IOM calls for sweeping efforts on patient safety
The IOM’s 10 recommendations:
Recommendation 1: The Secretary of Health and Human Services (HHS) should publish an action and surveillance plan within 12 months that includes a schedule for working with the private sector to assess the impact of health IT on patient safety and minimizing the risk of its implementation and use.
Recommendation 2: The Secretary of HHS should ensure insofar as possible that health IT vendors support the free exchange of information about health IT experiences and issues and not prohibit sharing of such information, including details (e.g., screenshots) relating to patient safety.
Recommendation 3: ONC should work with the private and public sectors to make comparative user experiences across vendors publicly available.
Recommendation 4: The Secretary of HHS should fund a new Health IT Safety Council to evaluate criteria for assessing and monitoring the safe use of health IT and the use of health IT to enhance safety. This council should operate within an existing voluntary consensus standards organization.
Recommendation 5: All health IT vendors should be required to publicly register and list their products with ONC, initially beginning with EHRs certified for the meaningful use program.
Recommendation 6: The Secretary of HHS should specify the quality and risk management process requirements that health IT vendors must adopt, with a particular focus on human factors, safety culture, and usability.
Recommendation 7: The Secretary of HHS should establish a mechanism for both vendors and users to report health IT-related deaths, serious injuries, or unsafe conditions.
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. This entity should also monitor and analyze data and publicly report results of these activities.
Recommendation 9a: The Secretary of HHS should monitor and publicly report on the progress of health IT safety annually beginning in 2012. If progress toward safety and reliability is not sufficient as determined by the Secretary, the Secretary should direct the FDA to exercise all available authority to regulate EHRs, health information exchanges, and PHRs.
Recommendation 9b: The Secretary should immediately direct the FDA to begin developing the necessary framework for regulation. Such a framework should be in place if and when the Secretary decides the state of health IT safety requires FDA regulation as stipulated in Recommendation 9a above.
Recommendation 10: HHS, in collaboration with other research groups, should support cross-disciplinary research toward the use of health IT as part of a learning health care system. Products of this research should be used to inform the design, testing and use of health IT.
Specific areas of research include:
a. User-centered design and human factors applied to health IT,
b. Safe implementation and use of health IT by all users,
c. Sociotechnical systems associated with health IT, and
d. Impact of policy decisions on health IT use in clinical practice.