HHS Proposes Framework for Development and Use of Health IT Products

HHS has issued a draft report, setting forth a proposed strategy and recommendations for a health information technology (health IT) risk-based framework. The report is the culmination of an intra-agency effort between the FDA, the HHS Office of the National Coordinator for Health IT (ONC), and the Federal Communications Commission (FCC), to promote product innovation, clarify health IT product oversight, and to reduce the inherent risks involved in such product use.

“This proposed strategy will facilitate innovation, protect patients and support FDA’s focused oversight on higher risk technology, similar to medical devices that are currently regulated,” stated FDA Director Jeffrey Shuren, M.D.in an HHS news release. “FDA looks forward to additional stakeholder feedback on the proposed framework in this draft report.”

Health IT

According to HHS, innovative health IT products offer significant benefits to patients, including better prevention of medical errors, reductions in unnecessary testing, better patient engagement, and quicker detection and response to health threats and emergencies. However, without a framework that guides the design, development, customization, implementation, integration, and use of such products, they could pose varying degrees of risk to patients who use them.

“The diverse and rapidly developing industry of health information technology requires a thoughtful, flexible approach,” stated HHS Secretary Kathleen Sebelius. “This proposed strategy is designed to promote innovation and provide technology to consumers and health care providers while maintaining patient safety.”

Draft Report

Consequently, the draft report sets forth three health IT categories that a product could fall under depending on its function and level of risk: (1) products with administrative health IT functionality, which could include software for billing and claims processing and poses little or no risk to patient safety; (2) products with health management health IT functionality, which could include software for health information and data management and poses a low risk to patient safety; and (3) products with medical device health IT functionality, which could include radiation treatment software and computer-aided detection software, and has potentially larger risks to patient safety.

“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,” stated FCC Director Matt Quinn. “We look forward to future collaboration with all stakeholders to achieve the promise of health IT.”

The intra-agency draft report was released pursuant to the health IT requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (P.L. 112-144).