HHS Development of a Risk-Based Regulatory Framework and Strategy for Health Information Technology

Editor’s Note:  The HHS advance Federal Register notice is attached here.  Below is an excerpt

From:  HHS/Office of the Secretary

SUMMARY:

The Food and Drug Administration (FDA), Office of the National Coordinator for Health Information Technology (ONC), and Federal Communication Commission (FCC) seek broad input from stakeholders and experts on the elements we should consider as we develop a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework for health IT, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication. To that end, we are requesting comments on the topics identified in Section III.

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