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Anthropic Is Aiming To Transform Healthcare—Here’s How
Anthropic is pushing Claude into prior authorization, medical records, drug discovery and global health. A physician explains what it means for doctors and patients.
FDA pilot offers generative AI medical devices a path to patients before they are authorized
AI products from Cadence and Limbic are among four devices recently accepted into the FDA’s TEMPO pilot that will allow digital health companies to release products without marketing authorization.
Reynolds is selling fruity new vapes unauthorized by FDA
The decision to move ahead with new products in the absence of FDA authorization could spur other big manufacturers to do the same, one tobacco-nicotine expert said.
An insider reveals the real goals of prior authorization
Years ago, Archelle Georgiou helped squash prior auths at one of America's biggest health insurers.
House committee advances radiology-backed legislation to curb prior authorization
The Improving Seniors’ Timely Access to Care Act seeks to streamline the “often cumbersome and time-consuming” task of approving requests for medical imaging in Medicare Advantage.
Executive Summary: A Patients’ Bill of Rights To Lower Health Care Costs
CAP’s plan would limit unjustified premium increases; reduce deductibles by reining in outlier hospital prices; and replace prior authorization with independent, evidence-based clinical review to lower health care costs and increase access to timely care.
Lung Association calls FDA nicotine pouch authorization 'another gamble with kids' health'
The FDA authorized four new flavored nicotine pouches, saying they may benefit adult tobacco users. The American Lung Association criticized the decision, warning it could increase youth nicotine use.
The board of directors of G5 Entertainment utilizes authorization of repurchase of own ordinary shares
The board of directors of G5 Entertainment AB (publ) (the “Company” or “G5 Entertainment”) has resolved to initiate repurchase of ordinary shares through authorization by the Annual General Meeting in the Company on June 15, 2026. The purpose with the authorization is to provide the Board with grea…
Need surgery or prescriptions? How to deal with prior authorization challenges
Prior authorization: Why insurers require approval for some drugs, tests and procedures.
Small Business Innovation Research (SBIR) 101: Following Re-Authorization, What Contractors (and Their Investors) Need to Know
On April 13, 2026, President Trump signed into law the Small Business Innovation and Economic Security Act, which reauthorized the Small Business Innovation Research (SBIR) and Small Business…
DOL Mental Health Parity Bulletin 2026: MHPAEA Compliance Best Practices
On September 8, 2026, the DOL's Employee Benefits Security Administration issued Field Assistance Bulletin No. 2026-03 to clarify MHPAEA compliance and nonquantitative treatment limitations. DOL enforcement will focus on blanket treatment exclusions, medical necessity/prior authorization processes, and network adequacy. Read our alert for a practical compliance roadmap.
Patients who fight health insurance denials often win
New data show how often insurers deny prior authorizations that can stall patients’ care — and how frequently those decisions get reversed.
Trump's FISA threat is like 'cutting off your nose to spite your face,' says Sen. Slotkin
Sen. Elissa Slotkin, D-Mich., says Trump's threat to block FISA reauthorization is like "cutting off your nose to spite your face."
Epic launches real-time prior authorization at four health systems
Real-time prior auth checks with United Healthcare, Network Health, Aetna, and other health insurers are being done through Epic’s API called Coverage Requirements Discovery.
UnitedHealthcare to cut prior authorization for 30% of services. Here's what to know.
As prior auth becomes an AI ‘arms race,’ Otter Health raises $8M for a different approach
Prior authorization has long been a source of friction between payers and providers, and now, with algorithmic tools for claims reviews and LLMs for appeals, it's evolved into an AI "arms race" as | The company built an AI-powered real-time clinical quality platform to better manage healthcare utilization by influencing care decisions rather than requiring clinicians to get permission for them.
Outcry after $1.15tn defense bill passes in the House
Donald Trump’s decision to attack Iran without first seeking congressional approval has sparked further controversy over the National Defense Authorization Act
Business briefs, July 27
New CMS voting memo sparks concerns over resident assistance in nursing homes … Initial jobless claims decline 22K week over week, falling to a seasonally adjusted tally of 187K … House Energy and Commerce Committee passes package to streamline Medicare Advantage prior authorization … 1 in 4 US workers sticking with a job strictly for health insurance … Fitch Ratings affirms Greenwood Village South at BBB-; outlook stable
Colorado Sues EarnIn For “Immoral, Unethical, Oppressive and Unscrupulous” Business Practices
Hey all, Jason here. When this hits your inbox, I should be en route to the airport — not to go anywhere myself, just to pick up my better half. I must admit, it’s been strange to be home alone (well, with two dogs) for two weeks! Really lets me “optimize” to spending more time on reading/writing/working, whether that’s healthy or not! Looking forward to getting back into a (somewhat) more balance routine. Subscribe or Support by Upgrading Compare Notes With the People Who Built Modern Fintech Partner content: Remitly CEO Sebastian Gunningham. Increase founder Darragh Buckley. Linda Du, Co-founder & President at Valon. They’ll unpack the decisions behind building and scaling major financial products: what they got right, what broke, what they would do differently, and how AI and new infrastructure are changing the operator playbook. Most events tell you where fintech is going. NerdCon puts the people who built the present in the room and asks them what comes next. Expect an operator-led conversation grounded in real products, real trade-offs and lessons earned the hard way. Fintech Business Weekly readers save 20% on Regular tickets with code FBW20 before standard pricing ends September 11. Meet the Builders Things To Know & Other Good Reads Advent and Stripe Abandon $50 Billion Pursuit of PayPal (Bloomberg) Trump Family’s New Crypto Bank Is Backed by Abu Dhabi Sheikh (Wall Street Journal) The multiplying risks of financing data centres (FT) Let the Bond Market Speak (Wall Street Journal) Did we waste a crisis? Modest proposals to reform deposit insurance. (Fintech Takes Banking) Untangling Guggenheim: How Private Credit Built Its Own Universe (Net Interest) The Hater’s Guide To Circular Financing — Part One (Ed Zitron) Fiat Ventures Rebrands to FGV Capital, Announces $35M Oversubscribed Fund II (BusinessWire) Socure Announces Strategic Growth Investment at $5.2B Valuation and Acquires Agentic Operations Platform Fravity (Socure) Listen: When Consumer Protection Disclosures Work Too Well (Consumer Finance Monitor Podcast) Colorado Sues EarnIn For “Immoral, Unethical, Oppressive