contract is a question that The author is an attorney in the Health Law Department of the law firm of Gardner, Carton & Douglas, in Chicago. She gratefully acknowledges the assistance of her colleagues Deborah K. Fulton and Bernadette M. Broccolo with the computer science and computer law aspects of this paper. 756

APPENDIX B 157 requires resort to doctrines of equitable remedies. A hardware or software vendor's insolvency raises issues under federal bankruptcy law. Finally, interaction of computer-based record systems with artificial intelligence systems can also raise issues concerning medical device laws and, to the extent that nonphysicians are able to diagnose and treat patients without physician involvement using these systems, physician licensure laws. Because of the plethora of laws that apply to computer-based patient records and record systems, one paper cannot encompass a full discussion of the application of these laws to the computer-based record. What fol- lows, therefore, is a summary discussion of the key legal issues raised by computer-based patient records and record systems: regulatory and accredi- tation issues, evidentiary issues, patient privacy and record access concerns, record ownership questions, legal risks specific to computer-based patient record systems, and computer contracting issues. STATE LICENSURE LAWS Computer-based patient records utilized by an institutional health care provider must meet the requirements of relevant state licensure laws, or the institution may face licensure sanctions. The statutes and regulations governing licensure of hospitals, nursing homes, health maintenance organ- izations, ambulatory surgical treatment centers, and other institutional providers generally contain specific standards and requirements concerning the creation, authentication, retention, and storage of patient records, as well as limitations on the media permissible for their creation and storage. Additional requirements typically found in state licensure statutes and regu- lations relate to confidentiality, record content, accuracy, completeness, timeliness, and accessibility. Hospital Licensure Laws as Barriers to Full Automation State hospital licensure laws still pose barriers to full automation of the patient record. State-to-state variances in medical records requirements and obsolete and ambiguous or conflicting laws and regulations pose obstacles to the full development of computer-based patient record systems.1 Although some state regulators may permit computerization of patient records in ways that technically are not permitted by state regulations, a health care institution 1State licensure requirements have lagged far behind the development of technology and have been criticized for so lagging for 20 years or more. See, e.g., Eric W. Springer, Automated Medical Records and the Law (Pittsburgh, Pa.: Health Law Center, 1971).

158 APPENDIX B investing in an automated patient data system is making too big an investment to risk learning later that the system does not meet state licensure requirements. Some states expressly permit use of computers in the creation, authenti- cation, and retention of patient records.2 Others state their medical records requirements for hospitals generally, impliedly permitting computer-based patient records, or explicitly address use of computers only for one func- tion, such as authentication, but not for other patient record functions.3 Even so, the wide variance from state to state in hospital licensure re- quirements for medical records may make it difficult to develop patient record systems that comply with hospital licensure laws in all 50 states. State-to-state variances make it expensive to determine if a record system (or set of system specifications) complies with hospital licensure require- ments in all states. They also leave open the possibility that inconsistencies between the requirements of two or more states could make it impossible for a system to meet all states' licensure requirements. Failure by a vendor to establish a patient record system's compliance with one (or more) state's licensure requirements may adversely affect the system's marketability in such states. Assuming that hospitals include com- pliance with legal requirements in their feasibility analysis of computer- based patient information systems, the lack of national uniformity in the medical records requirements of state licensure laws and regulations appli- cable to institutional health care providers may be expected to retard devel- opment and marketing of new computer-based patient record systems. In addition, state-to-state variations in requirements regarding the content of hospital medical records may make it difficult to develop standard formats for computer-based patient records that can be used nationally. Hospital licensure laws and regulations in many states still assume a paper patient record and at best leave the legal status of computer-based 2410 Ind. Admin. Code §15-1-9(1) (1988); Mo. Code of State Regulations, 19 C.S.R.§30- 20-.021(3)(D) (1990); Oreg. Admin. Rule §333-505-050 (1989); Neb. Regulations and Stand- ards for Hospitals §003.04 (1979); Pa. Rules and Regulations for Hospitals §115.25 (1987). In the regulations of these states, however, there is little reflection of any systematic examination of the special problems and challenges posed by automated patient records. Even Oregon, which of all the states has most systematically amended its regulations to be consistent with automated records systems, has done little more than adapt regulations from the era of paper records to permit automated patient records. 322 Calif. Admin. Code §70751; Conn. Pub. Health Code, ch. 4, §19-13-03(d); 77 111. Admin. Code §250.1510 (1990); Lic. Stds. for Hospitals, N.J.A.C. 8:43G:-15.2; R.I. Rules and Regulations for Licensing of Hospitals §25.0 (1989); S.D. Admin. Rules §44:04:09:04 (1989); Tex. Hospital Licensing Stds. §1-22-1.4 (1985); Utah Admin. Code §R432-100-7.405 (1989); Rules and Regulations for the Lic. of Hospitals in Virginia §208.0 (1982); Wisc. Admin. Code, ch. HSS 124 Hospitals, §124.14 (1988).

APPENDIX B 159 patient records used by hospitals under a cloud.4 Other state laws and regulations appear to permit some forms of automation but not others, or the use of automation for some but not all medical record functions.5 Oklahoma requires that all orders and medications be written in ink, a requirement that is incompatible with a fully automated medical record system. Oklahoma also prohibits substituting a signature stamp for the physician's signature, apparently requiring handwritten authentication of medical records, with the exception of records of diagnostic examinations, for which computer signatures are authorized.6 South Carolina also re- quires orders to be "written in ink and signed," but permits use of a signa- ture stamp with appropriate controls.7 Iowa requires medical records to be "written" and "signed" by the attending physician.8 North Carolina requires that records be "written" for all patients admitted to a hospital.9 If a medi- cal record must be signed in ink, the paper record—even if it is generated on a computer—becomes the original record, and many of the efficiencies of automated storage and retrieval of records cannot be realized. Other states restrict permissible medical record storage media to the original or microfilm.10 Such a restriction is incompatible with storage of records on 4See, e.g., the rules of states that, as of the time research was completed for this paper, still required that clinical reports or clinical information be filed in or with the medical record or that records of both inpatient and outpatient treatment be filed in one folder: Ariz. Rules, Regulations and Standards for the Licensing and Regulation of Health Care Institutions §R9-10-221 (1982); Rules, Regulations and Min. Stds. for Hospitals in Idaho, IDAPA §16.02.1360.10.a; Regulations for the Licensure of General and Specialty Hospitals in the State of Maine, ch. XII (1972); Min. Stds. for Operation of Miss. Hospitals §1704.4 (1990); N.Mex. Regulations Governing General and Special Hospitals §700.B.4.f (1989); Lic. Rules for General Hospitals in North Dakota, N.D.A.C. §33-07-01-16.6.3 (1990); Lic. Stds. for Hospitals and Related Institutions in the State of Oklahoma §13.5-A (1989); 64 W. Va. Legisl. Rules §10.3 (1987); Wisc. Admin. Code, ch. HSS 124 Hospitals, §124.14 (1988). 5See, e.g., Mo. Code of State Regulations, 19 C.S.R. §30-20.021(3)(D) (1990); Utah Admin. Code §R432-100-7.406 (1989); Hospital Rules and Regulations, Wash. Admin. Code. § 248- 18-440 (1989). 6Licensure Standards for Hospitals and Related Institutions, State of Oklahoma §13.1-8(4) and 13.9-D (1989). 7S.C. Standards for Licensing Hospitals and Institutional General Infirmaries §601.6 (1990). 8Iowa Admin. Code §641.51.5 (1988). 9Rules and Statutes Applying to the Licensing of Hospitals in North Carolina, Subchapter 3c, §.1400 (1988). See also 77 11l. Admin. Code § 250.350(a), which requires that all orders for medication and treatment be written except in emergencies. On the basis of this requirement, the Illinois Department of Public Health strongly discourages fully computerized medical records in hospitals. 10See, e.g., Colo. General Hospitals, ch. IV, §4.2 (1982); Conn. Pub. Health Code, ch. 4, §19-13-03(d) (1989); 410 Ind. Admin. Code §15-l-9(2)(b)(1) (1988); Regulations for the Licensure

