Ethics and Tort Liability in Robotically Assisted Surgery: An Analysis of Resolution 2.311/2022 of the Brazilian Federal Council of Medicine
Keywords:
Robotically assisted surgery, Brazilian Federal Council of Medicine, Ethics, Resolution n. 2.311/2022, Tort liabilityAbstract
Robotically Assisted Surgery (RAS) is an important therapeutic option, safe and effective when used appropriately and with adequate training. However, ethical and legal questions permeate the theme. Thus, the Brazilian Federal Council of Medicine has regulated the ASR through Resolution No. 2311, dated March 23, 2022. The research problem of this article consists of the following question: what is the most appropriate type of civil liability for ADR procedures and who should be the agent in charge of repairing or compensating the damage caused to the patient? The general objective is to analyze CFM Resolution 2311 of March 23, 2022, from the standpoint of the objective and subjective theories of Civil Liability. It is verified that due to the high risk, the most appropriate type of civil liability is the objective one. Thus, all those involved in the surgical act may be civilly responsible. Monographic and bibliographic research technique is used to reach this result.
Downloads
References
ALA. Association of College and Research Library (EUA). Framework for information literacy for higher education. Chicago: ALA, 2015.
BRASIL. Resolução n. 2.311/2022 do Conselho Federal de Medicina brasileiro. Conselho Federal de Medicina. 2022
BOYS, Joshua A. et al. Public perceptions on robotic surgery, hospitals with robots, and surgeons that use them. Surgical endoscopy, v. 30, p. 1310-1316, 2016.
DAVIES, A. Uber’s self-driving truck makes its first delivery: 50,000 beers. Wired, elérhető: 2016. Disponível em: www.wired.com/. Acesso em: 20 mar. 2022.
DE RAVIN, Emma et al. Medical malpractice in robotic surgery: a Westlaw database analysis. Journal of Robotic Surgery, p. 1-6, 2022. link.springer.com/. Acesso em: 21 mar.2023
DIVINO, Sthéfano Bruno Santos; ALMEIDA, Isabela. Telemedicina, ética e a Resolução n. 2.314/2022 do Conselho Federal de Medicina Brasileiro: parâmetros de aplicação, subsidiariedade, letramento e segurança informacional. Revista de Bioética y Derecho, p. 115-132, 2023.
ELIOT, L. B. Self-Driving Cars: " The Mother of All AI Projects" Practical Advances in Artificial Intelligence (AI). LBE Press Publishing, 2017.
EUROPEAN UNION. Europe fit for the Digital Age: Commission proposes new rules and actions for excellence and trust in Artificial Intelligence. European Comission. 2021. Disponível em: ec.europa.eu/. Acesso em: 20 mar. 2023.
EUROPEAN UNION. Proposal for a regulation of the European Parliament and of the Council laying down harmonised rules on Artificial Intelligence (Artificial Intelligence Act) and amending certain union legislative acts. European Comission. 2021. Disponível em: eur-lex.europa.eu/. Acesso em: 20 mar. 2023.
FOOD AND DRUG ADMINISTRATION. "FDA Approves New Robotic Surgery Device." ScienceDaily. ScienceDaily. 2000. Disponível em: www.sciencedaily.com/. Acesso em: 20 mar. 2023.
FOOD AND DRUG ADMINISTRATION. FDA clears new robotically-assisted surgical device for adult patients. FDA. 2017. Disponível em: www.fda.gov/. Acesso em: 20 mar. 2023.
FOOD AND DRUG ADMINISTRATION. FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy. FDA. 2021. Disponível em: www.fda.gov/. Acesso em: 20 mar. 2023.
FOOD AND DRUG ADMINISTRATION. Computer-Assisted Surgical Systems. FDA. 2022. Disponível em: www.fda.gov/. Acesso em: 20 mar. 2023.
GOMES, R. D. D. P. Carros autônomos e os desafios impostos pelo ordenamento jurídico: uma breve análise sobre a responsabilidade civil envolvendo veículos inteligentes. FRAZÃO, Ana; MULHOLLAND, Caitlin. Inteligência Artificial e Direito. São Paulo: Thomson Reuters Brasil, p. 567-585, 2020.
KFOURI NETO, Miguel; NOGAROLI, Rafaella. Responsabilidade civil pelo inadimplemento do dever de informação na cirurgia robótica e telecirurgia: uma abordagem de direito comparado (Estados Unidos, União Europeia e Brasil). Revista Científica da Academia Brasileira de Direito Civil, v. 4, n. 2, 2019. abdc.emnuvens.com.br/. Acesso em: 23 mar.2023.
LANCELOT, Eliot. Self-Driving Car is the Mother of All AI Projects: Why It is a Moonshot. Airtrends. 2017. Disponível em: www.aitrends.com/. Acesso em: 23 mar.2023.
MATTHIAS, Andreas. The responsibility gap: Ascribing responsibility for the actions of learning automata. Ethics and information technology, v. 6, p. 175-183, 2004.
NATIONAL CANCER INSTITUTE. Minimally invasive surgery. 2022, s/p. Disponível em: www.cancer.gov/. Acesso em: 20 mar. 2023.
NICE. NICE interventional procedures guidance. 2017. Disponível em: www.nice.org.uk/. Acesso em: 20 mar. 2023.
NOGAROLI, R.; KFOURI Neto, M. Procedimentos cirúrgicos assistidos pelo robô Da Vinci: benefícios, riscos e responsabilidade civil. Cadernos Ibero-Americanos de Direito Sanitário, v. 9, n. 3, p. 200-209, 2020. www.cadernos.prodisa.fiocruz.br/. Acesso em: 23 mar.2023.
O'SULLIVAN, Shane et al. Legal, regulatory, and ethical frameworks for development of standards in artificial intelligence (AI) and autonomous robotic surgery. The international journal of medical robotics and computer assisted surgery, v. 15, n. 1, p. e1968, 2019. onlinelibrary.wiley.com/. Acesso em: 21 mar. 2023.
PAGALLO, U. The laws of robots: Crimes, contracts, and torts (Vol. 10). Springer Science & Business Media, 2013.
PALEP, Jaydeep H. Robotic assisted minimally invasive surgery. Journal of minimal access surgery, v. 5, n. 1, p. 1, 2009.
SAE. Taxonomy and Definitions for Terms Related to Driving Automation Systems for On-Road Motor Vehicles. J3016_201806. 2018. Disponível em: www.sae.org/. Acesso em: 20 mar. 2023.
SKOVRLJ, Branko et al. Minimally invasive procedures on the lumbar spine. World Journal of Clinical Cases: WJCC, v. 3, n. 1, p. 1-9, 2015.
WACHTER, Sandra; MITTELSTADT, Brent; FLORIDI, Luciano. Transparent, explainable, and accountable AI for robotics. Science robotics, v. 2, n. 6, p. eaan6080, 2017.
YANG, Guang-Zhong et al. Medical robotics—Regulatory, ethical, and legal considerations for increasing levels of autonomy. Science Robotics, v. 2, n. 4, p. eaam8638, 2017.
ZMORA, O.; GERVAZ, P.; WEXNER, S. D. Trocar site recurrence in laparoscopic surgery for colorectal cancer. Tech Coloproctol, v. 6, p. 197-201, 2002.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Sthéfano Bruno Santos Divino, Isabela Gonçalves Almeida
This work is licensed under a Creative Commons Attribution 4.0 International License.
Civilistica.com is licensed under a 