Law Centre for Health and Life, Amsterdam Law School, University of Amsterdam, 1018 WV Amsterdam, The Netherlands.
Med Law Rev. 2024 Aug 1;32(3):373-391. doi: 10.1093/medlaw/fwae029.
As the use of Artificial Intelligence (AI) technologies in healthcare is expanding, patients in the European Union (EU) are increasingly subjected to automated medical decision-making. This development poses challenges to the protection of patients' rights. A specific patients' right not to be subject to automated medical decision-making is not considered part of the traditional portfolio of patients' rights. The EU AI Act also does not contain such a right. The General Data Protection Regulation (GDPR) does, however, provide for the right 'not to be subject to a decision based solely on automated processing' in Article 22. At the same time, this provision has been severely critiqued in legal scholarship because of its lack of practical effectiveness. However, in December 2023, the Court of Justice of the EU first provided an interpretation of this right in C-634/21 (SCHUFA)-although in the context of credit scoring. Against this background, this article provides a critical analysis of the application of Article 22 GDPR to the medical context. The objective is to evaluate whether Article 22 GDPR may provide patients with the right to refuse automated medical decision-making. It proposes a health-conformant reading to strengthen patients' rights in the EU.
随着人工智能 (AI) 技术在医疗保健领域的应用不断扩大,欧盟 (EU) 的患者越来越多地面临自动化医疗决策。这一发展对保护患者权利提出了挑战。患者有权不接受自动化医疗决策,这一特定权利并不被视为传统患者权利组合的一部分。欧盟人工智能法案也没有包含这样的权利。然而,《通用数据保护条例》(GDPR)第 22 条规定了“不接受仅基于自动化处理的决定”的权利。与此同时,由于缺乏实际效果,这一规定在法律学术界受到了严厉批评。然而,2023 年 12 月,欧盟法院首次在 C-634/21(SCHUFA)案中对这一权利进行了解释——尽管是在信用评分的背景下。在此背景下,本文对 GDPR 第 22 条在医疗背景下的适用进行了批判性分析。目的是评估 GDPR 第 22 条是否可以为患者提供拒绝自动化医疗决策的权利。它提出了一种符合健康的解读,以加强欧盟的患者权利。