Micky Tripathi, U.S. national coordinator for health informatics, and Troy Tazbaz, director of digital health at the U.S. Food and Drug Administration, resigned from the Coalition for Medical AI last week.
While the announcement followed concerns raised by GOP lawmakers — in a letter sent to the FDA last month and directly to its Center for Devices and Radiological Health during a May congressional hearing on medical device regulation — the agencies say the coalition’s and the administration’s efforts to advance AI in 2024 have led regulators to reach a level of commitment to CHAI.
Government Regulatory Involvement
When CHAI co-founder Dr. Brian Anderson, chief medical officer for digital health at MITRE, discussed the Blueprint for Trustworthy AI Implementation project on HIMSSTV, he said CHAI started by working with academia and nonprofits to build trustworthy AI solutions.
When the coalition launched nearly two years ago — because there was no consensus on best practices for managing the development, deployment and maintenance of AI in healthcare — it quickly became clear that government regulators would need to be involved in the talks.
Anderson said that as of August 2023, more than 700 organizations have signed on to the public-private AI innovation partnership. There are now thousands, according to an Anderson spokesman.
“CHAI is a private sector coalition of over 2,500 nonprofit and for-profit organizations that welcomes input from all stakeholders in the healthcare ecosystem,” she explained in an email Monday.
“We were extremely fortunate to have public sector observers and liaisons on the board who had unique perspectives and expertise,” adding that CHAI is focused on developing industry best practices “to address the urgent need for independent validation in quality assurance, representation and ethical practices.”
Anderson said last year that having senior ONC and FDA representatives at the negotiating table (Tripathi and Tazbaz were nonvoting members) was crucial to resolving issues that 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 laboratories for AI in healthcare,” he said in a personal message on social media. fasting On Friday, CHAI touted an “incredible week” by releasing a draft framework for responsible AI and saying goodbye to Tripathi and Tazbaz.
Congress Control and Schedule
Republican lawmakers have criticized CHAI, saying it is too heavily influenced by major technology and healthcare companies, including Microsoft, Google and the Mayo Clinic, and lacks sufficient representation of tiny businesses.
When FDA representatives appeared before the House Energy and Commerce Subcommittee on Health to testify about the regulation of drugs, biological products and medical devices, Minnesota Representative Dr. Mariannette Miller-Meeks expressed concerns about the subcommittee’s membership.
During a meeting of the U.S. Food and Drug Administration (FDA) Regulatory Affairs Subcommittee on May 22, representatives asked questions of FDA directors.
While Dr. Miller-Meeks accused the Center for Devices and Radiological Health of stifling innovation with a rule more than 500 pages long, she also questioned whether the FDA would outsource certification to CHAI, which she said is not a diverse body.
“It doesn’t pass the smell test,” she said, and shows “clear signs of trying to hijack regulatory control.”
Dr. Jeff Shuren, director of CDRH, responded that the agency had previously told CHAI that more diversity was needed.
“We also told CHAI they needed more representation in the health technology sector.” 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, GOP lawmakers wrote to the FDA citing a “clear conflict of interest” in working with CHAI to study AI tools, according to STAT, which said it received a copy of the letter in its plot.
The Food and Drug Administration (FDA) announced the creation of its own Digital Health Advisory Committee in October and is working with a variety of industry groups looking to shape AI in their sectors—not just CHAI.
“The government can’t regulate this alone because it’s happening at a pace that requires very, very clear public and private sector engagement,” Tazbaz said at a three-part session at ONC’s annual conference on addressing racial bias in December.
An agency spokesperson said Monday that “FDA continually evaluates our participation in external organizations,” and now that CHAI has made its standards and the Responsible AI Framework available for public consultation, that is no longer necessary.
“We have decided to withdraw the agency’s participation as a nonvoting member of the CHAI board because there is no longer a need for involvement at this level in the organization. FDA’s relationship with CHAI has been based on the organization’s role in developing standards, best practices, and a quality management framework,” which the agency will continue to work on.
Tripathi also said the time was right for him to step down, quickly pointing out that the decision has no impact on CHAI and the work it does to advance responsible AI adoption.
He became acting director of artificial intelligence for the Health and Human Services Department on May 24. During a December hearing in the House of Representatives’ Health and Human Services Committee, he said the up-to-date task force would address eight different areas, including health care delivery, Tripathi’s spokesman said.
The ONC leader told us in an email Tuesday that “it is because of my roles as CAIO and AI Task Force Co-Chair, which now formally work across all agencies in the department and put me in situations that could create conflict, that we felt it was best for me to step back.”
Tripathi and Tazbaz were involved in the public sector and government.
Previously, Tripathi was a fellow at Harvard University’s Berkman Klein Center for Internet & Society and, prior to that, was director of partnerships at healthcare data analytics company Arcadia.
Tazbaz has worked at Oracle for 11 years in technical and business roles, including as Senior Vice President, Industry Business Unit Strategy and Operations, according to his Biography of CHAI leader.
This type of cross-fertilization is common in many professions, from critical services to publishing.
In particular, there is a shortage of workers in the technology sector, and the risk to key sectors like health care and other public services is so great that the government is funding workforce initiatives, such as the federal cybersecurity workforce, in key technology areas because talented tech workers, like everyone else, often leave lower-paying government and nonprofit jobs for higher-paying ones.
The Biden administration and other governments have always turned to proven industry leaders like Tazbaz and Tripathi to add industry expertise to their regulatory work.