Health IT and Patient Safety Building Safer Systems for Better Care (2012) / Chapter Skim
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To protect America's health, health IT must be designed and used in ways that maximize patient safety while minimizing harm. Information technology can better help patients if it becomes more usable, more interoperable, and easier to implement and 1 The IOM identified six aims of quality improvement, stating that health care should be safe, effective, patient-centered, timely, efficient, and equitable.
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, and health information exchanges; excluded is software for medical devices. Clinicians expect health IT to support delivery of high-quality care in several ways, including storing comprehensive health data, providing clinical decision support, facilitating communication, and reducing medical errors.
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that can prevent users from sharing information about health IT–related adverse events. These barriers limit users' abilities to share knowledge of risk-prone user interfaces, for instance through screenshots and descriptions of potentially unsafe processes.
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Safer implementation and use of health IT is a complex, dynamic process that requires a shared responsibility between vendors and health care organizations. Features of Safer Health IT Safely functioning health IT should provide easy entry and retrieval of data, have simple and intuitive displays, and allow data to be easily transferred among health professionals.
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Testing at each of these stages is needed to ensure successful use of health IT. Responsible use requires diligent surveillance for evolving needs, gaps, performance issues, and mismatches between user needs and system performance, unsafe conditions, and adverse events.
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PATIENTS' AND FAMILIES' USE OF HEALTH IT: CONCERNS ABOUT SAFETY Health IT products are also being developed to engage and support patients and their families in decision making and management of their own personal health information. Examples of electronic patient engagement tools include PHRs (both integrated and freestanding)
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Recommendation 3: The ONC should work with the private and public sectors to make comparative user experiences across vendors publicly available. Another area necessary for making health IT safer is the development of measures.
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An appropriate balance must be reached between government oversight and market innovation. To encourage innovation and shared learning environments, the committee adopted the following general principles for government oversight: • Focus on shared learning, • Maximize transparency, • Be nonpunitive, • Identify appropriate levels of accountability, and • Minimize burden.
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High-priority health IT– related adverse events include death, serious injury, and unsafe conditions. Analyses of unsafe conditions would produce important information that could have a great impact on improving patient safety and enable adoption of corrective actions that could prevent death or serious injury.
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The committee believes reports of health IT–related adverse events and unsafe conditions that are verified and free of user-identifying information should be transparently available to the public. The committee believes reporting of deaths, serious injuries, or unsafe conditions should be mandatory for vendors.
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Because current federal agencies do not have this as their charge, nor the baseline funding to take on these activities, the committee believes an independent, federal entity is the best option to provide a platform to support shared learning at a national level. Recommendation 8: The Secretary of HHS should recommend that Congress establish an independent federal entity for investigating patient safety deaths, serious injuries, or potentially unsafe conditions associated with health IT.
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FDA has chosen to not exercise regulatory authority over EHRs, and controversy exists over whether some health IT products such as EHRs should be considered medical devices. If the Secretary deems it necessary for FDA to regulate EHRs and other currently nonregulated health IT products, clear determinations will need to be made about whether all health IT products classify as medical devices for the purposes of regulation.
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If progress toward safety and reliability is not sufficient as determined by the Secretary, the Secretary should direct FDA to exercise all available authorities to regulate EHRs, health information exchanges, and PHRs. Recommendation 9b: The Secretary should immediately direct FDA to begin developing the necessary framework for regulation.
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Transparency and cooperation between the private and public sectors are critical to creating the necessary infrastructure to build safer systems that will lead to better care for all Americans.
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