European regulation of digital respiratory healthcare

Author:

Gilbert Stephen

Publisher

European Respiratory Society

Reference78 articles.

1. Learning from experience and finding the right balance in the governance of artificial intelligence and digital health technologies;J Med Internet Res,2023

2. Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives;Expert Rev Med Devices,2023

3. Algorithm change protocols in the regulation of adaptive machine learning-based medical devices;J Med Internet Res,2021

4. European Union. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Document 32017R0745, OJL 117. 2017. https://eur-lex.europa.eu/eli/reg/2017/745/oj/eng

5. European Commission. Summary of references of harmonised standards published in the Official Journal – Regulation (EU) 2017/745. Date last updated: 5 July 2023. https://ec.europa.eu/docsroom/documents/55101

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1. Introduction;Digital Respiratory Healthcare;2023-12-01

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