The European Health Data Space (EHDS): Probable Impact, Possible Challenges and Proposed Solutions to Using Electronic Health Records (EHRS) for Research and Policy Shaping in the Region


Azad M1, Pandey R2, Bergemann R3
1Parexel Access Consulting, Delhi, Delhi, India, 2Parexel International, Bangalore, Karnataka, India, 3Parexel Access Consulting, Loerrach, Germany

OBJECTIVES: The European Commission published a legislative proposal on the “The European Health Data Space” (EHDS) on 3 May 2022, which will have a significant impact on the use of EHRs across Europe in order to promote reliability, security, and interoperability of healthcare data. Establishing EHDS will provide citizens of Europe to access their own health records, and these records will be utilized for research purpose and policy making. This initiative has the potential to transform how EHRs are used in the region, but its implementation can also bring several challenges. Aim of this study is to discuss the challenges, and potential solutions for more efficient use of health data to facilitate healthcare decision making through EHDS.

METHODS: We conducted a targeted literature review along with discussion with a selected group of experts to identify challenges and possible solutions for effective use of EHDS.

RESULTS: Maintaining the patient data privacy, minimizing conflicts due to overlapping cross border existing laws, deciding permitted purposes for the use of centralized EHRs and maintaining data quality along with consistency are identified as potential challenges.

European countries must come under centralized committee aligning with EU General Data Protection Regulation (GDPR) and other overlapping laws. The committee can also provide country-based flexibility based on country specific law enforcement. To avoid misuse, centralized data permissions should only be given for research and policy decision making purposes. Data quality depends upon the entities providing the data including physicians and hospitals. An incentive system will keep healthcare professionals and hospitals motivated to generate/provide quality data and allow for future auditability. Standardized formats, data collection parameters and data collection points during disease management can minimize the risk of inconsistency.

CONCLUSIONS: A wider panel including policy makers, physicians, hospitals and industry should be constructed to discuss and address challenges with effective implementation of EHDS.

Conference/Value in Health Info

2024-05, ISPOR 2024, Atlanta, GA, USA

Value in Health, Volume 27, Issue 6, S1 (June 2024)




Health Policy & Regulatory, Real World Data & Information Systems

Topic Subcategory

Coverage with Evidence Development & Adaptive Pathways, Distributed Data & Research Networks, Insurance Systems & National Health Care


No Additional Disease & Conditions/Specialized Treatment Areas

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