Comparison of Medical Mobile Apps Regulatory Frameworks

Medical Mobile AppsInfluencer healthcare authorities the largest being the US Food and Drug Administration and the European Commission are taking a cautious approach to regulating medical mobile apps. Most medical mobile apps or stand-alone software that run on mobile devices are considered as having low risk, and not subject to the full pre-market scrutiny required of conventional medical devices. The reason for keeping an arm’s length to digital healthcare apps or software is to give breathing room for more innovation in this space. Despite this easement, it does not mean that healthcare apps are completely scot-free of the regulatory net. The infographics below illustrate factors that turn medical mobile apps into regulated medical devices.

1. When Mobile Apps Become Medical Devices

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Medical Mobile Apps

2. US FDA Guidance on Mobile Medical Applications

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US FDA Medical Mobile Apps Guidance Infographic-01

3. UK MHRA Guidance on Medical Device Stand-Alone Software Including Apps

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UK MHRA Medical Mobile Apps Guidance Infographic

4. EC Guidelines on the Qualification of Stand Alone Software used in Healthcare

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EC Medical Mobile Apps Guideline

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