and Unscrupulous” Business Practices When Andreessen Horowitz led EarnIn’s $39 million Series B in 2017, Alex Rampell, a partner at the storied venture capital firm, described EarnIn’s small-dollar advance product as “free,” relying on “entirely on voluntary contributions instead of fees.” Rampell favorably compared EarnIn’s approach to typical payday loans, writing, “Payday loans historically have had the potential to be a slippery slope for consumers into financial distress: opaque systems and steep fees that are hard to repay and set individuals back further than where they started. For many Americans living paycheck to paycheck, that kind of slide into debt can be extremely difficult to recover from.” But EarnIn’s product — which, the company says, isn’t a “loan,” legally speaking — ends up being anything but free for most users. While it is technically possible to take a no-fee advance from the company, most users incur “Lightning Speed” (instant funding) fees and/or ostensibly optional tips that combined can equate to annualized percent rates that can reach over 1,000%. With an average term of 9.77 days, even fees and tips that are small on an absolute dollar basis are equivalent to high APRs on an annualized basis. A lawsuit filed last week by Colorado Attorney General Phil Weiser against EarnIn describes the company and its product and business practices quite differently than Andreessen’s Rampell; “EarnIn’s business practices are unfair because they are immoral, unethical, oppressive and unscrupulous,” the complaint, filed in District Court in Denver, Colorado, says. EarnIn’s marquee product, Cash Out, isn’t a loan, the company says, as Cash Out is not “[f]orward [l]ooking” because “[t]he money is transferred based on earnings to date,” does not carry a mandatory fee to access funds, and is “non-recourse,” meaning EarnIn cannot pursue recovery from users who don’t repay advanced funds. EarnIn is sometimes referred to as an “Earned Wage Advance” service. Though, unlike some others in the broader category, EarnIn does not integrate with employers’ payroll or time and attendance systems. Rather, EarnIn attempts to verify a user’s income and employment, by examining direct deposit transaction data in their linked external bank account, by using GPS location and Bluetooth data to estimate a user’s time spent at work, if they work in a fixed location, and/or by having a user provided a work email address. While repayment is theoretically optional, as EarnIn would have no recourse, such as reporting non-payment to the credit bureaus or a collections agency, this is anything but clear to users of the EarnIn app, Colorado’s complaint argues. During the process of taking a Cash Out, users must agree to a preauthorized debit of the amount advanced, plus any expedited funding fee and/or tips. Though users technically can revoke this ACH authorization, the fact that they have this right isn’t presented to users during the Cash Out process, but rather is included in linked terms and conditions few users are likely to actually read. And users who do wish to revoke their ACH authorization must do so three or more days before the scheduled transaction date by emailing EarnIn’s customer support. Similarly, EarnIn’s marketing claims that it carries “no interest” and “no mandatory fees” is technically true, but is not the reality for many of the app’s users, the Colorado complaint argues. Further, EarnIn has extensively marketed to users the ability to “access your pay today,” to get “instant” funds, and to get funds “the same day you work” — when, in reality, this speed of access was only possible by paying the additional, undisclosed Lightning Speed fee. The Colorado complaint highlights this contradiction specifically, noting: EarnIn tells consumers that they can ‘Make any day payday with EarnIn’ and that there no ‘hidden’ or ‘mandatory fees.’ For a consumer to access their pay on the same day requested, they would have to pay the Lightning Speed fee. In the fine print of the advertisement EarnIn discloses that ‘[f]ees apply to use Lightning Speed,’ a direct contradiction to the larger text of the advertisement, and a fact that would not be immediately understood by a consumer as ‘Lightning Speed’ is not defined nor explained. Like other small-dollar lending services, rather than explicitly charge interest, EarnIn collects a markup on the optional Lighting Speed fee, which, given the nature of the transactions, many users opt for, as well as offering users the option to leave “tips.” EarnIn leverages either Real-Time Payments (RTP) rails or push-to-card via debit rails if a user opts for the optional Lightning Speed. But while these capabilities cost EarnIn, on average, $0.075 or $0.20 per transaction, respectively, EarnIn charges users significantly more. Initially, EarnIn charged as little as $1.99 for Cash Outs up to $24. But EarnIn has hiked these fees multiple times, and now charges $4.99 for Cash Outs up to $75 and $6.99 for those over $75. According to the Colorado complaint, EarnIn leverages “dark patterns” to manipulate users and to make it more difficult to avoid tipping. Examples of these “road blocks” highlighted in the complaint include: As of 2023, in the EarnIn app, a consumer attempting to get a loan under the default settings had to make at least eighteen separate taps to complete the transaction and reduce the tip to $0. There is an alternative method to leave a $0 tip, via the “Custom tip” feature, but EarnIn made this option difficult to access by visually deemphasizing it and positioning it near devices’ “home” button. Using language and imagery such as “Tip to pay it forward,” “Your generosity supports the service + helps,” “Your tips make a difference,” and “[t]he APR for this cash out is 0%. Your tips help support us.” While Lightning Speed and tipping are, in theory, both optional, in practice, users nearly always ended up paying something. According to the Colorado suit, users were charged either a tip or an expedite fee for more than 92% of transactions, with an average APR of nearly 388%. And, although the advances are “non-recourse,” EarnIn successfully collects on nearly all transactions — 99.18%, according to the complaint, which, Colorado argues, “demonstrat[es] that EarnIn’s advances function as high cost loans, not voluntary payments.” The share of EarnIn users incurring fees — despite the product being marketed as 0% APR — is hard to reconcile with Andreessen investor Rampell’s favorable description of EarnIn vs. “opaque systems and steep fees” associated with payday loans, which, Rampell says, can be “extremely difficult” for borrowers to extricate themselves from. According to Colorado’s suit, EarnIn’s Cash Out product “trapped many consumers in extreme cycles of high-cost reborrowing.” The suit gives an example of one consumer in the state, who took out a whopping 1,151 loans, paying a total of $4,038.50 in Lightning Speed expedited funding fees on loans that averaged the equivalent of 1,421% APR. Another Colorado user, the suit says, took out 1,033 loans, paying $8,561.22 in tips and fees at an average APR of 1,539% . These types of usage patterns demonstrate “the severe and repeated financial harm