Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings.

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.