Category: Digital Health & Technology

  • STAT+: FDA spells out 2027 AI guidance plans

    STAT+: FDA spells out 2027 AI guidance plans

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    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

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    1. Health Tech Correspondent

      Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

  • Opinion: I’m a doctor. Here’s what I want the public to know about AI tools and health care costs

    Opinion: I’m a doctor. Here’s what I want the public to know about AI tools and health care costs

    When Blue Cross Blue Shield recently published research suggesting that hospitals use artificial intelligence tools to extract more money from insurers without providing additional care, people were mad. Amid growing concerns about AI, one glimmer of hope has been its potential to improve health — and yet, here it was: inflating health care costs without yielding any benefits.

    As a doctor who has used the kinds of tools being criticized, I’m frustrated, too: We can document honestly and still wind up inflating hospital bills. This is because comorbidities function as an on-off switch with respect to billing, even though they affect patient care in nuanced ways.

    Although the problem warrants a systemic fix, the best short-term solution is for hospitals to create more nuanced documentation tools, and for clinicians to exercise judgment when using them.

    What did the research show?

    BCBS suggested hospitals are using automated tools to document secondary diagnoses — like anemia, malnutrition, and low sodium — which allow them to charge more for caring for these patients.

    For instance, a patient might be admitted for diverticulitis (primary diagnosis), but found on post-op labs to have acute blood-loss anemia (secondary diagnosis). Hospitals can use these secondary diagnoses to label a patient as having a comorbidity or a complication, allowing them to bill more for the hospitalization, whether or not they treated the patient’s anemia. These “bump codes” have cost BCBS hundreds of millions of dollars over the past two years, and these costs are presumably passed along to patients in the form of higher premiums.

    BCBS claims that bump coding has become more widespread because hospitals are using AI tools to identify secondary diagnoses. Automated tools can skim a patient’s chart and prompt physicians to document that the patient is, for instance, anemic, and what they are doing about it.

    Are doctors to blame?

    A few weeks after I started medical residency, I began getting emails from hospital administrators I had never met, whose signatures said they were risk adjustment specialists. The emails were generic and polite, advising me to review clinical documentation integrity (CDI) queries on inpatients I was caring for. If I didn’t respond quickly, the request would be forwarded to the attending physician supervising me. A typical CDI query would point out that my note hadn’t commented on, say, a patient’s low sodium level, and would ask me to document that they had low sodium and what (if anything) we were doing about it.

    Like most residents, I was already spending far more time on my computer than I was with my patients. Soon, CDI queries streamed into my inbox with such regularity that I turned to a more senior doctor to ask how I might stave them off. That doctor showed me an automated tool that I could include in my notes. This tool would assess a patient’s lab results, automatically detect any additional diagnoses a patient had (like anemia, malnutrition, or low sodium), and prompt me to specify whether we were monitoring, evaluating, or treating.

    I assumed it was lucrative to the hospital for me to document these diagnoses (why else would they be paying risk adjustment specialists to email me about them?), but we almost always were at least monitoring the secondary diagnosis in question, and I accurately documented as much.

    Including this tool’s outputs in my notes kept the risk adjustment specialists from hounding me and won me back several minutes of each day — enough time to poke my head into a patient’s room before I went home, or call a patient’s family member to give a quick update. I always answered the questions included in my tool honestly, but in the back of my mind, I wondered whether I was doing my patients a disservice: Was I inflating the cost of their hospitalizations without actually improving their care?

    Where bump codes come from

    In general, hospitals are reimbursed for hospitalizing patients on the basis of diagnosis-related groups, or DRGs. DRG payments are set by the Centers for Medicare and Medicaid Services by analyzing claims data. (Medicare uses DRGs to set payments, while many commercial insurers, including BCBS, use the DRG system to negotiate reimbursement rates with hospitals.) Let’s say a patient is admitted with diverticulitis requiring surgery (typically billed as DRG 331 if there are no complications). CMS has estimated how much it usually costs to care for one of these patients and insurers prospectively pay hospitals on that basis; a hospital generally won’t get reimbursed more for keeping the patient longer, administering more drugs, placing more IVs, and so on.

    However, some hospitals care for sicker patients than others. The typical diverticulitis patient at a tertiary medical center in a poor area will require more support than a diverticulitis patient at a community hospital in an affluent area. The government does not want to penalize hospitals that see more complex patients, and so it allows hospitals to seek additional reimbursement forcomorbidities or complications that increase the cost of their care.

    This is where bump codes come from: Hospitals can bill more complex diverticulitis admissions as DRG 330, which is reimbursed at a higher rate. Not all comorbidities or complications count: In 2007, the last time DRGs were substantially changed, CMS analyzed claims data and used this analysis to decide which conditions qualify and set reimbursement rates. CMS pays hospitals more for patients with conditions like low sodium because it has found that it costs hospitals more to care for these patients (perhaps because they tend to be hospitalized longer and more often require ICU admissions).

    However, although CMS adjusts DRG payments from year to year, the list of bump codes hasn’t been overhauled in nearly two decades.

    Bump codes can help identify complex patients and ensure hospitals are paid more for caring for them. These are good things, in part because they reduce hospitals’ incentive to seek out healthier, more advantaged patients. While BCBS claims that hospitals are increasingly using these codes to bill more without actually providing more care, hospitals would presumably counter that they were being insufficiently reimbursed before, and that their coding is accurate. After all, the BCBS study does not claim that hospitals are engaging in fraud; the question is just whether the lab abnormalities hospitals are billing for warrant higher reimbursements.