caused by EarnIn’s illegal lending model,” the Colorado complaint argues. In aggregate, from January 2023 through July 2025, EarnIn extended 3.1 million loans to 56,778 users in Colorado — an average of nearly 55 transactions per person during the time period. EarnIn lent more than $300 million and collected more than $16 million from Colorado users in Lightning Speed fees and in tips. Ultimately, the Colorado complaint argues that “EarnIn’s Cash Outs are loans under Colorado law, and EarnIn’s contention that its product is not a loan based on its disclaimer of any legal repayment obligation lacks any real-world significance given how the Cash Out transactions actually operate in practice.” Colorado further argues that “EarnIn was not working with companies here in providing consumers with funds but acted as a third-party lender and charged illegally high rates, used deceptive design strategies to extract some charges, and trapped consumers in repeat borrowing. Colorado will continue to stand up for consumers and hold companies accountable when they violate our credit laws or attempt to evade them through misleading practices.” Colorado’s suit alleges EarnIn assesses finance charge in excess of that permitted by Colorado law, that EarnIn failed to make legally required disclosures to Colorado borrowers, that EarnIn made supervised loans to consumers without obtaining the requisite license, that EarnIn violated the state’s Deferred Deposit Loan Act, that EarnIn engage in unfair and deceptive trade practices, and that EarnIn made false or misleading statements concerning price. The suit seeks a court order enjoining EarnIn from violating relevant Colorado laws, for EarnIn to refund amounts charged in excess of state law, fees, costs, and penalties, and other relief the court deems to be just. Fintech Business Weekly is made possible by the generous support of paying subscribers — bringing you independent analysis of banking, fintech, and crypto without fear or favor. You can support my work by becoming a paying subscriber if you aren’t already. Paying subscribers enjoy: access to the entire archive of nearly six years of newsletters extended versions of the weekly newsletter, with additional content and analysis and (for founding member tier) quarterly personal 1:1 fintech Q&A / strategy calls with me, tapping into my unparalleled knowledge of the intersection of banking and fintech and experience working in the sector, including helping to launch Goldman Sachs’ retail bank Marcus Support Fintech Business Weekly You can also support Fintech Business Weekly by sponsoring a newsletter or podcast, putting you in front of 93,000+ of the most influential decision makers in banking, fintech, and crypto. Learn more about sponsor opportunities or request a media kit by dropping me an email. Q2 Quarterly Banking Profile: Five Quick Takeaways The FDIC released its quarterly banking profile, which is always worth a read, for the second quarter. The profile provides an aggregate snapshot about the overall health of the 4,238 institutions whose deposits are insured by the FDIC, who, collectively, hold more than $26 trillion in assets and saw a total net income of more than $90 billion in the second quarter. Net income was up 12% vs. Q1 2026, with lower provisions and realized gains on securities helping to drive the improvement, somewhat offset by increases in non-interest expense and applicable income taxes. Overall net interest margin was basically flat quarter over quarter (up 1 basis point vs. Q1 2026), though community banks saw NIM grow by 10 basis points, to 3.81%. Unsurprisingly, given that interest rates haven’t changed, unrealized losses on securities changed little, edging up slightly to $326.7 billion vs. $325.1 billion in Q1 2026. Aggregate credit quality has remained benign, with asset quality actually improving slightly in Q2. Overall, institutions reported a 9 basis point decline in their past-due and non-accrual rate, to 1.44%. Net charge off rate also declined by 2 basis points, to 0.57%. And finally, the FDIC’s deposit insurance fund stands at $161.1 billion, making the DIF reserve ratio 1.48% — above the statutory minimum of 1.35%, but still below the designated target reserve ratio of 2%. [Paid Subscriber Exclusive] Nissan Withdraws ILC App, State Associations Plan BankChain Alliance, FDIC Defines “Unsafe or Unsound Practice” For First Time Automaker Nissan withdrew its application to charter a Utah industrial loan company and its corresponding application to the FDIC for deposit insurance last week, on August 19th. Nissan’s application had been outstanding for more than a year, as it originally applied in June 2025. Recent applications to the OCC to form national banks have been decisioned, one way or the other, substantially more quickly than has historically been the case.
Senate Democrats’ push to end Medicare prior authorization pilot fails
Sen. Patty Murray, D-Wash., vice chair of the Senate Appropriations Committee, had recently introduced a resolution to overturn the Wasteful and Inappropriate Service Reduction.
The Osmo Pocket 4 Is the First True Victim of the US Government's DJI Ban
The Osmo Pocket 4, a follow-up to the uber-popular Pocket 3, didn't get FCC authorization before DJI was added to its Covered List, so it won't be coming to the US anytime soon.
Newly Launched Initiative Strengthens Delaware’s Health Information Technology Infrastructure
The Delaware Department of Health and Social Services (DHSS) and the Delaware Health Care Commission today announced a new Rural Health Transformation Program (RHTP) initiative that will support real-time insurance verification and prior authorization across the state.
MICC highlights renewed small business innovation authority
The reauthorization of two federal small business innovation programs is expected to strengthen how the Mission and Installation Contracting Command delivers emerging technology, shortens procurement timelines and expands opportunities for industry partners supporting Army readiness. The Small Business Innovation and Economic Security Act of 2026, signed into law April 13, reauthorized the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs through Sept. 30, 2031. The action restored continuity to programs that experienced a lapse after the end of fiscal year 2025, placing some Phase I and Phase II efforts on hold.
Rep. Salinas introduces bill for first responder mental health grants
Oregon U.S. Rep. Andrea Salinas introduced the bipartisan Lifeline for First Responders Act to fund federal grants for firefighter, EMS and dispatcher mental health services via the Transportation Reauthorization Bill.
Watch: As AI Makes More Health Coverage Decisions, the Risks to Patients Grow
Major health insurers and even Medicare are using artificial intelligence to make coverage decisions. But class action lawsuits have accused insurers of using AI to wrongfully withhold treatment, and new research illuminates the risks.
Trump Tells Congress Why He Doesn’t Need Its Authorization for the Iran War
In letters to the House and Senate, the president asserted that the hostilities had “terminated,” in an apparent attempt to avoid having to seek congressional approval.
