HHS releases FDASIA framework for risk-based health IT

The Department of Health & Human Services has published its long-awaited FDASIA framework for health IT.

The 34-page report, developed by the FDA in consultation with the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission, promotes product innovation while maintaining appropriate patient protections and avoiding regulatory duplication.

As proposed in the draft report, there would be three health IT categories based on function and level of risk that focus on what the product does--not on the platform on which it operates (i.e., mobile medical device, PC, or cloud-based).

• Category One focuses on products with administrative health IT functions, poses little or no risk to patient safety and as such requires no additional oversight. They include software for billing and claims processing, scheduling and practice and inventory management.
• Category Two focuses on products with health management health IT functions, including software for health information and data management, medication management, provider order entry, knowledge management, electronic access to clinical results and most clinical decision support software.
• Category Three focuses on products with medical device heatlh IT functions. This narrowly defined group poses greater risks to patients if they do not perform as intended. The report proposes that he FDA continue regulating these products, which include computer-aided detection software, software for bedside monitor alarms and radiation treatment software, among others.

The draft framework also proposes that ONC create a public-private Health IT Safety Center in collaboration with the FDA, the FCC, the Agency for Healthcare Research and Quality and other stakeholders. This center would work on best practices and provide a forum for the exchange of ideas and information focused on patient safety.

The FDA, ONC and FCC plan to announce a public meeting to solicit comments on the draft report.

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

Read the report here.