Historically, the healthcare sector has managed the ad hoc assembly of medical devices under existing regulations, where most combinations served a singular purpose. However, modern DHT suites are revolutionizing this approach by creating interconnected systems characterized by complex data flows and dynamic interdependencies in a manner that is not suitably addressed in current regulations and assessment processes. These advanced systems can function semi-autonomously and have the potential to develop into aggregated “super devices”, significantly reducing the need for human intervention and heralding a new era in medical device integration.
One prominent example of this evolution is the “Hospital at Home” (HaH) concept. A typical HaH setup includes a combined system of medical devices like health sensors, alert systems, continuous remote monitoring, and digital patient support tools, as well as non medical device products and humans in the loop, collectively providing comprehensive care outside traditional hospital settings.
Despite the promising benefits, the adoption of these grouped systems presents several challenges. Ensuring the safety and performance of each component within these systems is crucial, as their functionality relies heavily on the interdependence of individual elements. The cybersecurity of these interconnected DHTs and Internet-of-Medical-Things (IoMTs) devices requires careful regulation to protect both individual patients and the integrity of entire healthcare infrastructures, necessitating stringent attention to network device interactions and vigilance against potential emergent properties that could compromise system security.
Moreover, the adaptive nature of many DHTs, particularly those utilizing AI-based technologies, poses further regulatory challenges. While current regulations emphasize strict cybersecurity requirements for individual DHTs, there is a pressing need to address the unique demands of adaptive, flexible systems operating within networks. Balancing patient, device and system safety with innovation remains a critical priority.
Addressing these challenges is at the core of the CYMEDSEC project, an EU-funded initiative. This project, involving a consortium of twelve partners from various disciplines, focuses on integrating a security-by-design approach into DHTs and IoMTs. It also aims to establish a standard for cybersecurity, develop a benefit-risk toolbox, and conduct real-world case studies. Additionally, the project will explore the legal, ethical, societal, and privacy implications of these technologies, ensuring a comprehensive approach to the future of digital healthcare.
For further information, please refer to the detailed articles published in npj Digital Medicine.
Background info
The articles have been published on Nature Portfolio Journal (npj) – Digital Medicine by Rebecca Mathias & Stephen Gilbert from Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany; Peter McCulloch from Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Anastasia Chalkidou from National Institute for Health and Care Excellence (NICE), London, UK.
The articles were supported by the European Commission under the Horizon Europe Program, as part of the projects CYMEDSEC (101094218) and ASSESS-DHT (101137347).
Link to the articles:
Article 1- Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings – Published: 18th June 2024
https://www.nature.com/articles/s41746-024-01147-z
Article 2- How can regulation and reimbursement better accommodate flexible suites of digital health technologies? – Published 2nd July 2024
https://www.nature.com/articles/s41746-024-01156-y
For more information
Stephen Gilbert, TUD (CYMEDSEC Coordinator)
Giacomo Destro, ICONS (Press)
Want to know more about the project?
Photo credits: Natanael Melchor on Unsplash