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OpenEHR and General Data Protection Regulation: Evaluation of Principles and Requirements.

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Summary

The openEHR standard aligns well with the General Data Protection Regulation (GDPR) requirements for electronic health records (EHRs). Implementing openEHR-based EHR systems helps institutions comply with GDPR and protect patient data privacy.

Keywords:
GDPRdata protectionelectronic health recordhealth information interoperabilityopenEHR

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Area of Science:

  • Health Informatics
  • Data Privacy Law

Background:

  • European Union (EU) legislation reforms address privacy and personal data protection concerns.
  • The General Data Protection Regulation (GDPR) enhances EU citizens' control over their data and sets rules for personal data processing.
  • openEHR is an interoperable and secure standard for electronic health records (EHRs), recommended for hospital information systems.

Purpose of the Study:

  • To assess the extent to which the openEHR standard facilitates compliance of EHR systems with GDPR requirements.
  • To evaluate the alignment between openEHR design principles and GDPR mandates for health data protection.

Main Methods:

  • Identification of key GDPR requirements for EHR systems.
  • Compilation of openEHR design principles.
  • Expert-driven categorization and comparison of GDPR requirements against openEHR principles.

Main Results:

  • 50 GDPR requirements and 8 openEHR design principles were identified.
  • openEHR principles demonstrated alignment with all identified GDPR requirements.
  • A 30% direct conformance was found between openEHR principles and specific GDPR requirements (15 out of 50).

Conclusions:

  • openEHR principles exhibit strong conformity with GDPR, emphasizing the importance of built-in security and privacy.
  • Adoption of openEHR-based EHR systems brings institutions closer to GDPR compliance.
  • Utilizing openEHR supports the safeguarding of sensitive medical data.