760 APPENDIX B computer disks, magnetic tape, or optical disks—that is, unless the records were both originally created and authenticated by computer and are perma- nently retained on the original medium (which may be difficult or infea- sible, depending on the medium's durability). A serious legal barrier to full realization of the potential of computer- based patient records is the confusion and lack of clarity in some states' standards when they are applied to computer-based medical records. It is not always clear whether regulations requiring that records be kept in ink or "type" (or in ink or "typewritten") permit creation of medical records electronically or with the use of lasers, although a provision permit- ting authentication of records by computer key, such as that found in Colorado's rules, implies that patient records may be created on a computer." Simi- larly, it is unclear whether a requirement that medical records be recorded in ink, typewritten, or recorded electronically permits recording by lasers on optical disks.12 The regulations of some states require that medical records be "signed" but are silent on whether the substitution of a computer key or code for a physician's signature is permitted.13 This silence cannot be interpreted as of General and Specialty Hospitals in the State of Maine, ch. XII (1972); Min. Stds. for Operation of Miss. Hospitals §1702 (1990); Mo. Code of State Regulations, 19 C.S.R. §30- 20.021(3)(D) (1990); Operational Rules and Regulations for Health Facilities, Nev. Admin. Code §449.379 (1988); N.Mex. Regulations Governing General and Special Hospitals §700.B.l.b (1989); S.C. Standards for Licensing Hospitals and Institutional General Infirmaries §601.6 (1990); Tenn. Hospitals Rules and Regulations §1200-8-4-.03(f) (1986); Wisc. Admin. Code, ch. HSS 124 Hospitals, §124.14 (1988). Tennessee has recently amended its statute to permit storage of medical records on "non-erasable optical and electronic imaging technology." See Tenn. Code Ann. § 68-ll-306(b) (1991). "See, e.g., Rules of Alabama State Bd. of Hlth., Div. of Lic. and Cert., Hospitals, §420-5- 7.07(0 (1988); Rules and Regulations for Hospitals and Related Institutions in Arkansas §0601(C) (1988); Colo. General Hospitals, ch.IV, §4.4 (1982); Tenn. Hospitals Rules and Regulations §1200-8-4-.03 (1986); Vermont Lic. Stds. for the Construction, Maintenance and Operations of Hospitals §3-946 (1954); 64 W. Va. Legist. Rules §10.3 (1987). 12Mo. Code of State Regulations, 19 C.S.R. §30-20.021(3)(D) (1990). 13See, e.g., Ariz. Rules, Regulations and Standards for the Lic. and Regulation of Health Care Institutions §R9-10-221 (1982); Conn. Pub. Health Code, ch. 4, §19-13-03(d) (1989); Ga. Rules and Regulations for Hospitals §290-5-6-. 11 (1977); Rules, Regulations and Min. Stds. for Hospitals in Idaho, IDAPA §16.02.1360.13; Iowa Admin. Code §641.51.5 (1988); Ky. 902 KAR 20:016 (1989); Min. Stds. for Operation of Miss. Hospitals §1704.4 (1990); Nev. Operational Rules and Regulations for Health Facilities §449.379; N.Mex. Regulations Governing General and Special Hospitals §700; Lic. Rules for General Hospitals in North Dakota, N.D.A.C. §33- 07-01-16.9 (1990); Lic. Stds. for Hospitals and Related Institutions in the State of Oklahoma §13.5-A (1989); S.C. Standards for Licensing Hospitals and Institutional General Infirmaries §601 (1990); Tenn. Hospitals Rules and Regulations §1200-8-4-.03 (1986); Vermont Lic. Stds. for the Construction, Maintenance and Operations of Hospitals §3-946 (1954); 64 W.Va. Legisl. Rules §10.3 (1987); Wisc. Admin. Code, ch. HSS 124 Hospitals, §124.14 (1988); Wy. Stds., Rules and Regulations for Hospitals and Related Facilities §7 (1979).

APPENDIX B 161 necessarily permitting authentication of records by computer key or code. In addition, many states require that each patient's record contain a "signed" consent form or evidence of informed consent.14 It is not clear whether paper files of consent forms must be maintained or whether it is permissible for patients and patient representatives to authenticate consent on a com- puter by use of a computer key or code unique to each patient. State requirements that medical records (or "original" medical records) be retained in the hospital or on the hospital's premises, except under de- fined circumstances, mean that use of outside computer services for hospital medical records may constitute a technical violation of the hospital licensure requirements in some states.15 Indiana's regulations, although containing a provision that a computerized record shall be considered the same as a written record, also require that medical records be filed in a safe, acces- sible manner in the hospital and be kept on the nursing unit during the patient's hospitalization. These two requirements leave the status of out- side computer services for Indiana hospitals unclear.16 Other State Licensure Laws State licensure laws and regulations applicable to a variety of other health care providers—both institutional and individual—typically contain provi- sions concerning patient records or patient information and confidences, or both. State laws and regulations with respect to licensure of institutional pro- viders other than hospitals contain many of the same types of patient record requirements and raise many of the same issues raised by hospital licensure laws and regulations. Licensure laws and regulations for such providers may pose even greater barriers to fully computer-based patient records be- MSee, e.g., N.J. Lic. Stds. for Hospitals, N.J.A.C. 8:43G-15.2(d)(1) (1990). 15Rules and Regulations for Hospitals and Related Institutions in Arkansas §0601(V) (1988); Conn. Pub. Health Code, ch. 4, §19-13-03(d)(6) (1989); 410 Ind. Admin. Code §15-1-9(2) (1988); Iowa Admin. Code §641.51.5(1) (1988); Ky. 902 K.A.R. §20:016 (1989); Regulations for the Licensure of General and Specialty Hospitals in the State of Maine, ch. XII (1972); Min. Stds. for Operation of Miss. Hospitals §1701.4 (1990); N.J. Lic. Stds. for Hospitals, N.J.A.C. 8:43G-15.2(h) (1990); N.Mex. Regulations Governing General and Special Hospitals §700.8.1.b (1989); Rules and Statutes Applying to the Licensing of Hospitals in North Carolina, Subchapter 3c, §.1403(d) (1988); Licensure Standards for Hospitals and Related Institutions, State of Oklahoma §13.2-C (1989); Pa. Rules and Regulations for Hospitals §115.28 (1987); S.C. Standards for Licensing Hospitals and Institutional General Infirmaries §601.4 (1990); Tenn. Hospitals Rules and Regulations § 1200-8-4-.03(b)(1) (1986); 64 W. Va. Legisl. Rules §10.3.1(a) (1987); Wisc. Admin. Code, ch. HSS 124 Hospitals, §124.14(2) (1988). 16410 Ind. Admin. Code §15-1-9 (1988).

762 APPENDIX B cause, even more than hospital licensure laws and regulations, they may be keyed to a paper record. For example, Illinois' long-term care facility licensure regulations re- quire that (1) resident records be written in ink or typed and (2) all physi- cian orders, plans of treatment, Medicare and Medicaid certifications and recertification statements, and similar documents have the original written signature of the physician. Use of a rubber stamp signature, with or without initials, is not permitted. In addition, resident records must contain a "phy- sician's order sheet," a "medication sheet," and "treatment sheets," imply- ing that a manual record must be maintained.17 State licensure requirements for nonhospital institutional providers ex- hibit the same lack of national uniformity in standards for patient records exhibited by state hospital licensure requirements. In addition, similar con- cerns regarding obsolete and ambiguous laws and regulations arise in state licensure requirements for institutional providers other than hospitals. State laws and regulations applicable to physicians, nurses, and other individuals licensed to provide health care typically contain an express or implied obligation of confidentiality with respect to patient confidences and, in some statutes or regulations, with respect to patient records. Willful or negligent breaches of confidentiality may constitute grounds for profes- sional discipline.18 The canons of ethics of a profession may be incorporated into a state's licensure requirements, usually by a provision in a licensing act that makes "unprofessional conduct" grounds for professional discipline.19 The 1989 publication Current Opinions of the Council on Ethical and Judicial Affairs of the American Medical Association contains detailed guidelines on com- puterized patient databases.20 These may be impliedly incorporated into the statutes and regulations governing licensure of physicians in some states. Medicare Regulations To participate in the Medicare program, a provider must meet the appli- cable Medicare conditions of participation. The conditions of participation for hospitals include requirements for medical records but do not include 1777 111. Admin. Code §300.1810 (1985). 18See, e.g., Ill 11l. Ann. Stat. 1J4400-22.30 (Smith-Hurd 1990 Supplementary Pamphlet). "See, e.g., 52 Oreg. Rev. Stat. §677.188 (1989); Utah Code Ann. §58-12-35 (1990). 20American Medical Association (AMA), Chicago, Illinois. Although it may not be practical to implement all of the AMA's guidelines, it should be recognized that these guidelines are some of the most detailed, ethically sensitive standards for computerized patient databases that have been developed to date.

APPENDIX B 163 any express restriction on permissible media for creating and storing medi- cal records.21 Medical records may be authenticated by signature, written initials, or computer entry.22 Thus, the conditions of a hospital's participa- tion in the Medicare program pose no barrier to the use of computer-based patient records. The Medicare conditions of participation for long-term care facilities do not expressly restrict the media for creation and storage of the records.23 However, they require each individual who completes a portion of the as- sessment to "sign" the assessment.24 In addition, these conditions of par- ticipation require that, at each visit to a resident, the physician supervising the resident's medical care must "write, sign and date progress notes" and "sign all orders."25 It is not clear whether these conditions of participation permit a fully automated record because it is not clear whether authentica- tion by computer code or key provides the required signature and whether a progress note made on a computer fulfills the requirement that a physician must write the note.26 The Health Care Financing Administration (HCFA) permits physician certifications of medical necessity to be executed by computer or transmit- ted to a hospital by facsimile machines. A provider seeking permission for its physicians to attest to medical necessity on a computer or by facsimile must be able to demonstrate to its intermediary that its system contains adequate safeguards of accuracy and confidentiality and meets certain other standards.27 2142 C.F.R. §482.24. 2242 C.F.R. §482.24(c)(1)(ii). 2342 C.F.R. §483.75(n). 2442 C.F.R. §483.20(c)(2). 2542 C.F.R. §483.40(b). 26Apparently, the Health Care Financing Administration (HCFA) believes that these conditions of participation would permit a fully automated record because HCFA is discussing with nursing home operators the possibility of requiring that nursing homes computerize resident assessment records to comply with the provision of the Omnibus Budget Reconciliation Act of 1987 requiring maintenance of a uniform, minimum data set on residents' conditions. See Paula Eubanks, "Homes Doubt They Can Computerize per HCFA's Request," Hospitals 64, no. 23 (1990):56. "See the HCFA Medicare Hospital Manual Transmittal No.567 (July 1989). The provider's request must explain (1) the provider's physician identification system, (2) system safeguards to ensure confidentiality, (3) how data are displayed for physician review before electronic attestation, (4) how physician identity is determined upon certification and stored in the provider's system, (5) how the system records a system-generated date and time of entry at the point of attestation, (6) system backup procedures for prolonged downtime, and (7) how the physician verifies that attestations executed through the system have been correctly recorded. HCFA permits use of physician access systems that employ an alphanumeric identifier or biometric identification of physicians.