August Monthly Review: ChatGPT In Epic
Death, taxes, another frontier lab healthcare launch inspiring truly insane LinkedIn takes. As much as I want to stay away, I repeatedly am the crewman unplugging his ears whenever we pass these sirens. So it’s not the first and probably not the last time we dial up the typewriter rather than tie ourselves to the mast. The full blow-by-blow timeline: Health API Guy is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Subscribe The End of the Standalone PHR (Jan 8): ChatGPT Health arrives for consumers, at the time powered by b.well. I was bullish on the approach in that the best way for the PHR to finally solve distribution was to meet consumers were they already are (i.e. When Horizontal Meets Healthcare (Jan 9): OpenAI for Healthcare puts out the shingle for enterprises, with SharePoint ingestion standing in for the EHR integration the product actually needed. Another One: Anthropic’s Healthcare Debut (Jan 16): Claude's version, on HealthEx rails instead of b.well, with Agent Skills for FHIR development as the one true vertical-specific investment. ChatGPT for Clinicians: The Trap Sprung (Apr 24): OpenAI filled in the missing GTM middle with a free product for verified clinicians, effectively peeling the enterprise wrapper off ChatGPT for Healthcare and taking the PLG fight directly to OpenEvidence. OpenAI’s Second Attempt at Health (Jul 31): a relaunch of their patient specific app, now branded Health in ChatGPT, where the privacy partition came out, the connectors thinned, and b.well disappeared in favor of first-party FHIR work against a smaller network Beyond a Shingle So what was announced now? Today, we’re introducing a new electronic health record integration that brings authorized patient context from Epic into ChatGPT for Healthcare, along with the Healthcare Public Data plugin for direct, structured access to official healthcare datasets like PubMed, DailyMed, and CMS Coverage. Together, these capabilities bring ChatGPT closer to the systems and sources healthcare teams trust, while supporting the controls and compliance healthcare work requires. The core portfolio is unchanged from prior announcements we delineated and discussed (aside from the relaunch of patient-facing). Since trade publications still seem to be confusing them by using the wrong names: Enterprise sales motion: ChatGPT for Healthcare Protecting their core product / PLG: ChatGPT for Clinicians Consumer/patient-facing product: Health in ChatGPT So really, this is a feature release (specifically for ChatGPT for Healthcare when it comes to EHR integration). What’s cool about it, though, is that we are moving beyond just putting out a shingle. Everything in the January enterprise launch was horizontalizable: Horizontal tech companies thus generally start verticalization with their “putting out a shingle phase”. Telling the world you’re open for business as a horizontal tech company reliably attracts early inbound interest from buyers who are already trying to force-fit horizontal tools into domain-specific workflows and are eager for any signal that the vendor intends to support their use case more directly. Nothing was really vertical specific, which is exactly what you'd expect from the ultimate hypergrowth horizontal company dipping their toes into specific industries. But eventually you have to stop changing the sign on the door and start changing the product. Can you guess where the horizontal product was going to run out of road? This is the core dilemma writ large: verticalization requires differentiation, while scale economics of consumer and horizontal push toward unification. I’ve buried the lede so deep here it will be painful to some readers, but what should be shocking to no one is that my perspective is that EHR integration is the only path that meaningfully resolves this tension for ChatGPT for Healthcare. Integration with Microsoft Sharepoint is fine, but it is categorically insufficient for any product that hopes to influence clinical decision-making. SMART Money Well here we are, eight months later! Real vertical investment has begun, which surprised a few people. One friend in the industry messaged me: “Absolutely no way Epic gave ChatGPT API access.” Looking forensically at the announcements, the integration is notably read-only across appointment notes, laboratory results, medications, and specialist documentation. So while I’m not a betting man, I'd wager the house this is a SMART on FHIR launch: That sounds a lot like USCDI! The recommended path for the workflow they outline would be SMART on FHIR Their Health AI lead’s post is evocative of both standalone and EHR launch SMART, which another termed “ChartGPT” and “EHR Plugin” The implementation burden for SMART on FHIR is the lowest of the available integrative paths This is the team who literally did patient-facing SMART on FHIR with Epic last month Most importantly, if you’re a horizontal company, you generally still haven’t taken the full plunge and thus (overly) value reusability. SMART on FHIR is the logical compromise: healthcare-specific enough to matter, but standardized enough to reuse. Nobody Asked Judy Another friend asked “I thought they had to go to each health system, or did they go direct to Epic and now health systems opt in?” Given the trust paradigms in healthcare, this functionally cannot be Epic hoovering up all the data for OpenAI and shoving ChatGPT in their customers’ faces (or they would revolt). However, I do believe the aforementioned terrible coverage by TechCrunch and other outlets is probably responsible for that question, given the 325 million reference. When using FHIR as a business associate to an Epic customer, there is no EHR gatekeeping to speak of, as that isn’t how fhir.epic.com works: You register an app You pick your APIs You test against the sandbox APIs You list as “Ready for Production” Hospitals pick your app You test and go live with them Bluntly, nobody had to say yes or no in Verona (nor were they given the chance). Vendor Services (their next developer tier up that I doubt OpenAI is using quite yet in this initial release) certainly has contractual paperwork that some resent, but even there, the twin pressures of mounting antitrust and information blocking make outright gatekeeping increasingly fraught. My friend’s sentiment is, to me, representative of a broader industry neurosis, perhaps a sort of scar tissue of prior eras: people assume the gate is still there and never actually try the door. There are certainly other ways Epic (and any EHR) can put its thumb on the scale, but they are not so dumb as to stand in front of a federally mandated API and play bouncer at this exact moment in time. So I think they can and probably should go deeper, as this release is at best parity and at worst behind vertical-specific competition. OpenEvidence did a basic SMART launch with Sutter Health in February, allowing for more convenient evidence search by providers. They then add patient-context (the equivalent SMART on FHIR flow to what we see here) when Cedars-Sinai went enterprise-wide in May. UpToDate has four distinct applications across deeper workflows like patient engagement listed in Epic Showroom and announced a partnership with Epic to power Art at UGM Abridge and other ambient scribes have invested deeply into the deepest bidirectional clinical copilot workflow with integrations well beyond SMART on FHIR. In that light, the “Who is OpenAI primarily targeting here?” is clear. This release brings them into striking distance of OpenEvidence, but not the others quite yet. They are the only one of the three you can reach without building something truly Epic-specific. When will they go further? Competition is a great motivator to overcome the horizontal demons and start building things that can’t be reused: not across industries, not across EHRs, maybe not past the customer you built them for. That’s the price of actually verticalizing. The question is if and when OpenAI will be willing to pay it. Month in Review Here is the monthly review. As a reminder, this is a regular round-up of the month’s posts and other content to surface