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跨境电子健康服务互操作性的法律方面:对欧洲和国家法律框架的研究。

The legal aspect of interoperability of cross border electronic health services: A study of the european and national legal framework.

机构信息

Attorney & Counselor at Law, 112896Open University of Cyprus, Thessaloniki, Greece.

Lab of Medical Physics, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece.

出版信息

Health Informatics J. 2022 Jul-Sep;28(3):14604582221128722. doi: 10.1177/14604582221128722.

DOI:10.1177/14604582221128722
PMID:36124647
Abstract

Legal interoperability constitutes a prerequisite for the provision of high-quality cross border e-health services, like ePrescription and ePatientSummary. A review of EU legislation, policy initiatives and relevant judgments of the European Court of Justice (ECJ) and the European Court of Human Rights (ECHR) was held, concerning personal medical data. Four European social welfare systems, according to Esping - Andersen's typology, were selected and a study of health policy in relation to the national legal framework regarding the data protection regulation is examined. A model of legal interoperability for cross-border eHealth services is proposed for policy makers at EU level based on the following major domains: protection and security of data, transparency and liability, further analyzed in multiple axes and combined with EU targets, policy priorities and basic European legal principles. This model could be viable because of the EU's transnational existence, the coexistence of national and Community law, and the need of novel models of political governance under a unified regulatory and normative base.

摘要

法律互操作性是提供高质量跨境电子医疗服务的前提,例如电子处方和电子患者摘要。审查了欧盟立法、政策倡议以及欧洲法院(ECJ)和欧洲人权法院(ECHR)的相关判决,涉及个人医疗数据。根据艾斯平-安德森的类型学,选择了四个欧洲社会福利制度,并研究了与数据保护法规相关的国家法律框架下的卫生政策。根据以下主要领域,为欧盟层面的政策制定者提出了跨境电子医疗服务的法律互操作性模型:数据的保护和安全、透明度和责任,并在多个轴线上进行了进一步分析,并结合了欧盟目标、政策重点和基本欧洲法律原则。由于欧盟的跨国存在、国家和共同体法律的共存以及在统一监管和规范基础下新型政治治理模式的需要,该模型可能具有可行性。

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