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.