Biden’s AI healthcare leaders leave CHAI roles
Mickey Tripathi, the US national coordinator for Health IT, and Troy Tazbaz, the US Food and Drug Administration’s director of digital health, resigned from the Coalition for Health AI last week.
While the announcement followed 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 say the coalition and administration’s AI development efforts in 2024 have brought regulators’ involvement in CHAI to a close.
Involve government regulators
When CHAI co-founder Dr. Brian Anderson, head of digital health at MITRE, discussed the collaboration’s Blueprint for Trustworthy AI Implementation with Healthcare IT News On HIMSSTV he said that CHAI started with academics and non-profits to build trustworthy AI.
When the coalition launched nearly two years ago, it quickly became clear that government regulators needed a seat at the table, as there was no consensus on best practices around the development, implementation and maintenance of AI in healthcare.
By August 2023, Anderson said, more than 700 organizations had joined the public-private partnership for AI innovation. Today, that number is in the thousands, an Anderson spokesperson said.
“CHAI is a coalition of more than 2,500 private sector, nonprofit and commercial organizations, open to input from all stakeholders in the health system,” she said by email Monday.
“We are extremely fortunate to have public sector observers and contacts on the board, with unique perspectives and expertise,” he added. CHAI is focused on developing best practices in the sector “to address the urgent need for independent validation of quality assurance, representation and ethical practices.”
Last year, Anderson said it was essential to have senior leaders from ONC and FDA (Tripathi and Tazbaz were nonvoting members) at the table to regulate what would ultimately affect patients’ lives.
“We greatly value 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 message on social media after on Friday to promote the “incredible week” CHAI had by publishing its draft Responsible AI Framework and bidding farewell to Tripathi and Tazbaz.
Congress supervision 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 does not represent enough small businesses.
When FDA leaders appeared before the House Energy and Commerce Health Subcommittee hearing to testify about the regulation of drugs, biological products and medical devices, Minnesota Rep. Dr. Mariannette Miller-Meeks expressed concerns about the membership numbers.
During the House of Representatives Energy and Commerce Health Subcommittee hearing on the U.S. Food and Drug Administration’s regulation of drugs, biological products, and medical devices on May 22, representatives asked questions of the FDA directors.
Dr. Miller-Meeks accused CDRH of stifling innovation with the 500-plus page rule, but she also asked that the FDA outsource the certification to CHAI, which she said was not a diverse body.
“It doesn’t pass the smell test,” she said, and there are “clear signs of an attempt at regulatory containment.”
Dr. Jeff Shuren, director of the Center for Devices and Radiological Health, responded that the agency had previously provided feedback to CHAI that more diversity was needed.
“We’ve also told CHAI that they need more representation on the medtech side.” While his office may 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 a letter to the FDA pointing out a “clear conflict of interest” in working with CHAI to research AI tools, according to STAT, which said it received a copy of the letter in its story.
The FDA announced its own Digital Health Advisory Committee in October and is working with several industry groups that want to shape and implement AI in their sectors – not just CHAI.
“The government cannot regulate this alone, because things are moving so fast that there needs to be a very, very clear collaboration between the public and private sectors,” Tazbaz said in December during the three-part session of the ONC annual conference on solving racial bias.
A spokesperson for the agency said Healthcare IT News It was announced on Monday that “the FDA continually evaluates our participation with third-party organizations” and now that CHAI has released its standards and Responsible AI Framework for public comment, that is no longer necessary.
“We have decided to withdraw the agency’s participation as a non-voting member of the CHAI Board of Directors because there is no longer a need to be involved at that level in the organization. FDA’s work with CHAI has been based on the organization’s role in developing standards, best practices, and quality management frameworks,” which the agency will continue to work on.
For Tripathi too, now is the right time to step down, he said, while quickly pointing out that the decision has nothing to do with CHAI and the organization’s work to guide responsible AI.
On May 24, 2024, he became acting chief AI officer for Health & Human Services and during a House E&C hearing in December, he said a new task force would examine eight different areas, including health care delivery, a spokesperson for Tripathi said.
The ONC leader told us in an email on Tuesday that this is “due to my roles as CAIO and co-chair of the AI Task Force, which now formally places me across all agencies of the Department and places me in situations that could lead to conflict. Therefore, we felt it best for me to resign.”
Tripathi and Tazbaz are both active in the public sector and government.
Tripathi previously worked at the Berkman Klein Center for Internet & Society at Harvard University and before that was Chief Alliance Officer at healthcare analytics company Arcadia.
Tazbaz spent 11 years at Oracle in technical and business roles, including senior vice president of strategy and operations for the industrial division, his CHAI Leadership Biography.
Such cross-pollination occurs in many professions, from critical services to publishing.
The tech sector is particularly vulnerable to labor shortages. The risks are so great that it’s important for sectors like health care and other public services that the government is funding hiring initiatives, like a federal cyber workforce, in key tech sectors. This is because tech talent, like all other talent, is often leaving lower-paying government and nonprofit positions for higher-paying positions.
The Biden administration and other administrations have consistently looked to vetted industry leaders like Tazbaz and Tripathi to enhance their regulatory work with industry insights.
Andrea Fox is Editor-in-Chief of Healthcare IT News.
Email address: afox@himss.org
Healthcare IT News is a publication of HIMSS Media.
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