Abstract
The updated text of the Artificial Intelligence Act (AI Act) has raised some questions about tools using Artificial Intelligence in different fields. In particular, the specimen of AI technology for medical purposes has now become a concerning topic for the introduction of additional legal and procedural requirements. The AI Act is just one of several pieces of legislation regulating AI medical tools, as many have already been established (e.g. Medical Device Regulation) and the intersection of requirements and obligations needs to be assessed. With multiple layers of relevant provisions about AI medical tools, our main objective is to create a practical guideline for the introduction of AI tools in healthcare systems by ensuring their legal compliance. We also aim to show legal short circuits related to AI medical tools to have a comprehensive perspective on the issue of introducing AI in Healthcare.
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Notes
- 1.
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, from now on the Medical Device Regulation (2017/745).
- 2.
Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)Text with EEA relevance, AI Act from now on.
- 3.
According to the MDR framework, an AI application with medical purposes can be identified as Medical Devices Software (MDSW). In the MDR, medical devices are divided into invasive, non-invasive, and active devices.
- 4.
MDCG 2019-11, Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR October 2019.
- 5.
Recital 46 of the AI Act.
- 6.
Art. 26(5).
- 7.
Art. 26(6).
- 8.
Art. 26(7).
- 9.
Art. 26(9).
- 10.
Recital 102 of the AI Act.
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Acknowledgement
This study was funded in the context of the European Digital Innovation Hub (EDIH) for the Healthcare Digital and AI support and innovation (Circular Health European Digital Innovation Hub - CHEDIH) in Piedmont Region, Italy. The project is available on www.chedih.eu.
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Quaranta, M., Amantea, I.A., Molinari, M. (2025). The Introduction of AI in Healthcare: A Multi-layered Issue. In: Santos, M.F., Machado, J., Novais, P., Cortez, P., Moreira, P.M. (eds) Progress in Artificial Intelligence. EPIA 2024. Lecture Notes in Computer Science(), vol 14967. Springer, Cham. https://doi.org/10.1007/978-3-031-73497-7_19
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