Berlin Institute of Health at Charité - University Medicine Berlin.
Stud Health Technol Inform. 2022 Aug 31;298:132-136. doi: 10.3233/SHTI220922.
On May 3rd, 2022, the European Commission published its legislative proposal to create a European Health Data Space (EHDS) enabling citizens of the European Union to gain secure access to their electronic health data by establishing a market for digital health. This market will feature the primary and secondary use of electronic health records by digital products and services. The articles of the proposal address many aspects of ensuring health data interoperability. That includes the creation of a European Electronic Health Record Exchange Format for defined data categories including patient summaries and electronic prescriptions, the development of a central platform to provide a cross-border digital infrastructure and that each Member State institutes a digital health authority and a national point of contact. In addition, the Commission will define common specifications that electronic health record systems and medical devices will have to meet as interoperability requirements. In its current form, the proposal does not stipulate specific standards that need to be universally adopted to ensure semantic and syntactical interoperability. Considering that many datasets are not internationally harmonized and lack standardization, these specifications will need to be provided for example by existing standards like the International Patient Summary.
2022 年 5 月 3 日，欧盟委员会发布立法提案，旨在创建一个欧洲健康数据空间（EHDS），通过建立数字健康市场，使欧盟公民能够安全地获取其电子健康数据。该市场将以数字产品和服务对电子健康记录的主要和次要用途为特色。提案的各条款涉及确保健康数据互操作性的许多方面。这包括创建用于定义数据类别的欧洲电子健康记录交换格式，包括患者摘要和电子处方，开发一个提供跨境数字基础设施的中央平台，以及每个成员国设立一个数字健康管理局和一个国家联络点。此外，委员会将定义电子健康记录系统和医疗设备必须满足的共同规范，作为互操作性要求。就目前的形式而言，该提案并未规定需要普遍采用的具体标准，以确保语义和语法的互操作性。考虑到许多数据集在国际上没有协调，缺乏标准化，这些规范将需要通过现有标准（如国际患者摘要）来提供。
