Congress Pushes for Clarity on HHS' AI Assurance Lab Plans
Background and Concerns
With deregulation a priority for the incoming Trump Administration in 2025, Republicans have been closely monitoring how AI in healthcare will be regulated. In their letter to Micky Tripathi, who also serves as Assistant Secretary for Technology Policy Secretary and National Coordinator for Health IT, the representatives raised questions about the overarching objectives of the agency's reorganization and the potential for conflict of interest.
Part of a larger technology restructuring effort by HHS, the new ASTP - formerly Office of the National Coordinator for Health Information Technology - announced in July that it would have increased responsibilities, including over healthcare AI. However, the representatives believe that the creation of assurance labs could supplement the U.S. Food & Drug Administration's review of AI tools and lead to significant issues.
Specific Concerns about Assurance Labs
The representatives are particularly troubled by the possible creation of fee-based assurance labs that would be comprised of competing companies. They fear that larger, incumbent tech companies could gain an unfair competitive advantage and negatively impact innovation in the industry. This concern was highlighted when Miller-Meeks specifically asked if the FDA would outsource certification to the coalition, noting that Google and Microsoft are founding members while Mayo Clinic, which has more than 200 AI deployments, employs some of the coalition's leaders.
"It does not pass the smell test," she said, suggesting clear signs of an attempt at regulatory capture. CHAI, which unveiled standards for healthcare AI transparency, has said a long-awaited AI nutrition label will be coming soon. Dr. John Halamka, president of Mayo Clinic Platform, addressed the substantial potential benefits and real potential harms that could come from predictive and generative AI used in clinical settings earlier this year at HIMSS24.
"Mayo has an assurance lab, and we test commercial algorithms and self-developed algorithms," he said in March. "And what you do is you identify the bias and then you mitigate it. It can be mitigated by returning the algorithm to different kinds of data, or just an understanding that the algorithm can't be completely fair for all patients. You just have to be exceedingly careful where and how you use it."
Call for Responses and Ongoing Dialogue
The representatives included eleven questions and requested responses by December 20. A spokesperson for ASTP told Healthcare IT News by email that the agency is unable to comment on the letter at this time. CHAI has not responded to our request for comment, but this story will be updated if one is provided.
"The ongoing dialogue around AI in healthcare must consider the distinct authorities and duties of various agencies and offices to prevent overlapping responsibilities, which can lead to confusion among regulated entities," the four Republican members of Congress said in their letter. This highlights the importance of a clear and coordinated approach to AI regulation in healthcare.
Humana's Financial Leadership Transition
Diamond's Departure and Her Impact
Susan Diamond's decision to leave Humana after 18 years is a significant event. She has played a crucial role in the company's financial management during a challenging period. Her expertise and leadership have been instrumental in navigating the insurer through various financial situations. With her departure, Humana now faces the task of finding a suitable replacement to continue driving the company's financial success.During her tenure, Diamond has overseen important financial decisions and strategies that have shaped Humana's financial position. Her departure will leave a void that needs to be filled by a capable individual who can understand the intricacies of the healthcare industry and the insurer's financial operations.
Mellet's Appointment and Her Qualifications
Celeste Mellet, the chosen successor to Diamond, brings a wealth of experience to Humana. She comes from Global Infrastructure Partners and has previously worked at investment banks Evercore and Morgan Stanley, as well as mortgage financier Fannie Mae.Humana CEO Jim Rechtin praised Mellet, stating that she is a highly accomplished CFO with first-hand experience navigating dynamic and highly regulated industries. Her proven track record of working with cross-functional teams makes her well-suited to drive improved performance throughout the complex organization.
Financial Turmoil at Humana
Humana has been facing financial turmoil in recent months. In April, the company pulled its profit outlook for 2025 due to declining payment rates in Medicare Advantage. Payers in the privatized Medicare program are managing increased medical spending among beneficiaries, which has put pressure on Humana's finances.The insurer is also facing a significant drop in MA star ratings for next year, which could have a substantial impact on its financial performance. In late October, Humana sued the HHS over its star ratings, arguing that federal regulators calculated the scores in an arbitrary and capricious manner.
Progress in Improving Financial Position
Despite the challenges, Humana has made some progress in improving its financial position in the third quarter. The company posted better results than analysts anticipated and boosted its 2025 earnings guidance.On Tuesday, Humana reiterated its adjusted profit guidance for this year, expecting at least $16 per share. The insurer also expects adjusted profit for 2025 to be "at least in line with final 2024 results." These positive developments give hope for the company's future financial performance.
Unlocking IT Success in a Rural Healthcare Haven
Meeting Community Needs with Legacy Vendors
In our journey with a legacy vendor, we've managed to fulfill our community's needs while staying adaptable to new technology. We communicate with providers to ensure they can address patient needs promptly. It's our top priority to bring the right tech investments at the optimal time. Facilitating cross-department relationships is crucial as it leads to productive enhancements. The right partner should involve stakeholders throughout the facility, and we should take time to evaluate the best technology.For instance, when a new end-user requirement arises, we work in partnership with our legacy vendors to find solutions. This ensures that our IT systems remain agile and meet the evolving needs of our community.
We also understand that collaboration with the EHR partner is an enterprise-wide effort. By involving all departments, we can address pain points and enhance our systems effectively.
The Value of Optimizing Current Systems
Optimization over rip and replace offers several benefits. We initially faced meaningful use challenges and needed to migrate to one EHR system. A vendor that understood our small, acute care health system was crucial. Now, with proper tools, we deliver high-quality care at the right cost.Regular adaptations and improvements keep our systems up to date, preventing the need for new integrations. Optimization saves clinicians time, allowing them to focus on patient care. We aim to enhance our current technology rather than implementing new, costly systems.
Through this process, we've learned that the patient journey is at the heart of successful implementation. Regular dialogue between IT teams, leadership, and vendors is essential for continuous adaptation and relationship building.
Facilitating Social Determinants of Health Data Capture
Our facility values social determinants of health (SDOH) as it provides insights into our community's overall well-being. In a rural setting, we face unique challenges in patient privacy.We tapped case managers to perform SDOH data capture. Since nurses already had a lot of paperwork, additional documentation was not ideal. Case managers meet with patients before discharge and collect data at the bedside, increasing compliance and providing a comprehensive view of our community's social needs.
We also respect patient privacy by taking an educational approach. Patients and their families are willing to share sensitive information when they understand its importance in providing better care. Additionally, we evaluated our SDOH data and discovered transportation gaps. In response, we started an Artesia General shuttle service to transport patients to appointments. With accurate SDOH data, we are better equipped to meet our patients' and community's needs.
Eric Jimenez, the CIO at Artesia General Hospital, has shared these insights based on his experiences. As the hospital looks to the future, it continues to seek growth avenues and improve patient and employee experiences through technology.