Domains in Health Technology Assessment of Digital Health Technologies: A Mapping Review

OBJECTIVES: Health Technology Assessment (HTA) plays an important role in evaluating digital health technologies (DHTs) to inform decision making. Commonly used HTA frameworks have been criticized as inadequate for assessing DHTs leading to the development of many DHT-specific HTA frameworks. The proliferation of frameworks creates a lack of clarity around evidence expectations for DHT HTA and perceptions of divergence in approach to HTA. This study, which was completed for the European Digital Health Technology Assessment (EDiHTA) project, reviews the domains used for DHT HTA. METHODS: The study had 3 parts: (1) scoping review (2) targeted search of HTA agency websites and hospitals for DHT methods documents (3) review of European DHT HTA reports. Data were extracted into a common template and analyzed descriptively to identify the domains and topics included in the documents. RESULTS: A total of 44 documents were included: (1) 11 published studies (2) 13 HTA agencies' methods documents (3) a sample of 20 DHT HTA reports. From these documents, 13 domains were identified. Topics relating to HTA domains health condition, technology use, clinical safety, clinical effectiveness, economic aspects, and organizational aspects appeared consistently in retrieved documents. Topics relating to environmental, technical, legal and regulatory, and some ethical and human aspects were not consistently included or reported in the documents. CONCLUSION: This study identifies commonalities in DHT HTA across established areas of HTA and areas of DHT HTA in which there remains inconsistency in reporting of information and where efforts toward further alignment and refinement are still needed.