Drugs

Use Healthcare AI for Patients First: Califf

FDA commissioner Robert Califf says he is concerned that the main use of artificial intelligence (AI) algorithms in healthcare will be “decisions that optimize the bottom line rather than optimizing the longevity and well-being of patients.” Speaking 3/5 to the Coalition for Health AI, of which FDA is a member, Califf said that focusing AI on decisions that improve corporate earnings “is counter to the mission of FDA, where effectiveness means an improvement in a health outcome.”

Referring to the fact that the U.S. lags behind other high-income countries in health outcomes despite spending $4.5 trillion per year on healthcare, Califf said the combination of the primacy of finance over clinical outcomes and the optimization of those finances in a balkanized manner creates a problem that may explain our poor health status amid financial success. “The compelling need and advantage to sharing data and automating access to analysis could mean that AI could disrupt these unhealthy attributes,” he said.

“Imagine an AI system that is connected by a data infrastructure that enables a continuous learning loop between current practice, decisions, and outcomes,” Califf concluded. “At its best, AI could radically change our understanding of what practices, organizational and clinical, would lead to the best outcomes for patients and clinicians, and then the payment system could be aligned to reward best practices and outcomes. Broad education and collaboration will be needed to ensure that these challenges are met.”

Califf said he is concerned that health systems don’t have the infrastructure and tools to make the most important determinations about whether an AI application is “effective” for health outcomes. He said to know whether an algorithm of any kind is truly effective for health, one needs two conditions to be supported with a functional infrastructure:

monitoring the algorithm and testing its operating characteristics over time; and
following-up on the population to whom the algorithm is applied, at least in a valid sample, so the monitoring of the algorithm is based on a valid inference for its use in a particular population or clinical circumstance.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome