https://www.nbcnews.com/health/health-news/fdas-ai-tool-medical-devices-struggles-simple-tasks-rcna210340
A new Food and Drug Administration AI tool that could speed up reviews and approvals of medical devices such as pacemakers and insulin pumps is struggling with simple tasks, according to two people familiar with it.
The tool — which is still in beta testing — is buggy, doesn’t yet connect to the FDA’s internal systems and has issues when it comes to uploading documents or allowing users to submit questions, the people say. It’s also not currently connected to the internet and can’t access new content, such as recently publishedstudiesor anything behind a paywall.
The artificial intelligence, dubbed internally CDRH-GPT, is intended to help staffers at the agency’s Center for Devices and Radiological Health, a division responsible for ensuring the safety of devices implanted in the body as well as essential tools like X-rays and CT scanners.
The division was among those affected by the sweeping mass layoffs at the Department for Health and Human Services earlier this year. While many of the device reviewers were spared, the agency eliminated much of the backend support that enables them to issue approval decisions on time.
The work of reviewers includes sifting through largeamounts of data fromanimalstudies andclinical trials. Depending on the applicant, it can take months or evenover a year— which an AI tool could feasibly help shorten.
Experts, however, are concerned that theFDA’spush toward AI could outpace what the technology is actually ready for.
Since taking over the agency on April 1, Commissioner Dr. Marty Makary has pushed to integrate artificial intelligence across the FDA’s divisions. How this move into AI could affect the safety and effectiveness of drugs or medical devices hasn’t been determined.
Last month, Makary set a June 30 deadline for the AI rollout. On Monday, he said the agency was ahead of schedule.
But the two people familiar with CDRH-GPT say that it still needs significant work and that FDA staff were already concerned about meeting the June deadline, at least in its original form.
“I worry that they may be moving toward AI too quickly out of desperation, before it’s ready to perform,” saidArthur Caplan, the head of the medical ethics division at NYU Langone Medical Center in New York City. He stressed that reviewing medical devices accurately is essential, since people’slives depend on it.
“It still needs human supplementation,” Caplan said. AI “is really just notintelligent enough yet to reallyprobe the applicant or challenge or interact.”
The FDA directs all media inquiries to the Department of Health and Human Services. A spokesperson for HHS did not respond to a request for comment.
On Monday, Makary announced that a separate AI tool, called Elsa, had been rolled out to all FDA employees. Elsa is now intended for basic tasks agency-wide, such as summarizing data from adverse event reports.
“The first reviewer who used this AI assistant tool actually said that the AI did in six minutes what it would normally take him two to three days to do,” Makary said in an interview last week. “And we’re hoping that those increased efficiencies help. So I think we’ve got abright future.”
The reality inside the agency is quite different, the same two sources said.
While the concept is solid and a step in the right direction, they said, some staff feelit’s being rushed and not yet ready forprime time.
“AI tools to help with certain tasks for reviewers and scientists seemsreasonable given thepotential utility of AI,” one ofthe people said. However, the person said they disagree with the “aggressive roll out” and claims that it could reduce work “by hours and days.”
To be sure, experts say, it’s not uncommon for a company or government agency to launch a new product and then refine it through iterative updates over time.
Staff have worked hard to get Elsa up and running, the people said, but it still can’t handle some core functions and needs more development before it can support the agency’s complex regulatory work.
When staff tested thetool Monday with questions about FDA-approved products or other public information, it provided summaries that were either incorrect or only partially accurate, one of the people said.
It’s unclear, the people said, whether CDRH-GPT will eventually be integrated into Elsa or remain a standalone system.
Richard Painter,a law professor at the University of Minnesota anda former government ethics lawyer, said there are also concerns about potential conflicts of interest. He wondered whether there is aprotocol in place toprevent anygovernment official — such as an FDA reviewer using the technology — from having financial ties with companies that could benefit from AI. While the technology has existed for years, he said, it‘s still a new venture for the FDA.
“We need to make sure that the people involved in these decisions do not have a financial interest in the artificial intelligence companies that would get the contracts,” Painter said. “A conflict of interest can greatly compromise the integrity and the reputation of a federal agency.”
Some at the FDA don’t see AI as a solution to their overwhelming workloads — they see it as a sign that they may eventually be replaced.
The FDA is “already spread thin from the RIF [layoffs] and the steady loss of individuals while in a hiring freeze and no capacity to backfill,” one of the people said.
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>>1409608 (OP)Soon all government agencies Trump doesn't like will be downsized and outsourced to an AI prompt.
>>1409651Then it’s unfortunate that the AIs don’t fucking work.
>>1409654But who is getting paid to write these badly written AIs?
>CDRH-GPTIt seems like an off the shelf version of GPT 4.1?
>>1409924Any two bit startup willing to hustle. AI is the new blockchain/.com/digital.
In the 80s, shitheel companies were slapping the word "digital" on fucking anything and getting loads of investment money even when their product was distinctly analog. Any business that purported to be a website first and foremost around 1998-2001 got entire dump trucks worth of cash thrown at them. Everything was supposedly going to be "on the blockchain" a few years ago and the people saying that got billion dollar loans at 0.0000000001% interest for their troubles. Now it's AI. Anything and everything is AI, as long as the venture capitalists like those two letters. AI powered fridge, AI powered shoes, AI powered blockchain website. You want money, just start a business with AI in the name.
>>1409608 (OP)AI users are retarded. The FDA wasted taxpayer dollars for a worse search engine.