Healthcare AI & Digital Health — 2026年11月1日 月次レポート

The FDA approved the first heart valve designed to grow with children on October 1 and the first treatment for MCT8 Deficiency on September 28, extending its first-in-class approval cadence into pediatric devices and rare metabolic disease [10].

Thoreau committed $500 million to launch Ortet, founded by AI leaders from Genentech, Meta, AWS, Spotify, and Facebook, aiming to build a full-stack health intelligence platform with a foundation model spanning biological, clinical, operational, and financial dimensions [2h]. Introduces a new competitive category distinct from EHR-embedded or point-solution AI.

HHS Secretary RFK Jr.'s claim that AI provides a second opinion 'much better informed than any doctor in the country' triggered a joint statement from the AMA, AAFP, AAP, ACOG, ACP, and ACS on September 30, marking the first coordinated multi-society pushback against administration AI claims [6].

Heidi launched Heidi II with agentic AI completing administrative tasks autonomously (referral management, chart preparation, follow-up coordination), supporting 2.8 million patient visits weekly globally. AKASA debuted autonomous inpatient medical coding completing in approximately 90 seconds post-discharge [2a]. Both signal a structural shift from AI-assisted to AI-autonomous clinical workflows.

HRSA named 10 manufacturers including Pfizer, AbbVie, Merck, and AstraZeneca and 21 drugs for its revised 340B Rebate Model Pilot launching January 1, 2027, despite AHA opposition [2k]. Requires covered entities to submit claims-level data within 45 days of dispensation.

On October 6, the UK government endorsed all recommendations of the NHS doctors-led National Commission on the Regulation of AI in Healthcare and simultaneously opened Phase 3 of the MHRA's AI Airlock program, establishing the UK's first government-endorsed national blueprint for healthcare AI regulation [7].

A Texas attorney general report confirmed the 2025 Oracle Health Cerner breach compromised data of nearly 20 million people including approximately 3 million Texans. A federal court ruled the consolidated class-action lawsuit can proceed and that healthcare organizations cannot delegate data protection responsibility to vendors [2e].

CD&R and McKesson announced a $5.8 billion deal to acquire Option Care Health — the country's largest independent at-home and alternate site infusion services provider serving more than 308,000 patients annually — at a 37% premium, expected to close in the first half of 2027 [2c].

CMS released 2027 MA star ratings showing Humana's share of enrollees in four-star-or-above plans jumping from 20% to 93%, while Aetna fell from 81% to 69%, Alignment Healthcare dropped from 100% to 25%, and UnitedHealthcare fell from 78% to 67% [2i]. Centene and Alignment filed APA lawsuits against CMS over methodology.

Utah announced five new healthcare AI sandbox pilots including August AI's AI-assisted prescription renewals at $4 per renewal and Nolla Health's AI-driven acne treatment prescriptions, while adding independent evaluators including CHAI, Clarion AI Partners, and Stanford's Clinical Excellence Research Center [2m].

PMDA published an English translation of 'Review Points for Medical Devices Utilizing Generative AI (Draft)' on October 14, establishing Japan's first explicit generative AI review criteria for medical devices and creating an immediate compliance requirement for global manufacturers seeking Japan market access [5].

The MHRA published its 2030 Strategy on October 14 setting out plans to modernize patient-centered regulation for AI and personalized medicines, alongside authorization of once-weekly insulin Onswik (insulin efsitora alfa) for type 2 diabetes [7].

CMS issued a proposed rule on October 16 requiring MA plans to verify provider directories every 90 days with public accuracy scores, limit cost sharing when directories are inaccurate, and restrict PBM compensation tied to drug list prices in Part D, effective in the 2028 contract year [2n].

Epic announced a Prescription Marketplace for summer 2027 partnering with Amazon Pharmacy, Mark Cuban Cost Plus Drugs, Costco, and Eli Lilly's LillyDirect to enable point-of-prescribing price comparison, building on a real-time prescription benefit feature that saved patients more than $250 million in 2025 [14].

The AMA released a governance framework for agentic AI on October 16, asserting clinical authority must be earned through evidence and maintained through demonstrated performance, committing to guide work on liability, licensure, and regulation for AI systems taking on clinical functions [2b].

Medtronic completed the separation of MiniMed Group on October 15 (now trading as MMED on Nasdaq). Stryker announced a strategic alliance with CMR Surgical on October 12 to advance the Versius Surgical Robotic portfolio, extending Stryker's robotic surgery reach beyond orthopedics into soft tissue surgery [13].

UnitedHealth Group reported $4.1 billion in Q3 2026 profit, up from $2.3 billion in Q3 2025, with revenues of $112.7 billion and a medical loss ratio of 88.4% versus 89.9% prior year. Optum Health's operating margin improved to 3.2% from 0.2%. Full-year guidance raised to at least $20.50 per share [2o].

FDA approved GSK's Jemperli (dostarlimab) for locally advanced rectal cancer on October 19, with Phase 2 data showing nearly three-quarters of patients avoided surgery, radiation, or chemotherapy. FDA also approved Hibsago (bepirovirsen) for chronic hepatitis B on October 20 — the first antisense oligonucleotide in this indication offering a potential functional cure after six months [3c].

HHS and DOJ launched a six-month FCA self-disclosure pilot on October 23 offering coordinated civil release from liability in exchange for voluntary disclosure [2j]. CMS simultaneously deferred $1.2 billion in California Medicaid funds and put New York on notice following adult daycare fraud raids.

The UK government confirmed on October 21 that CE-marked medical devices will receive indefinite recognition in Great Britain, resolving a major post-Brexit regulatory uncertainty for device manufacturers and ensuring continued patient access to EU-approved devices [7].

The Commonwealth Fund reported the U.S. uninsured rate climbed to 11.2% in 2026 from 8.9%, driven by ACA subsidy expiration and Medicaid policy changes [2d]. KFF's employer survey found family premiums rose 5% to $28,303 with worker contributions up 9% to $7,471, outpacing wage growth of 3.7%.

Rush University System for Health and Endeavor Health announced a 12-hospital merger with nearly $11 billion in annual revenue that would become Illinois' largest health system by hospital count [2p]. Samaritan Health Services and MultiCare Health System cleared all regulatory approvals for their merger, set to close November 1, creating an 18-hospital system with more than $7.5 billion in revenue.

Redesign Health and Sheba Medical Center's ARC Global announced a merger valued at approximately $2 billion on October 22, with plans to acquire AVIA, creating an end-to-end platform embedding AI engineers inside health systems working with more than 100 health systems across five continents [2q].

Humana struck a $2.8 billion deal with BlackRock's HPS Investment Partners to manage its approximately 150 CenterWell primary care clinics, replacing its prior joint venture with Welsh, Carson, Anderson & Stowe [2r]. Establishes a replicable model of insurer-as-operator with private equity as capital provider for primary care clinic networks.