164 APPENDIX B Hospital Accreditation Requirements Technically, the Joint Commission on Accreditation of Healthcare Orga- nizations (JCAHO) is a voluntary organization, and JCAHO accreditation is voluntary. JCAHO accreditation standards, however, are incorporated in some state hospital licensure laws, at least in part,28 and a hospital is deemed to meet certain Medicare conditions of participation if it holds JCAHO accreditation.29 Although JCAHO accreditation standards do not explicitly address re- quired media for record keeping and storage, they assume that a hospital may participate in an automated medical record data processing system. JCAHO standards permit authentication of medical records by computer key. The JCAHO requires that all medical records be accurate, accessible, authenticated, organized, confidential, secure, current, legible, and com- plete.30 A computer-based medical record system can meet JCAHO stan- dards if the system is properly designed and maintained and if medical records are otherwise properly completed. PATIENT RIGHTS ISSUES Right of Privacy The Federal Privacy Act and similar acts in many states provide assur- ance that patient records held by the federal government and governments of states that have enacted privacy legislation will not be disclosed to third parties without the patient's consent, except under defined circumstances.31 However, privacy of patient records in other states and in the private sector is governed by a crazy quilt of statutory, regulatory, and common-law rules and is often inadequately protected.32 Growing demands for information contained in patient records pose an ever-increasing threat to patient privacy. Such demands come not only 28See, e.g., the following regulations, which incorporate JCAHO standards for medical records into state hospital licensure requirements: N.H. Code of Admin. Rules, Part He-P802 (1986); R.I. Rules and Regulations for Licensing of Hospitals §25.7; Rules and Regs, for the Licensure of Hospitals in Virginia §208.5 (1982). 2942U.S.C. §1395bb. 30Joint Commission on Accreditation of Healthcare Organizations, "Medical Record Services (MR)," Accreditation Manual for Hospitals (Chicago: 1990). 315 U.S.C. §552a. 32The threats to patient privacy posed by increased use of computers for health records were detailed by Alan F. Westin in Computers, Health Records and Citizen Rights (Washington, D.C: U.S. Government Printing Office, 1976).

APPENDIX B 165 from peer-review bodies, third-party payers (both governmental and non- governmental), outside billing and computer services, and government, but from employers, insurers, and others who use health care information for non-health care purposes. When information from patient records is disclosed by a provider— whether with or without the patient's consent—it is extremely difficult to control redisclosure of the information effectively, even though confi- dentiality agreements and notices are still advisable. Furthermore, when patient records are computerized, they can easily be transmitted across state lines, limiting the ability of any one state to protect the privacy of its citizens. To the extent that patients and providers are aware that computer- based patient records increase the threat to patient privacy, they may be unwilling to provide or record complete information in the patient record, particularly with regard to sensitive matters, such as abortions, AIDS (acquired immune deficiency syndrome), psychiatric problems, and drug or alcohol abuse. Thus, the lack of adequate, uniform, national protection of patient privacy with respect to patient records may hinder full develop- ment of computer-based patient record systems. The Uniform Health-Care Information Act skillfully addresses issues of confidentiality and release of patient information.33 Only Montana, how- ever, has enacted this act into law.34 Right of Access to Health Records Most states expressly allow a patient or a patient's authorized representa- tive to inspect and copy the patient's hospital records.35 Rights of access to health records maintained by physicians and other individual health care providers may not always be clear. Before records become available, the person seeking access typically must request such access in writing from the provider and pay reasonable clerical costs. A few states grant patients the right to review their hospital records only after discharge.36 Many states permit providers to refuse to grant a patient's request for disclosure where psychiatric records are involved and where release of the information would be detrimental to the patient's mental health or general "National Conference of Commissioners on Uniform State Laws, Uniform Laws Annual, vol. 9, part 1 (St. Paul, Minn.: West Publishing Co., 1988), p. 475. 34M.C.A. §50-16-501, etseq. 35See, e.g., Ala. Stat. §18.23.065. 36See, e.g., Fla. Stat. Ann. §395.017(1); 11l. Ann. Stat., ch. 110, §8-2001.

166 APPENDIX B health, or where a third party could be endangered by the release.37 How- ever, in such states, a provider may be required to deliver copies of the record to the patient's representative or attorney. Several statutes contain special provisions concerning a patient's access to particular portions of his or her record, such as X-rays.38 Still other states allow a provider to prepare a summary of the patient's record for inspection and copying rather than allowing the patient access to the entire record.39 In the absence of statute or regulation, some courts have recog- nized a provider's common-law duty to allow a patient limited access to his or her records.40 Where patient records become part of insurers' or other databases, the patient may not even know that the record exists and may have no way to enforce a right of access, even if such exists. In addition, even if the patient gains access to the record, he or she may have no legally enforceable right to correct inaccurate information contained in it. The Uniform Health-Care Information Act addresses access issues, as well as issues of confidentiality and information disclosure.41 As noted earlier, however, only Montana has adopted this legislation to date.42 Is- sues of access to databases maintained by insurers, correction of data main- tained on individuals by insurance companies, and limitations on redisclosure of such information are addressed in the Insurance Information and Privacy Protection Model Act developed by the National Association of Insurance Commissioners (NAIC). To date, at least 13 states have adopted some version of this model act as law.43 37See, e.g., Fla. Stat. Ann. §395.017(1); Okla. Stat. Ann., ch. 76, §19A; Cal. Health & Safety Code Ann. §1795.14(b); Colo. Rev. Stat. §25-1-801; Hawaii Rev. Stat. Ann. §622-57; Maine Rev. Stat. Ann. §1711; Minn. Stat. Ann. §144.335. 38See, e.g., Cal. Health & Safety Code Ann. §1795.12(c) and (e). 39See, e.g., Cal. Health & Safety Code Ann. §1795.20(a); Minn. Stat. Ann §144.335. "0See, e.g., Cannell v. Medical and Surgical Clinic, 21 11l. App. 3d 383, 315 N.E. 2d 278 (1974); Matter of Weiss, 208 Mise. 1010, 147 N.Y.S. 2d 455 (N.Y. Spee. Term. 1955); Hutchins v. Texas Rehab. Comm., 544 S.W. 2d 802 (Tex. Civ. Ct. App. 1976). 4I9 Uniform Laws Ann., Part 1 (West 1988), p. 475. 42M.C.A. §50-16-501, etseq. 43The NAIC model act is a good beginning but does not go far enough in protecting individuals whose health records are disclosed to insurance companies. One Kansas court, for example, found that transmission of health information concerning the plaintiff to the Medical Information Bureau did not invade the plaintiff's privacy (Senogles v. Security Benefit Life Insurance Co., 217 Kan. 438, 536 P. 2d 1358 [1975]). The Medical Information Bureau is a nonprofit association formed to conduct a confidential exchange of information between its more than 700 insurance company members, which pool information on underwriting decisions and the health status of individual insureds.

APPENDIX B 167 Ownership of Patient Data and of the Patient Record Ownership of the Patient Record It is generally accepted that a provider owns the physical patient records created by the provider in delivering care to patients, subject to the patient's limited interest in the information contained in the record.44 This rule concerning ownership of the patient record is established by statute in some states and by regulation in others (e.g., hospital licensure regulations).45 In the absence of statutory or regulatory authority, a few courts have held that a medical record is the property of the provider, subject to the limited property interest of the patient in the information contained in the record.46 Rights in Information Contained in the Record Provider ownership of patient records does not imply that the provider has a right to use, disclose, or withhold data in the record at will. Patients generally have a qualified property interest in the information contained in their medical records. However, the precise limits of this interest vary from state to state. EVIDENTIARY ISSUES Importance of Admissibility of Patient Records as Evidence A computer-based patient record system should be structured so that patient records created and stored on the system can be admitted as evi- dence in court in disputes between providers and patients or payers, in cases in which the medical condition of the patient is at issue, and in other litiga- tion. Because records of many businesses are computerized, courts have developed standards for establishing the trustworthiness of computerized records. "See, e.g., Position Statement, Confidentiality of Patient Health Information (American Medical Record Association, 1985); Joint Commission on Accreditation of Healthcare Organizations, "MR 3.1," Accreditation Manual for Hospitals (Chicago: 1990). 45See, e.g., Tenn. Code Ann. §68-11-304; Mo. Rules of Dept. of Health, 19 C.S.R. §30- 20.021(D)(6) (1990). 46See, e.g.. Bishop Clarkson Memorial Hospital v. Reserve Life Insurance Co., 350 F.2d 1006 (8th Cir. 1965); Pyramid Life Insurance Co. v. Masonic Hospital Association of Payne County, 191 F.Supp. 51 (W.D. Okla. 1961); Thurman v. Crawford, 652 S.W. 2d 240 (Mo. App. 1983); Hutchins v. Texas Rehab. Comm., 544 S.W. 2d 802 (Tex. Civ. App. 1976); Morris v. Hoerster, 377 S.W. 2d 840 (Tex. Civ. App. 1964).

