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AI Regulation Breakdown | Apple Watch Ban November 6, 2023
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Together with
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“I don’t see any silver bullets necessarily, but it does seem that we’re on the cusp of being able to build solutions that can begin to bend the burnout curve.”
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Cedars-Sinai CIO Craig Kwiatkowski
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The White House’s long-awaited executive order on “Safe, Secure, and Trustworthy” artificial intelligence is finally here, and it left little room to miss its underlying message: the laissez-faire era of AI regulation is over.
Among the 100+ pages of actions guiding the direction of responsible AI development, President Biden laid out several initiatives poised to make an immediate impact within healthcare, including…
- Calling on HHS to create an AI task force within six months to assess new models before they go to market and oversee their performance once they do
- Requiring that task force to build a regulatory structure that can “maintain appropriate levels of quality” in AI used for care delivery, research, and drug development
- That structure will require healthcare AI developers to share their safety testing outcomes with the government
- Balancing the added regulation by ramping up grantmaking for AI development in areas such as personalized immune-response treatments, burnout, and improving data quality
- Standing up AI.gov to serve as the go-to resource for federal AI standards and hiring, a decent signal that there’ll be actual follow-through to cultivate public sector AI talent
The FDA has already approved upwards of 520 AI algorithms, and has done well with predictive models that take in data and propose probable outcomes.
- However, generative AI products that respond to human queries require “a vastly different paradigm” to regulate, and FDA Digital Health Director Troy Tazbaz believes any new structure will involve ongoing audits to ensure continuous safety.
There’s already been tons of great post-game analysis on these developments, with the general consensus looking like a cautious optimism.
- While some appreciate the order’s whole-of-government approach to AI, others worry that “excessive preemptive regulation” could slow AI’s progress and delay its benefits.
- Others are skeptical that the directives will be carried out at all, given the difficulty of hiring enough AI experts in government and passing the needed legislation.
The Takeaway
President Biden’s executive order aims to thread the needle between providing protection and encouraging innovation, but time will tell whether it’ll deliver on some much-needed guardrails. Although AI is a lightning-quick industry that doesn’t exactly lend itself to the type of centralized long-term planning envisioned in the executive order, more structure should be an improvement over regulatory uncertainty.
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- Apple Watch Import Ban: The patent battle between Masimo and Apple took a somewhat unexpected turn last week when the US International Trade Commission issued a partial import ban on Apple Watches, declaring that the tech giant infringed on Masimo’s light-based blood-oxygen monitoring patents. The ruling “sends a powerful message that even the world’s largest company is not above the law,” although President Biden could still decide to veto it next month (an uncommon but not unheard-of move).
- Unnecessary Stents: More than one-in-five stents placed in Medicare patients between 2019 and 2021 were unnecessary, amounting to 229k excess procedures and $2.44B in wasteful costs. That’s the takeaway from a Lown Institute analysis of 1,733 facilities that also found wide variations across different hospitals. For example, 52.58% of all stents were deemed unnecessary at Northwest Texas Hospital, while just 1.58% were unnecessary at Kaiser Permanente San Francisco Medical Center.
- Hinge Preps for IPO: Digital MSK company Hinge Health is targeting profitability in 2024 as it gears up for an IPO “when the public markets stabilize.” In the meantime, Hinge is looking to acquire smaller startups that can help it reach break even and improve outcomes, particularly for its Medicare Advantage patients. The M&A would support Hinge’s own program launches, such as the senior fall-prevention program rolled out in October and the in-home physical therapy expansion of its women’s pelvic-health service.
- Cedars-Sinai Connect Update: Cedars-Sinai CIO Craig Kwiatkowski shared with Becker’s how the system’s two-pronged approach to AI and virtual care is helping alleviate in-person capacity issues. Kwiatkowski describes how the recently launched Cedars-Sinai Connect app co-developed with K Health has been able to provide any-time virtual access to its physicians, which takes pressure off of brick-and-mortar locations while giving patients more self-serve options to meet their needs.
- Telehealth Shaky for Serious Mental Illness: New research in JAMA Health Forum suggests that telehealth for serious mental illnesses might be leading to more visits, but not necessarily better care. The analysis of 120k Medicare beneficiaries with schizophrenia or bipolar disorder found that those at practices that went entirely virtual during the pandemic had 13% more visits than those at clinics that still relied on in-person care. Despite the heavier utilization, the telehealth group saw no improvement to medication adherence, hospital use, or mortality.
- Covera Lands $50M: Covera Health raised $50M in a Series C financing and simultaneously completed its acquisition of CoRead, an AI quality assurance company that’s developing generative AI to improve radiology performance. The Covera platform helps radiologists improve their accuracy and reduce misdiagnosis, and its Radiology Centers of Excellence help health plans and employers guide patients toward high-quality providers. CoRead’s tech is already being used by more than 2k US hospitals, and will now be folded into Covera’s platform.
- Chinese Medicine Heart Cure: A JAMA study found that Chinese medicine Tongxinluo significantly improves outcomes among patients with acute ST-segment elevation myocardial infarction (STEMI), carrying a list of ingredients that’s sure to raise Western eyebrows (plants, cockroach, scorpion, cicada, centipede, leech). Researchers randomized 3,777 patients to take either Tongxinluo or a placebo within 24 hours of STEMI, and as you might have guessed, the Tongxinluo group saw far fewer 30-day major adverse cardiac and cerebrovascular events (3.4% vs 5.2%). Our Cardiac Wire coverage has all the details.
- Beth Israel NY to Close in July: Mount Sinai Health proposed a July 12 closure date for its Beth Israel campus, a 799-bed teaching hospital in New York City. Beth Israel’s “unfortunate economic reality” is that it’s been running at under 25% capacity and is expected to incur $150M in losses this year. Mount Sinai expects the closure to be enough to ensure the continued operations of its other NYC facilities, including a new $140M behavioral health center.
- Online Experience User Demographics: A CDC report shows that over half of patients are now using the internet to find medical information, with four in 10 turning to online channels to communicate with doctors and look at test results. Women, White and Asian patients, and adults aged 30-44 were most likely to engage in online patient experiences, with a steady decline in usage as age increased from there.
- Emory + DrFirst: Emory Healthcare is tapping DrFirst to assist patients with medication adherence and cost barriers. The collaboration gives Emory access to DrFirst’s complete Fuzion platform that debuted at HLTH, which uses “clinical-grade AI” to streamline clinical workflows like medication reconciliation while offering analytics on drug fills, patient engagement, and improvement areas.
- NP Convicted in $200M Scheme: A Florida nurse practitioner was convicted for her role in a massive Medicare fraud scheme that involved over $200M in medically unnecessary genetic testing and durable medical equipment. The NP worked with over eight telemedicine and marketing companies to sign the fraudulent orders and personally pocket $1.6M, a decision that could turn into 75 years in prison after sentencing in December.
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