Lalova-Spinks Teodora, Valcke Peggy, Ioannidis John P A, Huys Isabelle
Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
Center for IT & IP law (CiTiP), KU Leuven, Leuven, Belgium.
NPJ Digit Med. 2024 Aug 16;7(1):215. doi: 10.1038/s41746-024-01205-6.
EU-US data transfers for health research remain a particularly thorny issue in view of the stringent rules of the EU General Data Protection Regulation (GDPR) and the challenges related to US mass surveillance programs, particularly the manner in which US law enforcement and national security agencies can access personal data originating from the EU. Since the entry into force of the GDPR, evidence of impeded collaborations is increasing, particularly in the case of sharing data with US public institutions. The adoption of a new EU-US adequacy decision in July 2023 does not hold the promise for a long-lasting solution due to the risks of being challenged and invalidated - yet again - at the Court of Justice of the EU. As the research community is calling for answers, the new proposal for a European Health Data Space regulation may hold a key to solving some of the existing issues. In this paper, we critically discuss the current rules and outline a possible way forward for transfers between public bodies.
鉴于欧盟《通用数据保护条例》（GDPR）的严格规定以及与美国大规模监控计划相关的挑战，尤其是美国执法和国家安全机构获取源自欧盟的个人数据的方式，欧盟与美国之间用于健康研究的数据传输仍然是一个特别棘手的问题。自GDPR生效以来，合作受阻的证据越来越多，特别是在与美国公共机构共享数据的情况下。由于存在在欧盟法院再次受到质疑和无效的风险，2023年7月通过的新的欧盟-美国充分性决定并不能保证提供持久的解决方案。随着研究界寻求答案，欧洲健康数据空间监管的新提案可能是解决一些现有问题的关键。在本文中，我们批判性地讨论了当前规则，并概述了公共机构之间数据传输的可能前进方向。
