Key Takeaways
- Jim O’Neill, a Silicon Valley investor and nominee for deputy HHS secretary, discussed AI applications during a Senate Finance Committee confirmation hearing, but not his controversial statements about FDA approval standards.
- O’Neill said AI could improve the accuracy and speed of research and allow for quicker Medicare and Medicaid reimbursement decisions.
- The hearing fell shortly before the FDA announced AI use in application reviews would be expanded from pilot stage to all centers by the end of June.
Silicon Valley investor Jim O’Neill said he will push for the broader adoption of artificial intelligence within the US Health and Human Services Department if confirmed as principal deputy secretary, but he largely avoided discussion of his thoughts on US Food and Drug Administration approval standards in recent confirmation hearings.
O’Neill, who worked for Silicon Valley investor Peter Thiel and most recently as CEO of the anti-aging SENS Research Foundation, formerly served as HHS principal associate deputy secretary in the George W. Bush Administration under Deputy Secretary Tevi Troy.
President Trump previously considered O’Neill as a candidate for FDA commissioner at the beginning of his first term. The pick was controversial at the time because of statements he has made about potentially eliminating the efficacy standard for drug approvals.
O’Neill’s position on FDA standards was not an issue for senators during his Senate Finance Committee confirmation hearing on 6 May. O’Neill briefly mentioned accelerating therapeutic development on a list of priorities, but was not pressed to explain or walk back any prior statements.
The majority of the discussion was focused on HHS Secretary Robert F. Kennedy Jr.’s response to the measles outbreak, Kennedy’s skeptical views on vaccines and whether O’Neill supported them, as well as the HHS reorganization and reductions-in-force. When pressed by Sen. Elizabeth Warren, D-MA, on Kennedy’s performance as secretary, O’Neill said, “I think he’s doing a great job.”
O’Neill listed four priorities if confirmed as HHS principal deputy secretary:
- Reform the food system to prioritize health for children and parents
- Pursue gold-standard basic and translational research that replicates
- Use science, economics, and artificial intelligence to improve health care quality and affordability
- Accelerate development and access to lifesaving and health-extending treatments
Finance Committee Chairman Mike Crapo, R-ID, asked how O’Neill would use AI at the US Centers for Medicare and Medicaid Services.
“Artificial intelligence, as well as neural nets and other machine learning technologies, have an immense potential in improving the delivery of healthcare, the accuracy and speed of research and the operations of the department,” O’Neill said. “It’s something that I heard about [from] many of your colleagues in meetings over the past month.”
“It’s important that … CMS, as well as by other affiliated entities that are involved in delivering and reimbursing Medicare and Medicaid, are able to make quick and accurate decisions for millions of beneficiaries,” he added. “Artificial intelligence always has the potential in helping human actors be faster and make better, informed and more objective decisions.”
Sen. Marsha Blackburn, R-TN, asked O’Neill to expand on AI applications.
“There are so many ways that technology can improve health care, health research, the operations of the department,” he responded. “Large language models obviously can play a huge role in providing decision support for doctors so that they’re aware of edge cases and the risk of those edge cases. Neural networks and foundation models and many other AI and machine learning technologies can improve medical research, add more accuracy to drug trials, ensure more rapid and more accurate decisions by Medicare and so forth.”
Interestingly, about the same time as O’Neill’s hearing, the FDA announced that its pilot project incorporating AI tools into application reviews was successful and would be expanded across all centers by the end of June. All centers will be using a common, secure, generative AI system integrated with FDA internal data platforms at that time.
AI would be used to tackle repetitive tasks so human reviewers could focus on core scientific work, although several questions remain about the AI tools that will be used and the activities they will take over.
Blackburn also wanted to discuss the CMS Innovation Center, saying “I’ll send you something on CMMI, we need to get them straightened out.”
That back-and-forth underscored that O’Neill bridges the experienced DC policy world that understands the pivotal role of regulation and statute in drug development and the tech investor world eager to push boundaries in fields like AI and life extension, areas seemingly at odds.
Based on his reception by the Finance Committee and during a follow-up hearing with the Senate Health, Education, Labor and Pensions Committee, O’Neill’s confirmation for the deputy post does not appear to be in doubt.
The Senate Finance Committee will vote on favorably reporting O’Neill’s nomination on 15 May.
