How can regulation and reimbursement better accommodate flexible suites of digital health technologies?

Individual digital health devices are increasingly being bundled together as interacting, multicomponent suites, to deliver clinical services (e.g., teleconsultation and ‘hospital-at-home services’). In the first article of this two-article series we described the challenges in implementation and the current limitations in frameworks for the regulation, health technology assessment, and reimbursement of these device suites and linked novel care pathways. A flexible and fit-for-purpose evaluation framework that can analyze the strengths and weaknesses of digital technology suites is needed. In this second article we describe adaptations that could enable this new technological paradigm while maintaining patient safety and fair value.