168 APPENDIX B Rule Against Hearsay Definition of Hearsay Hearsay is generally defined as a statement out of court by a declarant offered as evidence to prove the truth of the matter asserted in the out-of- court statement.47 Hearsay is not admissible as evidence in court unless one of the many exceptions to the hearsay rule applies.48 All medical records, including computer-based records, are hearsay. Business Records Exception To come within the business record exception to the rule against hearsay, records must be kept regularly in the ordinary course of business and not be specially prepared for trial. In addition, record entries must have been made at or near the time the events recorded. The identity of the person making or recording the entries must be captured in the record; in addition, the record must have been prepared by or from information transmitted by a person with firsthand knowledge of the event recorded who is acting in his or her ordinary business capacity.49 A computer-based medical record made in the normal manner at the time of delivering care should meet the requirement that a business record be kept regularly in the ordinary course of business. Providers should ensure that the computer records the date and time of each entry and update to a medical record so that the time and timeliness of that entry or update can be demonstrated in court. The computer should also record the identity of each person who makes an entry or modifies a record. Ensuring the integrity of a system's record of identity may be difficult if records are created directly on the system by health professionals—they could share or discover each other's computer passwords and key codes. A system of key cards and secret passwords similar to those used on automatic teller machines may provide greater integrity. Strict rules against disclosing passwords and codes should be publicized to all system users and should be strictly enforced. A provider may want to consider a system that verifies the identity of users by voice- or thumbprint; however, the cost of such sophisticated features may be prohibitive. 47See, e.g., Rule 801(c), Federal Rules of Evidence, and Rule 801(c), Uniform Rules of Evidence. 48See, e.g., Rule 802, Federal Rules of Evidence, and Rule 802, Uniform Rules of Evidence. 49See, e.g., Rule 803(6), Federal Rules of Evidence, and Rule 803(6), Uniform Rules of Evidence.

APPENDIX B 169 When an error is corrected in a computerized record, the system should preserve both the original entry and the correction, along with the identity of the person making the correction. Otherwise, it may appear that a record has been altered as part of a cover-up or that records on the system are not sufficiently reliable to be trustworthy as evidence and, thus, are not admis- sible in court. Write-once, read-many (WORM), or compact disk, read-only memory (CD-ROM), technology may be attractive in this context because disks cannot be altered once information is recorded. Write-protecting the por- tions of computer disks on which patient information is stored can also protect the integrity of records stored on a computerized patient record system. However, reliable software that preserves erroneous entries and tracks the history of each entry and correction to a record should provide adequate demonstration of the reliability of the record to a court. A provider should have an employee or technical consultant who can testify concerning the reliability of the system's identification and entry- dating process and the trustworthiness of the system as a whole, including system security features and procedures. Records stored on a properly designed and maintained computer-based system should come within the business records exception to the hearsay rule if the guidelines above are followed. Statements contained in such computerized records will generally be admissible if made by providers or their staffs acting in the ordinary course of business. Statements contained in such records may also be admissible if made by the declarant "for pur- poses of medical diagnosis or treatment and describing medical history, or past or present symptoms, pain, or sensations, or the inception or general character of the cause or external source thereof insofar as reasonably perti- nent to diagnosis or treatment."50 Best Evidence Rule The evidentiary rules of some jurisdictions provide that, in instances in which the contents of a writing are at issue, the original document must be proffered unless an exception to the rule is satisfied. The Federal Rules of Evidence state that "fi]f data are stored in a computer or similar device, any printout or other output readable by sight, shown to reflect the data accu- rately, is an 'original.'" The federal rules also provide for admissibility of duplicates to the same extent as originals unless a genuine issue of authen- 50Rule 803(4), Federal Rules of Evidence. This exception to the hearsay rule is known as the medical records exception.

170 APPENDIX B ticity or unfairness arises.51 Some states' evidentiary rules also accept computerized documents as originals.52 Other states permit reproductions to be admitted as evidence when such copies are made in the regular course of business and satisfy other criteria for trustworthiness.53 The trustworthiness of an automated system refers to the reliability of system hardware and software, the use of proper procedures for creating and storing records, the assurance that entries are made by adequately trained personnel, and the prevention of unauthorized access to the records and of tampering with the system. RISKS ARISING FROM COMPUTER-BASED PATIENT RECORD SYSTEMS Breaches of Confidentiality and Unauthorized Access The duty of health care providers to maintain the confidentiality of patient records and to protect them from unauthorized access arises from licensure laws and regulations, specific statutes and regulations with respect to certain patient records (e.g., alcohol and drug abuse patient records, psychiatric records, and records of positive human immunodeficiency virus [HIV] antibody test results), JCAHO standards, Medicare rules, and the common law. In addition, the necessity of keeping records in a manner that makes them admissible as evidence in court requires a provider to protect patient records from unauthorized access. The legal duties to preserve confidentiality and prevent unauthorized access to patient records are the same with respect to both paper and com- puter-based records. However, keeping computer-based records confiden- tial and free from unauthorized access poses special challenges, and a fail- ure to do so can have more onerous consequences than may occur in the case of paper records. The computer's capacity for collecting, storing, and permitting access to large quantities of information often means that more information is collected and stored on computer-based record systems than is collected and stored in paper records. Because of the computer's capacity for mass storage and copying, one breach of a system's security can result in the unauthorized disclosure of extensive information about large numbers of patients. In addition, the computer's capacity to provide health information on large numbers of patients at one time makes computer-based patient 51Rules 1001(3) and 1003. "See, e.g., Fla. Stat. Ann. §90.951. "See, e.g., Cal. Evid. Code §§1270-1272.

APPENDIX B 171 record systems an even more tempting target than paper records. As the medical information included in patient records becomes more sophisti- cated (e.g., genetic information), this temptation will only increase. Mass disclosure of patient information could result in catastrophic liabil- ity for a provider; it could also result in licensure sanctions or statutory penalties. Theories under which providers may be held liable for breaches of confidentiality include both statutory and common-law theories. Com- mon-law theories under which providers may be held liable for breaches of confidentiality include invasion of privacy, betrayal of professional se- crets, breach of contract, slander, and negligent or intentional infliction of emotional distress. Statutes such as the federal statute concerning confi- dentiality of drug and alcohol abuse patient records provide penalties for breaches. Security mechanisms and procedures can provide some level of protec- tion to computer-based patient records against unauthorized access by users both inside and outside a provider organization. Yet even the most sophis- ticated security measures will not provide fail-safe protection of patient records, particularly in decentralized systems. In fact, one of the biggest threats to the security of computer-based patient records comes from the trend toward networked systems. Security measures that are both ade- quate and affordable and that do not interfere with efficient patient care currently do not exist for such systems. A computer-based patient record system should include a security sys- tem that, as far as is practicable, permits only authorized users to access patient records and permits authorized users to access only those portions of the records that are relevant to their particular functions. The system should also ensure that access to each record is tracked by the system and monitored as a deterrent to unauthorized review of records. Access to sen- sitive records or portions of records should be sharply limited; this kind of access should also be tracked by the system and carefully monitored by the provider. Such records include HIV-antibody test results, records of drug and alcohol abuse patients, psychiatric records, and records of celeb- rity patients. With AIDS patients, the main and more easily accessible portion of the record can include a notation to use body fluid precautions without identifying the patient as having AIDS, hepatitis, or some other disease transmissible by body fluids. HIV-antibody test results can either be omitted from the automated system or stored in a restricted portion of the record. To the extent that sensitive records are not stored on the system, however, the advantages of a totally automated system cannot be realized. A provider with a computer-based patient record system that uses pass- words, access codes, and key cards should have and strictly enforce policies against disclosing or sharing such means of access. Alternatively, a pro- vider could use a system that identifies users biometrically through voice-

772 APPENDIX B prints, thumbprints, or other unique individual features; however, the so- phisticated technology required for this kind of system may still be prohibi- tively expensive for many health care providers. In a hospital, policies against sharing passwords, access codes, and key cards should apply to the medical staff as well as to employees. Violation of these policies should be grounds for discipline, up to and including termination of employment or revocation of medical staff membership. When employment or medical staff membership ends, computer access should terminate immediately. Hospital medical staff members should be asked to sign confidentiality statements acknowledging that passwords, access codes, and key cards are for personal use only. Physicians should be held liable for any entries to a record made by nurses or assistants using the physician's password. To discourage password and access code sharing, an individual should be available 24 hours a day to assist authorized users who forget their access codes and persons with a legitimate need for one-time record access. An institution should also develop a mechanism for overriding the computer security system in the event of an emergency. The use of computer networking, computer facilities owned or operated by others, or computer sharing could result in unauthorized access to com- puter-based records and breaches of confidentiality. In addition, outside computer consultants and technicians (including service personnel and ven- dor representatives) who obtain access to a computer-based patient record system conceivably could access records in an unauthorized manner or breach confidentiality. Thus, a provider should enter into confidentiality agreements with all outsiders who may have access to medical records and should have appropriate hardware and software security. To protect against mass access and extraction of information from a computer-based patient record system, the system should include special security measures against programs that permit mass copying of records at one time or that have the potential to access or alter large numbers of records at one time. Current computer security technology cannot provide perfect security for computer-based patient record systems. The security mechanisms available for decentralized systems and computer networks provide much less protec- tion than those available for mainframe systems. Given current technology, the need for security generally must be balanced with the need of health care professionals and hospital staff for easy, immediate access to patient records. Currently feasible security measures are particularly inadequate for net- worked systems and probably cannot protect providers that install com- puter-based record systems from substantial exposure to liability. To the extent that providers are aware of this exposure, they may be deterred from using computer-based patient record systems.

