Services Aim to Assure Health App Safety, Quality

August 1, 2013 | Evaluations & Guidance


As FDA works to devise a scheme for regulating the vast number of mobile health (mHealth) apps that can be considered medical devices, several companies have attempted to fill the quality and safety assurance void, according to an article in the May issue of ECRI Institute’s Health Technology Trends. (This discussion is not meant as an endorsement of any of the products.)

One such company is Happtique, an mHealth app store that aims to verify the safety of apps through its Health App Certification Program. The program is a two-year, fee-based service that costs “a few thousand dollars” said Happtique’s Ben Chodor, speaking to Matthew Holt at the Health Information and Management Systems Society conference, held March 3 to 7, 2013, in New Orleans, Louisiana. Third-party reviewers evaluate the app’s operability, privacy, security, and content. In addition, the app is evaluated by two clinicians related to the relevant specialty, said Chodor. To be eligible for certification, apps that require any public or...

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