To assess the implications of the European Commission’s Digital Omnibus proposal on healthcare data governance and patient rights.
Approach:
Methodological Framework: The article employs a policy-oriented perspective using doctrinal legal analysis and thematic policy analysis, focusing on the Digital Omnibus proposal and the EDPB-EDPS Joint Opinion.
Key Findings:
The Digital Omnibus aims to simplify the regulatory landscape but risks undermining data security and patient rights.
Proposed changes could narrow the scope of personal data protection, particularly concerning pseudonymised data.
The EDPB and EDPS warn that these amendments conflict with existing EU case law on personal data identification.
Interpretation:
The simplification of regulations must be balanced against the need to maintain robust data protection frameworks to safeguard sensitive health information.
Limitations:
The analysis is qualitative and does not include a systematic quantitative review.
Focus is limited to specific provisions that intersect with health data governance.
Conclusion:
The proposed changes in the Digital Omnibus could significantly impact health data governance, necessitating careful consideration to protect patient rights.
