Artificial Intelligence and Medical Devices: Do We Need New Regulation?
Roč.31,č.2(2023)
The article deals with the legal aspects of the use of artificial intelligence in health care, with a focus on clinical decision support systems and surgical robots. Emphasis is placed on the regulation of medical devices and product liability. The author analyses how the current European legislation affects the use of the above technologies in health care and examines its shortcomings. She then uses these findings to evaluate whether new comprehensive legislation is needed or whether it would be sufficient to adjust the current legislation to the specific features of artificial intelligence.
Artificial Intelligence; Robot; Health Care; Medical Devices; Civil Liability; Product Liability; European Law
381–394
ANESAR, S., CAGLE, Y., CHANDER, D., MOREY, J., FERNANDEZ-MIRANDA, J., KLIOT, M. Artificial Intelligence and the Future of Surgical Robotics. Annals of Surgery [online]. 2019, Vol. 270, no. 2, pp. 223–226. DOI: http://doi.org/10.1097/SLA.0000000000003262
ASIMOV, I. I, Robot. New York: Spectra, 1991, p. 30. ISBN 978-0553294385.
BELLMAN, R. An introduction to artificial intelligence: can computers think? San Francisco: Boyd and Fraser Publishing Company, 1978. ISBN 978-0878350667.
BENNET, C., DOUB, T. Expert Systems in Mental Healthcare: AI Applications in Decision Making and Consultation. In: LUXTON, D. (ed.). Artificial Intelligence in Behavioral and Mental Health Care. Elsevier, 2016, pp. 27–47. ISBN 978-0124202481. DOI: https://doi.org/10.1016/B978-0-12-420248-1.00002-7
ČAPEK, K. Dramata: Loupežník: R.U.R.: Věc Makropulos: Bílá nemoc: Matka. Prague: Československý spisovatel, 1992. ISBN 802020363X.
COMPTON, K. Da Vinci Surgical System. Drugwatch [online]. 2021 [cit. 5. 2. 2022]. Available at: https://www.drugwatch.com/davinci-surgery/
DETTLING, H. Künstliche Intelligenz und digitale Unterstützung ärztlicher Entscheidungen in Diagnostik und Therapie. Pharma Recht. 2019, Vol. 41, no. 12, pp. 633–642. ISSN 0172-6617.
DEVLIN, H. The Robots Helping NHS Surgeons Perform Better, Faster and For Longer. The Guardian [online]. 2018 [cit. 17. 4. 2022]. http://www.theguardian.com/society/2018/jul/04/robots-nhs-surgeons-keyhole-surgery-versius
ENGELBERGER, G. HelpMate, a service robot with experience. Industrial Robot [online]. 1998, Vol. 25, no. 2, pp. 101–104. DOI: http://doi.org/10.1108/01439919810204667
ESTEVA, A., KUPREL, B., NOVOA R. et al. Dermatologist level classification of skin cancer with deep neural networks. Nature [online]. 2017, Vol. 7639, no. 542, pp. 115–118. DOI: http://doi.org/10.1038/nature21056
FILIPPO, R., HILLIGOSS, H., KRISHNAMURTHY, V., BAVITZ, C., KIM, L. Artificial Intelligence & Human Rights: Opportunities & Risks. Berkman Klein Center for Internet & Society Scholarly Articles [online]. 2018 [cit. 8. 8. 2022]. Available at: https://dash.harvard.edu/handle/1/38021439
FROOMKIN, M., KERR, I., PINEAU, J. When AIs Outperform Doctors: Confronting the Challenges of a Tort-Induced Over-Reliance on Machine Learning. Arizona Law Review. 2019, Vol. 61, no. 33, pp. 32–99. ISSN 0004–153X.
HOLČAPEK, T. Občanskoprávní odpovědnost v medicíně a její uplatňování u českých soudů. Právní rozhledy. 2016, Vol. 24, no. 9, pp. 305–311. ISSN 1210-6410.
KURZWEIL, R. What Is Artificial Intelligence Anyway? As the techniques of computing grow more sophisticated, machines are beginning to appear intelligent – but can they actually think? American Scientist. 1985, Vol. 73, no. 3, pp. 258–264. ISSN 0003-0996.
MCDOUGALL, R. Computer knows best? The need for value-flexibility in medical AI. Medical Ethics [online]. 2019, Vol. 45, no. 3, pp. 156–160. DOI: http://doi.org/10.1136/medethics-2018-105118
O‘NEILL, M. Explainer: what is artificial intelligence? ABC News [online]. 2017 [cit. 16. 1. 2022]. Available at: http://www.abc.net.au/news/2017-08-07/explainer-what-is-artificial-intelligence/8771632
OIRSCHOT, J., KOLFSCHOOTEN, H. The EU Medical Devices Regulation and the EU AI Act: A short comparison. Health Action International [online]. 2023 [cit. 4. 6. 2023]. Available at: https://haiweb.org/wp-content/uploads/2023/03/MDR-AIAct_OnePager_FINAL.pdf
PETIT, N., COOMAN, J. de. Models of Law and Regulation for AI. Working paper EUI [online]. RSCAS 2020/63 [cit. 12. 3. 2022]. Available at: https://cadmus.eui.eu/handle/1814/68536
QUINN, T., JACOBS, S., SENADEERA, M., LE, V., COGHLAN, S. The three ghosts of medical AI: Can the black-box present deliver? Artificial Intelligence in Medicine [online]. 2022, Vol. 124. DOI: http://doi.org/10.1016/j.artmed.2021.102158
RUSSEL, S., NORWIG, P. Artificial Intelligence: A Modern Approach. 3. ed. New Jersey: Prentice Hall, 2009. ISBN 978-0136042594.
WACHTER, S., MITTELSTADT M., RUSSELL, C. Counterfactual Explanations without Opening the Black Box: Automated Decisions and the GDPR. Harvard Journal of Law & Technology [online]. 2018, Vol. 31, no. 2, pp. 841–887. DOI: http://doi.org/10.48550/arXiv.1711.00399
ZECH, H. Liability for AI: Public policy considerations. ERA Forum [online]. 2021, Vol. 22, no. 1, pp. 147–158. DOI: http://doi.org/10.1007/s12027-020-00648-0
Tato práce je licencována pod Mezinárodní licencí Creative Commons Attribution-NonCommercial-ShareAlike 4.0.
Copyright © 2023 Klára Zikmundová