A IA em Saúde Exige uma Supervisão Contínua
Fundamentos Jurídicos e Éticos Para um Novo Quadro de Responsabilização
DOI:
https://doi.org/10.34625/issn.2183-2705(39.2)2026.ic-5Palavras-chave:
Responsabilidade, Supervisão contínua, Tutela institucional, Consentimento informado, Dignidade Humana, IA na saúde, Mecanismos de reparaçãoResumo
Este artigo sustenta que os atuais instrumentos jurídicos que regem a inteligência artificial no sector da saúde na União Europeia são insuficientes para assegurar uma verdadeira responsabilidade ética e legal na fase pós-implementação dos sistemas. Argumenta que a arquitetura normativa vigente assenta em mecanismos estáticos de certificação e documentação, que não respondem à natureza distribuída e evolutiva da tomada de decisão clínica mediada por algoritmos. A partir de uma análise comparada e de uma reflexão normativa, identifica um desfasamento estrutural entre o cumprimento formal e a responsabilização efetiva. Defende que, para proteger a dignidade humana, a autonomia e para assegurar mecanismos efetivos de responsabilização, a supervisão deve tornar-se uma prática institucional viva: contínua, contextualizada, sempre com substancial envolvimento humano. O artigo desenvolve o conceito de responsabilidade por tutela (stewardship) como modelo de responsabilização partilhada e duradoura entre desenvolvedores, clínicos, instituições e reguladores. Apresenta implicações concretas para a governação da IA em saúde, como o consentimento dinâmico, auditorias pós-implementação e mecanismos de indemnização verdadeiramente executáveis. Conclui que a responsabilização deve estar incorporada no funcionamento efetivo dos sistemas, para que o uso de IA se mantenha compatível com os fundamentos morais dos cuidados de saúde.Referências
Normative Instruments
CHARTER of Fundamental Rights of the European Union [online]. Official Journal of the European Union, C 326, 26.10.2012. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A12012P%2FTXT [viewed 4 February 2026].
COUNCIL OF EUROPE. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine (Oviedo Convention) [online]. Strasbourg: Council of Europe, 1997. Available from: https://rm.coe.int/168007cf98 [viewed 4 February 2026].
COUNCIL OF EUROPE. Committee of Ministers. Recommendation CM/Rec(2020)1 of the Committee of Ministers to member States on the human rights impacts of algorithmic systems [online]. Strasbourg: Council of Europe, 2020. Available from: https://rm.coe.int/09000016809e1154 [viewed 4 February 2026].
EUROPEAN PARLIAMENT AND COUNCIL OF THE EUROPEAN UNION. Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union (NIS 2 Directive) [online]. Official Journal of the European Union, L 333, 27.12.2022. Available from: https://eur-lex.europa.eu/eli/dir/2022/2555/oj [viewed 4 February 2026].
EUROPEAN PARLIAMENT AND COUNCIL OF THE EUROPEAN UNION. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices [online]. Official Journal of the European Union, L 117, 5.5.2017. Available from: https://eur-lex.europa.eu/eli/reg/2017/745/oj [viewed 4 February 2026].
EUROPEAN PARLIAMENT AND COUNCIL OF THE EUROPEAN UNION. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices [online]. Official Journal of the European Union, L 117, 5.5.2017. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj [viewed 4 February 2026].
EUROPEAN PARLIAMENT AND COUNCIL OF THE EUROPEAN UNION. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act) [online]. Official Journal of the European Union, OJ L, 2024/1689, 12.7.2024. Available from: https://eur-lex.europa.eu/eli/reg/2024/1689/oj [viewed 4 February 2026].
EUROPEAN PARLIAMENT AND COUNCIL OF THE EUROPEAN UNION. Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 [online]. Official Journal of the European Union, OJ L, 2025/327, 5.3.2025. Available from: https://eur-lex.europa.eu/eli/reg/2025/327/oj/eng [viewed 4 February 2026].
ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT. Recommendation of the Council on Artificial Intelligence [online]. Paris: OECD, 2019 (amended 2024). OECD/LEGAL/0449. Available from: https://legalinstruments.oecd.org/en/instruments/OECD-LEGAL-0449 [viewed 4 February 2026].
UNITED NATIONS. Universal Declaration of Human Rights [online]. New York: United Nations, 1948. Available from: https://www.un.org/en/about-us/universal-declaration-of-human-rights [viewed 4 February 2026].
UNITED NATIONS GENERAL ASSEMBLY. Resolution A/RES/78/265: Seizing the opportunities of safe, secure and trustworthy artificial intelligence systems for sustainable development [online]. New York: United Nations, 2024. Available from: https://docs.un.org/en/A/res/78/265 [viewed 4 February 2026].
UNITED NATIONS HUMAN RIGHTS COUNCIL. Resolution A/HRC/RES/47/23: New and emerging digital technologies and human rights [online]. Geneva: United Nations, 2021. Available from: https://undocs.org/A/HRC/RES/47/23 [viewed 4 February 2026].
UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION. Universal Declaration on Bioethics and Human Rights [online]. Paris: UNESCO, 2005. Available from: https://unesdoc.unesco.org/ark:/48223/pf0000146180 [viewed 4 February 2026].
UNITED NATIONS EDUCATIONAL, SCIENTIFIC AND CULTURAL ORGANIZATION. Recommendation on the Ethics of Artificial Intelligence [online]. Paris: UNESCO, 2021. Available from: https://unesdoc.unesco.org/ark:/48223/pf0000381137 [viewed 4 February 2026].
UNITED STATES. Food and Drug Administration. Quality System Regulation [online]. Code of Federal Regulations, Title 21, Part 820. Washington, DC: US Government Publishing Office, 2024. Available from: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820 [viewed 4 February 2026].
WORLD HEALTH ORGANIZATION. WHO guidance on ethics and governance of artificial intelligence for health [online]. Geneva: WHO, 2021. Available from: https://www.who.int/publications/i/item/9789240029200 [viewed 4 February 2026].
WORLD HEALTH ORGANIZATION. Regulatory considerations on artificial intelligence for health [online]. Geneva: WHO, 2023. Available from: https://www.who.int/news/item/19-10-2023-who-outlines-considerations-for-regulation-of-artificial-intelligence-for-health [viewed 4 February 2026].
Jurisprudence
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).
Google Spain SL and Google Inc. v Agencia Española de Protección de Datos (AEPD) and Mario Costeja González, C-131/12, ECLI:EU:C:2014:317, Court of Justice of the European Union [online]. 2014. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A62012CJ0131 [viewed 4 February 2026].
Bibliographic References
ALLEN, Matthew R.; WEBB, Sophie; MANDVI, Ammar; FRIEDEN, Marshall; TAI-SEALE, Ming; KALLENBERG, Gene. 'Navigating the doctor-patient-AI relationship – a mixed-methods study of physician attitudes toward artificial intelligence in primary care'. BMC Primary Care [online]. 2024, 25(1), 42. https://doi.org/10.1186/s12875-024-02282-y.
AMERICAN LAW INSTITUTE. Restatement (Third) of Torts: Liability for Physical and Emotional Harm. St Paul, MN: American Law Institute, 2010.
BLEHER, Hannah; BRAUN, Matthias. 'Diffused responsibility: attributions of responsibility in the use of AI-driven clinical decision support systems'. AI and Ethics [online]. 2022, 2(4), pp. 747–761. https://doi.org/10.1007/s43681-022-00135-x.
BOUDERHEM, Rabaï. 'Shaping the future of AI in healthcare through ethics and governance'. Humanities and Social Sciences Communications [online]. 2024, 11(1), 416. https://doi.org/10.1057/s41599-024-02894-w.
