Since our last whitepaper on digital therapeutics (DTx) in Europe, much has changed on the digital health and digital therapeutics landscape. Many European countries have established new assessment frameworks and evidence requirements for the evaluation of digital health products, including DTx. New medical device regulations define and categorize DTx, and the brand-new European pharmaceutical strategy prioritizes digital health infrastructure and its objectives.
In this whitepaper, we consider current assessment frameworks across the four biggest European countries: Germany, the United Kingdom, France, and Italy, and we look at current DTx reimbursement policies.
- Relevant legislative developments at the European level
- Assessment of DTx across four major European countries (Germany, England, France, and Italy
- Learnings from the first HTA submissions and DiGA's arrival in care pathways
- Comparison of assessment criteria for digital health products accross countries