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Flying a kite: Around 150 health apps certified

150 health apps certified

The Belgian healthcare research and content provider company HealthSkouts maintains a library of links to medical apps certified by the US Food and Drug Administration (FDA) or given a CE mark in the European Union.

At the time of writing, there are around 150 medical device apps in their library that have been certified and blessed with the FDA or CE kitemarks. Glass half full says that this is significant progress, given the relative complexity and expense of certification. Glass half empty says this is still a minute percentage of the hundreds of thousands of apps out in the open market, many of which could be classed as medical devices.

Who is developing the certified apps?

The list of developers in the library is a who’s who of corporate life. On the pure pharma side, big pharma is much in evidence, including Sanofi, Eli Lilly, Abbott, Teva and Roche, applying their regulatory experience to create apps with minimised risk. On the pure technology side, huge players like Samsung, Nokia, Honeywell and Philips. Then you have a raft of medical device and wearable companies, from Medtronic to Nuvoair.

Although there are some smaller developers in the list, the process can be confusing, time-consuming and daunting and require legal expertise. For as long as we can remember, the shades of which types of apps required to be certified as medical devices, has been subject to debate and interpretation.

Recognising this, guidance appears to be improving. For example, the US Federal Trade Commission (FTC) has an easy-to-use algorithm to help developers to identify which regulations may apply to their app. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) keeps revising and improving its guide on the subject.

What do the certified apps do?

Currently the list of certified medical device apps is very focused on major therapy areas.  Here are the top five clusters:

  • 1st place – Diabetes
  • 2nd – Heart/circulatory
  • 3rd – Patient monitoring
  • 4th – Respiratory
  • 5th – Eyes and ears.

Many of the apps are tied to medical devices, whether delivering drug doses, monitoring body functions, or enabling remote monitoring of patients. This is partly a reflection of the importance of making sure that the certification effort is focused on the diagnostic and treatment apps that can potentially be of highest risk for patients.

Who knows what’s been certified?

This is the important gap that HealthSkouts are addressing by pulling together their library of FDA and EU CE-certified apps. At myhealthapps, we believe strongly in patients being able to make informed choices based on information from trusted sources.  

Certification and government kitemarking is only ever going to apply to a small group of apps, and probably those of highest risk. It can only work for patients if these kitemarked apps are easy to find. 

Certification is key to both patient and clinician acceptance of apps. So, it is frustrating that lists of trusted, certified apps seem to be buried away. Also, resources seem scarce to track down developers who bypass the requirements for apps which should be classed as medical devices. In the US, the 21st Century Cures Act helped to move digital health further up the agenda, but policing regulations requires people and resources. 

Finally, just as traditional clinical trial measures can be far too slow for the short life cycles of medical apps, is certification lagging far behind technology?  

The Belgian healthcare research and content provider company HealthSkouts maintains a library of links to medical apps certified by the US Food and Drug Administration (FDA) or given a CE mark in the European Union.

At the time of writing, there are around 150 medical device apps in their library that have been certified and blessed with the FDA or CE kitemarks. Glass half full says that this is significant progress, given the relative complexity and expense of certification. Glass half empty says this is still a minute percentage of the hundreds of thousands of apps out in the open market, many of which could be classed as medical devices.

Who is developing the certified apps?

The list of developers in the library is a who’s who of corporate life. On the pure pharma side, big pharma is much in evidence, including Sanofi, Eli Lilly, Abbott, Teva and Roche, applying their regulatory experience to create apps with minimised risk. On the pure technology side, huge players like Samsung, Nokia, Honeywell and Philips. Then you have a raft of medical device and wearable companies, from Medtronic to Nuvoair.

Although there are some smaller developers in the list, the process can be confusing, time-consuming and daunting and require legal expertise. For as long as we can remember, the shades of which types of apps required to be certified as medical devices, has been subject to debate and interpretation.

Recognising this, guidance appears to be improving. For example, the US Federal Trade Commission (FTC) has an easy-to-use algorithm to help developers to identify which regulations may apply to their app. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) keeps revising and improving its guide on the subject.

What do the certified apps do?

Currently the list of certified medical device apps is very focused on major therapy areas.  Here are the top five clusters:

  • 1st place – Diabetes
  • 2nd – Heart/circulatory
  • 3rd – Patient monitoring
  • 4th – Respiratory
  • 5th – Eyes and ears.

Many of the apps are tied to medical devices, whether delivering drug doses, monitoring body functions, or enabling remote monitoring of patients. This is partly a reflection of the importance of making sure that the certification effort is focused on the diagnostic and treatment apps that can potentially be of highest risk for patients.

Who knows what’s been certified?

This is the important gap that HealthSkouts are addressing by pulling together their library of FDA and EU CE-certified apps. At myhealthapps, we believe strongly in patients being able to make informed choices based on information from trusted sources.  

Certification and government kitemarking is only ever going to apply to a small group of apps, and probably those of highest risk. It can only work for patients if these kitemarked apps are easy to find. 

Certification is key to both patient and clinician acceptance of apps. So, it is frustrating that lists of trusted, certified apps seem to be buried away. Also, resources seem scarce to track down developers who bypass the requirements for apps which should be classed as medical devices. In the US, the 21st Century Cures Act helped to move digital health further up the agenda, but policing regulations requires people and resources. 

Finally, just as traditional clinical trial measures can be far too slow for the short life cycles of medical apps, is certification lagging far behind technology?  

See the current list of FDA and CE certified health apps curated by HealthSkouts at…

Click here



Review the FDA guidance on what is and is not a mobile medical application at…

Click here



Review the US Federal Trade Commission algorithm for determining which regulations apply to specific types of health app at…

Click here



Review the UK Medicines and Healthcare Products Regulatory Agency (MHRA) guide `Medical device stand-alone software including apps’…

Click here 

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