The draft report was developed by FDA, the Office of the National Coordinator for Health IT and the Federal Communications Commission (HHS release, 4/3).
BackgroundThe Food and Drug Administration Safety and Innovation Act directed the agencies to develop "a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health IT including mobile medical applications that promotes innovation, protects patient safety and avoids regulatory duplication" (iHealthBeat, 10/18/13).
The report was originally due to Congress by January 2014 (iHealthBeat, 3/20).
Details of Proposed FrameworkUnder the federal agencies' proposal, health IT products would be classified into three categories based on the function and risk level of the product, rather than on the product's platform.
The first category would include health IT products with administrative functions that pose little or no risk to patient safety and therefore require no additional oversight. Products in this category would include software for billing, claims processing, scheduling and inventory management.
The second category would include health IT products with health management functions, such as software for health information management, medication management, provider order entry and most clinical decision support. Because such products are of relatively low risk, FDA does not plan to focus its oversight on them. Instead, the draft report recommends relying on ONC and private-sector efforts to highlight quality management, industry standards and best practices. The draft report also proposes incorporating testing, certification and accreditation processes for products in this category.
The third category would include health IT products with medical device functions that could potentially pose significant risks to patients if they do not perform as intended. Such products would include computer-aided detection software, software for bedside monitor alarms and radiation treatment software. According to the draft report, FDA would continue to regulate health IT products that fall in this category.
The proposed framework also calls for ONC to work with FDA, FCC, the Agency for Healthcare Research and Quality and other stakeholders to create a public-private Health IT Safety Center. The center would be tasked with developing best practices and providing an avenue for sharing information and ideas related to patient safety.
FDA, FCC and ONC plan to hold a public meeting to collect comments and feedback on the draft report.
CommentsHHS Secretary Kathleen Sebelius said, "The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach," adding, "This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety."
National Coordinator for Health IT Karen DeSalvo said, "ONC welcomes comment on the draft report and stands ready to collaborate with stakeholders to ensure that health IT is designed and used with both innovation and patient safety in mind."
Matt Quinn, director of health care initiatives at FCC, said, "The draft report reflects FCC's narrow but important role in encouraging new and innovative wireless medical technologies and ensuring that developers and users of these technologies are minimizing the potential for causing potentially harmful interference to radio services," adding, "We look forward to future collaboration with all stakeholders to achieve the promise of health IT" (HHS release, 4/3).