Hogan Lovells 2024-2025 AI Trends Guide - Flipbook - Page 24
Regulatory strategies for AI-assisted software
Authors
Medical devices incorporating AI-enabled technologies raise unique regulatory
questions due to their iterative and potentially self-updating nature, which
is incongruent with historical regulatory approaches. The use of machine or
deep learning offers the opportunity for continual optimization of an algorithm
as new training data becomes available; whereas traditional regulatory
approaches have focused on frozen algorithms that require new clearance or
approval if changes are made over the life of the commercialized software.
Kelliann Payne
Partner
Philadelphia
While the global regulatory landscape varies, one threshold question with which
stakeholders must grapple is whether an AI-assisted software qualifies as a medical
device in the jurisdiction of interest. If software that embeds AI features meets the
definition of a ‘medical device’ according to local regulations, then the AI-assisted
software would have to comply with general safety and performance requirements
established for such devices.
Fabien Roy
Partner
Brussels
Adding to the complexities of this already highly regulated area, the landmark EU
AI Act now in force will impose an extensive set of new obligations on companies
across all sectors with broad extra-territorial scope. Assessment of medical
devices under the AI Act will add new (and in some ways overlapping) assessment
obligations to the existing regulations for devices. Medical device manufacturers
and other stakeholders will need to align with each of these standards, which may
be a challenging in balancing safe and responsible AI without having a negative
impact on innovation.
Jodi Scott
Partner
Denver
John J. Smith
Partner
Washington, D.C.
Additionally, while the U.S. federal government has yet to adopt far reaching laws
or regulations that govern the use of AI, the states, with Colorado being the first,
are enacting laws that may result in a patchwork of obligations across the states.
In the coming months, we expect that other geographies will also adopt laws and
regulations that govern the use of AI more generally as well as specifically AI used
in health care.
Arne Thiermann
Partner
Hamburg
Additional
resources
Spotlight
Spotlight
Spotlight
Medical Device
Artificial Intelligence
Implications of the EU AI
Act on medtech companies
Global impact of the EU AI
Act for health stakeholders
