Two high-ranking government officials have abdicated their roles on the board of the Coalition for Health AI, the organization and the Department of Health and Human Services (HHS) confirmed. The breakup is a strong departure from the approach the Biden administration has thus far taken in the regulation of healthcare artificial intelligence.
Troy Tazbaz, director of the Food and Drug Administration’s Digital Health Center of Excellence, and Micky Tripathi, Ph.D., the national coordinator for health IT at HHS, both held leadership positions in the coalition and sat on the board of directors as “federal liaisons” and “non-voting members” of the then-nine-member board.
Tripathi says his departure is a result of being appointed as the chief AI officer and co-chair of the HHS AI Task Force for the Biden Administration in accordance with President Joe Biden's executive order on AI in October 2023.
“My roles as CAIO [Chief AI Officer] and Co-Chair of the AI Task Force which now has me formally working across all agencies of the department and puts me into situations that could present conflicts, so we thought it best that I withdraw. Not a reflection at all on CHAI, their mission, the strength of the collaboration they’re building, and work that they’re doing to advance responsible and trustworthy AI,” Tripathi told Fierce Healthcare in a July 8 email.
An FDA spokesperson said on July 8 that the agency no longer has a need to interact closely with CHAI. "The FDA continuously evaluates our participation in external organizations. We have decided to withdraw the agency’s participation as a non-voting member on the board of CHAI because there is no longer a need to engage at that level in the organization. The FDA's work with CHAI was based on the organization's role in developing standards, best practices and quality management frameworks. The FDA continues to contribute to the development of best practices and standards," the spokesperson said.
FDA told Fierce Healthcare two weeks prior that it's regular practice for the agency to collaborate with industry stakeholders to more quickly advance and deploy medical technologies and further regulatory science research. It is involved in many industry groups and coalitions. Six such digital health partnerships are listed on its website.
CEO and co-founder of CHAI Brian Anderson confirmed the departure of the two HHS officials in a LinkedIn post on Friday: “We also had to say goodbye to both Micky Tripathi and Troy Tazbaz, who stepped down from CHAI's Board of Directors as federal observers. We deeply appreciate their insights and participation, and CHAI remains committed to working closely with our federal partners.”
While the administration has been hesitant to erect rules around the use and component parts of the technology, one thing the administration has been clear on is its commitment to partnerships with industry to reach broad strokes agreements on principles of healthcare AI as it builds out administrative infrastructure to oversee the technology. The White House has done this with its announcement about industry organizations who have signed on to a voluntary commitment to standards and values for AI last summer.
Republican lawmakers criticized FDA’s involvement with CHAI in a letter sent June 18. They asked the agency to respond to questions about FDA's role in CHAI's quality assurance labs and how the assurance labs depart from FDA's medical device approval authorities. The Republicans mostly took issue with the involvement of legacy technology companies like Google and Microsoft in CHAI.
"We support your objectives, but caution against outsourcing FDA equities to organizations, like CHAI, that currently do not ensure the small business community has a place in their governance,” the lawmakers wrote in the letter.
Michael Pencina, co-founder and board member of CHAI, told Fierce Healthcare in an interview that the statement was false. “I think there is this misconception that CHAI is somehow related in a closer way to large technology companies versus smaller developers … this can't be farther from the truth,” Pencina said.
Moreover, he said that large technology companies only have one out of seven votes on CHAI’s board.
Pencina later followed up, saying CHAI is composed of one-third academic, one-third commercial and one-third non-profit health systems and advocacy organizations, with “hundreds of startup members.”
Pencina also said Tazbaz and Tripathi had gotten the appropriate sign-offs from the federal government to participate on CHAI's board.
“We have no interest in pushing a certain regulation,” Pencina said. “We will be a place where the health systems, the users, the developers, big and small, founders, government .. and a patient representative … all come together, sit down, have a discussion, align on a set of national standards and best practices … We want everybody to be a member of CHAI, right? Everybody's invited to join.”
At CHAI’s virtual ribbon-cutting ceremony in March, FDA Commissioner Robert Califf gave a speech supporting the Coalition’s goals and touting FDA’s “collaboration and outreach." He said also the FDA does not have enough resources to create a framework for AI oversight.
“As part of our AI strategy, the Agency is collaborating with public/private partners to develop a framework for assessing the potential risks and benefits of healthcare AI—this issue is too large to be contained within the FDA,” Califf said at the launch.
Califf continued, “The goals of the COE (Center of Excellence) are consistent with the stated mission of CHAI: Foster responsible and high-quality digital health innovation and provide new options for facilitating prevention, early diagnosis, and management of chronic conditions outside of traditional care settings.”
He also said in the speech the agency would look to CHAI for an approach to regulate generative AI.
Tazbaz wrote a blog post on the agency's approach to healthcare AI, which also stressed collaboration. “Additionally, we seek to foster a collaborative approach and alignment within the health care ecosystem around AI in healthcare,” Tazbaz wrote.
“Partnerships help spur more rapid development and more rapid and widespread patient access to safe, effective, and high-quality medical devices of public health importance,” an FDA spokesperson said in an email.