Legal Framework for digital therapeutics (DTx) in the European Union

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15220%2F23%3A73625362" target="_blank" >RIV/61989592:15220/23:73625362 - isvavai.cz</a>

Výsledek na webu

<a href="https://reference-global.com/article/10.2478/eustu-2023-0014" target="_blank" >https://reference-global.com/article/10.2478/eustu-2023-0014</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.2478/eustu-2023-0014" target="_blank" >10.2478/eustu-2023-0014</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Legal Framework for digital therapeutics (DTx) in the European Union

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Legal Framework for digital therapeutics (DTx) in the European Union

Popis výsledku anglicky

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.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

50501 - Law

Projekt

<a href="/cs/project/GA20-27227S" target="_blank" >GA20-27227S: Vytváření, problémy a limity digitální suverenity Evropské unie</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2023

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

European Studies – The Review of European Law, Economics and Politics

ISSN

1805-8809

e-ISSN

2464-6695

Svazek periodika

10

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

CZ - Česká republika

Počet stran výsledku

26

Strana od-do

98-123

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85199036061