Micky Tripathi, the US national coordinator for health IT, and Troy Tazbaz, the US Food and Drug Administration’s chief digital health officer, resigned from the Health AI Alliance last week.
While the announcement comes after concerns raised by Republican lawmakers — in a letter to the FDA last month and directly to the Center for Devices and Radiological Health during a May congressional hearing on medical device regulation — the agencies said the coalition and the Administration’s AI development efforts by 2024 have brought the level of regulatory involvement in CHAI up to par.
Engaging government regulators
When Dr. Brian Anderson, co-founder of CHAI and chief digital health physician at MITRE, discussed the collaborative’s Trusted AI Deployment Plan with Healthcare IT News On HIMSSTV, he said CHAI is starting with academic and nonprofit organizations to build trustworthy AI.
When the coalition was formed nearly two years ago — because there was no consensus on best practices regarding how to manage the development, deployment, and maintenance of health AI — it became clear that government regulators needed to be involved.
By August 2023, Anderson said, more than 700 organizations had signed public-private partnerships to innovate AI. Today, that number is in the thousands, according to an Anderson spokesperson.
“CHAI is a private sector coalition of more than 2,500 nonprofit and for-profit organizations that welcomes input from all stakeholders across the entire healthcare ecosystem,” she said via email Monday.
“We are extremely fortunate to have public sector observers and liaisons on the board with unique perspectives and expertise,” he said, adding that CHAI is focused on developing industry best practices “to address the urgent need for independent validation of quality assurance, representation and ethical practices.”
Last year, Anderson said having senior leaders from ONC and the FDA at the table (Tripathi and Tazbaz are non-voting members) played a key role in regulating what would ultimately impact patients’ lives.
“We deeply appreciate their insights and participation, and CHAI remains committed to working closely with our federal partners to engage the entire CHAI community in defining the Quality Assurance Lab for Medical AI,” he said in a personal social media post Friday touting the “incredible week” CHAI had in releasing its draft Responsible AI framework and saying goodbye to Tripathi and Tazbaz.
Congressional oversight and timing
Republican lawmakers have criticized CHAI, saying it is too heavily influenced by the largest tech and health care companies, including Microsoft, Google and the Mayo Clinic, and lacks representation from small businesses.
As FDA leaders appeared before the House Energy and Commerce Committee’s Subcommittee on Health to testify about the regulation of drugs, biologics and medical devices, a Minnesota representative, Dr. Mariannette Miller-Meeks, voiced concerns about the subcommittee’s membership.
During a subcommittee hearing on the U.S. Food and Drug Administration’s regulation of drugs, biological products, and medical devices on May 22, representatives asked numerous questions of FDA directors.
While Dr. Miller-Meeks accused the Center for Devices and Radiological Health of stifling innovation with its 500-plus page rule, she also questioned whether the FDA would transfer certification to CHAI, which she said is not a diverse organization.
“It doesn’t pass the smell test,” she said, and shows “clear signs of attempted regulatory capture.”
Dr. Jeff Shuren, director of CDRH, responded that the agency had previously responded to CHAI that more diversity was needed.
“We’ve also told CHAI that they need more representation in the medical technology space.” While his office can review CHAI’s work, he said, “they don’t work for us and we don’t work for them.”
Then, on June 18, Republican lawmakers wrote to the FDA citing a “clear conflict of interest” in working with CHAI to closely monitor AI tools, according to STAT, which said it had received a copy of the letter in its article.
In October, the FDA announced the Digital Health Advisory Committee and is working with a variety of industry groups looking to shape and develop AI in their fields – not just CHAI.
“The government cannot manage this issue on its own, because it is happening at a pace that requires very, very clear public/private engagement,” Tazbaz said at the ONC’s three-part annual session on tackling racism in December.
An agency spokesman said Healthcare IT News Monday that “the FDA continually evaluates our engagement with outside organizations,” and now that CHAI has released its Responsible AI Framework and Standards for public comment, this is no longer necessary.
“We have decided to withdraw the agency’s non-voting membership on the CHAI board because there is no longer a need for that level of involvement in the organization. FDA’s work with CHAI builds on the organization’s role in developing standards, best practices, and quality management frameworks,” which the agency will continue to implement.
It was time for Tripathi to step down, he said, while being quick to point out that the decision had no impact on CHAI and the work the organization is doing toward responsible AI.
He became acting AI director at the Department of Health and Human Services on May 24 and told a House E&C Committee hearing in December that a new task force would look at eight different areas, including health care delivery, a Tripathi spokesperson said.
ONC leadership responded to us via email on Tuesday that “because my role as CAIO and Co-Chair of the AI Task Force now puts me formally at work across all of the department’s agencies and puts me in situations that could create conflict, we thought it best for me to step aside.”
Tripathi and Tazbaz have both been involved in the public sector and government.
Tripathi previously worked at Harvard University’s Berkman Klein Center for Internet and Society, but before that he served as director of alliances at health care analytics firm Arcadia.
According to his CHAI leadership bio, Tazbaz has worked at Oracle for 11 years in technical and business positions, including as senior vice president of strategy and operations for the industry business unit.
Such cross-pollination is common in many industries, from critical services to publishing.
In particular, the tech workforce is facing shortages and risks high enough for critical sectors like health care and other public services that the government is funding workforce initiatives, like the federal cybersecurity workforce, in critical tech sectors, because tech talent, like all talent, often leaves low-wage government and nonprofit roles for higher-wage roles.
The Biden administration and others have looked to vetted industry leaders like Tazbaz and Tripathi to fuel their management with industry insights.
Andrea Fox is senior editor of Healthcare IT News.
Email: [email protected]
Healthcare IT News is a publication of HIMSS Media.
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