APPENDIX B 173 Computer Viruses and Other Computer Sabotage Computer viruses and other forms of computer sabotage pose real threats to the integrity of computer-based patient record systems. Viruses or other forms of sabotage can result in the alteration or destruction of data or the creation of false data on the system; they can also cause the system to slow down or crash or otherwise make patient records inaccessible, either tempo- rarily or permanently. Sabotage can be carried out by both insiders and outsiders and by both authorized and unauthorized system users. Health care providers cannot discount the possibility of sabotage by disgruntled employees. In fact, the biggest threat to system integrity and patient record confidentiality comes from employees and other insiders. The risk of viruses or other sabotage from the outside can be substan- tially reduced by eliminating all networking and electronic data sharing with outside computers and by not using any disk from an outside source. Such isolation of a system is generally infeasible, however, and would rule out hospital-physician office linkages and other networking for which there may be important clinical or research reasons. Antivirus software can aid in blocking or detecting viruses and other sabotage. Software vendors have been known to sabotage a system when payment has been withheld for a system's failure to meet contractual standards. There- fore, a system purchaser or lessor should consider insisting that vendors in- demnify the purchaser against all damage and losses resulting from keylocks, viruses, worms, bombs, and the like inserted into software by the vendor or its agents, and from other computer sabotage by the vendor or its agents. Providers using computer-based record systems have a legal obligation to take security measures that are reasonable, at least by current standards. Currently available security technology for networked patient record sys- tems is insufficient to give providers total assurance that the confidentiality of their records will not be breached or that the integrity of patient records on the system cannot be destroyed. One catastrophic incident involving a computer-based patient record system could set the legal status of com- puter-based record systems back decades. Therefore, development of im- proved security technology is of utmost importance. Potential for Inaccessibility Medicare, the JCAHO, and most state hospital licensure laws require that medical records for current hospital patients be readily accessible and stored in a way that permits prompt retrieval of information. Keeping computer- based patient records available means minimizing system downtime and having adequate backup mechanisms.

/ 74 APPENDIX B In addition to its potential for hindering patient care, which may result in negligence liability, excessive patient record system downtime may also create regulatory violations or JCAHO accreditation deficiencies. The fol- lowing precautions can help protect against inaccessibility of computer- based patient records: 1. properly maintaining hardware and thoroughly debugging and main- taining system software; 2. ascertaining other users' experience with system downtime and their ability to bring a system back up quickly prior to contracting for purchase or lease of a system; 3. including performance standards in any lease or contract with a ven- dor, as well as guarantees of reliability and of ongoing maintenance sup- port; 4. taking adequate precautions against sabotage of the system; and 5. having adequate backup and emergency capability. Questions of Durability Medical records must be durable for a number of reasons: to meet state licensure requirements, to comply with Medicare rules, to preserve a record of patient encounters for use as evidence in malpractice and other lawsuits, to permit future treatment of the patient or future notification to patients who have received treatment that creates health risks for them or their descendants, and, in some cases, to support research. Some states require hospitals to retain medical records for 25 years.54 A researcher or research institution may need to preserve medical records for as long as 75 years. Changes in technology that cause patient record systems to become ob- solete before the need for records stored on the systems has ended can mean that old and new systems do not interface. Another potential risk is that unproven new technology may lack durability. For example, the long-term durability of optical disks has not yet been proven. Copying patient records from an old system to a new system raises spe- cial concerns. Reliable evidence of the chain of copying must be preserved so that the copied records can be admitted as evidence in court. The pro- vider must also ensure that copied records comply with a state's hospital and other institutional licensure requirements as to the media in which pa- tient records can be retained. 54Conn. Public Health Code §19-13-D3(e)(6); Nev. Operational Rules and Regulations for Health Facilities §449.379-2 (1988); Lic. Rules for General Hospitals in N. Dakota §33-07-01- 16.3 (1990).

APPENDIX B 175 Accuracy Issues Errors in computer-based patient records can result from faulty soft- ware or equipment or from human error. A patient record system should be free from significant errors in computer hardware and software. Laboratory equipment and other machines providing input to a computer-based patient record system should also be free from such errors. Mechanisms for minimizing human error, such as reviews of input for accuracy, are also advisable. When corrections are made, they should be logged on the system as suggested in the previous section concerning eviden- tiary issues. If clinical observations are recorded using bar coding or other programmed codes, there should be a mechanism in place for visual confir- mation or other verification of the codes entered into the computer. Selected Legal Issues in Computer Contracting Leases and acquisitions of computers may involve some or all of the following: hardware, operating, and application software licenses; installa- tion, testing, and implementation services; and postinstallation maintenance and support services for both operating and application software and equip- ment. Use of multiple agreements to address these interrelated components of computer system acquisitions creates the risk of conflict among the agree- ments and may confuse even more the issues of what law applies to these agreements. Unless multiple agreements cannot be avoided (e.g., different vendors for the hardware/operating software and application software), a single agreement is preferable. Because of the hybrid nature of contracts for computer systems, it is not always clear what law governs issues of contract interpretation, the rights of the parties, procedures for resolving disputes, and so forth. If a court characterizes a transaction as a sale of goods, the Uniform Commercial Code will apply. However, computer system acquisitions involve both goods and services and often involve licenses rather than sales of software (to which the Uniform Commercial Code may or may not apply). An inaccurate product definition in a contract for a computer-based pa- tient record system or a product definition that is not sufficiently detailed can result in delivery of a system that does not function properly as a patient record system or in a contract that does not require the vendor to deliver a system that has certain important features or the capability to perform crucial patient record functions. It is common for system vendors to "puff the capabilities of their prod- ucts in their marketing materials and in their proposals to health care pro- viders or to promise software or features that are still on the vendor's drawing board. Although some contracting strategies help to minimize

776 APPENDIX B puffery and vaporware, no currently available mechanism provides complete protection against such practices. In addition, software licenses may present problems. If a software li- cense is not sufficiently broad in scope or duration, a provider can find itself paying unexpected additional license fees to maintain its system. An insufficiently broad license could also leave a provider without rights to use software that is crucial to the functioning of its patient record system. Access to the source code for software is essential to a health care pro- vider's ability to support and maintain patient record application software. Therefore, the provider should attempt to obtain a copy of the source code, either as part of the initial license grant or in the event that the vendor breaches its support obligations or decides to discontinue supporting the software. Bankruptcy, particularly among small vendors, may make it more difficult, or even impossible, to obtain the source code from a software escrow or in the event the vendor discontinues its software support. If software licensed or sold in connection with a patient record system infringes the intellectual property rights of another, the consequences to the provider that acquires the system can be severe—both in terms of liability and loss of the right to use the software. Therefore, vendors should be required to warrant that they own the software being licensed or have the right to sublicense it. In addition, the vendor should agree to indemnify the provider and hold it harmless against claims by third parties asserting that the software or the provider's use of the software, or both, infringes on their proprietary rights. Of course, none of the legal remedies available to a health care provider for a patient record system vendor's breach of contract is as desirable as the vendor's performance of the acquisition agreement. Therefore, it is important to structure payment schedules and conditions to payment in such a way as to give the vendor incentives to perform the agreement. The vendor should be required to warrant that the record system will meet key performance standards, such as system response time, capacity, and batch-processing capabilities. The use of such software mechanisms as viruses and keylocks to enforce a purchaser's obligation to pay for software is becoming increasingly common, particularly among smaller vendors. Be- cause the law in this area is still unclear, the provider should insist on a warranty in the acquisition agreement that the software does not and will never contain such mechanisms. The provider should also obtain indemni- fication for resulting losses and damage if such mechanisms are ever used in the acquired software. Contractual limitations on the vendor's liability should be avoided because they may leave a provider without recourse to the vendor when a patient record system fails to function or malfunctions. Such limitations on liability include limitation on the dollar amount of damages, exclusion of liability for consequential damages, limitation of

APPENDIX B 177 liability for a provider's use of a system, and limitation of remedies to special remedies (e.g., termination and refund rights). For health care providers who use shared computing services for a pa- tient record system, patient record confidentiality is of special concern be- cause the computing service receives copies of (and possibly maintains the originals of) the provider's patient records. The contract should require the computing services vendor to maintain strict confidentiality and to give the provider all necessary access to patient records (including but not limited to returning the data in usable form to the provider when the relationship ends). In addition, the contract should require the vendor to cooperate with the provider to prevent discovery of data by third-party litigants when dis- closure is not legally required. OVERCOMING LEGAL BARRIERS TO COMPUTER-BASED PATIENT RECORDS AND RECORD SYSTEMS Adoption of Uniform National Licensure Standards and Health Information Laws Uniform national standards should be developed for patient records main- tained by health care institutions. Such requirements could be enacted at the federal or state level; however, given that regulation of health care providers falls within classic state police powers, development of uniform state licensure standards for patient records would be preferable to enact- ment of federal requirements. The chief disadvantage of achieving national uniformity through uniform state laws is that enacting such laws may be a lengthy process or may never actually occur. In addition, state legislatures may adopt amendments to the uniform act before enacting it as legislation. Nevertheless, the success of other uniform state legislation (e.g., the Uni- form Commercial Code) suggests that such legislation could be developed and enacted by all 50 states. If enacted, these uniform state licensure stan- dards for medical records should be applicable to all institutional health care providers that are required to maintain patient records. The problems arising from obsolete and ambiguous state licensure stan- dards for medical records could be resolved by the development and enact- ment of uniform state licensure standards expressly applicable to computer- based records and record systems. These standards should be clearly stated with respect to automated creation, authentication, storage, and retention of patient records, but should not be so detailed as to inhibit future improve- ments in technology. In order to protect the confidentiality of health records and to provide patients rights of access to their health records and the right to include corrections to information in health records, all states should adopt uniform

