8. The HHS Secretary 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.
9. The HHS Secretary 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. 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.
10. HHS, in collaboration with other research groups, should support
cross-disciplinary research toward the use of health IT as part of a learning
healthcare system. Products of this research should be used to inform the design, testing, and use of health IT. Specific areas of research include