    So who’s right?

    This issue boils down to the following question: How much more does it cost to care for a patient with a secondary condition, and do current coding rules accurately reflect this?

    The answer is that it depends. For instance, not all low sodium levels are created equal. If a patient briefly has a sodium level that falls below the normal range, but their sodium immediately corrects once they’re able to eat again, they probably don’t require any additional resources, and hospitals shouldn’t be reimbursed more for caring for them.

    By contrast, a patient with dangerously low sodium levels requiring an ICU stay, frequent lab checks, and carefully titrated IV fluids undoubtedly does use more resources.

    This leaves doctors in a tough spot: Risk adjustment specialists ask us to document real diagnoses that we know could increase the cost of a patient’s bill, but we have no idea by how much. Moreover, there’s no medical school module on how much any of these comorbidities affects the true cost of the hospitalization. Against this backdrop, it makes sense that doctors try to just tell the truth: yes, this patient has low sodium, and we are monitoring it, even though this probably allows hospitals to code some patients as being more resource-intensive than they truly are.

    What we can agree on

    This entire enterprise — risk adjustment specialists spamming doctors, who are already nose-deep in documentation burden, to document diagnoses that often do not affect patient care, while insurers publish reports that fail to capture the nuance of the issue, leaving the public angry and confused — highlights a more general problem with respect to how the U.S. health care system works.

    By design, hospitals and insurers are meant to compete with each other, with hospitals trying to collect as much money as they can for providing care, and insurers trying to pay as little as possible. Hospitals bolster their side by hiring risk adjustment specialists and employing AI tools, while health insurers hire payment integrity specialists and employ different AI tools.

    Patients lose out because the administrative bloat inflates the cost of medical care, while making costs less transparent and harder to contest. Ultimately, the fix should be structural: At a minimum, we need to overhaul the list of secondary conditions that are eligible for bump coding. CMS attempted to do this in 2019, when it proposed downgrading or eliminating many bump codes based on new data showing they were not associated with increased costs. But hospitals pushed back, and the effort eventually stalled.

    What should we do in the meantime?

    Secondary diagnoses are supposed to be billed only when they are clinically significant — for instance, when they require further evaluation, treatment, diagnostic procedures, or monitoring. But in practice, the bar for clinical significance is probably lower than it should be. (Even rechecking a lab may qualify as monitoring.) Accordingly, I suspect the BCBS study is tracking a real problem, and that much of the documentation of secondary diagnoses isn’t linked to patient complexity.

    Early in residency, I was caring for an immunosuppressed patient who kept spiking fevers. My colleagues and I wondered whether he might have an indolent infection lurking somewhere and ordered an echocardiogram to rule out endocarditis. His heart valves showed no signs of bacterial growth, but trace backflow was detected across one of his valves, a finding present in most people.

    Soon, I received a CDI query inviting me to document his valve dysfunction in my note. I did not do this, because his incidental valve finding was irrelevant to his hospitalization. Instead, I typed out a response indicating as much. However, it would have been easier and quicker to click through the check boxes, and, despite answering them honestly, potentially inflate the patient’s bill.

    At least some CDI tools built into electronic medical records — including the one I have used — default to including secondary diagnoses in ways that are likely to lead to bump coding. One way to improve the status quo would be to ensure that such tools give physicians the option to document whether a secondary diagnosis is clinically significant or not, rather than simply asking them how they are addressing it (on the presumption that it is clinically significant).

    Hospitals should build such tools, and regulators should ensure they do. In the meantime, I’ll exercise clinical judgment when using my CDI tool — if the low sodium seems important, I’ll document it, and if it doesn’t, I’ll politely decline when a risk adjustment specialist invariably asks me to.

    Leah Pierson is a resident physician.

  • Equitable Care Depends on Intelligent Infrastructure: Actuarial AI and Value-Based Risk Contracts

    Equitable Care Depends on Intelligent Infrastructure: Actuarial AI and Value-Based Risk Contracts

    Najib Jai, MD, Chief Operating Officer, Arbital Health

    Equitable access to health care is more than just about geographical coverage. It depends on the healthcare system’s ability to identify risk early, intervene intelligently, and sustain those interventions across the most clinically and socially complex populations.

    This is why many value-based care (VBC) models struggle. Underserved Medicaid and Medicare populations frequently experience a disproportionate burden of chronic diseases, behavioral health challenges, transportation barriers, food insecurity, language gaps, and disconnected care journeys. Once patients present in the emergency department or experience an avoidable admission, the opportunity for lower-cost, lower-acuity care is often less possible. 

    The challenges are well understood – most organizations are still operating with lagging data, subsequent incomplete visibility into contract performance, and limited ability to connect contractual risk with clinical action in real time. As healthcare continues shifting toward value-oriented reimbursement models, equitable care delivery increasingly depends on infrastructure capable of turning population-level data into timely, actionable clinical and operational decisions.

    One Provider’s Experience

    A large provider organization that serves roughly 141,000 Medicaid and Medicare patients recently confronted this reality. Nearly 45% of its patients managing diabetes were also navigating multiple comorbidities, creating a population vulnerable to acute exacerbations, hospitalizations, and readmissions.