178 APPENDIX B health care information legislation such as the Uniform Health-Care Infor- mation Act. Adoption of such legislation should make patients more will- ing to disclose sensitive information related to their health status and to have that information recorded in their health records. If such uniform legislation were in place, health care providers presum- ably would have less concern about unauthorized disclosure and misuse of sensitive patient information and should, therefore, be less hesitant to record sensitive patient information in a computer-based patient record. If legisla- tion were passed obligating third parties to whom patient information is disclosed to protect the confidentiality of such information, abuse of patient information and invasions of patient privacy should decrease. In addition, if health care information laws were uniform across all states, the appli- cable law would be clear and uniform, regardless of whether patient data were stored in the same state in which patients were located. Adoption by all states of uniform health care information legislation such as the Uniform Health-Care Information Act would provide predict- able access by patients to their health records and would ensure their being able to correct (or at least protest) inaccuracies contained in such records. Overcoming Special Legal Risks Related to Computer-based Patient Records Most of the special legal risks connected with computer-based patient records that are enumerated in this paper can best be reduced by develop- ment of new and better computer technology, including software specifi- cally designed to reduce these risks. The greatest legal risk from computer- based patient record keeping comes from unauthorized access to record systems and from computer viruses and other sabotage, particularly in cases in which computer networks are used and there is telephone access to the patient information system. Research efforts should be directed toward developing affordable computer security technology that can adequately protect patient records without severely reducing system user friendliness. The following would also help to reduce the potential legal risks associ- ated with computer-based systems: • Technological advances that make computer-based record systems more reliable and development of enhanced backup capabilities would decrease the legal risks, as well as the risks to patients, that arise when computer- based records become inaccessible. • Development of new storage media or technology that increases and ensures the long-term durability of records stored on optical disks and other currently available media would decrease the risks arising from the uncer- tain or inadequate durability of current computer-based patient records.

APPENDIX B 179 • More reliable equipment and software for computer-based patient record systems and better mechanisms for checking and correcting human input errors would help to reduce the risks that arise from inaccurate computer- based patient records. CONCLUSION The promise offered by fully computer-based patient records for im- proving the quality of patient care and advancing medical knowledge through research is enormous. Therefore, concerted efforts should be made to overcome legal and technological barriers that stand in the way of full development of computer-based records and record systems. In the future, with increasing use and development of artificial intelli- gence systems, computer-based patient records may be expected to become interactive, providing diagnostic assistance and even treatment recommen- dations. An interactive patient record promises improved quality of care, but the interaction of such "smart" systems with computer-based patient records will also raise a host of legal and policy issues that are beyond the scope of this paper. Among them will be allocation of responsibility (and liability) for errors in the artificial intelligence system, whether caused by faulty hardware, faulty software, or error in the system's medical rules. The more advanced such systems become, the more questions they will generate about the practice of medicine and whether nonphysicians can use these systems to diagnose and treat patients without physician involvement. In addition, systems that can diagnose or treat patients without interven- ing professional involvement may be classified and regulated as medical devices under food and drug laws. Finally, these "smart" systems can be ex- pected to lead to a redefinition of the physician's role, as they begin to perform functions that formerly only a physician could perform.

Index Academic research, 68, 70, 106, 115 Access issues, 18, 23, 30, 36, 37-39, 92, 135, 137 computer technology and, 24, 57 insurers, 36, 165, 166 legal right to, 39, 165-166, 170- 172, 173-174 outpatient records, 19 software source code, 176 system redundancy, fault tolerance, 74,75 system response, 39, 62, 76, 82, 101-102, 176 see also Confidentiality Accreditation, 21, 31, 33, 66, 105, 116, 124-125, 164, 170, 173, 174 Accuracy issues, 51, 66, 83, 163, 175 see also Errors and error analysis Acute disorders and care, 22, 79-80, 87 Administrative functions, 2,3,7,21, 45,49, 51,77, 137, 151 billing, 20, 34, 62, 76 costs, 2, 7, 24, 54, 149 Advocacy, patients, 109-110 Agency for Health Care Policy and Research, 22-23, 111, 120, 122, 123, 131, 140, 141 AIDS, 171 Ambulatory care records, see Outpatient records American College of Radiologists, 64 American Medical Society, 23, 162 American Society for Testing and Materials, 64 Arden syntax, 81 Artificial intelligence, 157, 179 see also Knowledge-based systems Attitudes toward diffusion of innovations, 98, 99-100, 101, 108 public, 109, 151 systems vendors, 91-93 B Bibliographic databases, 3, 25, 30, 48- 49,51,75, 80, 137 Billing, 20, 34, 62, 76 Case studies hospital information systems, 75-76 maternal and child health care, 129- 131 181

182 INDEX Centers for Disease Control. 1 11-1 12, 141 Change agents, 107-117, 119, 122, 124-125, 139, 140 Chart Checker, 79-80 Chronic diseases, general, 2, 20, 22 Clinical practice guidelines, 7, 23, 54, 120, 137, 146 Clinical processes and systems, 3, 4, 12, 22-23,41, 56-57, 77-82 decision support/problem solving, 7, 9, 11, 17-18, 19-20, 24-25, 30, 37,40,46-49, 51,61, 68, 73, 80-81, 92, 105, 137, 179 department-level information systems, 68, 69, 92 historical perspectives, 67-69 knowledge-based system, 30, 44, 48, 51,61,66,75,80-81, 137 laboratory tests, 20, 72, 79 linkages, 44 Classification, see Standards: data exchange and vocabulary Composite Health Care System, 77 Computer-based Patient Record Institute, 6, 123, 124, 133, 138, 139-141, 143, 144, 145, 147-151 Computer-Stored Ambulatory System Record Systems (COSTAR), 68, 71-73 Computers at Risk: Safe Computing in the Information Age, 145 Confidentiality, 2, 3, 4, 23, 38, 36, 42- 43,51, 103-104, 109, 125, 137, 144, 148, 156, 163, 164-165, 170-172, 177-178 contract provisions, 177 design for, 95 future systems, 50 individual practitioners' patient records, 13, 23 insurer access and, 36, 165, 166 pharmacy records, 13 privacy defined, 23 secondary databases, 66 standards, 87, 144 state law, 103-104, 164-165 technological aspects, 66, 82, 83- 85 Connectivity, see Linkage and integra- tion Content issues, 15, 16-17, 36 definition of, 119, 139 outpatient records, 19 standards, 19, 96, 143 tables of, in computerized records, 38 Contracts, 156-157, 175-177 Coordination, see Organizational factors COSTAR, 68, 71-73 Cost factors, 2, 5, 9, 14, 22, 24, 45, 49, 109, 110, 114, 117, 125-126, 134, 135, 137, 138, 142, 145-146 administrative, 2, 7, 24, 54, 149 clerical, 79, 97 computing technology, 25-26, 61-62, 68, 82, 83, 92, 93, 97, 102 data entry, 40, 45, 82 demonstration projects, 113 design and development aspects, 95, 96-97, 96-98, 120 diffusion of technology, 101-102 hospital systems, 9, 19, 20, 93, 97 insurers, 21-22, 101, 110, 150 malpractice insurance, 80 maternal and child health care program, 112 medical information systems, 97, 102 per patient, 9, 101 secondary databases, 6, 66, 133, 149 sharing, 6, 7, 133, 121-124, 139, 149-150, 152 standards, 102 technological innovations, general, 25-26, 61-62, 68, 82, 83, 92, 93, 97, 102 voice recognition, 83 Council on Ethical and Judicial Affairs of the American Medical Association, 162 Court cases, see Litigation

INDEX 183 D Database management systems, 57, 59- 60, 135 specific, 67-81 Databases, 6, 57-59, 104, 106, 135 AM A guidelines, 162 bibliographic, 3, 25, 30, 48-49, 51, 75, 80, 137 federal role, 23 linkage of, 5, 25, 44, 45, 51, 61, 62- 63, 66-67, 80; see also Networks problem-oriented medical record, 47 query languages, 62, 73 secondary, 5, 6, 11-12, 25, 30, 51, 33-34, 54, 66-67, 80, 117, 119, 133, 135, 137, 138, 139, 147-149 specific, 67-81 see also Knowledge-based systems Data entry, 73-74, 78, 81-82, 92, 93, 142 cost factors, 40, 45, 82 errors, 40, 45, 61 physician incentives, 82, 101, 124, 142 voice recognition, 62, 82-83, 87, 135, 142 Data quality, 40-42 Data retrieval, 3, 4, 9, 61-62, 67, 135, 137 Data storage, general, 37-46, 67 Decentralized Hospital Computer Program, 76-77 Decision support and problem solving, 7, 9, 11, 17-18, 19-20, 24-25, 30, 37, 40, 46-49, 51, 61, 68, 73, 80-81, 92, 105, 137, 179 knowledge-based systems, 30, 44, 48, 51, 61, 66, 75, 80-81, 137 Defense Advanced Research Projects Agency (DARPA), 106 Definitional issues, 11-12, 46, 51, 119, 139 contract law, 175 change agents versus stakeholders, 107, 140 computer-based patient record, 11, 51,91-92,95 data integrity, 42^-3 development versus diffusion, 94 health care needs, 30-35 hearsay, evidence, 168 patient records, 11, 51, 91-92, 95 privacy, 23 users, 31 Demographic factors, 2, 20, 22, 26, 72, 129-130, 151 see also Epidemiology Demonstration projects, 5, 6, 23, 113, 116, 117, 119, 124, 138, 139, 141, 142 Department-level information systems, hospitals, 68, 69, 92 Department of Defense, 77, 85-86, 97, 106, 113, 121, 122, 131 Department of Energy, 106 Department of Health and Human Services, 111, 120, 123, 141 see also specific subordinate agencies Department of Veterans Affairs, 76-77, 85-86,97, 113-114, 121, 122, 131 Design and development, 5, 7, 23, 56, 94-98, 94-98, 107-125, 138, 141 costs, 95, 96-97, 96-98, 120 defined, 94 modular, 72, 76-77, 80-81 problem-oriented medical record, 47 for system phasing, 49 Dictionaries, see Vocabulary control Diffusion, innovations, 1, 4-5, 25, 95, 98-107, 125, 138 attitudes, 98, 99-100, 101, 108 costs, 101-102 defined, 94 insurers, 99, 101, 102, 110-111 see also Education and training; Professional education DIOGENE, 78, 83 Drugs, see Pharmacies and pharmaceu- ticals

