Abstract
OBJECTIVES: The rapid evolution of digital health technologies (DHTs) presents distinct challenges for health technology assessment (HTA). Existing HTA frameworks, largely designed for conventional health interventions, may not sufficiently address these unique complexities. This scoping review provides an overview of existing assessment frameworks for DHTs, analyzing their purpose and the guidance they offer within the domains of the EUnetHTA Core Model. METHODS: The review followed the Joanna Briggs Institute methodology and PRISMA-ScR guidelines. The literature was identified through searches in PubMed and Embase, covering publications from 2015 to 2024 in English or German, and was complemented by a manual hand search. The studies were screened and analyzed using Covidence, with data categorized inductively based on the EUnetHTA Core Model domains. RESULTS: Of 3,576 screened records, 15 met inclusion criteria; an additional 45 frameworks were identified through hand searching, resulting in a total of 60 frameworks. Most frameworks focused on digital health applications (68 percent), while only a few addressed technologies such as artificial intelligence (2 percent). The frameworks primarily provide guidance on assessment, with varying focus on evidence requirements. The domains of the EUnetHTA Core Model were variably represented across the frameworks. Technical characteristics were most frequently addressed, while ethical, legal, and organizational domains received limited attention. CONCLUSIONS: This review highlights the diversity of existing frameworks for DHT assessment. This emphasizes the potential relevance of a future standardized framework that contains explanations of the methodological approach to the assessment of DHTs and is modularly customizable depending on the type of technology.