This article, titled “Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings,” authored by Rebecca Mathias, Peter McCulloch, Anastasia Chalkidou, and Stephen Gilbert, and published in partnership with Seoul National University Bundang Hospital, addresses a crucial emerging phenomenon in medicine: the grouping of individual Digital Health Technologies (DHTs) into integrated packages. This is the first in a two-article series, focusing on the challenges associated with the implementation and current frameworks for the regulation, health technology assessment (HTA), and reimbursement of these combined device suites and their associated novel care pathways.
The article highlights that DHTs encompass a broad range of tools, including wearables, mobile health (mHealth) devices, health information technology (IT), telehealth and telemedicine solutions, and personalized medicine tools. There is a global trend towards their increased use in medical practice, driven by their potential to offer customized and adaptable care, facilitate safer home-based and local care, and empower patients in their health management. These technologies are also expected to contribute to the economic affordability and environmental sustainability of healthcare systems.
A key concept introduced is the bundling of individual DHTs, each with its own specified medical purpose and regulatory approvals, into suites designed to deliver aggregated “intended purposes”. These aggregated purposes can sometimes differ from those of any single component device. Unlike traditional medical device groupings, such as a surgeon’s instrument pack, these DHT aggregations are networked and interconnected, featuring complex data flows and dynamic dependencies among devices. While many still require human intervention, there is a realistic potential for these aggregated “super devices” to transition to greater automation with limited human involvement in the future.
The article provides several examples of services delivered through these device-aggregates of DHTs:
- Remote monitoring of chronically ill patients at home by healthcare providers (HCPs).
- Hospital-at-Home (HaH) programs, which typically include aggregated health sensors, alert systems, smart pill boxes, continuous remote monitoring, and digital patient support. The HaH concept, while existing previously, gained significant traction during the COVID-19 pandemic due to temporary regulatory and reimbursement changes globally.
- Improved treatment efficiency in hospital or care home settings.
- ‘Smart clinics’ that enable physical exams by remote clinicians, often with the patient or family’s assistance, using mHealth platforms and wireless devices like thermometers, stethoscopes, otoscopes, and laryngoscopes.
Despite their significant potential, the adoption and evaluation of DHT suites face considerable challenges:
- Safety and performance issues arise from networked-device interactions and unexpected “emergent” properties of the combined systems.
- Ensuring interoperability and applicability across diverse patient demographics is a major hurdle.
- Cybersecurity of both individual components and the aggregated system, especially for critical infrastructure like HaH services, is paramount, as risks could extend beyond individual patients to threaten entire healthcare systems.
- The adaptive nature of many DHTs (e.g., through agile software refinements or ongoing AI model training) adds complexity to their assessment.
- Regulatory frameworks are lagging; for example, in the EU, commercial providers of medical device (MD) and non-MD DHT systems must treat them as MDs and risk-assess all components, providing clinical data for the combination. This can be impractical for app developers who might need to assess and provide evidence for every sensor configuration across a multitude of smartphone brands.
- Reimbursement presents difficulties, including assessing cost-effectiveness and gathering sufficient evidence for extensive modular DHT suites, often complicated by the absence of suitable comparators and the complex estimation of initial investments for staff training and system development.
The authors emphasize that a significant portion of the transformation in healthcare quality and efficiency due to DHTs will stem from these novel suites operating within interactive ‘fuzzy’ care networks with HCPs, rather than from individual DHTs alone. They note that while temporary regulatory and HTA framework adaptations served during the pandemic, there is a clear opportunity to develop new frameworks and paradigms for these complex multi-device digital/human workflows. The second article in this series will delve into what these new frameworks could entail.
Reference: Mathias, R., McCulloch, P., Chalkidou, A., & Gilbert, S. (2024). Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings. npj Digital Medicine, 7(1), 1–5. https://doi.org/10.1038/s41746-024-01147-z