BURRELL, Jenna. 'How the machine "thinks": understanding opacity in machine learning algorithms'. Big Data & Society [online]. 2016, 3(1), 2053951715622512. https://doi.org/10.1177/2053951715622512.
CESTONARO, Clara; DELICATI, Arianna; MARCANTE, Beatrice; CAENAZZO, Luciana; TOZZO, Pamela. 'Defining medical liability when artificial intelligence is applied on diagnostic algorithms: a systematic review'. Frontiers in Medicine [online]. 2023, 10, 1305756. https://doi.org/10.3389/fmed.2023.1305756.
CORREIA, Mónica; RÊGO, Guilhermina; NUNES, Rui. 'Gender transition: is there a right to be forgotten?' Health Care Analysis [online]. 2021, 29(4), pp. 283–300. https://doi.org/10.1007/s10728-021-00433-1.
CORREIA, Mónica; RÊGO, Guilhermina; NUNES, Rui. 'The right to be forgotten and COVID-19: privacy versus public interest'. Acta Bioethica [online]. 2021, 27(1), pp. 59–67. Available from: https://actabioethica.uchile.cl/index.php/AB/article/view/63954 [viewed 4 February 2026].
CORREIA, Mónica; RÊGO, Guilhermina; NUNES, Rui. 'The right to be forgotten versus the right to disclosure of gamete donors' ID: ethical and legal considerations'. Acta Bioethica [online]. 2021, 27(1), pp. 69–78. Available from: https://actabioethica.uchile.cl/index.php/AB/article/view/63955 [viewed 4 February 2026].
CORREIA, Mónica; RÊGO, Guilhermina; NUNES, Rui. 'The right to be forgotten regarding genetic data: a legal and ethical analysis'. Acta Bioethica [online]. 2024, 30(2), pp. 231–243. Available from: https://actabioethica.uchile.cl/index.php/AB/article/view/76137 [viewed 4 February 2026].
DUFFOURC, Mindy; GERKE, Sara. 'Decoding U.S. tort liability in healthcare's black-box AI era: lessons from the European Union'. Stanford Technology Law Review [online]. 2024, 27(1), pp. 1–58. Available from: https://law.stanford.edu/wp-content/uploads/2024/02/Publish_27-STLR-1-2024_Decoding-U.S.-Tort-Liability-in-Healthcares-Black-Box-AI-Era.pdf [viewed 4 February 2026].
FEDERAL JUDICIAL CENTER; NATIONAL RESEARCH COUNCIL. Reference Manual on Scientific Evidence [online]. 3rd ed. Washington, DC: National Academies Press, 2011. Available from: https://nap.nationalacademies.org/catalog/13163/reference-manual-on-scientific-evidence-third-edition [viewed 4 February 2026].
FLORIDI, Luciano. The Fourth Revolution: How the Infosphere Is Reshaping Human Reality. Oxford: Oxford University Press, 2014.
FLORIDI, Luciano. The Ethics of Artificial Intelligence: Principles, Challenges, and Opportunities. Oxford: Oxford University Press, 2023.
GOZUM, Ivan Efreaim A.; FLAKE, Chastene Christopher D. 'Human dignity and artificial intelligence in healthcare: a basis for a Catholic ethics on AI'. Journal of Religion and Health [online]. 2024. Available from: https://doi.org/10.1007/s10943-024-02206-1 [viewed 4 February 2026].
GROTE, Thomas; BERENS, Philipp. 'On the ethics of algorithmic decision-making in healthcare'. Journal of Medical Ethics [online]. 2020, 46(3), pp. 205–211. https://doi.org/10.1136/medethics-2019-105586.
HERZOG, Christian; BRANFORD, Jason. ‘Relational ethics and structural epistemic injustice of AI in medicine’. Philosophy & Technology [online]. 2025, vol. 38, no. 4, 160 [viewed 4 February 2026]. Available from: https://doi.org/10.1007/s13347-025-00987-1
KEETON, W. Page; DOBBS, Dan B.; KEETON, Robert E.; OWEN, David G. Prosser and Keeton on the Law of Torts. 5th ed. St Paul, MN: West Publishing Co., 1984.
