Health IT Policy Committee’s safety workgroup convenes
The Health IT Policy Committee’s (HITPC’s) newly formed FDA Safety Innovation Act Workgroup (FDASIA) kicked off its first meeting on April 29, and began to pursue its statutory purpose: proposing strategies and recommendations for a risk-based regulatory framework for health IT that promotes innovation, protects patient safety and avoids regulatory duplication.
FDASIA will provide recommendations to the HITPC, and these strategies eventually will be posted on websites for the FDA, the Federal Communications Commission, and the Office of the National Coordinator for Health IT.
At the first meeting, the workgroup and three ex officio members from the FDA, FCC and ONC made introductions and heard presentations on all three agency missions and regulatory responsibilities. Some resources and topic areas they discussed included:
- FCC-FDA cooperative activities
- The FCC’s national broadband plan
- The ONC health IT certification program
- Medical device regulations
- The FDA’s draft guidance on mobile medication applications
- The Institute of Medicine report, “Health IT and Patient Safety: Building Safer Systems for Better Care”
The next FDASIA meeting is scheduled for May 6.