    The organization faced significant operational headwinds common to many serving underserved communities. Payer data often arrived months late, making it difficult to understand why contracts were under-performing or which patients were trending toward acute episodes before costs escalated. The organization was effectively trying to manage complex value-based risk arrangements while looking backward through incomplete data.

    Unfortunately, this dynamic is not unique; across healthcare, providers serving high-risk populations are frequently asked to manage increasingly sophisticated contracts without the same actuarial visibility historically available to payers. The result is reactive care management instead of proactive intervention, particularly for populations where earlier outreach can make the greatest difference. Actuarial AI and predictive intelligence can help alter VBC’s trajectory by offering a more comprehensive, forward-looking framework. 

    Traditional Predictive Models Aren’t Up to the Challenge

    Traditional predictive models often focus narrowly on utilization forecasting or retrospective reporting. The next generation of actuarial AI systems is beginning to amalgamate claims data, contract logic, demographics, utilization trends, and clinical workflows into a more operationally useful framework. Instead of simply identifying what happened, these systems can help organizations understand what is likely to happen next, and where intervention opportunities exist before costs spike.

    The Importance of Operationalizing Insight 

    Risk presents heterogeneously across communities, age groups, languages, comorbidity profiles, and care access patterns; a one-size-fits-all intervention strategy inevitably leaves gaps. Predictive intelligence that can stratify risk dynamically across diverse patient populations allows providers to target outreach more precisely and allocate finite care management resources where they can have the greatest impact. This reduces costs as well as the friction that prevents appropriate care from happening proactively.

    Much like with the technology that has preceded it, we’ve learned that AI adoption in healthcare only succeeds when it streamlines and is integrated into existing workflows rather than creating new administrative burdens. Physicians are not resistant to tools that help them, just to those that add unnecessary steps to already compressed processes and cluttered workdays. Organizations most likely to improve outcomes for vulnerable populations will not necessarily be the ones with the most sophisticated dashboards, but the ones capable of operationalizing insight directly into care delivery. If AI can surface which patients are at risk for avoidable admissions, identify the clinical and social drivers contributing to that risk, and simplify the pathway for intervention, then providers can act earlier and more impactfully.

    Actuarial AI in Action

    The experience of the provider organization mentioned earlier offers a practical example. After implementing actuarial AI tools, they were able to analyze utilization patterns and contract performance in real time, uncovering insights that traditional reporting had obscured. While initial payer data suggested pediatrics and OB were driving readmissions, deeper analysis identified hypertension as a leading root cause of avoidable hospital utilization. That insight materially changed their intervention strategy.

    The system launched a hypertension management initiative specifically targeting Medicaid and Medicare patients with complex comorbidities, embedding prompts into clinical workflows and expanding outreach to previously unengaged patients within its risk contracts. Multi-lingual engagement campaigns helped convert previously disconnected patients back into care.

    The organization moved from reacting to adverse events after they occurred to identifying risk trajectories earlier enough to intervene. That is the promise of combining actuarial AI with VBC infrastructure: strengthening the system’s ability to consistently deliver appropriate care at scale.

    Transparency and Trust Are Critical Ingredients

    There is a growing tension between regulated clinical AI and the informal use of ungoverned AI tools across healthcare environments. Across the industry, leaders agree that black-box outputs cannot become the foundation for clinical, operational, or financial decision-making.

    For AI-driven VBC models to meaningfully support underserved populations, providers must understand how risk is being calculated, how interventions are prioritized, and how recommendations align with real-world patient needs. Otherwise, the industry risks replicating existing inequities inside more sophisticated systems.

    The Future of Equitable Care

    The future of equitable care delivery will depend on whether healthcare organizations can unify clinical intelligence, actuarial rigor, and operational execution into a single framework that supports both outcomes and sustainability. Healthcare already possesses enormous volumes of claims, utilization, demographic, and clinical information. The problem has been the inability to synthesize and operationalize that information quickly enough to change patient trajectories while there is still time to act. Actuarial AI and predictive intelligence are beginning to close that gap.

    As VBC continues to evolve, the organizations best positioned to improve equity may be the ones that can transform data into earlier intervention, precise outreach, and more informed clinical decisions, not just for the easiest patients, but for the populations that healthcare has historically struggled to serve well.


    About Najib Jai, MD,

    Dr. Najib Jai, MD, is the Chief Operating Officer of Arbital Health. His career evolved from supporting value based care (VBC) models through private equity investing to joining Oak Street Health to lead specialty care strategy, improving outcomes for patients with complex, multimorbid conditions. He later co-founded Conduce Health, pioneering the first multi-specialty VBC platforms that match the right specialist with the right patient, considering their social drivers of health. Through predictive modeling and innovative contracting structures, his work improved care coordination and outcomes for high-risk populations. Now at Arbital Health, Dr. Jai continues to influence the industry by embedding clinical and operational insight into its Actuarial AI infrastructure, which enables payers and providers to identify the highest-risk members and their emergent needs to drive positive outcomes at scale.

