Toward a Harmonized Health Technology Assessment Framework for Digital Health Technologies in Europe

Area of Science:

• Digital Health Technologies (DHTs)
• Health Technology Assessment (HTA)
• European Healthcare Policy

Background:

• Digital health technologies (DHTs) offer potential benefits for healthcare delivery and outcomes.
• Existing health technology assessment (HTA) methods struggle to accommodate the dynamic and diverse nature of DHTs.
• The Horizon Europe funded European Digital Health Technology Assessment (EDiHTA) project seeks to address this gap.

Purpose of the Study:

• To explore the perspectives of diverse stakeholders on developing a harmonized HTA framework for DHTs.
• To identify key requirements and challenges for a flexible and adaptable HTA process for DHTs.
• To inform the development of the EDiHTA framework.

Main Methods:

• Mixed-method research involving 97 stakeholders across European countries.
• Thematic analysis of data from stakeholder surveys, interviews, and focus groups.
• Utilized the Innovation Health Technology Assessment Methods (IHTAM) framework for analysis.

Main Results:

• Strong consensus among stakeholders for a harmonized HTA framework for DHTs.
• Identified key themes including the need for harmonization, valued DHT characteristics, multistakeholder collaboration, and framework design principles.
• Highlighted persistent differences in evaluation timing, flexibility, evidence requirements, and stakeholder engagement.

Conclusions:

• A harmonized approach to HTA for DHTs is essential but requires careful consideration of stakeholder differences.
• The EDiHTA project will pilot a framework and utilize workshops and advisory groups to reconcile divergent views.
• Successful implementation necessitates addressing variations in evaluation criteria and stakeholder involvement for effective DHT assessment.