Digital health developers, manufacturers and distributors of mHealth apps, and any connected software as medical devices (SaMD) or Artificial intelligence (AI) system, must comply with significant Data protection regulations in parallel with regulatory compliance throughout the life cycle of an app’s development and commercialisation to market. This Practice Note focuses, in particular, on the data protection and privacy considerations for mHealth (or mobile health). Further discussion also addresses the more stringent protections surrounding the collection of an individual user’s health data.

The note does not consider broader life sciences regulatory concerns, for example, around medical devices. For further information on the regulation of medical devices, see Practice Note: The regulation of medical software, including mHealth apps.

For further information on the data protection implications of mobile app development more generally, see Practice Note: Mobile app development and data protection.

For a discussion on data protection challenges posed by digital health through different case studies, including wearables and AI diagnostic tools, see Practice Note: Digital health—data protection and privacy case studies