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House Energy And Commerce Committee, Subcommittee On Health: Examining Federal Regulations Of Mobile Medical Apps And Other Health Software

624 words - 3 pages

As technology continues to develop, its place in people’s lives is constantly evolving and breaking into new fields. The number of mobile devices and the applications that they utilize are growing every day and making their way into every corner of our lives. The field of healthcare is not immune to this and many health apps have been developed to help doctors diagnose, patients take care of themselves, or caregivers track patient progress. Throughout this enormous time of growth, the Food and Drug Administration (FDA) has interpreted their 1970’s definition of a medical device to include these health technologies in their regulations.
However, at a hearing in March 2013 on Health Information Technology, it became evident that there was a need for increased clarity on FDA regulation in this space in order to maintain patient safety. In September 2013, the FDA released guidance on their intent to regulate mobile medical apps as medical devices but with discretion, only regulating certain subsets of apps. However, there is still a pressing need for increased transparency and safety in this area to ensure that patients remain safe and these tools are effective. Current bipartisan legislation entitled the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act of 2013 moves to provide the FDA with a new tool to regulate certain mobile medical apps and emerging technologies without considering them medical devices for the sake of regulatory certainty. This hearing discussed the FDA guidance on this issue from September and considered the SOFTWARE Act while including the voices and concerns of the FDA, the technology industry, and patient groups.
The pervasiveness of technology into everyday life and the lack of clarity in its development and regulation is a significant issue in many areas, public health especially. To have medical apps used by providers, caregivers, and patients that provide false information or...

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