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All Things HIT

Jun 27 2012   9:42PM GMT

Senate stops FDA delay for mHealth

Posted by: AllinHIT

Thanks to the Senate, the proposed bill on mobile medical app guidance will not face the delay originally planned. Senate bill S.3187, proposed by Sen. Tom Harkin, originally wanted the FDA to submit a “full scale” report to the Senate pertaining to regulating mobile medical apps….within 18 months!  Industry proponents, like myself, thought this timeframe was very detrimental to the industry, and gladly, I think the Senate agreed. Due to the hypergrowth of mobile health technologies, similar to the Internet industry in the 90’s, eighteen months would be an eternity.  It certainly would have negatively impacted innovation and growth, at a time when delivering care mobilily is essential.  

The Senate decided that the “guidance report” instead should be the responsibility of HHS, with input from the FDA, the FCC, and the ONC. I suspect the ONC will be driving this effort, as they should.  Don’t get me wrong I believe everyone, including the FDA, has a valid reason to influence the outcome.  However, the ONC, has a better understanding of industry needs, the innovative products currently being used and developed, all thanks to HITECH.  

Lastly, there was one good thing about the previous version of the bill I liked. It originally required input from those outside of Washington, such as vendors, consultants, and industry organizations.  Now, the new version gives HHS the authority to receive this input, but it is NOT required. This in my opinion is a mistake.  Similar to the importance EHR vendors, AHIMA, MGMA, and the AMA, had on Meaningful Use and the implementation of 5010, it would give the industry a needed voice at the table.  Lets hope HHS agrees with me and invites industry vendors and organizations to the table.  If not, the uncertainty of “what is to come” could stifle business plans, putting on hold innovations for ACO’s, access to care, and most importantly, patient care!                    


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