  • Vocca Raises $20M for Specialty-Specific AI Phone Agents Handle 1M+ Monthly Patient Calls

    Vocca Raises $20M for Specialty-Specific AI Phone Agents Handle 1M+ Monthly Patient Calls

    What You Should Know

    • Healthcare conversational AI platform Vocca secures $20M Series A funding round led by Norrsken VC, bringing total cumulative funding to $25M.
    • The financing syndicate features participation from Heal Capital, Speedinvest, and Firstminute Capital, alongside angel backing from founders of European tech unicorns Alan and Datadog.
    • Records explosive enterprise growth: expanded from 2,000 practitioners at its seed round to 15,000 medical practitioners in twelve months, operating across 1,500 medical practices and 20+ clinical specialties in the United States and Europe.

    Commercial Expansion and Deployment Footprint

    The Series A follows significant enterprise expansion across the United States and Europe over the past 12 months:

    • Rapid Practitioner Density: Grew from 2,000 medical practitioners at its September 2025 seed round to more than 15,000 active practitioners today.
    • Enterprise Clinic Footprint: Deployed across 1,500 clinical practices spanning 20+ distinct medical specialties.
    • Volume and Top-Line Trajectory: Platform conversation volume expanded 10x year-over-year, now processing over 1 million inbound patient conversations each month, while top-line revenue increased 7x over the same period.
    • High Autonomous Resolution: Vocca resolves an average of 70% of inbound calls fully end-to-end with zero human staff intervention, with mature specialty implementations exceeding 85% autonomous resolution.

    Large-Scale Deployments Across Acute and Specialty Care

    Vocca has established enterprise deployments across multi-site specialty consolidators and acute hospital networks:

    • Hôpital Fondation Adolphe de Rothschild: The major specialty hospital system handles patient intake, call management, and appointment confirmations using Vocca for its 350,000 annual patients across more than 300 physicians. The system resolves over 75% of incoming calls autonomously (handling bookings, exam-prep guidance, and administrative inquiries), instantly routing clinical emergencies to front-desk staff and queuing low-priority requests for structured callbacks.
    • DAG Dental: Automates front-office intake and scheduling across 37 dental practices, absorbing repetitive scheduling volume and returning hours of operational capacity daily to office coordinators.
    • Point Vision: Manages high-throughput scheduling across 67 ophthalmology clinic locations.
    • Résonance Imagerie: Directs complex diagnostic scheduling and exam-preparation workflows across 60 outpatient medical imaging centers.

    Architecture: Vertical Scheduling Engines Over Generic Bots

    Vocca differentiates its voice platform by pairing natural language models with a specialized deterministic rules engine:

    • Specialty-Specific Rule Libraries: Unlike horizontal LLMs prone to hallucinating appointment rules, Vocca encodes specialized clinical scheduling taxonomies—distinguishing between hundreds of imaging and procedural examination codes to route patients to the correct clinical modality, facility, and preparation regimen.
    • Rapid Deployment Velocity: Because scheduling logic is pre-built into specialty-specific modules rather than built from scratch per clinic, practices can achieve production deployment within days rather than months.
    • Dual Sovereign Cloud Architecture: Operates isolated data and compute environments, hosting U.S. client data within domestic boundaries and European data inside the EU. The underlying infrastructure maintains SOC 2, ISO 27001, and French HDS (Hébergeur de Données de Santé) healthcare certifications, operating as a compliant HIPAA Business Associate.

    “Practices don’t ask us about price. They ask how fast we can deploy and how we handle their edge cases,” said Eliott Hoffenberg, CEO and Co-founder of Vocca. “Doctors want an AI that works like their best scheduler, follows the rules of their specialty to the letter, and fills more appointments without compromising on quality.”

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  • Bain & Bessemer 2026 Scorecard Reveals Healthcare AI Delivers 3.5x ROI in 12 Months

    Bain & Bessemer 2026 Scorecard Reveals Healthcare AI Delivers 3.5x ROI in 12 Months

    Bain & Bessemer 2026 Scorecard Reveals Healthcare AI Delivers 3.5x ROI in 12 Months

    What You Should Know

    • Bessemer Venture Partners and Bain & Company published their joint benchmark report, The 2026 Healthcare AI ROI Scorecard, surveying 226 healthcare C-suite executives across 65 discrete use cases spanning health systems, commercial payers, and biopharma enterprises.
    • The multi-year transformation has compressed rapidly: while 84% of healthcare executives in 2025 expected generative AI to transform treatment decisions within three to five years, 71% confirm it already has in 2026.
    • Financial payback is arriving twice as fast as originally underwritten: enterprise buyers modeled a 24-month horizon, yet realized a material return within ~12 months, generating an average 3.5x return on investment (ROI) and exceeding initial financial underwriting in roughly 40% of deployed use cases (with 54% seeing material ROI within year one).

