Google adds a new health app policy to its set of requirements for health content and services. This policy goes into effect at the end of May 2024 and applies to health apps. This includes medical apps that enhance healthcare and facilitate diagnosis and treatment, health and fitness apps that help users achieve their fitness and wellness goals, and health research apps used for research studies. Google classifies them all as health apps.
The new healthcare app policy also applies to apps that have health-related functionality and access health data, but are not primarily health apps, such as insurance-related apps.
IMPORTANT DISCLOSURES AND PRIVACY NOTICE
The new policy introduces a requirement for privacy notices to include comprehensive content that describes access, collection, use, and sharing of personal data. This policy also includes requirements regarding the accessibility, format, and location of privacy notices.
Apps that access health data but are not primarily health apps should make clear to users the relationship between the app’s core functionality and the collection of health-related data.
Other requirements
Other requirements introduced by the policy include:
- If your app is considered a medical device or SaMD (Software as a Medical Device), obtain an approval letter or other approval documentation from a regulatory authority or other responsible body.
- If the app conducts health-related human subjects research, we will obtain consent from the participants (parents or guardians in the case of minors) and, except in exceptional cases, from an institutional review board or other independent ethics committee. Securing approval from the Society.
- If you are developing your app with permission to develop your app in partnership with a government or other healthcare organization, submit an eligibility form
Nagia Parascho contributed to this article
Disclaimer: While every effort has been made to ensure the accuracy of the information contained in this article, neither its author nor Sir Patton Boggs accepts liability 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.