The COVID-19 pandemic is a global tragedy that has affected many lives. The general response to the outbreak comprised in many countries, among other things, a lockdown. The impact of the pandemic on public and social life is generally considered detrimental, but it has also clearly demonstrated opportunities and benefits of the use of digital solutions in healthcare around the globe.1 For example, when the COVID-19 outbreak started, millions of people in China turned to online doctors and online health tools to find the needed support for their health.1 The global upswing in willingness to use digital solutions represents an unprecedented opportunity to establish healthcare 4.0 for the benefit of patients.
It is anticipated that investments in digital health instruments, in particular digital therapeutics (DTx), will continue to accelerate after the COVID-19 pandemic, with an estimated market compound annual growth rate (CAGR) of 20,8% from 2017 to 2025. (see Figure 1).2
However, for the effective and safe proliferation of DTx, public institutions at all levels must create appropriate frameworks that ensure data privacy and protection. The aim of this paper is to describe and analyze the current and developing institutional frameworks for the integration of digital health solutions into the healthcare system at the European Union (EU) level, in Germany, and in the United Kingdom (UK). Considering the relatively new fields of digital health, and DTx in particular, it is important to define them before continuing.