Artificial Intelligence in Healthcare: The Paths For Its Regulation
DOI:
https://doi.org/10.11606/issn.2316-9044.rdisan.2024.207653Keywords:
Self-Regulation, Business Ethics, Artificial Intelligence, Regulation, Digital HealthAbstract
We live in an “artificial intelligence winter”: while humankind witnesses significant advances in the technical capabilities of artificial intelligence, its benefits are inferior to those aspired by society – and often seem to be outgrown by the disadvantages. This scenario of distrust in artificial intelligence is contemporary to a dispute over which actors should be responsible for the regulation of artificial intelligence. Healthcare has been suffering deep reflexes from this debate, due to the increasingly prominent role of these technologies and the fact that it is a highly regulated sector. The present paper aimed to explore the paths for the regulation of artificial intelligence in healthcare, considering the urgency in protecting fundamental rights in view of the development of new technologies and the relative failure of strategies that have prioritized self-regulation. The paper begins as an exposure of the risks associated with the adoption of artificial intelligence in healthcare, to then analyze the ways for the regulatory strategy of the sector in light of a general theory of regulation. We opted for an inductive approach, based on bibliographic and document research with the goal of identifying guidelines for the regulation of artificial intelligence in healthcare. Three principles have shown to be imperative for its construction: (i) the diffusion of knowledge, through informational and procedural duties of the organizations that own and utilize these technologies; (ii) the social role of property, understood as a limiting factor to potential violations to fundamental rights; and (iii) the incentive to cooperation between actors, by means of regulatory frameworks which guarantee the previous principles, promote competition, and stimulate self-regulation in a complementary manner.
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AGÊNCIA NACIONAL DE VIGILÂNCIA SANITÁRIA - Anvisa. Resolução da Diretoria Colegiada (RDC) n. 657, de 24 de março de 2022. Dispõe sobre a regularização de software como dispositivo médico (Software as a Medical Device – SaMD). Disponível em: https://in.gov.br/en/web/dou/-/resolucao-de-diretoria-colegiada-rdc-n-657-de-24-de-marco-de-2022-389603457. Acesso em: 16 out. 2023.
AITH, Fernando Mussa Abujamra. Fundamentos e desafios da regulação da saúde digital em Estados democráticos. In: AITH, Fernando Mussa Abujamra; DALLARI, Analluza Bolivar (orgs.). LGPD na Saúde Digital. São Paulo: Thomson Reuters Brasil, 2022. p. 41-59.
AKERLOF, George A. The market for “lemons”: quality uncertainty and the market mechanism. The Quarterly Journal of Economics, v. 84, n. 3, p. 488-500, 01 ago. 1970. DOI: https://doi.org/10.2307/1879431.
BOBBIO, Marco. O doente imaginado. Tradução: Monica Gonçalves. São Paulo: Bamboo Editorial, 2014.
BONNA, Alexandre Pereira; SÁ, Victória Vasconcelos. Responsabilidade civil do médico por erros ocasionados no uso da inteligência artificial. Revista Brasileira de Direito Civil em Perspectiva, v. 7, n. 1, p. 45-66, ago. 2021. DOI: http://dx.doi.org/10.26668/IndexLawJournals/2526-0243/2021.v7i1.7754.
BRASIL. Constituição da República Federativa do Brasil de 1988. Disponível em: https://www.planalto.gov.br/ccivil_03/constituicao/constituicaocompilado.htm. Acesso em: 16 out. 2023.
BRASIL. Lei n. 13.709, de 14 de agosto de 2018. Lei Geral de Proteção de Dados Pessoais (LGPD). Disponível em: https://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm. Acesso em: 16 out. 2023.
CÂMARA DOS DEPUTADOS – CD. Projeto de Lei n. 21/2020. NOVA EMENTA: Estabelece fundamentos, princípios e diretrizes para o desenvolvimento e a aplicação da inteligência artificial no Brasil; e dá outras providências. Disponível em: https://www.camara.leg.br/proposicoesWeb/fichadetramitacao?idProposicao=2236340&fichaAmigavel=nao. Acesso em: 16 out. 2023.
CEPI. Speeding up vaccine development: can we go from lab to jab in just 100 days?. Gavi, 8 jun. 2021. Disponível em: https://www.gavi.org/vaccineswork/why-world-set-getting-next-pandemic-vaccine-out-just-100-days. Acesso em: 20 jun. 2022.
CONSELHO FEDERAL DE MEDICINA - CFM. Resolução n. 2.311, de 28 de março de 2022. Regulamenta a cirurgia robótica no Brasil. Disponível em: https://sistemas.cfm.org.br/normas/visualizar/resolucoes/BR/2022/2311. Acesso em: 16 out. 2023.
