FDA Continues To Struggle With How Best To Regulate Health Apps

Posted on June 22, 2012

A potential battle is shaping up between the Food and Drug Administration and the technology sector.

At issue is what to do about apps that can be used for healthcare purposes.  This past Monday, the FDA was given the go-ahead from Congress to outline the types of apps, such as those in smart phones and tablet devices, that should require oversight by the safety organization.  At the same time, the agency is also being tasked with figuring out the best way to promote innovation and safety at the same time.

People in the technology sector, especially startups, worry that the FDA approval process will stifle their ability to make money and also prevent the public from reaping the benefits of such technology in an expedient manner.  An app that lets healthcare professionals use their smartphone to view MRIs, for instance, required two years of wrangling and fees adding up to $150,000 before it was approved.

An increased prevalence in healthcare apps could theoretically cut costs and change the entire industry.  But the FDA worries about the safety of such software.  Even though many apps could be considered technological marvels, with the ability to check blood sugar, test for cancer, or get a handheld EKG, there are numerous issues to consider.  Any error could be life threatening, especially if said error led to the wrong dosage of a drug, for instance.

Stay tuned for any developments on the app regulation front.

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