Double Trouble in Digital Twin Healthcare Systems - Dispute Resolution Beyond Liability

Authors

DOI:

https://doi.org/10.52028/rbadr.v8.i15.ART01.RU

Keywords:

Digital twin, Healthcare, Dispute resolution, Risk governance, Legal liability, Medical AI, ADR, Data governance, Cybersecurity, Evidence, Compliance

Abstract

The paper examines dispute resolution in healthcare digital twin (HDT) systems, focusing on the transformation from traditional liability models toward integrated risk governance frameworks. The study employs doctrinal, comparative, and socio-technical analysis to explore how emerging regulatory regimes (EU, US, UK), standards, and case law interact with the architecture of HDT systems. It is argued that disputes in this domain are inherently multi-layered, involving data governance, model performance, human-system interaction, and lifecycle management. The research identifies key failure modes and stakeholder responsibilities, demonstrating that classical liability doctrines are insufficient to address the complexity of HDT ecosystems. Particular attention is given to the role of standards (ISO, IEC, NIST) and regulatory compliance as sources of evidentiary value in disputes. The paper proposes an integrated model (ILRG-HDT) that aligns the technical architecture, legal accountability, and dispute-resolution mechanisms, including ADR pathways. It is concluded that dispute resolution in HDT systems should be understood as the legal dimension of risk governance, where traceability, documentation, and institutional design determine both liability allocation and the possibility of fair adjudication.

Author Biography

Aleksandra E. Zorina, University of Tyumen

Candidate of Legal Sciences, Senior lecturer, Academic Department, School of Law and Governance, Head, “4Bio” Laboratory, Center for Innovative Design and Applied Research.

References

BADGELEY, M. A.; ZECH, J. R.; OAKDEN-RAYNER, L.; GLICKSBERG, B. S.; LIU, M.; GALE, W. et al. Deep learning predicts hip fracture using confounding patient and healthcare variables. npj Digital Medicine, v. 2, art. 31, 2019. DOI: https://doi.org/10.1038/s41746-019-0105-1.

BRUYNSEELS, K.; SANTONI DE SIO, F.; VAN DEN HOVEN, J. Digital twins in health care: ethical implications of an emerging engineering paradigm. Frontiers in Genetics, v. 9, art. 31, 2018. DOI: https://doi.org/10.3389/fgene.2018.00031.

COUNCIL OF THE EUROPEAN UNION. EU brings product liability rules in line with digital age and circular economy. Brussels: Council of the European Union, 2024. Press release, 10 Oct. 2024. Disponível em: https://www.consilium.europa.eu/en/press/press-releases/2024/10/10/eu-brings-product-liability-rules-in-line-with-digital-age-and-circular-economy/. Acesso em: 03 abr. 2026.

DE HOND, A. A. H.; LEEUWENBERG, A. M.; HOOFT, L.; KANT, I. M. J.; NIJMAN, S. W. J.; VAN OS, H. J. A. et al. Guidelines and quality criteria for artificial intelligence-based prediction models in healthcare: a scoping review. npj Digital Medicine, v. 5, art. 2, 2022. DOI: https://doi.org/10.1038/s41746-021-00549-7.

EUROPEAN COMMISSION. Artificial intelligence in healthcare. Brussels: European Commission, 2024. Disponível em: https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en. Acesso em: 02 abr. 2026.

EUROPEAN COMMISSION. Directorate-General for Health and Food Safety. MDCG 2025-6: FAQ on interplay between the Medical Devices Regulation, In Vitro Diagnostic Medical Devices Regulation and the Artificial Intelligence Act. Brussels: European Commission, 2025. Guidance document. Disponível em: https://health.ec.europa.eu/document/download/b78a17d7-e3cd-4943-851d-e02a2f22bbb4_en. Acesso em: 02 abr. 2026.

EUROPEAN UNION. Court of Justice of the European Union. Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – Die Gesundheitskasse and Betriebskrankenkasse RWE. Joined Cases C-503/13 and C-504/13. Judgment of 5 March 2015. ECLI:EU:C:2015:148. Luxembourg: Court of Justice of the European Union, 2015.

