Ethical Considerations in Health Technology Assessment for Precision Medicine: A Delphi Study in a Greek Setting

Area of Science:

• Bioethics
• Health Technology Assessment (HTA)
• Genomic Medicine
• Health Policy

Background:

• Precision medicine integration into practice necessitates robust ethical evaluation.
• Current Health Technology Assessment (HTA) instruments lack specific ethical considerations for genomic profiling, AI decision-support, and high-cost therapies.
• Ethical frameworks for precision medicine HTA are underdeveloped.

Purpose of the Study:

• To develop an empirically grounded ethical framework for precision medicine Health Technology Assessment (HTA).
• To create a practical ethics checklist for integrating into national HTA processes.
• To provide a transferable methodological template for European health systems.

Main Methods:

• A modified two-round Delphi study involving 18 Greek experts.
• Rating of 32 candidate ethical statements across seven domains using Content Validity Ratio (CVR) and agreement thresholds.
• Consensus definition in Round 2: median ≥ 2.0 and ≥80% agreement.

Main Results:

• Fifteen of 32 statements met initial retention criteria.
• All 15 statements achieved consensus in Round 2 (median 3.0, 94.4-100% agreement).
• The final framework comprises five domains: ethical principles, transparency/accountability, equity/access, digital health/AI, and system resilience.

Conclusions:

• Presents a novel, empirically grounded ethical framework for precision medicine HTA in an EU Member State.
• The framework is operationalized via a ready-to-use ethics checklist for HTA integration.
• The methodology offers a transferable template for other European health systems.