Digital Therapeutics remain in a legal grey area as a clear and unique definition is not provided by the European Union nor by EU Member State legislation. Although they are often considered as, or similar to, medical devices, this approach may be inadequate and misleading as it tends to mistake the device with the therapy that it delivers. The evolving and expanding sector of digital therapies mandates the adoption of new rules, hopefully at European Union level, to properly address the challenges of digital health technologies both from the legal and the regulatory perspective.