Comparison of Medical Mobile App Regulatory Frameworks

Influencer 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 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

2. US FDA Guidance on Mobile Medical Applications

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

Including Apps

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

Healthcare

Nealda Yusof is a medical technology writer and founder of Semoegy.com. Click here to contact the author.

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Original article: http://medtechupdates.semoegy.com/2015/03/comparison-of-medical-mobile-app-regulatory-frameworks/