Scholarlink

<p>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.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

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

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年1月3日

查看全文
  • Martin Breidenbach,
  • Sandra Geisler

摘要

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.