HHS publishes FDASIA framework for health IT

The U.S. Department of Health & Human Services, on Thursday, published the long-awaited proposed strategy and draft recommendations for a health IT risk-based framework mandated by the Food and Drug Administration Safety and Innovation Act.

The 34-page draft report--a collaborative effort by officials from the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health IT--outlines a strategy that identifies three categories of health IT: administrative health IT functions; health management health IT functions; and medical device health IT functions. Risk and corresponding controls, the report's authors said, should focus on the functionality of health information technology, as opposed to the platforms on which that functionality lives.

"The proposed strategy and recommendations reflect the Agencies' understanding that risks to patient safety and steps to promote innovation: 1) can occur at all stages of the health IT product lifecycle; and 2) must consider the complex sociotechnical ecosystem in which these products are developed, implemented and used," the authors said.

The authors stressed a more narrow approach health IT guidance equally reliant on private sector capabilities and activities coordinated by ONC, but without additional oversight by the FDA.

"We believe a better approach is to foster the development of a culture of safety and quality; leverage standards and best practices; employ industry-led testing and certification; and selectively use tools such as voluntary listing, reporting and training to enable the development of a healthcare environment that is transparent and promotes learning to foster continual health IT improvement," they said.

Four areas prioritized by the report's authors for the report include:

  • Promotion of the use of quality management principles
  • Identification, development and adoption of standards and best practices
  • Leveraging conformity assessment tools
  • Creation of an environment that focuses on learning and continual improvement

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

Federal officials, including Jodi Daniel, director of ONC's office of policy planning, said at HIMSS14 in Orlando, Fla., in February that the report--originally due out in January--would be published by the end of March.

Bakul Patel, senior policy advisor to the director of the Center for Devices and Radiological Health at FDA, foreshadowed the report's point about focusing on functionality during the HIMSS session.

"It does not matter how you get to the endpoint of providing better outcomes or decisions or support or healthcare," Patel said. "It's about what [the tools] do at the end of the day. It's not about platforms."

Added Matt Quinn, director of healthcare initiatives at FCC at the session: "This is really about the entire life cycle. It's not just about products and getting on the market, it's about implementing them. Because in the real world, it's not just one product that's in a hospital, it's a conglomerate of a bunch of products."

The agencies are requesting feedback on the report; the comment period will last for 90 days, at which time a public meeting will be held to discuss such feedback.

"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," National Coordinator for Health IT Karen DeSalvo said in a statement.

To learn more:
- read the draft report (.pdf)
- here's the accompanying announcement