Micky Tripathi, U.S. National Coordinator for Health IT, and Troy Tazbaz, the U.S. Food and Drug Administration's digital health director, stepped down from the Coalition for Health AI last week. 

While the announcement followed concerns raised by Republican lawmakers – by letter last month to FDA and directly with its Center for Devices and Radiological Health during a May Congressional hearing looking at medical device regulation – the agencies say AI development efforts by the coalition and Administration in 2024 brought the regulators' level of involvement in CHAI to the finish line.

Engaging government regulators 

When CHAI cofounder Dr. Brian Anderson, discussed the collaborative's Blueprint for Trustworthy AI Implementation with Healthcare IT News on HIMSSTV, he said CHAI started with academics and nonprofits to build trustworthy AI. 

When the coalition launched nearly two years ago – because there was no consensus on best practices around how to manage the development, implementation and maintenance of health AI – it became clear quickly that government regulators were needed at the table.

By August 2023, Anderson said more than 700 organizations signed onto the public-private partnership for AI innovation. Today, there are thousands, according to a spokesperson for Anderson.

"CHAI is a private sector coalition of over 2,500 nonprofit and for-profit organizations, open to input from all stakeholders across the health ecosystem," she said by email Monday.

"We have been extremely fortunate to have public sector observers and liaisons on the board with unique perspectives and expertise," adding that CHAI is focused on developing industry best practices "to address the urgent need for independent validation for quality assurance, representation and ethical practices."

Last year, Anderson said that having senior leaders from ONC and FDA at the table (Tripathi and Tazbaz were nonvoting members) was key for regulating what would ultimately affect the lives of patients.

"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 Quality Assurance Labs for Health AI," he said in a personal social media post on Friday promoting the "incredible week" CHAI had releasing its draft responsible AI framework and saying goodbye to Tripathi and Tazbaz.

Congressional scrutiny and timing

Republican lawmakers have been critical of CHAI. They have said it is too heavily influenced by the largest tech and health companies, including Microsoft, Google and Mayo Clinic, and lacks enough small business representation.

When FDA leaders went before the House Energy and Commerce Health Subcommittee hearing to testify on the regulation of drugs, biologics and medical devices, a Minnesota Representative, Dr. Mariannette Miller-Meeks, voiced concern about its membership.

During that subcommittee hearing on the U.S. Food and Drug Administration's regulation of drugs, biologics and medical devices on May 22, representatives fired questions at FDA directors. 

While Dr. Miller-Meeks accused Center for Devices and Radiological Health of stifling innovation with the 500-plus page rule, she also asked if the FDA would outsource certification to CHAI, which she said was not a diverse body.

"It does not pass the smell test," she said, and shows "clear signs of attempt at regulatory capture."

Dr. Jeff Shuren, director of the CDRH, responded that the agency had previously given CHAI feedback that more diversity was needed.

"We've told CHAI, too, that they need to have more representation in the medtech side." While his office might consider 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 partnering with CHAI to scrutinize AI tools, according to STAT, which said it received a copy of the letter in its story.

FDA announced its own Digital Health Advisory Committee in October and works with a variety of industry groups that want to mold and shape AI in their sectors – not just CHAI.

"The government cannot regulate this alone, because it is moving at a pace that requires a very, very clear engagement between the public/private sector," Tazbaz said at the ONC annual conference three-part session on solving racial bias in December. 

An agency spokesperson told Healthcare IT News Monday that "the FDA continuously evaluates our participation in external organizations," and now that CHAI has delivered its standards and Responsible AI Framework for public comment, it's no longer necessary.

"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," which the agency will continue to work on.

The time to step down now is right for Tripathi, too, he said, quick to point out that the decision has no reflection on CHAI and the work it is doing on shepherding responsible AI.

He became Acting Chief AI Officer for Health & Human Services on May 24, and said at a House E&C hearing in December that a new task force would look at eight different areas, including healthcare delivery, a spokesperson for Tripathi said.

The ONC leader told us Tuesday by email that it is "because of my roles as CAIO 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." 

Tripathi and Tazbaz have both been involved in the public sector and government. 

While Tripathi was previously with the Berkman Klein Center for Internet & Society at Harvard University, he served as chief alliance officer with healthcare analytics firm Arcadia before that. 

Tazbaz worked at Oracle for 11 years in technical and business roles, including as senior vice president of industry business unit strategy and operations, according to his CHAI leadership bio.

Such cross-pollination is common in many professions, from critical services to publishing. 

In particular, the tech workforce is facing shortages, and risks are high enough to critical sectors like healthcare and other public services that the government is funding workforce initiatives, like a federal cyber workforce, in key tech areas, because tech talent, like all talent, often leaves lower-paying government and nonprofit roles for higher-paying ones.

The Biden Administration and other administrations have always looked to vetted industry leaders such as Tazbaz and Tripathi to propel their regulatory work with industry insights.

Andrea Fox is senior editor of Healthcare IT News.
Email: afox@himss.org
Healthcare IT News is a HIMSS Media publication.

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