DIB, Caio Caesar. O acesso ao conhecimento como dimensão do direito aos benefícios do progresso científico na saúde. In: CONGRESSO BRASILEIRO DE BIOÉTICA, 14, 2021, On-line. Anais […]. On-line, 2021.
FLORIDI, Luciano. AI and its new winter: from myths to realities. Philosophy & Technology, v. 33, n. 1, p. 1-3, 2020. DOI: https://doi.org/10.1007/s13347-020-00396-6.
FLORIDI, Luciano. The end of an era: from self-regulation to hard law for the digital industry. Philosophy & Technology, v. 34, p. 619-622, 03 nov. 2021. DOI: https://doi.org/10.1007/s13347-021-00493-0.
FULLER, Lon L. The morality of law. 15. ed. New Haven: Yale University, 1978. DOI: 10.2307/2217903.
HAGEMANN, Ryan; LECLERC, Jean-Marc. Inteligência Artificial: equilíbrio entre a regulação e a autorregulação. Tradução: IBM Brasil. 2022. Disponível em: https://www.ibm.com/blogs/policy/latin-america/2020/01/22/inteligencia-artificial-equilibrio-entre-regulacao-e-autorregulacao/. Acesso em: 10 jun. 2022.
HAGEMANN, Ryan; LECLERC, Jean-Marc. Precision Regulation for Artificial Intelligence. IBM, 2020. Disponível em: https://www.ibm.com/policy/ai-precision-regulation/. Acesso em: 10 jun. 2022.
MARTINS-COSTA, Judith. Bioética e Dignidade da Pessoa Humana: Rumo à Construção do Biodireito. Revista da Faculdade de Direito da UFRGS, v. 18, n. 18, 2017. DOI: 10.22456/0104-6594.71207. Disponível em: https://seer.ufrgs.br/index.php/revfacdir/article/view/71207.
MINISTÉRIO DA SAÚDE - MS. Contas de saúde na perspectiva da contabilidade internacional: conta SHA para o Brasil, 2015 a 2019. Brasília: Fiocruz; IPEA, 2022.
MÖLLER, Leticia Ludwig. Bioética e direitos humanos: delineando um biodireito mínimo universal. Revista Filosofazer, ano 16, n. 30, p. 91-109, 2007.
MORLEY, Jessica et al. The ethics of AI in health care: a mapping review. In: FLORIDI, L. (ed.). Ethics, governance, and policies in artificial intelligence. London: Springer, 2021. Philosophical Studies Series, v. 144, p. 313-346. DOI: https://doi.org/10.1007/978-3-030-81907-1_18.
NUFFIELD COUNCIL ON BIOETHICS. AI in healthcare and research. Policy Briefing, 15 maio 2018. Disponível em: https://www.nuffieldbioethics.org/publications/ai-in-healthcare-and-research. Acesso em: 8 jun. 2022.
POTTER, van Rensselaer. Bioética: ponte para o futuro. Tradução: Diego Carlos Zanella. São Paulo: Edições Loyola, 2016.
RAY, Ishita et al. Skin tone, confidence, and data quality of heart rate sensing in WearOS smartwatches. In: INTERNATIONAL CONFERENCE ON PERVASIVE COMPUTING AND COMMUNICATIONS WORKSHOPS AND OTHER AFFILIATED EVENTS (PerCom Workshops), Kassel (Alemanha), 2021. Proceedings […]. Kassel (Alemanha): IEEE, 2021. p. 213-219. Disponível em: https://ieeexplore.ieee.org/document/9431120/. Acesso em: 26 jun. 2022.
SALOMÃO FILHO, Calixto. Regulação da atividade econômica: princípios e fundamentos jurídicos. 3. ed. São Paulo: Quartier Latin, 2021.
SALOMÃO FILHO, Calixto. Uma perspectiva jurídica neo-estrutural para a análise do poder econômico. Revista Direito e Práxis, v. 7, n. 4, p. 447-482, 2016. DOI: 10.12957/dep.2016.26509.
SANTOS, Lenir. A natureza jurídica pública dos serviços de saúde e o regime de complementaridade dos serviços privados à rede pública do Sistema Único de Saúde. Saúde em Debate, v. 39, n. 106, p. 815-829, 2015. DOI: https://doi.org/10.1590/0103-1104201510600030021.
THIGA, Moses; KIMETO, Pamela; KIPTOO, Daisy. Collecting blood pressure and activity data using an integrated mobile and smartwatch application. In: INTERNATIONAL RESEARCH CONFERENCE ON COMPUTING AND INFORMATION SYSTEMS, 10, 2020, Nakuru (Quênia). Proceedings […]. Nakuru (Quênia), 2020. Disponível em: http://ir.kabarak.ac.ke/handle/123456789/458. Acesso em: 10 jun. 2022.
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