clear the reasons why further oversight actions are or are not needed. In parallel, the Secretary should ask FDA to begin planning the framework needed for potential regulation consistent with Recommendations 1 through 8 so that, if she deems FDA regulation to be necessary, the agency will be ready to act, allowing for the protection of patient safety without further delay. The committee recognizes that not all of its recommendations can be acted on by the Secretary alone and that some will require congressional action.

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 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. 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.


The committee identified a number of research gaps during its information gathering. Research is needed to continue to build the evidence to determine how to develop and adopt safer health IT most effectively. A greater body of conclusive research is needed to fully meet the potential of health IT for ensuring patient safety.

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.

Creating an infrastructure that supports learning about and improving the safety of health IT is needed to achieve better health care. Proactive steps must be taken to ensure that health IT is developed and implemented

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