Abstract

IntroductionRecently, there have been calls for the development of new health technology assessment (HTA) methodologies to address the growing emergence of novel digital health technologies (DHTs). In particular, the lack of robust evidence base and technology-specific considerations of DHTs, such as software updates, present challenges for evaluation with conventional HTA methods. In Singapore, the Agency for Care Effectiveness (ACE) has established a horizon scanning (HS) system to provide the healthcare system with advance notice on emerging medical technologies (MedTechs) that may enter the Singapore market. This study aims to investigate the anticipated emergence of DHTs identified by ACE’s HS system and the potential implications on subsequent HTA methodology.MethodsBased on ACE’s HS methodology, which is in line with international best practices, new and emerging MedTechs that address the top five local disease burden (i.e., cardiovascular, cancer, mental, neurological and musculoskeletal disorders) were identified from various sources and monitored for its development. These MedTechs were further filtered to shortlist potential technologies for HS assessment based on its innovative nature and appropriate time horizon to local regulatory approval. For this exercise, the filtered MedTechs were classified into categories such as DHTs, comprising technologies involving software or artificial intelligence (AI), and non-DHTs.ResultsBetween 2021 and 2022, ACE has completed two topic filtration exercises. Based on 807 and 1,231 monitored MedTechs, 35 and 42 technologies remained after filtration, respectively. Among them, six out of 35 (17%) and 15 out of 42 (36%) filtered MedTechs were classified as DHTs, accounting for approximately two-fold increase in the number of DHTs shortlisted year-on-year. These DHTs include standalone AI software, software in a medical device, and digital therapeutics.ConclusionsThere is a substantial increase in DHTs identified that are anticipated to enter the local healthcare system. Given their unique characteristics, this may call for the modification of current HTA method to enable meaningful evaluation of DHTs.

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