Health IT U.S. Regulation Update

How Health IT will be regulated was being discussed by the U.S. government in February. A Health IT Patient Safety Action & Surveillance Plan was circulated by the Office of the National Coordinator for HIT (ONC) in December and is at the link provided. https://www.healthit.gov/sites/default/files/safetyplanhhspubliccomment.pdf

A report on An Oversight Framework for Assuring Patient Safety in Health was released by the Bipartisan Policy Center in February and can be viewed at: Health IT Legislation.

The ONC solicited members for a work group for developing the report on a framework for regulating HIT required by the Food and Drug Administration Safety Innovation Act (FDASIA) legislation that was adopted last summer.

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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