things you may have missed across regulation, litigation, interoperability, and beyond. AI assistance is used in these bullet summaries so I can focus on articles. Articles Published: None this month Video Content: The Information Exchange: Standards-based Thruple Edition (Aug 14): Back to school for us too, with Brad reporting in from the CMS Health Tech Ecosystem’s one year anniversary in DC. We get into the January CMS-0057 deadline, the fall rulemaking reading list, and why enrollment still keeps most apps off FHIR. The Information Exchange: Epic Dúnadan Edition (Aug 25): A UGM roundup with Ryan Brickner joining for the first time to check our takes against what the building actually thinks. Rangers, Ergo sitting on top of EHI, and a down-market lineup that needs some cuts. Regulatory: Stacked Deck, Bad Hand (Aug 05): ONC’s website refresh took the entire HIT Policy Committee record with it, so I rebuilt the archive and went looking for the regulatory capture story everyone assumes is buried in there. Stacking the deck and winning the hand turn out to be very different things. The Sixth Generation of Patient Access (Aug 19): A quick catalog of the five generations of patient access we’ve layered on since HIPAA, and the two candidates now competing to be the sixth. One is planned. The other is the market routing around the plan entirely. Court cases: Three Cases Walk Into a Docket (Aug 06): Two surprise settlements cleared the board in a single week, and then Judge Maddox dropped ninety-four pages on Vyne v. Henry Schein. The sleeper is a DMCA holding that makes direct-to-database a considerably riskier business model. Epic v. Health Gorilla: Into the MDL (Aug 10): Nine class actions are headed to Miami, and the Panel signaled it wants to bring the case that spawned them along too. That would leave Epic arguing the requests were obviously fraudulent in one courtroom and unknowable in the other. Amazon v. Perplexity: Agents Are Legalized! (Aug 11): The Ninth Circuit vacated the injunction against Comet, holding that the user is the one accessing the servers rather than the company that built the agent. A real win for agentic access, and a much narrower one than the headline suggests. Veeva v. Epic: Come At Me, Bro (Aug 26): Epic’s response brief wants the dismissal affirmed and, unusually, wants the opinion published as precedent. Buried in it is Epic’s own description of what its non-competes actually prohibit, which current and former employees should read closely. EHRs: The Contract Epic Would Never Sign Today (Aug 04): A 1999 SEC exhibit catches Epic licensing nearly its entire product line, Tapestry included, to the company that became TriZetto. The marketing services menu attached to it is the part that will make you blink. Forecast from Verona (Aug 07): The Epic Almanac makes one argument six different ways: the AI is only as good as the networks behind it. Emmie headlines, Art’s context stack is the most ambitious part, and Penny finally gets an autonomous coding date on the calendar. Works With Epic MyChart (Aug 17): Epic’s first new Showroom category since the death of Workshop certifies hardware instead of software, badge on the box and all. Made for iPhone, but for blood pressure cuffs, and rough news for anyone selling the RPM stack sitting in between. UGM Hot Takes 2026 (Aug 20): Everyone else covered the AI announcements, so I went after Savvy deleting the payment gateway, Rangers as Boost with the timer removed, and a down-market lineup with too many entries. Plus the Health Grid tidbits I cannot help myself on. MyChart Central Grows Up (Aug 24): Device data and Emmie turn Epic’s identity hub into a full consumer platform, which is both a logical answer to ChatGPT and a bit of a mistake. It also happens to be the best scraping target Epic has ever shipped. Industry Analysis: The Wrong Yardstick (Aug 12): Vertical software keeps getting judged against Superhuman and Notion, which is the wrong bar entirely. Your user is comparing your product to a whiteboard and forty phone calls before lunch. Primitives vs. Abstractions (Aug 27): Developers want building blocks, systems of record prefer to hand out business logic, and both sides have a real case. There’s no test from the outside that separates the engineering reason from the competitive one, which is why this keeps ending up in court. Cross-industry Comparisons: The Two Kinds of Platform Power (Aug 18): Attention power and record power are different problems that keep getting handed the same regulatory toolkit. Congress’s latest swing at Big Tech shows both what’s possible and where it falls apart. The Dogs of (Platform) War (Aug 21): A CourtListener alert turned up a property management fight with healthcare’s exact shape and none of the Cures Act. Shell prospects, ghost accounts, a notetaker bot that came back to haunt someone, and a lawyer arguing both sides of the same theory in two states. Fractals All the Way Down (Aug 31): Yardi dominates property management right up until you zoom into one segment, where AppFolio owns it outright and Yardi doesn’t appear at all. Where you draw the line around a B2B software market is about to decide an awful lot of cases. Other News: If Judy Had the Courage (Aug 13): A short eulogy for the era when software was allowed to look insane: WinAMP, bold colors, and everything the grey chatbot era has taken from us. External Media: Portland Monthly Health Tech Meetup: Erin O’Brien channeled my own feelings - maybe it’s just because it’s August and beautiful, but the monthly edition of the PDX Health community meetup was a ripper. Make sure to reach out if interested to join for the next one. STAT’s Coverage of Epic This Month: Brittany Trang of STAT did a fantastic job of breaking the FTC investigation that’s been lurking, as well as UGM related coverage, so I had to give her her wish of a meme. Fall Conferences: I’m pumped to be kicking off my fall conference season in NYC at Nabla Accelerate next month, which Chrissy provided the link to apply for. Here’s the rest of my schedule in case you want to meet up: Commonwell (Redwood Shores, CA): Oct 13-14 Open@Epic (Madison, WI): Oct 21-22 eHealthExchange (Austin, TX): Oct 27 Sequoia Project (Austin, TX): Oct 28-29 HLTH (Vegas): Nov 15-18 RSNA (Chicago): Nov 29-Dec 3 Posts I Liked: HTI-6 Should Unbundle API Certification: Josh Mandel makes the case that HTI-6 should split (g)(10) into separate authorization and data certifications, so a PACS or a genomics platform can certify only the role it actually performs. Imaging is the urgent example, but the structure solves a much bigger problem. On implementing ePrior Auth with Epic: Scott Rossignol’s field notes from a live ePrior Auth build on Epic, including the two app registrations nobody warns you about and the CPT mapping problem waiting at the end. CMS-0057 implementations are going to be such a beast. Healthcare point solutions are starting to look a lot like streaming services: Spencer Dorn runs the cable-to-streaming arc against health IT and lands squarely on the bundling half of the cycle. Bundling can be good! It can also be bad! Life is nuanced. Health API Guy is a reader-supported publication. To receive new posts and support my work, consider becoming a free or paid subscriber. Subscribe
Mozambique strengthens regulation of medicines and imported vaccines, boosting health protection
