ONC, FCC, FDA Seek Comment On Pending Health IT Regulations

This is big stuff, folks.  The FCC, FDA and the ONC are asking the public for comments they can use in developing a regulatory framework for health IT, according to iHealthBeat.  While the agency alphabet soup doesn’t sound very exciting on the surface, I’d argue that this is a turning point for health IT as a whole, as such a framework is likely to change the way the HIT market does business.

So why go ahead with such a request  now?  iHealthBeat reports that the request for comments cites “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.”

The report is being executed by a 32-member workgroup, housed under the ONC’s Health IT Policy Committee. It’s being tasked under the authority of the 2012 FDA Safety and Innovation Act, which requires the group to submit a report by January 2014.  One portion of the report will be dedicated to mobile health applications.

According to iHealthBeat, the request for comments covers three key 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.

Commenters are encouraged to offer their in put no later than June 30, but the comment period will remain officially open until August 31.