Formerly-Law School, University of Strathclyde, Glasgow, UK. Now-Graz, Austria.
Department of Computer & Information Sciences, University of Strathclyde, Glasgow, UK.
Med Law Rev. 2023 Aug 25;31(3):317-339. doi: 10.1093/medlaw/fwac038.
Medicine is one of the biggest use cases for emerging information technologies. Data processing brings huge advantages but forces lawmakers and practitioners to balance between privacy, autonomy, accessibility, and functionality. ICT-connected Implantable Medical Devices plant themselves firmly between traditional medical equipment and software that processes health-related personal data, and these implants face many data management challenges. It is essential that healthcare providers and others can identify and understand the legal grounds they rely on to process data. The European Union is currently updating its framework, and the special provisions in the GDPR, the current ePrivacy Directive, and the coming ePrivacy Regulation all provide enhanced thresholds for processing data. This article provides an overview and explanation of the applicability of the rules and the legal grounds for processing data. We find that only a cumulative application of the GDPR and the ePrivacy rules ensure adequate protection of this data and present the legal grounds for processing in these cases. We discuss the challenges in obtaining and maintaining valid consent and necessity as a legal ground for processing and offer use case-specific discussions of the role of consent long-term and the lack of an adequate 'vital interest' exception in the ePrivacy rules.
医学是新兴信息技术的最大应用领域之一。数据处理带来了巨大的优势，但也迫使立法者和从业者在隐私、自主权、可及性和功能性之间进行权衡。与信息和通信技术（ICT）相连的植入式医疗设备将自己牢固地置于传统医疗设备和处理与健康相关的个人数据的软件之间，这些植入物面临着许多数据管理挑战。医疗保健提供者和其他方能够识别和理解他们依赖的数据处理法律依据至关重要。欧盟目前正在更新其框架，《通用数据保护条例》（GDPR）、现行的《电子隐私指令》（ePrivacy Directive）和即将出台的《电子隐私条例》中的特殊规定都为数据处理设定了更高的门槛。本文概述并解释了这些规则的适用性以及数据处理的法律依据。我们发现，只有综合适用 GDPR 和 ePrivacy 规则，才能确保对这些数据的充分保护，并提出在这些情况下处理数据的法律依据。我们讨论了在获得和维持有效同意方面的挑战以及作为处理法律依据的必要性，并就同意在长期内的作用以及 ePrivacy 规则中缺乏适当的“重大利益”例外的情况进行了具体用例的讨论。
