FDASIA Health IT Report

Proposed Strategy and Recommendations for a Risk-Based Framework

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Health information technology (HIT) presents tremendous benefits to the American public, including greater prevention of medical errors, improved efficiency and health care quality, reduced costs, and increased consumer engagement However, if HIT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.

Federal law passed by U.S. Congress in 2012 requires that the Food and Drug Administration (FDA), in consultation with the Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC) develop and post on their respective web sites "a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication." This report fulfills that requirement.

The FDA, ONC, and FCC seek public comment on whether the focus areas identified in the report are the appropriate ones, and whether the proposed next steps will lead to an environment where patient safety is protected, innovation is promoted, and regulatory duplication is avoided.

The three agencies sought and collected public comment in a collaborative and transparent manner, which is reflected in the draft framework. Much of the draft framework is based on recommendations from the public, industry, a 2011 Institute of Medicine report on HIT and Patient Safety, and input from the FDASIA Working Group.

There are some areas of health IT oversight that will benefit from continued engagement, including clinical decision support IT and electronic health records. For that reason, the FDA is opening a docket (FDA-2014-N-0339) to accept comments on the report.