    Realized ROI and Autonomy Across Enterprise Domains

    Rather than relying on soft satisfaction surveys or speculative multi-year projections, the 2026 Scorecard tracks realized return multiples on deployed capital:

    • Provider Revenue Cycle Management (RCM): Delivers a 4.0x realized ROI, with 67% of solutions operating as semi- or fully autonomous agents. Value is primarily driven by faster speed to output, increased net revenue capture, and direct labor efficiencies.
    • Payer Claims Operations: Generates a 3.4x realized ROI, powered by direct FTE reductions and accelerated claims turnaround times.
    • Pharma Preclinical Discovery: Posts a 3.4x realized ROI, driven by frontier model efficiency gains across target identification and molecular screening pipelines.
    • Payer Provider Network Management: Achieves a 3.3x realized ROI, primarily through accelerated credentialing timelines and automated directory maintenance.
    • Payer Member Engagement: Delivers a 3.2x realized ROI, with 62% of solutions deployed as semi- or fully autonomous agents that handle digital navigation and inbound call deflection.
    • Provider Front Office (Patient Access): Returns a 3.1x realized ROI, driven by conversational scheduling agents that expand capacity capture, maximize slot utilization, and reduce patient no-show rates.
    • Provider Clinical Workflows: Sits at a 2.9x realized ROI, with only 4% of solutions running with semi- or fully autonomous agency. Returns remain concentrated in optimized decision-making and quality metrics rather than hard-dollar labor reductions or new top-line revenue.
    • Pharma Commercial: Realizes a 2.6x realized ROI, led by field-force targeting and automated marketing content generation.
    • Pharma Clinical Development: Achieves a 2.3x realized ROI, where realizing near-term value remains constrained by multi-year clinical trial execution timelines.
    • Payback Speed Has Exposed Systematic Underinvestment: Nearly every enterprise healthcare AI budget approved between 2024 and 2025 assumed a 24-month payback window. Because actual returns landed in roughly 12 months—exceeding expectations in approximately 40% of use cases—organizations continuing to model two-year paybacks are materially underinvesting relative to their own realized financial performance.
    • The Decay of Internal Hospital Builds: In 2025, health systems heavily favored proprietary internal software builds. Today, 61% of organizations report that half or fewer of their internally developed AI tools are still actively maintained and in use, with 32% reporting that less than a quarter survived. While internal IT teams successfully created functional MVPs, they struggled to maintain production-grade reliability, manage model drift, and defend algorithms during compliance audits.
    • Aggressive Vendor Consolidation: 42% of healthcare buyers have completed or are actively executing vendor consolidation initiatives, driven by desires to simplify their IT stacks (37%) and reduce software licensing costs (32%). Market share for recent deployments shifted sharply toward healthcare-specific AI vendors (+12 percentage points) and established HCIT incumbents (+7 percentage points), while internal builds dropped by 16 percentage points.
    • Platform Wedges Outcompeting Point Tools: With 57% of executives reporting that they are inundated by point-solution pitches, enterprise momentum has consolidated around platforms that entered via a sharp clinical or operational wedge (such as Abridge in ambient scribing or SmarterDx in prebill review) and systematically expanded into adjacent administrative workflows.
    • Workforce Restructuring and Headcount Reductions: 50% of surveyed organizations have already reduced headcount as a direct result of AI or plan to within six months, with targeted reductions averaging 8% to 13% of affected functions.
    • Labor Displacement Centered in the Back Office: Workforce reductions track financial returns closely: 73% of providers reporting labor cuts cite revenue cycle and billing, while 71% of payers cite claims operations.
    • Absorbing Structural Shortages Over Mass Displacement: Back-office automation is cushioning severe structural labor shortages rather than creating net unemployment. With the American Medical Association estimating a 30% nationwide shortage of certified medical coders (and the average certified coder now over age 50), automation closes an unfillable labor gap. Furthermore, health systems are actively redeploying clinical administrative staff—such as utilization review nurses—back into bedside care management and patient coordination.

    The Clinical AI Paradox: Four Blockers to the $3 Trillion Opportunity

    While 71% of healthcare executives state that generative AI has already begun transforming clinical treatment decisions (up from an expected 3-to-5-year horizon in 2025), clinical AI realization significantly lags administrative workflows, constrained by four structural barriers:

    • The Trust and Override Gap: Only 46% of clinicians trust AI-generated tools for clinical decision-making, and 77% override AI clinical recommendations more than half the time. Clinicians report that establishing trust requires stronger peer-reviewed clinical validation (67%), transparent recommendation rationales (53%), patient-specific performance data (47%), and native EHR integration (44%).
    • Individual Clinician Liability: 58% of providers affirm that the treating clinician bears primary legal responsibility for AI-influenced decisions, and 50% identify medico-legal exposure as the primary reason clinical AI fails to scale past pilots. The 77% override rate reflects a rational risk-mitigation strategy by clinicians who bear personal malpractice liability.
    • Regulatory and Compliance Ambiguity: 36% of organizations have canceled or delayed a clinical AI deployment due to regulatory uncertainty, driven by the absence of established FDA post-market surveillance regimes for autonomous, pan-indication clinical reasoning models.
    • Payment and Reimbursement Architecture: Fee-for-service payment models reimburse clinician time and specific procedural actions, offering no established billing codes for autonomous algorithmic care delivery. 48% of commercial payers explicitly refuse to reimburse fully autonomous AI care, whereas only 5% object to AI-assisted care where a clinician reviews and signs off on the recommendation.

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  • STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    STAT+: Utah plows ahead with more health AI pilots for prescriptions, women’s health

    Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.

    Utah regulators on Monday announced a plan to allow an artificial intelligence product to evaluate patients for acne treatment and write new drug prescriptions without prior human review. 

