Classifying Health IT Still Key Focus For Digital Health Regulation
This article was originally published in The Gray Sheet
Conceptual fuzziness still an issue with regulating health IT, observers agree.
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On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue
The group will assist mandatory efforts by FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology to issue recommendations for a risk-based regulatory framework for health IT, including mobile medical apps.