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Abstract
Digital Health Technologies (DHTs) are being applied in a widening range of scenarios in medicine. We describe the emerging phenomenon of the grouping of individual DHTs, with a clinical use case and regulatory approval in their own right, into packages to perform specific clinical tasks in defined settings. Example groupings include suites of devices for remote monitoring, or for smart clinics. In this first article of a two-article series, we describe challenges in implementation and limitations in frameworks for the regulation, health technology assessment, and reimbursement of these device suites and linked novel care pathways.
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1 TUD Dresden University of Technology, Else Kröner Fresenius Center for Digital Health, Dresden, Germany (GRID:grid.4488.0) (ISNI:0000 0001 2111 7257)
2 University of Oxford, Nuffield Department of Surgical Sciences, Oxford, UK (GRID:grid.4991.5) (ISNI:0000 0004 1936 8948)
3 National Institute for Health and Care Excellence (NICE), London, UK (GRID:grid.416710.5) (ISNI:0000 0004 1794 1878)