Clinical Data as the Basic Staple of Health Learning Creating and Protecting a Public Good: Workshop Summary (2010) / Chapter Skim
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8 Clinical Data as the Basic Staple of Health Learning: Ideas for Action
8 Clinical Data as the Basic Staple of Health Learning: Ideas for Action
Pages 249-268
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From page 249... ...
Although many challenges exist to the use of such data -- coding discrepancies, platform incompatibilities, patient protection tools -- as evident throughout this publication, practical approaches can be developed for most. The most significant challenge may be the barrier to data access and the restrictions in treating clinical outcome data as a proprietary commodity.
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From page 250... ...
The • starting point for expanded access and use of clinical data for knowledge development is agreement on some of the fundamental notions to guide the activities for all individuals and organizations with responsibility for managing clinical data. Workshop partici pants repeatedly mentioned the need for consensus on approaches to such issues as data structure, standards, reporting requirements, quality assurance, timeliness, deidentification or security measures, access, and use procedures -- all of which will determine the pace and nature of evidence development.
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From page 251... ...
Patient demand could be instrumental in spreading the availability of electronic health records for improving patient care and knowledge development. Such demand will depend upon much greater patient access to, comfort with, and regular use of programs that allow either the maintenance of personal elec tronic health records or access through a dedicated portal to their provider-maintained electronic medical record.
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From page 252... ...
ISSUES AND OPPORTUNITIES Workshop discussions touch on various issues and opportunities to improve the clinical data utility. These related to notions summarized below on clinical data stewardship, clinical data infrastructure, incentives for data sharing, creating the next generation data utilities and models, creating next generation data policies, and engaging the public.
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From page 253... ...
If an overarching goal is to make data more readily available and accessible for informing medical decision making, new solutions need to be identified and implemented to ease the tensions inherent in data ownership. A significant challenge noted by participants is the need to break down barriers to data access based in assumptions and practices that treat clinical outcome data as a proprietary commodity.
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From page 254... ...
For example, instead of looking at how to achieve public health objectives from a data perspective, progress may require approaching issues and opportunities in evidence collection from the perspectives of medical decision makers, defined broadly to include providers, consumers, payers, and policy makers. Such a model for the clinical data utility would start in a climate of trust, with a policy framework that enables information liquidity.
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From page 255... ...
The model of the Human Genome Project was offered as an example of the benefit of open data sharing, as were the public registration of clinical trials and the growth of new models of disclosure/publication of research results in open-access journals and digital repositories. Expanded access and use, though, go hand in hand with clarity, assurance, and transparency as to security safeguards and nature of health research processes.
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From page 256... ...
has developed The Coverage with Evidence Development program to require the delivery of clinical data over and above the typical claims data as a provision for payment for certain services. Such an approach has the potential to provide significant amounts of information if we can learn how to meet the challenge of what we can do with data that have been collected, and merge those data with other sources of data so that data collection can inform clinical practice.
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From page 257... ...
There was also the sense that correction is needed to what is perceived as a market failure for expanding electronic health records. As evidenced by participant observations such as the insufficient demand by providers or patients in the face of the considerable expense of EHR adoption to small organizations, and challenges related to the diversity of platforms and reporting requirements, market incentives have not resulted in the large-scale EHR adoption needed.
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From page 258... ...
Importantly, though, strong policies and clear operating standards are needed when anyone, including patients, access and use sensitive health information. Interoperability, Data Aggregation, and Data Mining Across the $2.5 trillion healthcare system few resources are devoted to data sharing, despite its centrality to patient care and improvement.
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From page 259... ...
Workshop presentations illustrated that while some progress has been made in all of these areas, additional efforts are needed, including collaborative initiatives involving many stakeholders and a commitment of more energy and resources to the ongoing collection, integration, and interpretation of health data in order to better inform policy makers and the public. In an examination of the trade-offs between pulling data from different data aggregators and the concept of a pooled mega-database, it was suggested that the need is growing for such a database that would pull data from different health plans, the Department of Veterans Affairs, state Medicaid programs, Medicare, and other sources.
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From page 260... ...
Although large repositories of controlled clinical trial data exist, including primary data, much of that information exists on paper in various archives, not in any electronic form that would enable sharing. Efforts to digitize health records continue, but further work is needed to effectively retire the paper generation and fully migrate data to electronic forms.
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From page 261... ...
HIPAA's Privacy Rules were characterized as confusing and, among other drawbacks, HIPAA limits the portability of data and overall data sharing, does not encourage standardization, and is inadequate in ensuring timely use of data. Moreover, enforcement of HIPAA was seen as nearly nonexistent.
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From page 262... ...
; guidance on implementation specification to deidentify protected health information; individual right to access personal information in electronic format; annual guidance on the most effective technical safeguards for carrying out the HIPAA Security Rule; recommendations on technologies that protect the privacy of health information and promote security; restrictions on use of protected health information for marketing; and consumer access required to an accounting of disclosures of information maintained in EHRs" (Markle Connecting for Health Collaborative. Achieing the Health Objecties of the American Recoery and Reinestment Act [April 2009]
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From page 263... ...
Such efforts simultaneously present the opportunity to reinstate the patient as the focal point of the data utility, in contrast to a role somewhere on the periphery, and to engage the public as a key driver of change to improve data utility overall. Finding genuine ways to respond to the public's desires regarding key issues, including access to data in language they can understand, portability of individual data throughout the healthcare system, and quality data that informs health care at the point of care was viewed as an important means to fostering broader public engagement in a healthcare system.
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From page 264... ...
To date, there has not been a public demonstration of the utility of data sharing and of the potential impact of data on personal lifestyle, bottom line, or other meaningful endpoints -- an area viewed by some participants as ripe for further exploration. National public information campaigns and programming could go a long way to help convince consumers and patients of the public good aspect of sharing their medical data.
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From page 265... ...
As noted by several participants, some hospitals and research institutions have shown innovation in educating their patients about how important clinical research is to patient care; many have started what are essentially marketing campaigns to educate patients and their families on the importance of participation in clinical trials and related research endeavors. Learnings from these initial efforts might help shape broader efforts to educate people on the importance and potential benefits of using data for secondary purposes.
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From page 266... ...
2. Use of electronic health records for knowledge deelopment: Con vene an affinity group of EHR users and vendors to consider approaches to cooperative work on knowledge development, including issues related to standards and rules for governed data query and application (EHR Innovation Collaborative)
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From page 267... ...
2 IDEAS FOR ACTION These issues, and other related issues, will be further explored by the members of the IOM Roundtable on Value & Science-Driven Health Care, in collaboration with their colleagues in the field.
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