The FDA, the FCC and ONC issued a long-awaited joint report with a proposed strategy and recommendations for a risk-based framework for regulation of Health IT.
The report identifies four key priority areas and outlines next steps to take in each area:
I. Promote the Use of Quality Management
II. Identify, Develop, and Adopt Standards and
III. Leverage Conformity Assessment Tools; and
IV. Create an Environment of Learning and
This report should be read together with the FDA framework for regulation of mobile medical applications which was supposedly up in the air pending release of this report. It now seems that they are directed at related, but different, parts of the ecosystem. Both are part of a bigger story, including pending legislaton.