EHDS Highlights October 2024 - Regulatory Implementation and National Preparations
In October 2024, key highlights include the regulatory implementation of the European Health Data Space (EHDS) with deadlines and priorities for implementing acts, as well as the emphasis on national preparations for the EHDS. The focus is on building common European data spaces, such as in health, and evolving existing cooperation frameworks to ensure seamless exchange of health data. Preparations at the national level aim to establish digital health authorities, national contact points, and testing environments for harmonized electronic health record systems.
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Presentation Transcript
EHDS - highlights as of October 2024 18. 10. 2024, K. Jir kov
Health is the first common EU data space Source: EC, DG SANTE 2 1 How to make common European data spaces a reality | data.europa.eu
Regulatory implementation of the EHDS Deadlinefor main implementingacts 2024 Entry into force 2030 2032 2034 2036 2028 2026 Entry into application General application Exchange of 1st group of priority categories patient summary, electronic prescriptions and dispensations Primary uses of health data (Chapter II) Exchange of 2ndgroup of priority categories medical images, medical tests results and discharge reports Only sell compliant products 1st categories EHR Systems certification (Chapter III) Only sell compliant products 2nd categories Secondaryuse in general Secondary uses of health data (Chapter IV) Selectedcategories Genomics, omics, wellness applications connections Third countries 3 Deadline for main implementingacts Source: EC, DG SANTE Entry into application Entry into force
Building on existing cooperation MyHealth@EU under Cross-border Healthcare Directive Voluntary system for exchanging patient summaries, prescriptions and dispensations ( first group of priority categories) Health Data structured according eHealth Network guidelines 14 MS live with at least one service, 6 more scheduled to go live with first service(s) this year Evolution of MyHealth@EU for the EHDS Voluntary => mandatory New services New data categories Source: EC, DG SANTE 4
Preparations on national level (1) Prepare one or more digital health authorities to become responsible for implementing Chapter II of the Regulation. Prepare a national contact point for digital health for the provision of services linked to cross-border exchange of personal electronic health data. Ensure connection of all healthcare providers to their national contact points for digital health. Ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions. Preparing the entities for setting up a digital testing environment for the assessment of harmonised components of EHR systems. 5
Preparations on national level (2) Prepare to designating the market surveillance authority or authorities responsible for implementing Chapter III of the Regulation. Prepare health professionals in order to understand and effectively exercise their role in the primary use of and access to electronic health data. For more details, check the tasks for national authorities and Member States in the provisional agreement on the EHDS Regulation! Source: EC, DG SANTE
Secondary uses of health data Implementation Deadline for main implementingacts Entry into force 2021 2022 2023 2024 2025 2026 2027 Implementingacts Developmentof main Implementingacts EHDS Regulation Negotiation TEHDaS 2 TEHDaS INCEPTION HDABs and TEFs for AIs HealthData@EU Pilot PILOT HealthData@EU Central Services HDABs set up + HealthData@EU Scale Up SCALE UP Capacity building Data quality and utility label (QUANTUM) EHDS2 Compliance checks OPERATIONS EHDS2 Stakeholders Engagement Entry into force Deadline for main implementingacts Source: EC, DG SANTE 7
