Dive Brief:
- House Republicans have sent a letter to National Coordinator for Health IT Karen DeSalvo questioning her office's authority to regulate health IT products.
- As called for by the Food and Drug Administration Safety and Innovation Act, HHS recently released a draft report including a proposed strategy and recommendations for creating a risk-based health IT regulatory framework.
- The GOP legislators conceded that the FDA has the authority to regulate medical devices but question whether ONC has such statutory authority.
Dive Insight:
If ONC shifts from a cheerleader and coordinator role to a regulatory agency, that would be a significant change in its role. It's understandable that legislators want more information on what ONC expects to do in the near future and have questions as to the extent of its regulatory authority. This may lead to a dispute over just what ONC can and can't do. If that happens, things could get ugly for a while.