KISELEVA, Anastasiya; KOTZINOS, Dimitris; DE HERT, Paul. 'Transparency of AI in healthcare as a multilayered system of accountabilities: between legal requirements and technical limitations'. Frontiers in Artificial Intelligence [online]. 2022, 5, 879603. https://doi.org/10.3389/frai.2022.879603.
KOLFSCHOOTEN, Hannah B. van. 'A health-conformant reading of the GDPR's right not to be subject to automated decision-making'. Medical Law Review [online]. 2024, 32(3), pp. 373–391. https://doi.org/10.1093/medlaw/fwae029.
LAY, Winnie; GASPARINI, Loretta; SIERO, William; HUGHES, Elizabeth K. 'A rapid review of the benefits and challenges of dynamic consent'. Research Ethics [online]. 2025, 21(1), pp. 180–202. https://doi.org/10.1177/17470161241278064.
LE MOLI, Ginevra. 'Intelligence artificielle vs dignité humaine: quand la sous-performance humaine est légalement requise'. Revue européenne du droit [online]. 2022, 4(1), pp. 122–127. https://doi.org/10.3917/red.004.0122.
LEE, Ah Ra; KOO, Dongjun; KIM, Il Kon; LEE, Eunjoo; YOO, Sooyoung; LEE, Ho-Young. 'Opportunities and challenges of a dynamic consent-based application: personalised options for personal health data sharing and utilisation'. BMC Medical Ethics [online]. 2024, 25(1), 92. https://doi.org/10.1186/s12910-024-01091-3.
LORENZINI, Giorgia; ARBELAEZ OSSA, Laura; SHAW, David Martin; ELGER, Bernice Simone. 'Artificial intelligence and the doctor–patient relationship expanding the paradigm of shared decision making'. Bioethics [online]. 2023, 37(5), pp. 424–429. https://doi.org/10.1111/bioe.13158.
MALIHA, George; GERKE, Sara; COHEN, I. Glenn; PARIKH, Ravi B. 'Artificial intelligence and liability in medicine: balancing safety and innovation'. Milbank Quarterly [online]. 2021, 99(3), pp. 629–647. https://doi.org/10.1111/1468-0009.12504.
MEDTECH EUROPE. Liability challenges in AI medical technologies: key considerations for policymakers and industry [online]. MedTech Europe White Paper. Brussels: MedTech Europe, 2022. Available from: https://www.medtecheurope.org/resource-library/liability-challenges-in-ai-medical-technologies/ [viewed 4 February 2026].
MOLBÆK-STEENSIG, Helga; SCHEININ, Martin. 'Human rights and artificial intelligence in healthcare-related settings: a grammar of human rights approach'. European Journal of Health Law [online]. 2025, 32(2), pp. 139–164. https://doi.org/10.1163/15718093-bja10146.
O'FLAHERTY, Michael. Human rights oversight of artificial intelligence [online]. Strasbourg: Council of Europe, Commissioner for Human Rights, 2025. Available from: https://www.coe.int/en/web/commissioner/-/human-rights-oversight-of-artificial-intelligence [viewed 4 February 2026].
ORWAT, Carsten. 'Algorithmic discrimination from the perspective of human dignity'. Social Inclusion [online]. 2024, 12, 7160. https://doi.org/10.17645/si.7160.
PALANIAPPAN, Kavitha; LIN, Elaine Yan Ting; VOGEL, Silke; LIM, John C. W. 'Gaps in the global regulatory frameworks for the use of artificial intelligence (AI) in the healthcare services sector and key recommendations'. Healthcare [online]. 2024, 12(17), 1730. https://doi.org/10.3390/healthcare12171730.
