Google is adding a new Health App Policy to its set of requirements for Health Content and Services. The policy will become effective at the end of May 2024 and will apply to health apps – medical apps enhancing medical care and facilitating diagnosis and treatment, health and fitness apps enabling users to reach fitness and wellness goals and health research apps used for research studies are all classified as health apps by Google.

The new Health App Policy will also apply to apps that have health-related features and access health data, but which are not primarily health apps (for example, insurance-related apps).

Prominent Disclosures and Privacy Notices

The new policy introduces requirements for the inclusion of comprehensive content in privacy notices describing the access, collection, use and sharing of personal data. The policy also includes requirements for the accessibility, format and location of privacy notices.

Apps that access health data but which are not primarily health apps must make clear to users the connection between the app’s core functionality and the collection of health-related data.

Other Requirements

Other requirements introduced by the policy include:

  • Obtaining a clearance letter or other approval documentation by a regulator or other responsible body when the app is considered a medical device or SaMD (Software as a Medical Device)
  • Obtaining consent from participants (or, in the case of minors, parents or guardians) when the app is conducting health-related subject research, as well as securing approval from an Institutional Review Board or other independent ethics committee, unless exempt
  • Submitting an eligibility form if the app is being developed under permission from the government or another healthcare organisation to develop an app in affiliation with them

Disclaimer: While every effort has been made to ensure that the information contained in this article is accurate, neither its authors nor Squire Patton Boggs accepts responsibility for any errors or omissions. The content of this article is for general information only, and is not intended to constitute or be relied upon as legal advice.