{"id":15282,"date":"2024-02-21T00:00:23","date_gmt":"2024-02-21T00:00:23","guid":{"rendered":"https:\/\/letslaw.es\/?p=15282"},"modified":"2024-02-09T13:54:56","modified_gmt":"2024-02-09T13:54:56","slug":"features-and-objectives-of-the-european-health-data-space","status":"publish","type":"post","link":"https:\/\/letslaw.es\/en\/features-and-objectives-of-the-european-health-data-space\/","title":{"rendered":"Features and objectives of the European Health Data Space"},"content":{"rendered":"<p>In May 2022, the European Commission introduced a regulation to establish a <strong>European Health Data Space<\/strong> (EHDS). The EHDS is defined as a specific health ecosystem consisting of common rules, standards, and practices, infrastructure, and a governance framework.<\/p>\n<p>During December 2023, the permanent representatives of the European Union member states reached a consensus on the Council&#8217;s mandate for the creation of a new regulation aimed at facilitating the exchange of health data and its access at the European Union level.<\/p>\n<h2>Main objective of the European Health Data Space<\/h2>\n<p>The main objectives of this proposal are:<\/p>\n<ul>\n<li><strong>Empower individuals to take control of their health data<\/strong>, whether they are in their home country or another EU member state.<\/li>\n<li><strong>Support the use of health data to enhance various sectors<\/strong> such as healthcare provision, research, innovation, and policy development.<\/li>\n<li><strong>Enable the European Union to harness the potential<\/strong> offered by secure exchange, use, and reuse of health data.<\/li>\n<li><strong>EU member states are required to establish a digital health authority to implement the new provisions.<\/strong><\/li>\n<\/ul>\n<p>Currently, the ability to access health data across borders varies among EU countries. The recent regulation aims to facilitate scenarios such as a Spanish visitor obtaining a prescription from a pharmacy in Belgium or healthcare professionals accessing health information of an Italian patient undergoing treatment in Portugal.<\/p>\n<h2>Council&#8217;s Position about the European Health Data Space<\/h2>\n<p>The mandate agreed upon in December 2023 elaborates on the Commission&#8217;s proposal in several key aspects:<\/p>\n<ul>\n<li><strong>New clarifications:<\/strong> The Council&#8217;s mandate seeks to address uncertainties regarding the regulation&#8217;s scope, adaptation to the General Data Protection Regulation (GDPR), and criteria for providing electronic health data.<\/li>\n<li><strong>Steering groups:<\/strong> In its mandate, the Council proposes the creation of two steering groups composed of representatives from member states, responsible for managing MiHealth@EU and DataHealth@EU. Other stakeholders may be invited as observers to discuss relevant issues.<\/li>\n<li><strong>Governance:<\/strong> The mandate expands the roles of EU member states in the proposed EHDS management board and requires national digital health authorities to publish an activity report every two years.<\/li>\n<li><strong>Electronic health records:<\/strong> According to the Council&#8217;s mandate, the format for exchanging electronic health records at the European level may have distinct national and cross-border profiles.<\/li>\n<li><strong>Opt-Out pption:<\/strong> Member states have discretion to allow patients to opt out of the new data exchange system.<\/li>\n<\/ul>\n<p>The mandate includes a delay in the regulation&#8217;s implementation for up to two years after its entry into force.<\/p>\n<h2>European Health Data Space: Parliament&#8217;s position<\/h2>\n<p>In December 2023, the Parliament adopted its position, suggesting the following aspects:<\/p>\n<ul>\n<li><strong>Certain sensitive health data should only be used for research and development<\/strong>, policy-making, education, patient safety, or regulation if patients provide explicit consent.<\/li>\n<li><strong>Implementation of a voluntary opt-out mechanism if individuals choose not to share other types of data.<\/strong><\/li>\n<li>The need to prohibit the use of health data in the job market or the provision of financial services.<\/li>\n<\/ul>\n<p>As next steps, the <strong>Parliament is ready to commence negotiations with EU governments on the final legislative text<\/strong>, and the approval of relevant regulations is expected in a short period.<\/p>\n<p>At<strong> Letslaw<\/strong> our team of <a title=\"Digital lawyers - Letslaw\" href=\"https:\/\/letslaw.es\/en\/digital-lawyers\/\">digital lawyers<\/a> specialised in data protection will assist you in this matter and any other related matter you may need. 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