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Comprehensive Overview of European Health Data Space: What You Need to Know

In this whitepaper, you will learn:

  • EHDS Flow Chart, key definitions, scope,
  • Entities governed by EHDS, relationship with GDPR,
  • Obligations of Health Professionals, Manufacturers of EHR Systems, Importers and Distributors of EHR Systems, Manufacturers of Wellness Applications, Data holders & Health Data Access Bodies
  • Rights of natural persons about the primary use of Electronic Health Data,
  • How Securiti helps ensure swift compliance.

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The European Union has established guidelines and standards for sharing electronic health data via the European Health Data Space (EHDS). The EHDS aims to establish a unified digital health market across the EU and promotes policymaking, research, and healthcare delivery. It will also enable secure data utilization to enhance public health, diagnosis, and treatment.

This whitepaper provides a comprehensive overview of the EHDS, starting with an introduction and a flow chart illustrating the EHDS framework, definition of key terms, and scope. It specifies which entities the EHDS governs, including its relationship with the GDPR.

It covers the primary use of electronic health data and details the obligations of health professionals, electronic health record (EHR) system manufacturers, importers, distributors, and wellness application manufacturers. It also highlights individuals' rights regarding the use of their health data and addresses governance mechanisms.

The document also addresses the secondary use of health data, the obligations of data holders, and access procedures, including cross-border data access. It concludes with details on European governance, the role of the European Commission, penalties for non-compliance, recommendations for action, and how Securiti helps ensure compliance.

Overview of European Health Data Space

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Frequently Asked Questions

An EU initiative, the European Health Data Space (EHDS), aims to enhance access to health data for patients, healthcare providers, and researchers across Europe. It facilitates the secure sharing and use of electronic health data to improve healthcare, research, and policy-making while ensuring robust data protection and privacy rights.

The EHDS Flow Chart visually represents the processes and interactions within the EHDS. It outlines how health data is collected, shared, and accessed between stakeholders like patients, healthcare providers, and researchers, ensuring secure data flows, compliance with regulations, and patient consent management.

The EHDS applies to several entities, including manufacturers and suppliers of EHR systems and wellness applications in the EU, controllers and processors in the EU handling electronic health data of EU citizens and legal residents, controllers and processors from third countries interoperable with MyHealth@EU, and data users accessing electronic health data provided by data holders in the EU.

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