Obligations of healthcare providers when using artificial intelligence systems under the AI Act

Czech version

Authors: Tomáš Doležal ^{1, 2}; Adam Doležal ^{2, 3}
Authors‘ workplace: Ústav veřejného zdravotnictví a medicínského práva 1. LF UK v Praze ¹; Oddělení deliktního a medicínského práva a etiky, Ústav státu a práva AV ČR, v. v. i. ²; Ústav lékařské etiky a humanitních základů medicíny 2. LF UK v Praze ³
Published in: Čas. Lék. čes. 2026; 165: 159-162
Category: Review Article

Overview

The Artificial Intelligence Act (AI Act) establishes specific obligations for entities that use AI systems. In healthcare, these obligations primarily concern high-risk AI systems, which include a significant proportion of medical applications. The aim of this article is to provide a systematic analysis of the obligations of healthcare providers as deployers of high-risk AI systems, with particular emphasis on clinical practice. The text outlines the key obligations imposed on deployers and analyzes them in a structured manner. The article also highlights the relationship between these obligations and existing requirements of healthcare law, in particular the principles of lege artis practice and informed consent.

Keywords:

artificial intelligence – healthcare – AI Act – high-risk systems – deployer

Sources

van Kolfschooten H, van Oirschot J. The EU Artificial Intelligence Act (2024). Implications for healthcare. Health Policy 2024; 149 : 105152.
Metodický pokyn pro poskytovatele zdravotních služeb k využívání umělé inteligence. Věstník MZ ČR 2025; 9 : 37–49.
Doležal T, Doležal A. Užití umělé inteligence při poskytování zdravotních služeb a poučení pacienta. Čas Lék čes 2025; 164 : 324–327.

Labels

Addictology Allergology and clinical immunology Angiology Audiology Clinical biochemistry Dermatology & STDs Paediatric gastroenterology Paediatric surgery Paediatric cardiology Paediatric neurology Paediatric ENT Paediatric psychiatry Paediatric rheumatology Diabetology Pharmacy Vascular surgery Pain management Dental Hygienist

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