The U.S. Food and Drug Administration (FDA), Federal Communications Commission and Office of the National Coordinator for Health Information Technology have released a  report outlining the agencies’ draft strategy and recommendations for a “risk-based” regulatory  framework for health- information technology (health IT), as required by Section 618 of the Food and Drug Administration Safety and Innovation Act. Comments are requested by July 7, 2014.

According to retiring Health and Human Services Secretary Kathleen Sebelius, who notes that the  diverse and rapidly developing industry of health infor- mation technology requires a “thoughtful,  flexible approach,” the strategy outlined in the report is designed to “promote innovation and  provide technology to consumers and health care providers while maintaining patient safety.”

While acknowledging the benefits that a nationwide health IT infrastructure can offer to the  American public, including the prevention of medical errors, improved efficiency and health care  quality, reduced costs, and increased consumer engagement, the agencies note that if health IT  products are not properly designed, developed, implemented, maintained, or used, they may pose  risks to the patients who use them.

Among other things, the reports suggests that (i) risk and corresponding controls should focus on  health IT functionality rather than the platform(s) on which the functionality resides; (ii) no new  or additional areas of FDA oversight are necessary; (iii) the regulatory framework should be flexible enough to  accommodate innovative, continuously-evolving products and should account for the complex  environment in which the products operate, as well as the multiple stakeholders that play key roles  in development, implementation and use; and (iv) FDA should continue  to oversee medical device  health IT functions such as computer-aided detection software, remote display or notification of  real-time alarms from bedside monitors, and robotic surgical planning and control, because these  products “generally pose greater risks to patient safety” and FDA oversight is better suited to  provide safety assurance. See FDA Press Release, April 3, 3014; Federal Register, April 7, 2014.