EUROPEAN UNION. Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Official Journal of the European Union, L 119, p. 1-88, 4 May 2016. Art. 9. Disponível em: https://eur-lex.europa.eu/eli/reg/2016/679/oj. Acesso em: 03 abr. 2026.

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 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). Official Journal of the European Union, L, 2024/1689, 12 July 2024. DOI: https://doi.org/10.2804/4225375.

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. Official Journal of the European Union, L, 2025/327, 5 Mar. 2025. Disponível em: https://eur-lex.europa.eu/eli/reg/2025/327/oj. Acesso em: 02 abr. 2026.

GERKE, S.; BABIC, B.; EVGENIOU, T.; COHEN, I. G. The need for a system view to regulate artificial intelligence/machine learning-based software as medical device. npj Digital Medicine, v. 3, art. 53, 2020. DOI: https://doi.org/10.1038/s41746-020-0262-2.

HERNANDEZ-BOUSSARD, T.; BOZKURT, S.; IOANNIDIS, J. P. A.; SHAH, N. H. MINIMAR (minimum information for medical AI reporting): developing reporting standards for artificial intelligence in health care. Journal of the American Medical Informatics Association, v. 27, n. 12, p. 2011-2015, 2020. DOI: https://doi.org/10.1093/jamia/ocaa088.

HUANG, P.-H.; KIM, K.-H.; SCHERMER, M. Ethical issues of digital twins for personalized health care service: preliminary mapping study. Journal of Medical Internet Research, v. 24, n. 10, e37674, 2022. DOI: https://doi.org/10.2196/37674.

INTERNATIONAL ELECTROTECHNICAL COMMISSION. IEC 62304:2006+AMD1:2015: Medical device software: software life cycle processes. Geneva: IEC, 2015.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO 13485:2016: Medical devices: quality management systems: requirements for regulatory purposes. Geneva: ISO, 2016.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION. ISO 14971:2019: Medical devices: application of risk management to medical devices. Geneva: ISO, 2019.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION; INTERNATIONAL ELECTROTECHNICAL COMMISSION. ISO/IEC 23894:2023: Information technology: artificial intelligence: guidance on risk management. Geneva: ISO, 2023.

INTERNATIONAL ORGANIZATION FOR STANDARDIZATION; INTERNATIONAL ELECTROTECHNICAL COMMISSION. ISO/IEC 42001:2023: Artificial intelligence: management system: requirements. Geneva: ISO, 2023.

JACOBS, M.; PRADIER, M. F.; MCCOY, T. H.; PERLIS, R. H.; DOSHI-VELEZ, F.; GAJOS, K. Z. How machine-learning recommendations influence clinician treatment selections: the example of antidepressant selection. Translational Psychiatry, v. 11, art. 108, 2021. DOI: https://doi.org/10.1038/s41398-021-01224-x.

KATSOULAKIS, E.; WANG, Q.; WU, H. et al. Digital twins for health: a scoping review. npj Digital Medicine, v. 7, art. 77, 2024. DOI: https://doi.org/10.1038/s41746-024-01010-3.

KELLY, C. J.; KARTHIKESALINGAM, A.; SULEYMAN, M.; CORRADO, G.; KING, D. Key challenges for delivering clinical impact with artificial intelligence. BMC Medicine, v. 17, art. 195, 2019. DOI: https://doi.org/10.1186/s12916-019-1426-2.

KOLBINGER, F. R.; VELDHUIZEN, G. P.; ZHU, J.; TRUHN, D.; KATHER, J. N. Reporting guidelines in medical artificial intelligence: a systematic review and meta-analysis. Communications Medicine, v. 4, art. 71, 2024. DOI: https://doi.org/10.1038/s43856-024-00492-0.

KUERSTEN, A. Health digital twins, legal liability, and medical practice. The American Journal of Bioethics, v. 23, n. 12, p. 93-95, 2023. DOI: https://doi.org/10.1080/15265161.2023.2272501.

LIU, X.; CRUZ RIVERA, S.; MOHER, D.; CALVERT, M. J.; DENNISTON, A. K. et al. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension. Nature Medicine, v. 26, n. 9, p. 1364-1374, 2020. DOI: https://doi.org/10.1038/s41591-020-1034-x.