Mozambique has reached a major milestone in strengthening the regulation of medicines and imported vaccines, with its national regulatory authority recognized by the World Health Organization (WHO) as having a stable, well-functioning and integrated regulatory system.The Autoridade Nacional Reguladora de Medicamentos de Moçambique (ANARME) has achieved Maturity Level 3 (ML3) for the regulation of medicines and imported vaccines under WHO’s global classification of national regulatory authorities.Mozambique becomes the 10th country in Africa to reach ML3, joining Egypt, Ethiopia, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania and Zimbabwe and marking further momentum in strengthening regulatory systems across the region.For people in Mozambique, stronger regulation means greater assurance that medicines and vaccines are appropriately evaluated for quality, safety and efficacy and monitored throughout their lifecycle. It also strengthens the country’s ability to identify and respond to safety concerns and substandard or falsified products, while supporting timely access to quality-assured health products.“Mozambique’s achievement is the result of sustained investment in regulatory capacity that will deliver crucial benefits for public health,” said Dr Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data. “Strong regulatory systems protect people, build confidence in health products and help countries respond more effectively to evolving public health needs and challenges. Mozambique’s progress also contributes to advancing regulatory capacity across Africa and promoting more equitable access to safe and quality-assured medicines and vaccines.”Building a stronger regulatory systemMozambique’s achievement follows years of sustained efforts to build the institutions and capabilities needed for effective regulation.WHO worked closely with ANARME throughout this process, assessing the national regulatory system and supporting the authority in addressing identified gaps and strengthening priority areas.WHO evaluates national regulatory systems using its Global Benchmarking Tool (GBT), which assesses the regulatory functions required to ensure the quality, safety and efficacy of medical products. These include registration and marketing authorization, licensing, market surveillance and control, pharmacovigilance, regulatory inspection, laboratory testing and oversight of clinical trials, as applicable. WHO’s maturity levels range from 1 to 4. Reaching ML3 confirms a stable, well-functioning and integrated regulatory system, while ML4 represents an advanced system focused on continuous improvement.Benefits for Mozambique and the African continentAn ML3 regulatory system can support more timely and predictable regulatory decisions, reinforce safety monitoring and help ensure that health products entering and remaining on the market meet appropriate standards.It also creates greater opportunities for regulatory cooperation and reliance – approaches that help authorities make use of the work and decisions of trusted regulators, reduce unnecessary duplication and allocate limited resources more efficiently, while maintaining rigorous standards for quality, safety and efficacy.As the first Portuguese-speaking country in Africa to reach ML3, Mozambique’s experience can also contribute to strengthening regulatory systems and fostering greater cooperation, knowledge sharing and reliance among Portuguese-speaking countries and across the African continent. Its achievement further reinforces a more connected African regulatory ecosystem, providing a solid foundation on which the newly established African Medicines Agency can build to advance regulatory convergence and cooperation across the region.Strengthening confidence in regulatory recognitionMozambique’s achievement comes as WHO strengthens the process through which the performance of national regulatory systems is recognized.The newly established Technical Advisory Group on Regulatory Systems Strengthening (TAG-RSS) brings together independent international experts to advise WHO on whether recommendations concerning regulatory authorities reaching ML3 and ML4 and WHO-Listed Authorities, are supported by the findings of WHO evaluation processes. Its recommendations provide an additional level of independent assurance, strengthening the impartiality, transparency and credibility of WHO’s recognition process.Mozambique is among the first countries to achieve ML3 following consideration and recommendation by the TAG-RSS. As part of the same TAG-RSS process, South Africa was recommended to retain its ML3 status for the regulation of vaccines manufactured, imported or distributed in the country, following an additional WHO assessment. This extends the recognition first granted in 2022 and underscores the sustained performance of the South African Health Products Regulatory Authority (SAHPRA).The two recognitions highlight continued progress in strengthening regulatory systems across Africa, as well as the importance of continued performance, improvement and assessment in sustaining regulatory maturity.WHO will continue working with ANARME and SAHPRA to sustain these gains and support continuous improvement as science, technologies and public health needs evolve.
New Trump proposal would require tax filers to disclose citizenship status to IRS
The Trump administration would require U.S. taxpayers to disclose their citizenship and work authorization status to the IRS as part of a proposed change to the annual tax form that nearly all workers file each year.
The politics of Trump's ballroom
WEST PALM BEACH, Florida — President Trump was about a half-hour into his second speech of the day, musing about the danger he faced last week at the White House Correspondents’ Dinner. “Saturday night, it was good for one thing. People are loving my ballroom now,” Trump told a crowd last night. “That’s the only thing. They love my ballroom.” Ever since he was hustled off stage at the Washington Hilton last week, after an attempted shooter breached the dinner’s security perimeter and sent guests diving to the floor, the president has argued that the incident is proof for why his White House ballroom is needed. Only his planned $400 million, 90,000-square-foot project, Trump has reasoned, can keep a president truly safe at major events. It’s true that a bunch of GOP lawmakers have jumped on board with new legislation and words of support for Trump’s project. House Speaker Mike Johnson, Sen. Rand Paul and other prominent Republicans went on TV to talk about the need for a ballroom. But as we reported at The Washington Post this week, “people” aren’t really changing their minds on Trump’s ballroom. A new Post-ABC News-Ipsos poll found that most Americans still oppose the ballroom project: 56 percent against it versus 28 percent in favor. The numbers are the same as a poll from last year, the Post’s polling whiz Scott Clement found. Other new polls have found similar margins, too. “I’m just not a giant fan, especially of extravagance,” one independent voter told me. “I mean, in the era we’re in right now, given how much people are struggling, it just doesn’t make a lot of sense to me to spend $400 million on a ballroom.” How we got here The Washington Post has followed Trump’s ballroom project very closely. (My colleague Jonathan Edwards may have written the most total words of any reporter about the project; I may be second.) The project exploded as a national issue after Trump tore down the White House’s East Wing after initially promising not to touch it.1 Historic preservationists sued, and about a month ago, a federal judge ordered a halt to ballroom construction.2 The only way the ballroom could proceed, U.S. District Judge Richard Leon ruled, was if Congress explicitly authorized Trump’s plans. (An appeals court has stayed Leon’s order for now.) The judge’s ruling raised an obvious question: would Congress authorize the project? Keep in mind, “authorization” doesn’t mean that Congress needs to necessarily fund the planned $400 million project; they could just sign off on the private donations that Trump has solicited to pay for the ballroom.3 But GOP lawmakers really didn’t want to talk about the ballroom, we reported at The Post just a few weeks ago. One major reason was the ballroom’s bad polling — not a small detail with many of their own midterm elections looming. The White House Correspondents’ Dinner incident, and Trump’s advocacy, may have changed the political conversation around the ballroom. As this week’s polling shows, it doesn’t seem to have affected the fundamental questions surrounding the project. To put it another way, voters still say that cost-of-living concerns are top-of-mind heading into the midterms. Some Republican and independent voters have told me that they see the ballroom as a vanity project that will help Trump but do nothing for their own lives. It might not help