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Meaningful Health Care Informatics Blog

Mar 18 2013   9:23PM GMT

MHealth regulations: helping the market or patients?



Posted by: RedaChouffani
Apps, FDA, mhealth, telemedicine

On March 1, the subcommittees on communications and technology at the health and oversights hearing discussed both the role technology is playing in healthcare and FDA regulations to ensure the patient safety. These regulations apply to medical devices like tablets and smartphones, and consist of taxation, mainly. The committees discussed how they could potentially harm innovation in the field, and possibly create excessive costs for the consumers who are meant to benefit from these devices.

There will be more discussions beginning March 19, 2013 between members and staff of the subcommittee on communications and technology. They will review current taxation laws and mandates that affect some of the medical devices and mhealth apps, which include those used to treat specific health conditions.

The outcome of these discussions will be extremely important, as it could potentially define how mHealth apps are classified.

It could also speak to potential barriers for software developers, thus slowing down innovation. There are certainly many questions and technical challenges that app developers will face if they are required to continuously get certified or cleared for their apps anytime there is a minor app update, or even an OS update. These would increase maintenance cost and limit both updates and app improvements to only a few a year, which could mean less new functionality and innovation.

While it is certainly important to ensure the safety of patients who rely on and trust their mobile devices to provide accurate feedback and quality of information, it is imperative that a balance be maintained between reducing barriers to market and ensuring consumer care.

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