BANGALORE, INDIA - Today’s world swarms with innumerable digital apps influencing our health in a trend Covid-19 has further pushed, with an app for seemingly every element of health and wellness.⁽¹⁾ 

A plethora of unregulated apps with varied use cases compounds the complexity of this situation.⁽²⁾ Often, their stickiness is non-optimal, while their credibility has not been proven.(3) This makes it hard for users to accurately judge the return on efforts that drives down their utilization.⁽³⁾ These apps are impacting healthcare as we know it, but their effects are still being assessed. Thus, to regulate this new phenomenon, many countries are putting together regulatory boundaries for their judicious use.

As in many fields disrupted by technology, regulations in healthcare have also been slow to catch up.⁽⁴⁾ As part of this catch-up game, existing health regulations are now being amended. In most countries, changes are being made to the current frameworks to accommodate the new shifting paradigm of health apps.⁽⁵⁾ Countries are formulating regulations for innovation at a national level, with a special focus on elements like data privacy, secured data handling, informed user consent, and interoperability.⁽⁵⁾ They are not simply leaving everything to the iOS app store (Apple) or Google Play store (Android) where these apps reside.⁽⁵⁾ 

Upcoming regulations reflect priorities mentioned in international agreements like the European Union General Data Protection Regulation’s Medical Device Regulation (MDR) and Singapore’s Personal Data Protection Act. For example, to ensure minimum quality standards, the European Institute of Standardization emphasizes that all countries should have some elements of regulations on digital health. Some are racing ahead in this, e.g., Germany, which operationalized and implemented market access-related regula