    A startup called Nolla Health will launch an AI-powered service in the state that will assess a patient for mild-to-moderate acne treatment using a structured intake and by analyzing photos of their skin. The product may determine whether one of a list of low-risk drugs is appropriate. In the first stages of the pilot, the decisions of the AI will be reviewed by a licensed clinician who will sign off on prescriptions, but Nolla may eventually be allowed to prescribe drugs without this review. The company last year announced it raised $4.5 million from investors including General Catalyst, and Nolla aspires to direct treatment for a host of conditions using AI.

    The new pilot is part of a significant expansion of a closely watched “AI sandbox” program that allows Utah’s Office of Artificial Intelligence Policy, or OAIP, to waive regulations, including around the practice of medicine, for companies that want to test AI products under state supervision. 

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  • Arcadia Unveils Ascent, CareJourney, and LifeScience to Operationalize Agentic Population Health

    Arcadia Unveils Ascent, CareJourney, and LifeScience to Operationalize Agentic Population Health

    Arcadia Unveils Ascent, CareJourney, and LifeScience to Operationalize Agentic Population Health

    What You Should Know

    • Healthcare data platform Arcadia announced a major product portfolio restructuring during its annual customer conference, Aggregate, introducing three core solutions: Arcadia Ascent™, Arcadia CareJourney™, and Arcadia LifeScience.
    • The solutions transition healthcare organizations from retrospective data reporting into active, coordinated execution across clinical, operational, and financial domains using embedded artificial intelligence and agentic workflows.
    • The portfolio is anchored by the Ascent™ Platform, unified by Ascent™ Connect—a standards-based interoperability layer that synchronizes disparate EHR and claims systems without typical integration overhead—supporting five purpose-built operational applications. 

    One Performance Platform for Payer and Provider Workflows

    At the core of the portfolio is the Ascent Platform, which couples Ascent Connect—a standards-based interoperability layer designed to link EHRs, payer claims, and operational data without standard integration friction—with five purpose-built workflow applications:

    • Ascent Performance: Targets clinical quality improvement, proactive care gap closure, and compliant risk adjustment to protect revenue across risk-bearing contracts.
    • Ascent Care: Combines AI-driven patient prioritization with an autonomous care navigation agent, scaling longitudinal whole-person care coordination beyond accountable cohorts to an organization’s entire attributed population.
    • Ascent Insight: Employs conversational AI, automated report delivery, and predictive risk modeling underpinned by governed data management to deliver explainable intelligence to executive and clinical leadership.
    • Ascent Finance: Coordinates the complete value-based contracting lifecycle—from actuarial modeling and risk scenario forecasting to contract execution and multi-payer reconciliation across Medicare, Medicaid, and commercial books of business.
    • Ascent Network: Combines provider performance scoring, episode-level analytics, and market benchmarks to evaluate network adequacy, optimize steerage, and prevent costly out-of-network referral leakage.

    Governance Strategy: Calibrated Autonomy Over “All-or-Nothing” AI

    Addressing enterprise skepticism regarding generative AI safety and hallucination risks, Arcadia introduces a variable governance framework:

    • The Spectrum of AI Oversight: In contrast to point tools configured only as “always on,” Arcadia calibrates agentic automation according to clinical and financial risk. Workflows run in an assistive mode while trust and baseline accuracy are verified, progressing toward autonomous execution only after performance thresholds are proven.
    • Auditable Action Logging: Every autonomous intervention—whether an outreach dispatch, scheduling trigger, or quality documentation prompt—maintains a complete, tamper-evident audit log detailing the algorithmic reasoning and data lineage behind the action.

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  • Opinion: Will Claude ever win a Nobel Prize for medicine?

    Opinion: Will Claude ever win a Nobel Prize for medicine?

    On Monday morning, the Nobel Prize for medicine was announced. This year, I wonder: Will Claude or a future artificial intelligence agent ever win the most prestigious award for medical discovery?

    Imagine a future AI agent responding to a scientist’s insightful prompt by successfully identifying a completely novel approach to curing cancer, along with a detailed and actionable plan for implementing it. Given the toll of cancer on our species, I suspect few today would consider that a bad outcome.

    But as a former medical school dean who was regularly called upon to adjudicate complex issues of credit, I’m uncertain how credit for such a future world-changing discovery would or should be assigned. Until today, human scientists have been the agents responsible for discovering cancer cures, and for doing so they (and key associates) have been showered with academic credit and awards, perhaps even a Nobel Prize. Are we now entering a world in which some (or all) Nobels will be awarded to Claude, ChatGPT, or their AI successors, rather than human scientists? And if so, would it matter?

    The Nobel statutes don’t mention “human” but refer instead to “persons.” In 2024, two of the three winners of the Nobel Prize in chemistry were given credit for their work on the AlphaFold model at DeepMind — even though many more were involved. So without changes to the rules, a future prize for a discovery made by AI would most likely go to some “persons” given credit for making the AI possible — at least at first. But the committee may elect to change the rules or interpret them differently. The Nobel Peace Prize, for instance, has gone to organizations rather than persons.

    Today, credit for discovery plays a central role in the reward structure of science. As “the currency of the realm,” credit powerfully influences the norms and practices of the research ecosystem. It’s required for scientists to secure appointments, promotions, funding, access to students, and other necessities. It’s also a mechanism for evaluating research impact and providing accountability for research claims.

