Evaluating Regulatory Compliance in Maturity Models for Patient-Centred Health Data Sharing: A Literature Review

Data Science and Engineering, vol. 11, pp. 455–471

Abstract

Abstract The European Health Data Space (EHDS) aims to enable secure, standardized, and cross-border use of health data for both care and research. While maturity models (MMs) are widely applied to support digital transformation in healthcare, their alignment with EHDS-specific legal and strategic goals remains unclear. This study presents a systematic literature review of 37 publications using a keyword analysis and qualitative content analysis based on a custom coding framework aligned with the EHDS Regulation. The results show that while technical aspects such as interoperability and security are frequently addressed, patient centered critical legal dimensions — such as data sovereignty and privacy — are underrepresented. Similarly, goals related to secondary use, transparency, and cross-border data portability are insufficiently covered. Both the implementation of EHDS principles by healthcare actors and the design of maturity models are hindered by structural, regulatory, and technological barriers. In conclusion, existing maturity models offer only partial support for the EHDS. To bridge this gap, future models must more comprehensively integrate legal compliance, governance, and trust-enabling mechanisms.

Authors 2

1. M Breidenbach corresponding Aachen

   RWTH Aachen University

   Affiliation as printed

   RWTH Aachen, Ahornstraße 55, 52074, Aachen, Germany

2. Sandra Geisler Aachen

   RWTH Aachen University

   Affiliation as printed

   RWTH Aachen, Ahornstraße 55, 52074, Aachen, Germany