mHealth—data protection considerations
Produced in partnership with Francesca Blythe of Sidley Austin and William Long of Sidley Austin

The following Life Sciences practice note produced in partnership with Francesca Blythe of Sidley Austin and William Long of Sidley Austin provides comprehensive and up to date legal information covering:

  • mHealth—data protection considerations
  • What is mHealth?
  • The GDPR regimes
  • Key guidance
  • UK and EU ePrivacy law considerations
  • Personal data
  • Data concerning health, genetics and biometrics—‘special category’ personal data
  • Controller or processor
  • Lawful grounds for processing
  • Transparency
  • More...

mHealth—data protection considerations

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. 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.

What is mHealth?

‘mHealth’ (ie mobile health) like telehealth is a subset of eHealth (ie the use of information and communication technologies for health) under the digital health umbrella and refers to the use of mobile applications to allow users to monitor, evaluate and improve their health using their mobile devices. Mobile devices include smart phones, tablets, smart watches and other ‘wearable tech’, and other devices that run apps on an operating system that acts as a platform onto which apps are built and displayed to

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