Devices

Implement Digital Technologies Carefully: GE HealthCare

David McFarland

— 1 min read
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Commenting on an FDA 11/20-11/21/2024 Digital Health Committee meeting, GE HealthCare says generative artificial intelligence (GenAI) and foundation models (FM) “have immense potential to revolutionize clinical care and medical technology, including medical devices.” In its letter, the company says it is “essential to implement these technologies thoughtfully and responsibly, prioritizing patient safety and access.”

GE offers detailed comments and recommendations on:

  • regulating GenAI/FM-enabled devices like other medical device software;
  • applying the existing FDA regulatory framework to GenAI/FM-enabled medical devices, focusing on defining the intended use, adopting robust risk management practices, premarket authorization, and establishing change control and lifecycle management processes;
  • postmarket monitoring of GenAI/FM-enabled medical devices; and
  • examples of methods for detecting and mitigating hallucination (instances where the system generates inaccurate or misleading information).

“Collaboration among FDA, manufacturers, and healthcare providers is essential to develop best practices for monitoring and managing GenAI/FM-enabled medical devices, while also supporting the realization of the potential of AI to increase access for patients,” GE concludes. “The responsible integration of GenAI and FM into medical devices requires a balanced approach that prioritizes patient safety, regulatory compliance, and the practical realities of healthcare delivery.”

In its response, AdvaMed says it is important to continue to acknowledge that the specific use cases of GenAI in medical imaging devices are still emerging and that use cases for GenAI in medical devices and their associated risks should be well understood before new regulatory approaches are considered. The trade group says it also is imperative to maintain flexibility in regulatory approaches to account for the ongoing evolution of GenAI technology.

“FDA’s current framework is likely sufficiently robust to manage the unique considerations of GenAI in medical devices,” AdvaMed says. “By maintaining a focus on risk-based regulation and leveraging existing pathways, FDA can continue to support innovation while ensuring the safety and effectiveness of these devices.”

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