Republicans that Trump has dismissed some of the cost-of-living concerns. He’s described “affordability” as a buzzword manufactured by Democrats whose policies helped cause inflation. “They’ve got one good line of bullshit,” Trump said in his first speech yesterday, delivered at a Florida retirement community known as The Villages. Thanks for reading Dan Diamond's newsletter! Subscribe for free to stay up-to-date on my work. Subscribe Speaking of Trump’s speeches… I’m down in Florida because it’s my “duty week” as a White House reporter — basically, I follow the president wherever he goes. (And then hand the baton off to one of my Washington Post colleagues next week.) As part of my duty week, I’ve spent a few days covering the White House’s reaction to Saturday’s attempted shooting, including officials’ review of the security protocols to protect the president. Trump was restrained in the wake of the incident, addressing the nation from the White House briefing room about the need for peaceful dialogue and trying to lower the temperature. But he’s clearly been itching to get back out of the White House, and I was curious to hear how his Florida speeches would go. And — to my ears — it was an unburdened Trump. Not the one we saw Saturday night in the White House briefing room, but the one we witnessed on the campaign trail in 2024. Loose, dropping profanities, mocking everyone, including members of his team. “We have a man here who knows more about Medicaid, Medicare, medical crap than any human being. Where’s Dr. Oz? Where the hell are you, stand up,” Trump said, referring to Mehmet Oz, the administrator of the Centers for Medicare and Medicaid Services. “It’s the most boring trip I’ve ever made. He’s telling me about Medicare, Medicaid. All I want to do is take care of you, I don’t care. I said, ‘You work out the details.’” I wrote up the speech, as Trump headed to West Palm Beach to deliver more remarks a few hours later. The White House didn’t like my story. Their rapid-response team called it the work of a “total loser”4 and “a miserable TDS-ridden moron.” You can be the judge of whether it’s a fair story or the product of someone afflicted with “TDS.” (The White House’s shorthand for “Trump Derangement Syndrome.”) I’ve pasted the story below with a gift link, meaning that you don’t need to be a Washington Post subscriber to read it. It might prompt you for an email address, though. Meanwhile, I’ll be down in Florida for the rest of the weekend, covering the president. It’s TBD whether those stories will be deemed TDS-afflicted, too. 1 Jonathan details the past six months of ballroom fallout, reactions and the implications for executive authority here. I also had a great time talking about Trump’s ballroom and other projects with Australia’s ABC News Daily on a podcast this week. 2 The judge allowed underground construction and national security-related work to continue. But that hasn’t been enough for Trump, who says the ballroom itself is essential for his protection. 3 The ballroom donors include companies like Palantir, Google and Amazon. For transparency, Amazon founder Jeff Bezos owns The Washington Post, where I work. No one has ever interfered with our team’s coverage of the ballroom or our mentions of Amazon or Bezos, and if that changed, I’d speak out. 4 To be fair, I’ve spent the morning working on stories and writing this Substack post rather than enjoying the beautiful Florida weather. So they may be onto something about who’s winning and who’s losing.
Lobbying Update: $340,000 of LIVE NATION ENTERTAINMENT INC. lobbying was just disclosed
$340,000 of LIVE NATION ENTERTAINMENT INC. lobbying was just disclosed, from Q2 of 2026, in a new Lobbying Disclosure Act filing.This included lobbying on issues like:"Issues related to FAA Reauthorization Act of 2024 (PL 118-63), including drone issues. Issues related to drones in H.R.5061 - Counter-UAS Authority Security, Safety, and Reauthorization Act. Issues related to drones in National Defense Authorization Act for Fiscal Year 2026 (PL 119
OU Health alerts patients after data breach involving former employee
OU Health has informed patients about a data breach after a former employee accessed sensitive medical records without authorization over several months.
Medicine goes global: How international students break into pre-health fields
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UnitedHealth, CVS standardize prior authorization rules
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Major US health provider drops prior authorization for 30% of services — and 93% of doctors say it's long overdue
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Grad Students, Academic Workers Rally at Science Center as HGSU-UAW Sets Strike Authorization Vote
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Medicare delays prior authorization pilot program for key interventional radiology service
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House Again Thwarts Bid to Halt Iran War Unless Congress Approves It
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RxLogic and Epidaurus Health Bring Automated Prior Authorization Live on an Independent Adjudication Platform
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Medicare Advantage plans denied prior authorization requests at unusually high rates, HHS report finds
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Insurer reviews get an automation boost
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Business declares war on Pentagon stock buyback, dividend restrictions moving in Senate
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Dua Lipa Sues Samsung for $15 Million After Company Refuses to Remove Her Photo From TV Boxes
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House committee votes to halt prior authorization pilot impacting radiology services
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House approves short-term extension of key surveillance law after dealing GOP leadership pair of floor defeats
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Epic debuts instant prior authorization checks at 4 health systems
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What has AI done for healthcare administration lately?
Administrative AI can meaningfully cut providers’ price tags on prior authorization processes. Yet the technology adds to billing intensity, inflating medical spending as it does so.
FDA's Draft MDUFA VI Commitment Letter: What It Means for AI and Digital Health
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MICC highlights renewed small business innovation authority
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Lobbying Update: $17,000 of SCIENCE APPLICATIONS INTERNATIONAL CORPORATION lobbying was just disclosed
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Trump administration’s proposed rule would limit some immigrants’ ability to legally work in the U.S.
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The Cigna Group, Leading Health Plans Advance Work to Simplify Prior Authorization
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U.S. Health Insurers Step Up Prior Authorization Reforms
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Reauthorization of Small Business Innovation Research and Technology T
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US health insurers advance measures to standardize prior authorization requirements
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NC families fear losing access to autism therapy as new rules take effect
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Are Health Insurance Companies the Reason for Our Health System’s Ills?
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Is CVS Health (CVS) Cheap As Renewables And Cancer Care Expansion Lift Optimism?
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U.S. Debt Smashes Through Unthinkable Milestone. Can It Be Stopped? | WSJ Politics Newsletter for May 1
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Small Business Report
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Can AI solve our mental health access problem?
