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Diving overview:
- HHS on Thursday released an update on its plan to accelerate the adoption of artificial intelligence in clinical care as part of an effort to improve the health of Americans and reduce health care costs.
- During the webinar, department leaders outlined key points from a request for information issued late last year and asked industry how HHS can leverage its regulatory, research, and reimbursement powers to accelerate the use of AI in health care.
- Arman Sharma, HHS deputy chief AI officer, said the industry is looking for coordination across HHS agencies, support for AI implementation and governance, and help determining what makes a good AI tool. “We believe that starting with these three things and acting on continued engagement from this community is what is needed to establish trust,” he said. “And trust in this technology is the only thing that will lead to responsible and effective implementation.”
Dive Insight:
AI is a promising technology for the healthcare field, and is expected to be able to handle a variety of tasks, including documenting care, analyzing health data, helping healthcare providers find clinical studies, and creating messages and other care-related guidance for patients.
HHS leaders said in a presentation Thursday that the technology is essential to expanding the health sector’s ability to care for an aging population with increasing health needs. The implementation also has the potential to reduce administrative costs, provide patients with tools to help manage their health, and reduce the nation’s ever-increasing healthcare spending.
But it’s not always easy for healthcare organizations to deploy AI products. Introduction of AI comes with many risks, but Experts say these include inaccurate output, biased data, model degradation over time, and privacy and security concerns.
Despite calls for stronger federal oversight, the Trump administration has largely pursued a deregulatory approach to AI, concerned about slowing technology development.
Still, HHS says it has done a lot of work to determine what the industry wants from AI-related regulators. To this end, the Department rolled out an RFI in December seeking further input from industry. And now, HHS is detailing its takeaways from the hundreds of comments it received from health care providers, researchers, and expert groups.
Healthcare organizations are looking for practical guidance from HHS on implementing and building AI governance structures, Sharma said.
We’re also looking for evaluation and benchmarking tools to help us determine which AI products work well. Finally, the industry wants HHS to coordinate AI strategies across agencies, he said.
“Too often in government, the right hand does not speak to the left hand,” Sharma said. “And the healthcare AI opportunity that we have, so to speak, is too important for us to immerse ourselves in.”
HHS agency leaders also discussed what they are doing to accelerate the adoption of AI. For example, earlier this year, the Department of Community Living launched a competition for technology developers to create AI tools to help caregivers assisting older adults and people with disabilities in the United States.
The Health Advanced Research Projects Agency is also working on a project to develop AI agents that can autonomously manage treatments for cardiovascular diseases.
Dr. Rick Abramson, director of the FDA’s Digital Health Center of Excellence, said he could not provide details of its approach because the Food and Drug Administration is actively working on policy development.
However, he said the FDA is focusing on several key themes when it comes to oversight of AI, including gaining greater clarity on what the agency regulates and what it requires of developers, and creating regulations commensurate with the risks of AI tools.
The agency is also considering how to regulate AI products throughout their lifecycle, including balancing the need for pre-market and post-market oversight of tools, and coordinating policies with other government agencies, professional bodies, and international regulators.
“They say technology evolves on a scale of weeks to months, but regulations evolve on a scale of months to years,” Abramson said. “There is some truth to this, and the world is looking to FDA for leadership on how to approach advanced clinical AI tools.”
