国际数字健康技术价值评价指南范围综述OA

Objective This study aims to systematically review digital health technology(DHT)assessment guidelines published by international official departments and integrate their content onto an established health technology assessment(HTA)model to provide recommendations for constructing a DHT assessment system in China.Methods PubMed and grey literature were searched using keywords related to HTA,assessment frameworks,and DHT,covering the period from January 2010 to June 2024.The included guidelines were systematically reviewed and characterized,and the EUNetHTA HTA Core Model(version 3.0)was selected as the assessment framework to provide a detailed summary of DHT-specific content.Results A total of 24 DHT-related guidelines published by international official HTA departments were included.Most of the guidelines covered key domains such as clinical effectiveness(92%)and safety(100%),but only a few addressed domains such as cost economic evaluation(25%)and patient and societal aspects(42%).The included frameworks recommended DHT-specific content for 20 of the 145 questions in the HTA Core Model,covering all 9 HTA domains.This study additionally identified 12 DHT-specific issues not currently addressed by the HTA Core Model.Conclusions Existing HTA frameworks have limitations in assessing DHT and there is a need to develop more comprehensive and targeted assessment methods.China should establish a comprehensive DHT assessment framework,clarify assessment standards and procedures,and fully evaluate the safety,effectiveness,economic value,and ethical impact of DHT to promote its sound development and application.