FDA: Risk-based framework for health IT forthcoming

The FDASIA Work Group soon will release a proposed strategy for a risk-based regulatory framework for health IT, FDA Commissioner Margaret Hamburg, MD, told the Senate Health, Education, Labor and Pensions Committee during a hearing that examined FDA’s initiatives and priorities.

A collaboration between the FCC, the Office of the National Coordinator for Health IT (ONC) and the FDA, the work group specifically will recommend a risk-based regulatory framework pertaining to health IT that promotes innovation, protects patient safety and avoids duplicative regulation.

This work group held open meetings, made documents and information discussed available to the public, and solicited public input during every meeting and through a public docket. In developing the report, FDA, FCC and ONC took into account all of the Health IT Policy Committee’s recommendations and adopted them in full, according to the testimony.

“Implementing FDASIA is a considerable undertaking, requiring detailed planning to integrate these tasks with the rest of FDA’s workload. All told, the 140-page law called for multiple deliverables of all types, including more than 30 proposed and final rules, more than 40 draft and final guidance documents, more than 20 reports to Congress, and many other additional reports, assessments, public meetings and plans,” wrote Hamburg. The testimony went on to say that FDA continues to meet most of its FDASIA milestones and is on track to implement more provisions “very soon.”

In the meantime, a FDASIA web portal has been established, which includes a link to a regularly updated three-year implementation plan, the commissioner wrote.