Are CE-marked AI ‘Configurable Platforms’ the Future and What Are Their Legal and Regulatory Bounds?

Description: Current and future regulations often rub up the wrong way with the current and future visions of medical AI held by medical doctors, technical experts and product developers. This is a growing problem with the increasing overlap and layering of regulations, even where they consider adaptivity/self-learning systems. As recognized for wearables and apps in the FDA’s Health at Home Initiative, regulation can disincentivise sensible and pragmatic interoperability and the flexible interaction between products/devices developed by different manufacturers.

How can this problem be addressed? Better regulation, standards and guidance development may help, but another approach that the market itself is developing is that of platforms that deliver multiple AI solutions together to the clinical end-user.

One type of platform, most known in radiology, brings together multiple regulatory approved medical devices (e.g., CE marked or FDA approved/cleared). Such platforms may also deliver (alongside approved tools,) in-house developed AI-devices from medical universities direct to local clinical users.

A second interesting but potentially more controversial AI platform innovation is Class IIb CE-marked medical products, which present themselves as clinical indication / target population agnostic configurable AI-enabled SaMD disease management platforms, providing algorithms alongside an array of remote patient monitoring (RPM) systems, companion apps, risk assessment tools, dose calculators, all of which being flexibly health system configurable.

Both platform approaches are highly interesting to consider and the presentations and panel will delve deep into the promise and pitfalls of such approaches, considering current legal reality and future directions The latter platform approach raises many legal and practical regulatory oversight questions: do the Class IIb CE approvals really allow this, does the utilizing health system not become the legal manufacture, are quality management SOPs and responsibilities shared, is this permitted, how is change management done, and how are responsibilities split?