Legal Framework for digital therapeutics (DTx) in the European Union
Legal Framework for digital therapeutics (DTx) in the European Union
Author(s): Kätlin Joala, Tanel Kerikmäe, Ondrej Hamuľák, Hovsep KocharyanSubject(s): Political Sciences, Public Law, Health and medicine and law, EU-Legislation, Comparative Law, Administrative Law
Published by: Univerzita Palackého v Olomouci
Keywords: digital therapeutics; healthcare; medical device; public health; wellness application;
Summary/Abstract: This paper examines the origins and limitations of EU medical device law. The main questions asked are whether EU medical device law defines the concept of medical purpose for software, whether the concept of medical purpose is understood as a medical service defined by national law, and whether it requires the involvement of medical professionals as users. Particular attention is paid to the aspect of Recital 8 of the Regulation (EU) 2017/745 on medical devices (MDR), alongside the general internal provisions of EU law and its sector-specific subsidiarity provisions. In practice, Member States have taken different legal approaches to address DTx-related challenges, creating legal uncertainty within the EU as to which DTx should be defined as a medical device.
Journal: European Studies - the Review of European Law, Economics and Politics
- Issue Year: 10/2023
- Issue No: 2
- Page Range: 98-123
- Page Count: 26
- Language: English