Health Data-Driven Research - Time for a Stronger Human Rights Governance Structure?

Area of Science:

• Biomedical Ethics
• Health Law and Policy
• Data Science

Background:

• Growing reliance on data-driven health research in Europe.
• Inspiration from academic emphasis on human rights in biomedicine.
• Danish case study on large-scale electronic health record access.

Purpose of the Study:

• Evaluate adequacy of European regulatory frameworks for data-driven health research.
• Assess protection of data subjects' rights and freedoms.
• Examine alignment of public interest justifications with patient expectations.

Main Methods:

• Analysis of European regulatory frameworks.
• Case study examination of Danish health data access.
• Ethical and legal principles review.

Main Results:

• Existing frameworks may inadequately safeguard data subjects' rights.
• The concept of 'public interest' in research is underdefined.
• Current legal instruments may not encompass all relevant human rights (dignity, integrity, non-discrimination).

Conclusions:

• Recalibration of safeguards and governance is needed for health data research.
• Strengthened ethical review and participatory structures are recommended.
• Ensuring respect for individual rights and societal values in technological advancement.