6. The HHS Secretary should specify the quality and risk management process requirements that health IT developers must adopt, with a particular focus on human factors, safety culture, and usability.
7. The HHS Secretary should establish a mechanism for both developers and users to report heath IT-related deaths, serious injuries, or unsafe conditions. Reporting of health IT related adverse events should be mandatory for developers, but voluntary, confidential and nonpunitive for users. Efforts to encourage reporting should be developed, such as removing the perceptual cultural, contractual, legal, and logistical barriers to reporting.
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. The entity also should monitor and analyze data and publicly report results of these activities.
9. The HHS Secretary should monitor and publicly report on health IT safety progress. The Secretary also should immediately direct the Federal Food and Drug Administration to begin developing the necessary framework for 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. Specific areas of research include user-centered design and human factors, safe implementation use of health IT by all users, socio-technical systems associated with health IT, and the impact of policy decisions on health IT use in clinical practice.