LYELL, D.; COIERA, E.; CHEN, J.; SHAH, P.; MAGRABI, F. How machine learning is embedded to support clinician decision making: an analysis of FDA-approved medical devices. BMJ Health & Care Informatics, v. 28, n. 1, e100301, 2021. DOI: https://doi.org/10.1136/bmjhci-2020-100301.

PRICTOR, M. Where does responsibility lie? Analysing legal and regulatory responses to flawed clinical decision support systems when patients suffer harm. Medical Law Review, v. 31, n. 3, 2023. DOI: https://doi.org/10.1093/medlaw/fwad021.

RAJKOMAR, A.; OREN, E.; CHEN, K.; DAI, A. M.; HAJAJ, N.; HARDT, M. et al. Scalable and accurate deep learning with electronic health records. npj Digital Medicine, v. 1, art. 18, 2018. DOI: https://doi.org/10.1038/s41746-018-0029-1.

REDDY, S.; ALLAN, S.; COGHLAN, S.; COOPER, P. A governance model for the application of AI in health care. Journal of the American Medical Informatics Association, v. 27, n. 3, p. 491-497, 2020. DOI: https://doi.org/10.1093/jamia/ocz192.

RINGEVAL, M.; ETINDELE SOSSO, F. A.; COUSINEAU, M.; PARÉ, G. Advancing health care with digital twins: meta-review of applications and implementation challenges. Journal of Medical Internet Research, v. 27, e69544, 2025. DOI: https://doi.org/10.2196/69544.

SAVAGE, T.; NAYAK, A.; GALLO, R.; RANGAN, E.; CHEN, J. H. Diagnostic reasoning prompts reveal the potential for large language model interpretability in medicine. npj Digital Medicine, v. 7, art. 20, 2024. DOI: https://doi.org/10.1038/s41746-024-01010-1.

SHAMANNA, P.; DHARMALINGAM, M.; SAHAY, R.; MOHAMMED, J.; MOHAMED, M.; POON, T. et al. Retrospective study of glycemic variability, BMI, and blood pressure in diabetes patients in the Digital Twin Precision Treatment Program. Scientific Reports, v. 11, art. 14892, 2021. DOI: https://doi.org/10.1038/s41598-021-94339-6.

TABASSI, E. Artificial intelligence risk management framework (AI RMF 1.0). Gaithersburg: National Institute of Standards and Technology, 2023. NIST AI 100-1. DOI: https://doi.org/10.6028/NIST.AI.100-1. Acesso em: 05 abr. 2026.

TIMMERMANS, S.; EPSTEIN, S. A world of standards but not a standard world: toward a sociology of standards and standardization. Annual Review of Sociology, v. 36, p. 69-89, 2010. DOI: https://doi.org/10.1146/annurev.soc.012809.102629.

TUDOR, B. H.; SHARGO, R.; GRAY, G. M. et al. A scoping review of human digital twins in healthcare applications and usage patterns. npj Digital Medicine, v. 8, art. 587, 2025. DOI: https://doi.org/10.1038/s41746-025-01324-8.

UNITED KINGDOM. High Court of Justice. Queen’s Bench Division. Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB). London: High Court of Justice, 2016. Disponível em: https://www.crownofficechambers.com/wp-content/uploads/2017/01/Wilkes-v-DePuy-Approved-Judgment.pdf. Acesso em: 02 abr. 2026.

UNITED KINGDOM. House of Lords. Bolitho v City and Hackney Health Authority [1997] UKHL 46. London: House of Lords, 1997. Disponível em: https://www.bailii.org/uk/cases/UKHL/1997/46.html. Acesso em: 02 abr. 2026.

UNITED KINGDOM. Medicines and Healthcare products Regulatory Agency. Software and artificial intelligence (AI) as a medical device. London: MHRA, 2025. Disponível em: https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device/software-and-artificial-intelligence-ai-as-a-medical-device. Acesso em: 02 abr. 2026.

UNITED KINGDOM. Supreme Court. Montgomery v Lanarkshire Health Board [2015] UKSC 11. London: Supreme Court of the United Kingdom, 2015.

