The U.S. Food and Drug Administration intends to issue a long-awaited report on health IT regulation by April.
Originally due in January, the report was delayed until March, and at a Senate subcommittee meeting this week, FDA Commissioner Margaret Hamburg, MD, affirmed that the report is on its way to meeting that deadline.
It comes amid a growing rift on Capitol Hill over who should regulate mobile health devices. Some members of Congress think Congress is best suited to regulate it, by means of legislation. FDA officials, meanwhile, argue that the FDA is better suited, by way of its experience so far.
Either way, the territory to be regulated — the ever-changing mobile app world — is new for everyone. So no one knows exactly the best way to regulate new apps and devices. Everyone, however, seems to agree that if an app behaves as a medical device and could potentially harm a patient, it needs to be regulated.
Some confusion over the issue lifted last Sept. 23 when the FDA released its non-binding final guidance on mobile health app regulation — but not nearly enough. Many in the industry still have concerns, including venture capitalists and physician practices that have created their own apps. Innovation wants to move forward. The free market is driving it. But folks can’t help looking back over their shoulders and asking “will there be ramifications?”
The March report will be written by the FDA Safety and Innovation Act (FDASIA) workgroup, in collaboration with the Federal Communications Commission and the Office of the National Coordinator for Health IT.
“This working 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,” Hamburg testified at the Senate hearing.
“In developing the report, (the) FDA, FCC and ONC took into account all of (the) ONC’s Health IT Policy Committee’s recommendations,” she added. “The committee adopted in full the external stakeholder working group’s recommendations.”
Since the hearing was called to look at the FDA’s progress overall, Hamburg reported that implementing FDASIA has been “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,” she said.
