Regulating health apps: A cross-country comparison of 7 different national approaches

In various areas of health care, digital applications hold great promise for expanding access to services, substituting for and/or complementing existing standards of care, and creating value and convenience for patients. Yet globally, health care systems are struggling with how to incorporate and leverage the accelerating innovation of new digital tools that could potentially prevent and improve the treatment of illness.

Mobile health apps (health apps) epitomize this challenge. Although there is an abundant supply of health apps in the commercial tech-sector, the number can be bewildering, and the challenge for the health care system is to facilitate the identification of safe and effective apps for health care practitioners and patients to generate the most health benefit.

Public debates across countries reveal a demand for ‘someone’ to provide a quality stamp on the apps that fulfil basic medical and privacy criteria, that is, to provide some kind of formal approval. Nearly all governments are attempting to define policy frameworks that will be effective for improving health in this context. 

Our goal in this project is compare the national regulatory approaches currently in development/use for health apps in seven countries, many of which are taking different paths.

This project builds on a collaboration between 7 Universities, led by researchers at SSE/House of Innovation, Harvard Medical School, and Harvard Business School.

Please contact Anna Essén for further information!