Health providers shift AI device liability
National healthcare groups are urging the government not to hold them responsible for the safety and performance of medical devices that use generative artificial intelligence. Instead, they argue that developers should be accountable for these devices.
The American Hospital Association, American Medical Association, and American Telemedicine Association submitted comments to the Food and Drug Administration, stating that monitoring devices with generative AI would be too burdensome for providers, especially small and rural practices.
Developers should carry the responsibility of monitoring AI devices used in healthcare, and the FDA should create ways for providers to report problems with devices, according to the comments submitted by ATA Action, the lobbying arm of the American Telemedicine Association.
Manufacturers should remain responsible for the safety and performance of the devices they sell, the comments stated.
Regulating Generative AI-Enabled Medical Devices
The healthcare industry is struggling to determine who is responsible for the mistakes made by AI tools. Providers are concerned that taking on responsibility could increase their exposure to malpractice lawsuits, while tech companies could face negligence claims.
A major issue is the lack of transparency into the AI models themselves. Hospitals told the FDA that they usually have established governance to review AI-backed devices, but a lack of understanding into how the models work would make it hard for providers to identify flaws.
The American Hospital Association said that while hospitals and health systems support evaluation and monitoring activities, vendors and developers must be responsible for the ongoing performance, maintenance, and integrity of the tools they market.
Provider Groups’ Concerns
Provider groups generally agreed with the FDA’s proposed approach to regulating generative AI-enabled medical devices, but they had suggestions on how to tweak the framework. The American Hospital Association noted that activity or action alone may not be enough to predict risk.
The Workgroup for Electronic Data Interchange suggested that the FDA create a process for reporting adverse events and develop labels to give patients and clinicians insights into a tool’s functions and potential risks.
Trust in Health AI
Trust in health AI is critical to encourage adoption. Physicians want AI that is validated by a trusted entity and is continuously monitored. They also want a clear liability framework and more oversight of AI-enabled medical devices by governing bodies, like the FDA.
Rick Abramson, director of the FDA’s Digital Health Center of Excellence, said that the agency plans to post draft guidance on its approach to regulating generative AI-enabled medical devices in the coming months.
