ONC, FCC, FDA Seek Public Input on Health IT Regulatory Framework


On Thursday, the Office of the National Coordinator for Health IT, the Federal Communications Commission and FDA issued a request for comments as the agencies develop a health IT regulatory framework, mHIMSS reports.

Developing Framework

A 32-member workgroup -- housed under ONC's Health IT Policy Committee -- was tasked under the 2012 FDA Safety and Innovation Act to submit a report on health IT regulation by January 2014 (Brino, mHIMSS, 5/30).

According to the request for comments, the agencies are developing the report to address "a growing need for the federal government to develop a coordinated approach to its oversight of health IT that promotes innovation, protects patient safety and avoids regulatory duplication."

A portion of the report will be dedicated to mobile health applications (Conn, Modern Healthcare, 5/30).

Seeking Comments

The request for comments seeks public input on three main areas:

  • Taxonomy, including what types of health IT the agencies should address in the report;
  • Risk and innovation, including what types of risks health IT poses to patient safety; and
  • Regulation, including what regulatory areas are overseen by more than one of the agencies and what can be done to minimize such overlap.
The request for comments will remain open until Aug. 31, but commenters are encouraged to provide feedback no later than June 30 (Murphy, EHR Intelligence, 5/30).

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