Frameworks for assessing digital health technologies: a scoping review

Area of Science:

• Health Technology Assessment
• Digital Health Technologies
• Framework Analysis

Background:

• Digital health technologies (DHTs) present unique challenges for traditional health technology assessment (HTA) frameworks.
• Existing HTA methodologies may not adequately address the complexities of DHTs.
• This review examines current assessment frameworks for DHTs in relation to the EUnetHTA Core Model.

Purpose of the Study:

• To provide an overview of existing assessment frameworks for DHTs.
• To analyze the purpose and guidance offered by these frameworks.
• To evaluate their alignment with the EUnetHTA Core Model domains.

Main Methods:

• Scoping review following Joanna Briggs Institute methodology and PRISMA-ScR guidelines.
• Searches in PubMed and Embase (2015-2024), supplemented by manual searching.
• Data analysis using Covidence, categorized inductively based on EUnetHTA Core Model domains.

Main Results:

• 60 frameworks were identified, primarily focusing on digital health applications (68%) with limited attention to AI (2%).
• Frameworks offer varying guidance on assessment and evidence requirements.
• Technical characteristics were most addressed, while ethical, legal, and organizational aspects received less focus.

Conclusions:

• A significant diversity exists in current DHT assessment frameworks.
• There is a need for a standardized, modular, and customizable framework for DHT assessment.
• Such a framework should provide clear methodological guidance tailored to different DHT types.