Emerging trends and challenges in the grouping of digital health technologies

The widespread adoption of Digital Health Technologies (DHTs) is now evolving, with a growing trend towards the integration of these technologies into interconnected device suites. A recent series of two publications in npj Digital Medicine by the CYMEDSEC consortium partners explores this significant shift, shedding light on the opportunities and challenges associated with the implementation and evaluation of these DHT suites.

One article is titled “Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings” and the second is “How can regulation and reimbursement better accommodate flexible suites of digital health technologies?“

Historically, the health care 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 health care 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. 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 health care.