184 INDEX E Early Clinical Information System, 76 Economic issues physician incentives, data entry, 82, 101, 124, 142 productivity, 2, 24, 50, 110, 149 see also Cost factors; Financial factors; Funding Education and training, 5, 7, 23 change agents and stakeholders, 119, 139 diffusion of innovations, general, 98, 99-101, 102, 117 patient, 31, 39 users, general, 5, 39, 99-101 see also Professional education Efficiency/effectiveness, 9, 14, 22, 23, 45-46, 51, 83, 117, 119, 123, 135 system response time, 39, 62, 76, 82, 101-102, 176 Electronic mail, 3, 75, 106, 145 Emergency care, see Acute disorders and care Employers and employment, 22, 110- 111 Encounter-oriented medical records, 71 Epidemiology, 44, 83 national, 22, 111, 130 risk factors, 22, 40, 49 Error and error analysis, 175 data entry, 40, 45, 61 on-line, 46, 61 voice recognition, 83 see also Accuracy issues Evaluation, 31, 138 computer applications costs, 97 data validity tags, 43 of patient care, defined, 12 peer review, 21, 113 reliability of records, 15, 37, 65-66 see also Efficiency/effectiveness Event-oriented medical records, 73 Exmouth Project, 78-79 Expert systems, see Knowledge-based systems Federal government, 6, 21, 22-23, 76- 77, 111-114, 117, 120-124, 129- 131, 140-141 Computer-based Patient Record Institute, 6, 123, 124, 133, 138, 139-141, 143, 144, 145, 147- 151 cooperation with public sector, 87, 121-124, 138, 140, 141 funding, 6, 111, 120-124, 140-141 interagency coordination, general, 131, 140, 141 national information system, 6, 51- 54, 122-124, 125, 129, 130, 133, 138-141, 145 organizational role, general, 22-23, 131, 140, 141 research, 23, 111, 120-121, 130, 131 standards, 22, 23, 85-87, 111, 117 see also Laws, specific federal Federal Networking Council, 106, 145 Federal Privacy Act, 164 Financial factors, 2, 5, 7, 21, 38, 54, 75-76 federal role, 21,22-23 see also Billing; Cost factors; Funding; Insurance and insurers Flexibility, 43, 69, 93, 135, 137 Flow sheets, 17 Food and Drug Administration, 104- 105, 141, 145 Foundations, 117, 119, 141, 145 Format issues, records, 15, 17-18, 36, 46-47, 71 outpatient records, 19 problem-oriented, 17-18, 46-47, 49, 71, 73, 80 standards, 19, 96, 142, 147 tables of contents/indexes, 38 Funding, 5, 6, 99, 111, 117, 121, 130, 133, 135, 138, 140-141 federal, 6, 111, 120-124, 140-141 hospital systems, 97 standards development, 85

INDEX 185 G General Accounting Office, 8-9, 97, 123-124 Government role, see Federal govern- ment; Local governments; State governments; and specific departments and agencies Graphics, 3, 49, 51, 60, 61-62, 106, 135 windowing, 73, 93 see also Images and image process- ing Group practices, 70-71 H Harvard Community Health Plan, 68, 71-73 Harvard Medical School, 75 HEALTH, 111 Health Care Financing Administration, 21, 85-86, 87, 112-113, 120- 121, 122, 131, 141, 163 Health Evaluation through Logical Processing (HELP), 68, 74-75, 81, 83 Health maintenance organizations, 71- 73 Health Resources and Services Admin- istration, 112, 129-130, 131, 141 Hearsay, evidence, 168-170 High-Performance Computing Act, 106 Historical perspectives, 4, 8, 12-13, 67-69 committee study, 9-11 COSTAR, 68, 71-73 hospital systems, 67, 97 networks, 106 THERESA, 68, 73-74 HL 7 standards, 64 Hospitals systems, 38, 45, 67, 73-77, 92 costs, 9, 19, 20, 93, 97 defined, 12 department-level information systems, 68, 69, 92 historical perspectives, 67, 97 licensure laws, 103, 157-161, 173 multi-institution, 24, 44, 76-77, 97, 113, 121 THERESA, 68, 73-74, 83 Human-computer interface, see Users Images and image processing, 20, 24, 60, 62, 63, 70-71, 106, 135, 145 see also Graphics Indexes, 38 Information Security Foundation, 145 Insurance and insurers, health, 3, 6, 21- 22,31, 33, 34, 114, 125-126, 133, 150 confidentiality and access by, 36, 165, 166 contract provisions, 177 cost factors, 21-22, 101, 110, 150 diffusion of innovation and, 99, 101, 102, 110-111 electronic claims submission, 45 employer provided, 110-111 health maintenance organizations, 71-73 physician incentives, data entry, 101, 124 see also Medicaid; Medicare Insurance Information and Privacy Protection Model Act, 166 Insurance, malpractice, 80 Institute of Electronic and Electrical Engineers, 143 Institute of Medicine, 1, 9-10, 15, 23, 91, 114, 132, 151 Integrated Academic Information Management System, 116 Integrated Services Digital Network, 65 Intellectual property, 176 Intelligence, 5, 36, 37 artificial intelligence, 157, 179 see also Knowledge-based systems Intermountain Health Care Corporation, 74

M'6 INDEX International programs and activities, 78-79. 95, 143-144 Internet, 106 Joint Commission on Accreditation of Healthcare Organizations, 21, 116, 121, 164, 170, 173, 174 K Knowledge-based system, 30, 44, 48, 51, 61,66, 75, 80-81, 137 Laboratory tests, 20, 72, 79 Laws, specific federal Federal Privacy Act, 164 High-Performance Computing Act, 106 Omnibus Budget Reconciliation Act, 22-23, 113 Social Security Act, 129, 130 Uniform Health-Care Information Act, 148, 166, 178 Legal issues, 5, 98, 103-105, 117, 138, 139, 148-149, 156-179 contracts, 156-157, 175-177 evidentiary, 167-170 licensure laws, 103, 148, 156, 157- 162, 176, 177-178 information access, right to, 39, 165-166, 170-172, 173-174; see also Confidentiality intellectual property, 176 malpractice, 80, 100 ownership of data, 103, 148, 167, 176 systems defect liability, 105, 156 vendors, 105, 156-157, 158, 175- 177 viruses, computer, 173, 178 see also Laws, specific federal; Litigation; Regulations Legislation, 46 model, 6, 148-149, 166, 177-178 see also Laws, specific federal Linkage and integration, 3, 18, 36, 43- 45, 51, 137 confidentiality and, 103 of databases, 5, 25, 44, 45, 51, 61, 62-63,66-67,80, 135, 137; see also Secondary databases development and diffusion re- sources, 5, 7 financial-care information, 21 multi-site care, 24, 44, 76-77 see also Organizational factors Lockheed Corporation, 76 Licensure laws, 103, 148, 156, 157- 162, 176 national, 177-178 Litigation, 21, 35 contracts, 175 evidentiary issues, 167-170 systems defect liability, 105, 156 Longitudinal approaches, 22 institutional planning, 21 patient records, 3, 4, 17, 22, 24, 130 M Malpractice, 80, 100 Management of care, general, 21, 34, 49, 50; see also Administrative functions Maternal and child health care program, 112,129-131 Medicaid, 113, 130, 162 Medical information systems, 67 costs, 97, 102 defined, 12 Medical Logic Modules, 80-81 The Medical Record (TMR), 70-71 Medicare, 112-113, 114, 121 peer review, 21, 113 regulations, 162-164, 170, 173 Medix, standards, 64 MEDLARS, 111 MEDLINE, 80, 111 MILNET, 106 Modular design, 72, 76-77, 80-81

INDEX 187 N National Aeronautics and Space Administration, 106 National Association of Insurance Commissioners, 166 National Conference of Commissioners on Uniform State Laws, 104 National Research and Education Network, 106-107, 145 National Electrical Manufacturers Association, 64 National Institutes of Health, 9,111 National Library of Medicine, 80, 111, 116, 122 National Research Council, 10 National Science Foundation, 106 Networks, 5,1, 24, 51, 65, 106, 142, 145 design for, 95 diffusion of innovations, 98, 105- 107 electronic mail, 3, 75, 106, 145 national information systems, 6, 51- 54, 106-107, 119, 122-124, 125, 129, 130, 133, 138-141, 145 security, 44, 52, 104, 172 standards, data exchange and vocabulary, 4, 6, 7, 41-42, 52, 62, 63-65, 72, 82, 83, 85-87, 96, 105-107, 111, 119, 124,125, 130, 131, 133, 135, 137, 139, 142- 144, 147-148, 152 Nurses, chart writing, time spent, 19 o Office of Technology Assessment, 97 Omnibus Budget Reconciliation Act, 22-23, 113 Organizational factors, 5-6, 7, 8, 118- 124, 132, 135-136, 138-139 accreditation, 21, 31, 33, 66, 105, 116, 124-125, 164, 164, 170, 173, 174 change agents and stakeholders, 107-117, 119, 122, 124-125, 135, 139, 140 Computer-based Patient Record Institute, 6, 123, 124, 133, 138, 139-141, 143, 144, 145, 147-151 cost sharing, 6, 7, 133, 121-124, 139, 149-150, 152 federal interagency coordination, 131, 140, 141 federal role, general, 22-23, 131, 140, 141 institutional planning, 21, 92 health care system, general structure, 98-99, 135 medical record practices, physicians, 15, 17, 19 private/public cooperation, 87, 121- 124, 138, 140, 141 professional associations, 6, 21, 23, 99, 109, 116, 121, 124, 135-137, 150, 162, 164, 166, 170, 173, 174 standard-setting organization, 126 technological innovation, 94, 107- 117, 124-125 see also Administrative functions; Format issues; Linkage and integration; Management of care Outpatient records, 19, 68, 97 COSTAR, 68, 71-73 summary time-oriented record, 18 Ownership issues, 103, 148, 167, 176 PaperChase, 75 Paper records, 13-19, 37, 40, 46, 134 Patient record, general, 12-13 defined, 11, 51, 91-92, 95 paper, 13-19, 37,40,46, 134 users and uses, 31-34 Patients, general, 109-110 access to information, legal right, 39, 165-166, 170-172, 173-174 cost per, 9, 101 as data users, 21, 39 education, 31, 39 see also Confidentiality Peer review, 21, 113 Personal identification numbers, 104

