Life Sciences Horizons Brochure 2025 - Flipbook - Page 93
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2025 Horizons Life Sciences and Health Care
How medical device companies should navigate the evolving AI regulatory landscape
The rapid advancement of artificial intelligence in
health care has placed medical device companies at
the forefront of innovation and regulatory scrutiny.
Companies are also facing a patchwork of vastly
different regulatory schemas in different regions;
for example, the EU AI Act imposes stringent
requirements on AI-powered medical devices, while
the Trump Administration in the U.S. appears headed
for a regulation-light approach to AI oversight. Given
the evolving — and sometimes conflicting — global
landscape for AI regulation, medical device companies
must adopt proactive strategies to ensure compliance,
mitigate risks, and maintain market competitiveness.
Align with the EU AI Act
Monitor federal U.S. developments closely
The EU AI Act classifies AI systems based on risk levels, with
high-risk applications — including AI-driven medical devices —
facing strict compliance requirements. Medical device companies
seeking to commercialize in the UK should align their AI systems
with the Act’s provisions, particularly in areas such as data
transparency, risk management, and human oversight.
In January 2025, U.S. President Trump rescinded a Biden-era
Executive Order (EO) on AI, which had emphasized safety
restrictions and increased oversight for potential discriminatory
AI impacts. In its place, the Trump administration issued EO
14179, “Removing Barriers to American Leadership in Artificial
Intelligence,” which focuses on clearing a path for U.S. innovation
that promotes economic competitiveness and directs the U.S.
government to identify existing U.S. AI regulations for potential
suspension, rescission, or revision.
Given the EU’s influence on global regulatory trends and being the
first AI law with broad applicability, compliance with the AI Act
framework help future-proof a company’s AI model for upcoming
regulations in other regions. In terms of regulatory oversight, the
EU AI Act may represent one end of the spectrum globally, but its
example as a rigorous oversight framework is being mimicked in
other parts of the world, including in legislation pending in
several U.S. states, such as California and Washington.
Following the issuance of EO 14179, the White House published
a solicitation for input on a new cross-industry AI Action Plan,
which will likely include recommendations with downstream
impacts for medical device manufacturers going forward. While
federal agencies such as FDA have issued recent guidance on AI
and machine learning (ML) in medical devices, those publications
may be subject to change under the new American leadership.
Companies should actively monitor emerging U.S. federal
proposals that may impact their operations.