UNITED STATES. Department of Health and Human Services. Office for Civil Rights. Summary of the HIPAA Privacy Rule. Washington, DC: HHS, 2025. Disponível em: https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html. Acesso em: 02 abr. 2026.

UNITED STATES. Food and Drug Administration. Cybersecurity in medical devices: quality management system considerations and content of premarket submissions: guidance for industry and Food and Drug Administration staff. Silver Spring: FDA, 2026. Disponível em: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-management-system-considerations-and-content-premarket. Acesso em: 03 abr. 2026.

UNITED STATES. Food and Drug Administration. Cybersecurity in medical devices: quality system considerations and content of premarket submissions: guidance for industry and Food and Drug Administration staff. Silver Spring: FDA, 2023. Disponível em: https://www.fda.gov/media/119933/download. Acesso em: 03 abr. 2026.

UNITED STATES. Food and Drug Administration. Marketing submission recommendations for a predetermined change control plan for artificial intelligence-enabled device software functions: guidance for industry and Food and Drug Administration staff. Silver Spring: FDA, 2024. Disponível em: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence. Acesso em: 02 abr. 2026.

UNITED STATES. Supreme Court. Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341. Washington, DC: Supreme Court of the United States, 2001. Disponível em: https://supreme.justia.com/cases/federal/us/531/341/. Acesso em: 03 abr. 2026.

UNITED STATES. Supreme Court. Riegel v. Medtronic, Inc., 552 U.S. 312. Washington, DC: Supreme Court of the United States, 2008. Disponível em: https://supreme.justia.com/cases/federal/us/552/312/. Acesso em: 03 abr. 2026.

VASEY, B.; NAGENDRAN, M.; CAMPBELL, B.; CLIFTON, D. A.; COLLINS, G. S. et al. Reporting guideline for the early-stage clinical evaluation of decision support systems driven by artificial intelligence: DECIDE-AI. Nature Medicine, v. 28, n. 5, p. 924-933, 2022. DOI: https://doi.org/10.1038/s41591-022-01772-9.

VENKATESH, K. P.; RAZA, M. M.; KVEDAR, J. C. Health digital twins as tools for precision medicine: considerations for computation, implementation, and regulation. npj Digital Medicine, v. 5, art. 150, 2022. DOI: https://doi.org/10.1038/s41746-022-00694-7.

VOAS, J.; MELL, P.; LAPLANTE, P.; PIROUMIAN, V. Security and trust considerations for digital twin technology. Gaithersburg: National Institute of Standards and Technology, 2025. NIST IR 8356. DOI: https://doi.org/10.6028/NIST.IR.8356.

WORLD INTELLECTUAL PROPERTY ORGANIZATION. WIPO ADR options for life sciences dispute management and resolution. Geneva: WIPO Arbitration and Mediation Center, 2022. Disponível em: https://www.wipo.int/documents/d/amc/docs-en-2022-lifesciences_adroptions.pdf. Acesso em: 02 abr. 2026.

WORLD INTELLECTUAL PROPERTY ORGANIZATION. WIPO ADR procedures. Geneva: WIPO Arbitration and Mediation Center, [s. d.]. Disponível em: https://www.wipo.int/amc/en/center/wipo-adr.html. Acesso em: 03 abr. 2026.

WORLD INTELLECTUAL PROPERTY ORGANIZATION. WIPO alternative dispute resolution (ADR) for life sciences. Geneva: WIPO Arbitration and Mediation Center, [s. d.]. Disponível em: https://www.wipo.int/amc/en/center/specific-sectors/lifesciences/. Acesso em: 02 abr. 2026.

ZECH, J. R.; BADGELEY, M. A.; LIU, M.; COSTA, A. B.; TITANO, J. J.; OERMANN, E. K. Variable generalization performance of a deep learning model to detect pneumonia in chest radiographs: a cross-sectional study. PLOS Medicine, v. 15, n. 11, e1002683, 2018. DOI: https://doi.org/10.1371/journal.pmed.1002683.

Published

2026-07-09

Issue

Section

Artigos