AI policy
Deregulation denied
Despite a mandate from the Trump administration to remove barriers for health artificial intelligence companies, the Food and Drug Administration has denied a proposal that would have made it easier for large developers of AI-enabled medical devices to put their products on the market.
Last year, Harrison.ai, a developer of AI products radiologists use to help evaluate medical images, petitioned the FDA to partially exempt AI devices in six categories from premarket review, provided a manufacturer had previously received FDA clearance for a device in a relevant category. Developers would also need to meet other criteria, including establishing a plan for monitoring the product's performance once it's on the market. In short, the argument goes that meeting the requirements to get one device on the market shows a company can be trusted to safely do so for additional similar products. If you need a refresher, Katie Palmer and I reported in depth on the petition in February.
Contributing to the intrigue, the new head of the FDA's Digital Health Center of Excellence used to work for a Harrison.ai subsidiary.
The FDA’s point-by-point rejection is thorough and complete. While there was some question as to whether FDA leaders might see an opportunity to accomplish deregulatory goals by partially accepting the proposal, the response makes it clear that the FDA thinks whole thing is a bad idea. In their rejection, officials points out that many of the objectives of the proposal can be accomplished with predetermined change control plans that allow developers to seek approval for updates to their AI devices in advance.
Among FDA’s rebuttals to Harrison.ai are that the petition “does not address how generally following the same processes during product development obviates the need for FDA review and clearance;” that the petition lumps together devices that have different uses; and that the proposal to add a nebulous post-marketing plan to devices “would allow the manufacturer to determine what action… is necessary to mitigate the risks of the device in lieu of FDA review and clearance of a 510(k).” Such an approach, FDA says, is "neither consistent with the statute nor in the best interest of public health.”
The petition argues at length that there have been few examples of adverse events tied to the device types in the petition. The agency notes that performance failures that pose risks to patients, like false positives, aren’t documented as adverse events. Moreover, FDA’s review of the devices and the agency's interactions with sponsors “may play a role in reducing the number of recalls or adverse events observed postmarket.”
If you are a close observer of regulatory policy, the whole document is a great read. Let me know if you have thoughts! (H/T to Christian Robles from Inside Health Policy for spotting the response before I did.)
DTx
Boehringer Ingelheim invests $50 million in Click
Is this a feel-good digital therapeutics story? You tell me.
In a surprising reversal, drug giant Boehringer Ingelheim is handing over commercialization of an app to treat symptoms of schizophrenia to its development partner, digital health company Click Therapeutics. As part of the deal, Boehringer will invest $50 million in Click, and also provide "material" funding to aid in the commercialization.
Six years ago the companies started working together to develop the app, called CT-155. At the time, Click received an upfront payment and was promised over $500 million in milestone payments plus royalties. Under the new arrangement, Boehringer Ingelheim will take an equity stake in Click and reap rewards as a shareholder.
That is, if profits ever materialize. There has yet to be an unqualified success in FDA-cleared digital therapeutics, and there have been a few high-profile failures. David Benshoof Klein, Click's CEO and founder, is undeterred.
"I'm super confident," Klein told me. "We're on cloud nine. This is the best deal that we've ever done. The time is now for the space."
CT-155 is currently sitting with the FDA, and Klein told me he hopes clearance is "imminent," but he declined to comment on specifics. (In December, I reported on the app being readied for FDA submission.)
The 16-week treatment digitizes elements face-to-face psychosocial treatments for schizophrenia as an adjunct to antipsychotic drug treatment. In a 464-participant randomized control trial, users of the experimental app improved on a rating scale for negative symptoms of schizophrenia compared to a group that used a control app. These lesser known symptoms — including lack of motivation and the inability to experience pleasure — don't have approved treatments.
In addition the CT-155, Click last year received FDA clearance for a digital therapeutic that treats migraines.
business
AI scribes increase costs. What's next?
AI scribes that automate clinical documentation were originally pitched as a way to take the burden off stressed-out doctors. But then, they've got another use that may be even more appealing to hospital CFOs: Scribes can help supercharge billing and ensure a provider gets paid for every possible service delivered during an appointment.
As Brittany Trang reports, there's a growing consensus that this is already driving up health care costs. The big question now is what to do about it.
Read more here
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