188 INDEX Pharmacies and pharmaceuticals, 13, 20. 113 Physician Payment Review Commis- sion, 114 Physicians, 3, 20,43, 70-71 confidentiality, 13, 23 data entry incentives, 82, 101, 124, 142 diffusion of innovations, 100 group practices, 70-71 managers, relationship, 49 medical record practices, 15, 17, 19 personal computer system, England, 79 time factors, 19, 39 Physicians' Desk Reference, 75 Personal computers, 79, 80 Policy development, 33, 35, 38 Politics, 2,4-5, 151 public opinion, 109, 151 Population dynamics, see Demographic factors Poverty, 112 maternal and child health care, 112, 129-131 Medicaid, 113, 130, 162 Primary patient record, general, 33, 34 defined, 11 Privacy, see Confidentiality Private sector, 6, 133, 35, 85, 121-122, 124 cooperation with public sector, 6, 87, 121-124, 133, 138, 140, 141 employers, 110-111 foundations, 117, 119, 141, 145 information system vendors, 56, 91- 93, 105, 116-117, 118, 125, 141, 156-157, 158, 175-177 see also Insurance and insurers; Professional associations and societies Problem-knowledge coupler, 80 Problem-oriented medical record (POMR), 17-18, 46-47, 49, 71, 73,80 Problem solving, see Decision support and problem solving Productivity health professionals, 2, 24, 50, 149 insurers and, 110 Professional associations and societies, 6,21,99, 109, 124, 135-137, 150, 166 AMA, 23, 162 JCAHO, 21, 116, 121, 164, 170, 173, 174 Professional education, 6, 24-25, 31, 33, 35,48-49, 115-116, 124, 125, 133, 138, 139, 150-151 academic research, 68, 70, 106, 115 diffusion of innovations, 98, 99-101, 102, 117 physicians, 39 teaching hospitals, 38 Professionals, general, 6, 7, 32, 108- 109, 124, 134, 136-137 licensure laws, 162 productivity, 2, 24, 50, 149 see also Nurses; Physicians; Users Projections, 12, 50-54, 137 digital switching, 65 imaging, 63 text processing systems, 62 Prospective Payment Assessment Commission, 114 Prototypes, see Demonstration projects Public Health Service, 22, 131, 141 Public opinion, 109, 151 Quality control, 31, 33, 40^*2, 142, 146-147 accreditation, 21, 31, 33, 66, 105, 116, 124-125, 164, 164, 170, 173, 174 of care, 2, 7, 20, 24, 49, 50, 79, 101, 109, 110, 114, 134, 137, 146-146 of data, 40-42, 46 on-line, 46, 61 see also Accreditation; Error and error analysis; Regulations; Standards Query languages, 62, 73

INDEX 189 Read Clinical Classification, 64 Real time, 67, 113 Recommendations, IOM, general, 6-7, 132-152 Redundancy, fault tolerance, 74, 75 Registered Record Administrators (RRAs), 151 Regulations, 6, 35, 46, 103-105, 133, 148-149, 160-161 Medicare, 162-164, 170, 173 see also Licensure laws; Standards Reliability, 15, 37, 51, 65-66, 135, 174 design for, 95 see also Accuracy issues Research, 3, 4, 5, 6, 10, 24, 31, 33, 35, 66, 125, 138, 141-142, 146, 178 academic, 68, 70, 106, 115 demonstration projects, 5, 6, 23, 113, 116, 117, 119, 124, 138, 139, 141, 142 epidemiology, 22, 44, 40, 49, 83, 111, 130 federal role, 23, 111, 120-121, 130, 131 health services, support of, 1, 2, 50 problem-oriented medical record, 47 uniform record systems, 42 see also Design and development Risk factors, 22, 40, 49 Secondary databases, 5, 6, 25, 30, 51, 33-34, 54, 66-67, 80, 117, 119, 133, 135, 137, 138, 139, 147- 149 costs, 6, 66, 133, 149 defined, 11-12 Security, data, 42-43, 65-66, 82, 83- 85, 103-104, 135, 171, 170-173 design for, 95 networks, 44, 52, 104, 172 standards, 4, 6, 7, 52, 87, 119, 124, 133, 139, 142, 144-145, 147- 148, 152 see also Confidentiality Smart cards, 78-79 Social factors, 103-105, 112, 130 politics, 2,4-5, 109, 151 public opinion, 109, 151 Social Security Act, 129, 130 Speech recognition, see Voice recogni- tion Stakeholders, 107-117, 122, 135, 139 Standard Guide for Nosologic Stan- dards and Guides for Construc- tion of New Biomedical Nomen- clature, 64 Standards, 5, 6, 7, 66, 87-88, 116, 117, 119, 133, 136-137, 142-148, 177-178 accreditation, 21, 31, 33, 66, 105, 116, 164, 164, 170, 173, 174 clinical practice guidelines, 7, 23, 54, 120, 137, 146 confidentiality, 87, 144 content, general, 19, 40-42, 96, 142, 143 cost factors, 102 database queries, 62, 73 data exchange and vocabulary, 4, 6, 7, 41-42, 52, 62, 63-65, 72, 82, 83,85-87,96, 105-107, 111, 119, 124, 125, 130, 131, 133, 135, 137, 139, 142-144, 147- 148, 152 federal role, 22, 23, 85-87, 111, 117 format, general, 19, 40-42, 43, 147 international, 79, 143-144 outpatient records, 19 security, 4, 6, 7, 52, 87, 119, 124, 133, 139, 142, 144-145, 147- 148, 152 state-level, general, 160 see also Licensure laws State governments, 6, 113, 115, 117, 125, 130-131, 133, 148, 156-179 confidentiality laws, 103-104, 164- 165 demonstration projects, 113, 124 licensure laws, 103, 148, 156, 157- 162, 173, 177-178

190 INDEX model legislation, 6, 148-149, 166, 177-178 standards, 160 Statistical analysis, 49, 51, 74 Summary time-oriented record, 18 Surgery, 77 Systematized Nomenclature of Medi- cine, 64 Task-oriented medical records, 71, 73 Technicon, 76 Technological innovations, 2, 4, 24, 30, 37,50,56-88,91-93,94 barriers, general, 82-87 confidentiality and, 66, 82, 83-85 costs, 25-26, 61-62, 68, 82, 83, 92, 93, 97, 102 see also Design and development; Diffusion; Research Telecommunications, 65 electronic mail, 3, 75, 106, 145 reliability, 51 workstation linkages, 44 see also Networks Text processing, 62-63, 64, 82, 83, 87, 135 THERESA, 68, 73-74, 83 Third-party payers, see Insurance and insurers; Medicaid; Medicare Time factors, 20 chart writing, 19 clerical functions, 79, 97 clinician/MEDLINE linkage, 80 data timeliness, 43 design and development of systems, 97 system response, 39, 62, 76, 82, 101-102, 176 see also Longitudinal approaches Time-oriented medical record, 71, 73 TMR (The Medical Record), 70-71 Transfer of technology, see Diffusion u Unified Medical Language System (UMLS), 62-63, 64-65, 111, 144 Uniform Clinical Data Set, 87, 112-113 Uniform Commercial Code, 156, 175, 177 Uniform Health-Care Information Act, 148, 166, 178 United Kingdom, 64, 78-79 Universities, 115-116 academic research, 68, 70, 106, 115 UNIX, 93 Users, 2-3, 14, 21, 26, 30-49, 99-101, 137 computer interface with, general, 43, 44, 82-83, 135 diffusion of innovations, 98, 99-101 needs, general, 2-3, 32-49 multiple, 21 patients as, 21, 39 projections, 50-54 see also Access issues; Change agents; Stakeholders Vendors, 56, 116-117, 118, 125, 141 legal issues, 105, 156-157, 158, 175-177 survey of, 91-93 Veterans Administration, see Depart- ment of Veterans Affairs Viruses, computer, 173, 178 Vocabulary control, 4, 6, 7, 41-42, 52, 62, 63-65, 72, 82, 83, 85-87, 96, 105-107, 111, 119, 124, 125, 130, 131, 133, 135, 137, 139, 142-144, 147-148, 152 Voice recognition, 62, 82-83, 87, 135, 142 w Windowing, 73, 93 Word processing, see Text processing Workstations, 44, 60-61, 135

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