    It didn’t always work this way. The current credit ecosystem arose in the mid-19th century, as science emerged as a profession alongside the rise of the modern scientific journal. It’s been further modified by many factors, from today’s online publishing platforms to new means for assessing and quantifying scientific impact, and the increasingly interdisciplinary and team-based nature of research.

    As we begin to acknowledge AI as a generator of scientific discovery, will the approach to scientific credit be transformed as well? Current and future scientists would certainly like to know.

    Despite many unknowns, it’s hard to imagine the status quo holding. In perhaps the most likely outcome, humans will continue to be responsible for many discoveries, often aided by AI along the way. The credit ecosystem will continue to recognize these human achievements, while finding ways to appropriately recognize the contributions of their AI collaborators.

    But if AI itself is recognized as the responsible agent for some discoveries — even profoundly important ones, such as a cancer cure mentioned above — how would credit be handled? Would assignment of credit as we know it today even matter?

    In that world, humans might retain (for a while) a desire to acknowledge the role of AI in those discoveries, even bestowing previously human-only awards upon the responsible AI agents. Perhaps some credit would also go to their human creators, those putting forth insightful prompts, and those creatively implementing the work.

    But in a world of predominantly AI-driven discovery, the current role of credit as an incentive for the human research ecosystem would dramatically change.

    In considering this future, we must consider another role that credit plays. Beyond serving as an incentive and accountability mechanism in the human academic research ecosystem, there are commercial incentives for discovery, and credit plays a different role in that setting. A major commercial incentive for biomedical research involves the awarding of patents for discovery, and today only humans are eligible to be named discoverers. If future laws change to allow recognition of AI agents and/or their human creators as discoverers (with or without human collaborators), how might this affect accountability, ownership, and the ability to profit from discoveries?

    For research conducted today in both academic organizations and for-profit companies, ownership of intellectual property is generally held by these organizations rather than the human discoverers now named in patents. Patent law might evolve to allow organizations to name AI agents — even proprietary AI versions — as discoverers. But assigning credit would remain complicated to the extent humans will likely play creative roles in successfully implementing AI-generated ideas, though efforts are underway to create AI-automated research systems.

    Today, the science community is composed of humans who seek and often compete with others for discovery as well as credit, and this feature of scientific culture is believed to play an important role in the success of the enterprise. As AI becomes a key enabler and even primary driver of discovery, the current culture of credit will evolve to accommodate that reality. Changes to the credit economy may be among the many trade-offs we accept to realize the benefits of AI-driven discovery, in biomedical research and other domains of human activity.

    Whether an AI agent will ever receive a Nobel laureate is, at least in part, a question about what jobs we want credit to perform. If it’s mainly an incentive for human scientists and the overall enterprise, its role will change as machines play a greater role in discovery. If credit continues to influence allocation of trust, resources, and responsibility, those needs will persist, necessitating decisions on how best to manage them in an AI dominated research ecosystem. This may be further complicated by recent debates about whether AI agents may evolve into moral agents whose status would justify their receiving credit for “their work.” 

    I don’t know how these questions will ultimately be resolved. And I suspect the answers will differ across diverse domains related to research: human scientific careers, journals, funders, universities, biopharmaceutical companies, patent offices, and yes, prize committees. The current system was designed for a world of human discoverers. Though that day may never be fully behind us, we must begin serious conversations about what changes the age of AI science will bring to scientific credit.

    Jeffrey S. Flier is a Harvard University distinguished service professor and the former dean of Harvard Medical School.

  • Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals

    Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals

    Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals
    Aaron Cohen, Vice President, Data Strategy at Definitive Healthcare

    Site selection and enrollment failures are persistent challenges for life sciences organizations. A Tufts Center for the Study of Drug Development analysis of nearly 16,000 investigative sites across 151 Phase II and III global trials found that nearly half of all selected sites either failed to enroll a patient or under-enrolled.1 Site-selection decisions commonly draw on historical performance indicators like prior trial participation and past enrollment, typically favoring sites with an established track record over fresh site opportunities. This creates a sampling problem: if the pool of potential sites is largely composed of those selected in previous trials, analyses of that pool will naturally favor characteristics associated with prior selection. When sponsors draw candidates from a pool shaped by prior selection decisions, established sites are more likely to be selected again and trial speed, diversity, and overall quality are potentially impacted.   

    AI can help organizations identify new clinical trial sites by evaluating a broader range of characteristics to inform site selection so that appropriate candidates are not overlooked. Using predictive algorithms to target new research characteristics including suitable patient populations, investigators, and clinical capabilities, among other data points, sponsors can potentially identify sites that are a unique fit, expanding their approach to site selection.

    Basing site selection on trial history

    Sponsors commonly evaluate sites across four broad categories: likely eligible-patient volume, clinical capability, investigator availability, and prior-trial performance. Problematically, these criteria are frequently measured using historical proxies, with past trial participation among the most readily available. As a result, these screens tend to return sites that already have a research history; they also fail to address the highly protocol-specific nature of enrollment.

    By leveraging different data points for site selection, sponsors can identify the next generation of capable clinical trial sites. The key to tapping into new opportunities is broadening sponsors’ traditional searches to include specific characteristics of a particular trial. 

