Advocacy - Lab Advocate
Artificial Intelligence (AI) continues to be a transformative force in healthcare, promising improvements in safety, efficiency, and affordability. However, with these advancements come significant concerns regarding potential risks to patient safety. The Agency for Healthcare Research and Quality (AHRQ) has recently issued a new Notice of Funding Opportunity (NOFO) titled "Examining the Impact of Artificial Intelligence (AI) on Healthcare Safety." This NOFO invites grant applications focused on assessing the impact of AI technologies that are already in use within healthcare settings, rather than supporting the development of new AI systems.
The key objectives of this funding opportunity include:
- Evaluating whether and how breakthrough uses of AI systems affect patient safety.
- Exploring the safe implementation and utilization of AI systems in clinical settings.
This NOFO is a direct response to growing concerns about AI's potential to both enhance and complicate medical decision-making processes. For more information on this funding opportunity, you can visit the official NOFO page.
In a recent study published by the National Institutes of Health (NIH) in Nature, researchers have highlighted significant concerns regarding the performance of AI models in clinical settings. The study found that while AI can often match or even surpass human physicians in diagnostic accuracy, it frequently fails in explaining its reasoning or correctly interpreting medical images. For example, an AI model misinterpreted two lesions on a patient's arm as unrelated due to differences in angle, a mistake that a human physician easily avoided.
These findings underscore the importance of rigorous evaluation and cautious implementation of AI technologies in healthcare. Moreover, legal experts are now warning that the Supreme Court’s recent decision to overturn the Chevron doctrine may limit the FDA's ability to regulate AI and machine learning software in medical devices without new congressional action. This judicial shift increases the urgency for Congress to establish a clear regulatory framework that ensures the safe and effective use of AI in medicine. ADLM has been closely evaluating developments in healthcare AI and will provide input to agencies as warranted
The association will continue to monitor regulatory developments closely, and participate actively in discussions to ensure that the voices of laboratories and the patients they serve are heard in the federal policy-making process.