PIERCE, Robin L.; VAN BIESEN, Wim; VAN CAUWENBERGE, Daan; DECRUYENAERE, Johan; STERCKX, Sigrid. 'Explainability in medicine in an era of AI-based clinical decision support systems'. Frontiers in Genetics [online]. 2022, 13, 903600. https://doi.org/10.3389/fgene.2022.903600.
PRICE, W. Nicholson II. 'Medical malpractice and black-box medicine'. In: COHEN, I. Glenn; FERNANDEZ LYNCH, Holly; VAYENA, Effy; GASSER, Urs (eds.). Big Data, Health Law, and Bioethics. Cambridge: Cambridge University Press, 2018. https://doi.org/10.1017/9781108147972.027.
RUSTAMZADE, Aykhan; BAGIROV, Anar Ramiz; HUSEYNOV, Sahil Zahir. 'Justice and artificial intelligence'. Revista Jurídica Portucalense [online]. 2024, 36, pp. 163–184. https://doi.org/10.34625/ISSN.2183-2705(36)2024.IC-7.
SANTOS, Elisabete. 'Workers under the aegis of artificial intelligence: new risks and challenges in the light of data protection'. Revista Jurídica Portucalense [online]. 2025, 38, pp. 427–449. https://doi.org/10.34625/ISSN.2183-2705(38)2025.IC-22.
SCHMIDT, Jelena; SCHUTTE, Nienke M.; BUTTIGIEG, Stefan; et al. 'Mapping the regulatory landscape for artificial intelligence in health within the European Union'. npj Digital Medicine [online]. 2024, 7(1), 229. https://doi.org/10.1038/s41746-024-01221-6.
SUBRAMANIAN, Harishankar V.; CANFIELD, Casey; SHANK, Daniel B. 'Designing explainable AI to improve human-AI team performance: a medical stakeholder-driven scoping review'. Artificial Intelligence in Medicine [online]. 2024, 149, 102780. https://doi.org/10.1016/j.artmed.2024.102780.
TANG, Lu; LI, Jinxu; FANTUS, Sophia. 'Medical artificial intelligence ethics: a systematic review of empirical studies'. Digital Health [online]. 2023, 9, 20552076231186064. https://doi.org/10.1177/20552076231186064.
THE PRECISE4Q CONSORTIUM; AMANN, Julia; BLASIMME, Alessandro; VAYENA, Effy; FREY, Dietmar; MADAI, Vince I. 'Explainability for artificial intelligence in healthcare: a multidisciplinary perspective'. BMC Medical Informatics and Decision Making [online]. 2020, 20(1), 310. https://doi.org/10.1186/s12911-020-01332-6.
TONEKABONI, Sana; JOSHI, Shalmali; McCRADDEN, Melissa D.; GOLDENBERG, Anna. 'What clinicians want: contextualising explainable machine learning for clinical end use' [online]. Preprint, arXiv, 2019. https://doi.org/10.48550/ARXIV.1905.05134.
VILAS BOAS PINTO, João. '"I don't know where I'm going, I know I'm (not) going that way": some notes about the opportunities, challenges, and limits of artificial intelligence in the scope of administrative law'. Revista Jurídica Portucalense [online]. 2025, 38, pp. 286–307. https://doi.org/10.34625/ISSN.2183-2705(38)2025.IC-15.
VILLEGAS-GALAVIZ, Carolina; MARTIN, Kirsten. 'Moral distance, AI, and the ethics of care'. AI & SOCIETY [online]. 2024, 39(4), pp. 1695–1706. https://doi.org/10.1007/s00146-023-01642-z.
YEUNG, Karen; LODGE, Martin (eds.). Algorithmic Regulation. Oxford: Oxford University Press, 2019.
ZHANG, Jie; ZHANG, Zong-ming. 'Ethics and governance of trustworthy medical artificial intelligence'. BMC Medical Informatics and Decision Making [online]. 2023, 23(1), 7. https://doi.org/10.1186/s12911-023-02103-9.
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Direitos de Autor (c) 2026 Eva Dias COSTA, Mónica CORREIA, Rui NUNES
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