    Further informing a sponsor’s site selection approach, data shows that trial participation varies sharply by care setting. For example, across Commission on Cancer programs from 2013 to 2017, the overall adult cancer treatment trial participation rate was 7.1%.2 

    Participation rates varied significantly by program type:

    • 21.6% at NCI-designated comprehensive cancer centers
    • 4.1% at community programs
    • 5.4% at academic, non-NCI-designated programs
    • 5.7% at integrated network programs

    While these NCI findings reflect data from several years ago, little suggests that site selection practices have changed meaningfully in the interim. This noted variation is impactful because a site with a strong trial participation history is likely to appear more attractive in a selection process than those with little or none. Prior participation is a real signal. The problem is that it is also a filter, and using it as a primary screen ensures the pool never expands.

    Selecting the next generation of sites with AI

    By identifying specific characteristics related to clinical capability, patient population, investigator or site capability, and data visibility, AI-enabled tools can perform a look-alike analysis to find sites that resemble other ones that have successfully conducted a very similar trial, potentially surfacing new sites that are an appropriate match but lack a trial track record.

    Using real-world patient claims data, procedure volumes, investigators’ expertise, and capabilities to perform specific services and procedures, AI can evaluate broader signals unrelated to trial history. This can be particularly important in the rare disease space, where diagnosis codes are often not specific enough to identify the patients who meet a study’s criteria. By incorporating broader clinical and longitudinal signals, AI can estimate which patients are likely affected by the disease of interest and, by extension, where those patients are receiving care. This can help sponsors identify qualified sites that may be overlooked by diagnosis-code- or trial-performance-based approaches alone. 

    Although these models rely on prior data, they can use care-delivery and patient-level signals to estimate future suitability without requiring prior performance in a similar trial. AI is not a shortcut around the limitations of the underlying data, but rather a tool that can evaluate more data at scale. The opportunity comes from evaluating different signals, such as patient populations, care-delivery patterns, investigator expertise, and protocol-specific capabilities that can help identify qualified sites traditional approaches may overlook.  

    The foundation of any analysis is and always will be the quality of the input data. AI makes it possible to evaluate larger and more complex datasets. Where data capture can be reliably estimated, it may also help differentiate genuinely low patient volume from limited data visibility.

    It can be effective at extracting variables from clinical text where appropriately governed data are available to supplement site validation. AI can also be used for modeling across full feature sets at scale, beyond manual feasibility capabilities, to screen large numbers of sites that lack prior trial experience.

    While AI cannot fully resolve trial eligibility from claims data, determine site selection, or directly recruit appropriate patients, it can quickly provide valuable estimates, helping sponsors better understand the patient population that is likely to meet treatment criteria. Of course, sponsors will still need to thoroughly assess the capabilities of sites and investigators, and consider the primary factors for managing and running the trial.

    A practical way to evaluate these approaches is through a controlled exploration cohort. Sponsors could reserve a defined percentage of candidate sites for model-identified, trial-naïve organizations and subject them to the same readiness assessments and operational reviews as traditional candidates. Enrollment and study performance could then be measured against established benchmarks. This allows organizations to test whether expanding the candidate pool improves recruitment and site performance without abandoning proven site-selection practices.

    Life sciences organizations don’t need to abandon their current site-selection approach entirely, but they should recognize that relying too heavily on past enrollment performance can create a self-reinforcing system in which the sites selected yesterday become the sites considered tomorrow. This approach comes at a cost: a smaller and less diverse enrollment pool, limited geographic and demographic representation, overlooked patient populations, slower recruitment, and higher costs. By incorporating AI-enabled approaches into site selection, sponsors can base decisions on capabilities and patient populations in addition to prior trial experience, broadening the candidate pool, expanding potential matches, and reaching more patients.


    References

    1. Getz, K. “Enrollment Performance: Weighing the ‘Facts’.” Applied Clinical Trials, May 2012, Vol. 21, Issue 5. Tufts CSDD study of nearly 16,000 investigative sites across 151 Phase II and III global trials conducted 2008–2010, with performance data supplied by 10 pharmaceutical companies and two CROs; typical trial ran in 11 countries among adult patients. Enrollment activation rate is defined as the percentage of sites ready to enroll that enroll at least one patient. Findings: 11 percent of ready-to-recruit sites enrolled no patient; 41 percent of activated sites did not achieve the target enrollment number, defined as a band from sites enrolling only one patient through those missing target by 10 percent or more; 40 percent hit target and 15 percent exceeded it; sites enrolling at least one patient reached 85 percent of target on average; and 48 percent of all selected sites enrolled nobody or under-enrolled.
    2. National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data,’ Journal of Clinical Oncology, 2024, doi:10.1200/JCO.23.01030 (covering 2013-2017).

    About Aaron Cohenthe Author: 

    Aaron Cohen is Director of Life Sciences Solutions Consulting at Definitive Healthcare. He specializes in healthcare claims data and real-world data, with deep expertise in claims analytics, provider reference data, patient tokenization and linkage, and cloud analytics. In his more than seven years at Definitive, Aaron has worked in Customer Success, Solutions Consulting, and leadership roles. He leads a team of subject matter experts supporting biopharma, diagnostics, and medical device customers, and is a co-author on a conference poster analyzing Medicare claims data.

    Prior to joining Definitive, Aaron focused on patients’ access to novel medical devices at a reimbursement consulting firm, where he was a Definitive Healthcare customer. Aaron is completing an MS in Data Science at the University of Colorado Boulder.