Congress introduces bill to regulate mobile health apps — the SOFTWARE Act

Following up on our September 2013 blog entry, “How much pre-market regulation should the FDA impose on health IT?,” we note that Congress last week introduced a bill empowering the Food and Drug Administration to regulate mobile health applications.  Entitling their bill the SOFTWARE Act – Sensible Oversight for Technology which Advances Regulatory Efficiency — the bill’s bipartisan sponsors concur with the prevailing view that such regulation should be kept to a minimum, supporting innovation while protecting consumer safety,

As the September blog entry emphasized, the crux of the issue is defining which mobile health apps are considered to be employed in “’higher risk’ use cases” – and should therefore be regulated – and which apps are considered to be employed in lower risk or no risk situations, and can therefore be subject to less or no regulation.

Posted in ARRA, Higher Ed, HITECH Act, News, Privacy & Security Tagged with: , , , , ,

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