Last week I asked you what worries you most about AI in health. It was close, but your top answer was “AI giving bad health advice.” Last week’s poll results: You’re in good company. This concern was top of mind at a conference I joined at Stanford last week, where researchers, clinicians, and people who build AI systems spent a day debating trust and safety in health AI. Stepping back, I’m also hearing your emerging concerns about AI’s impact on our well-being generally. I see this as a matter of public health, and we’ll take it in pieces as we learn together. Today we’ll focus on AI chatbots used for therapy for mental health. Early this month, Governor Newsom vetoed Senate Bill 903, California’s most ambitious attempt to regulate AI use for mental health. It’s at the center of active debate, and raises the questions patients, family members, citizens, and voters will face as AI moves deeper into health care. Let’s work through it. What is “AI-based therapy”? It’s really two things: purpose-built mental health apps designed to deliver structured support, and general chatbots like ChatGPT, Claude, and Gemini that people increasingly use for emotional support—even if they weren’t built for it. Spoiler alert: I don’t know whether the shift toward AI therapy is good or bad. The evidence isn’t there yet. But I do know it’s already happening, and I have some ideas about how we can roll it out with safety in mind. The therapy dilemma, in a nutshell Mental health challenges are common, and strain health and well-being across populations. Therapy (interactive dialogue with a trained, empathetic practitioner) helps many people heal. The demand for licensed therapists far exceeds the supply in California, and AI-based therapy can narrow that gap. AI-based therapy remains novel, unproven, and not well tested. Right off the bat, we can see we’re dealing with trade-offs here. Since the main driver of demand for therapy from a robot is lack of access to therapy from a human, we’ll start there. It’s too hard to find and afford a human therapist California is short roughly 55,000 licensed, non-prescribing therapists and counselors, about 40% of what we need. Psychiatrists, who rely on talk therapy as a complement to prescribed medications, are even more scarce. Eight counties have none, and density ranges from 1.7 per 100,000 residents in San Benito County, to 68.1 in Marin County. My wife is a psychiatrist in Marin, and even here access is tight. If it’s hard in the best-supplied county, imagine rural Sierra County, or the San Joaquin Valley. In 2024, more than half of Californians who tried to make a mental health appointment struggled to find a provider who took their insurance, compared with 14% for physical health care. When Senate staff posed as “secret shopper” patients and called 120 mental health providers in Medicare Advantage networks, they landed an appointment less than once for every five tries. Insurers pay behavioral health clinicians about 22% less than medical and surgical clinicians for comparable office visits. On top of that, billing denials and prior authorizations hit hardest at the solo and small practices common in mental health. Psychiatrists opt out of Medicare at the highest rate of any specialty. In many places, a cash practice for therapy fills quickly with patients paying $250 or more an hour, with no insurance paperwork at all. Families who can pay cash find providers more easily. Those who rely on insurance, including Medi-Cal enrollees, older adults, rural residents, and non-English speakers, compete for what’s left. So we can’t pretend the human system works, and we can’t blame people for turning to AI for support when they’re in distress. AI is filling the gap It’s estimated that roughly a quarter of AI users use it for mental health support. If you have internet, it’s available 24/7, it’s cheap, and it speaks your language. Uninsured adults are about twice as likely as insured adults to do it (30% vs. 14%). It feels anonymous in ways that may enable people to ask things they’re unsure or embarrassed about. The largely hidden, personal use makes it hard to study whether it’s actually helping people with their mental health issues, but researchers are trying. Does AI therapy work? A 2026 analysis of nearly 40 randomized trials found chatbots showed a real but small reduction in depression symptoms. But most of these trials were compared to an alternative of no therapy, not a human therapist. So the benefit of AI therapy is probably real, but modest, and mostly untested against the alternative of human contact. We need more studies. Serious concerns OpenAI’s own estimate is that more than a million ChatGPT users each week show signs of suicidal planning or intent. These are high stakes encounters, and AI doesn’t always get it right. That’s partly because a chatbot can sound like a therapist, but it has no license, no duty of care, and it’s not clear who to hold accountable when it gets things wrong. AI is also designed to help users in whatever task they’re seeking to accomplish. People may feel like they’re getting therapy, but they’re mainly getting a convincing conversation. It’s easy for an AI companion to wander into gray areas, like playing along with “creative writing” that may be about the user’s own suicidal intent. Courts are driving safety conversations A wave of lawsuits have been filed on behalf of families claiming that chatbots pushed people they loved toward self-harm, including teens who died by suicide. The first settlements came this year. OpenAI is headquartered in San Francisco, and dozens of cases alleging that ChatGPT drove users to suicide or self-harm are now before a San Francisco judge. Character.ai has filed for bankruptcy after several states brought lawsuits accusing the chatbot of pushing dangerous content to kids. But the technology seems to be improving. Last month, an independent evaluation found that newer AI models “almost never endorse suicide.” That’s progress, but our societal appetite for even one preventable death is very low. So how do we move forward? Finding a middle ground Earlier this month the governor vetoed Senate Bill 903, a bill designed to place guardrails on the use of AI for therapy. The bill would have prohibited any AI-based platform from being advertised as psychotherapy, and would have required a licensed professional to review and approve each encounter where AI was used to support therapeutic decisions. Newsom called it overly broad, since even routine screening questions would have needed clinician sign-off. Knowing we’re already short on mental health providers, requiring human review of AI encounters may not relieve our access problems. Still, the answer isn’t no oversight. Here’s one feasible short term solution. Rather than reviewing each encounter, a licensed clinician can design the guardrails: what counts as a crisis, what triggers an immediate handoff to a human, and what gets sampled for audit each month. The AI runs inside that structure. Conversations get checked, failures get reported, and a real clinician owns the framework. Medicine already has models to learn from. The FDA process for rolling out newly approved medications is an example. After a product reaches patients, we keep watching for adverse events. Patient-facing AI needs the same “digital pharmacovigilance”: systematic tracking of harms, near misses, and the types of groups that get hurt and why. It’s also critical that users know that they can reach a human if they’re in crisis. Most chatbots now include messages like these: Bottom line The rush to use unproven AI tools for mental health support is mostly a workaround, a sign of a health system people can’t get into. We need better access to proven care from licensed clinicians. That takes reimbursement that makes accepting insurance viable, and a bigger workforce. But, built and tested well, AI could be part of the answer. It could be the 2 a.m. check-in when no one else is awake, or a way for patients to practice skills their therapist taught them. It could be the first step to get someone the right level of care, and take paperwork off clinicians’ plates so they spend more time with patients. None of this is simple. The SB 903 veto doesn’t end the debate, and the legislature will be back. In the meantime, those of us using these tools need to stay informed, ask hard questions, and hold the companies building them accountable. I’ll try to do my part, and we’ll keep learning together. Love,Matt P.S. If you or someone you know is struggling with mental health challenges, emotional distress, substance use problems, or just needs to talk, call or text 988- you’ll reach a real person— or chat at 988lifeline.org 24/7. Dr. Matt Willis is the author of Your Local Epidemiologist in California. A California native, he’s served as a primary care physician, CDC epidemiologist, and public health officer for Marin County, where he guided the pandemic response. He lives in Marin with his family and their dogs, Teddy and Ramona. Thank you Cynthia He, MD, PhD, and Parnika Saxena, MD, for their guidance in preparing this article. Cynthia works in an outpatient mental health clinic, treating patients who have Medi-Cal or, sometimes, no insurance. Parnika works in an inpatient psychiatric unit, treating patients with public or private insurance or self-pay ability. All opinions are their own and do not represent their employers.
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