Federal panel finalizes proposals for HIT regulatory framework

09/5/2013 | Health Data Management

The HIT Policy Committee has finalized its proposals for a risk-based approach to health IT regulation, which include exempting HIT products from FDA premarket approval except for medical device accessories and certain types of software based on definitions to be crafted by the FDA. The recommendations will be forwarded to the ONC, the FDA and the Federal Communications Commission, with a proposed rule expected to be issued for public comment in January.

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