Physician in the Loop

Surgical robots are inching toward choosing where to clip, cut or sew. Any robot that does should be judged against a good surgeon doing the standard operation, not against other robots.

Read the special topic and its sources: https://physicianintheloop.org/specials/surgeon-is-the-benchmark/

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OpenEvidence joins Johns Hopkins on medical training; EHR vendors' AI disclosures fall short; Agilent buys Proscia; Suki raises $90 million

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Johns Hopkins Medicine and OpenEvidence said Tuesday they will redesign medical education and build clinical AI tools together, a day after Northwestern Medicine opened OpenEvidence inside its Epic record to nurses and pharmacists.

All 35 electronic health record developers reviewed in a study published Wednesday in npj Digital Medicine were certified as meeting federal AI transparency requirements, although their public risk disclosures were inconsistent and often incomplete, the authors said. Agilent Technologies agreed to buy the digital pathology software company Proscia for up to $270 million, and the ambient documentation company Suki raised $90 million.

Separately, authors in NEJM AI said Medicare's repeal of the breakthrough-device route to new technology add-on payments will likely disadvantage independent AI developers, and researchers reported retrieving 1,000 stored conversations from a patient chatbot without logging in.

In this episode

• Johns Hopkins and OpenEvidence plan to redesign medical training; Northwestern opens the tool in Epic to nurses and pharmacists
• All 35 EHR developers won certification despite inconsistent, often incomplete AI risk disclosures, npj Digital Medicine study finds
• Agilent agrees to buy Proscia, whose digital pathology software serves more than 4,000 labs, hospitals and clinics, for up to $270 million
• Suki raises $90 million and says encounters on its AI documentation tools grew more than 190% this year
• Repeal of Medicare's breakthrough-device pathway to add-on payments will likely disadvantage independent AI developers, authors say
• About 75% of Intermountain Health radiologists use Microsoft AI that drafts report impressions, system says
• Researchers retrieve 1,000 stored conversations from a public patient chatbot without a login, NEJM AI paper says
• Character.AI seeks Chapter 11 sale; Pennsylvania sued the chatbot company in May over bots claiming to be psychiatrists
• Function lab results will flow into the Google Health app, where an AI coach can use them for wellness guidance

Language models lean toward whatever the request or the chart suggests, so their agreement is weak evidence. Before they reach patients, the FDA should require tests against unsafe orders and loaded wording.

Read the special topic and its sources: https://physicianintheloop.org/specials/yes-doctor/

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Epic pediatric sepsis alert misses most cases; FDA warns of Lumify ultrasound failures; Stryker puts $400 million into CMR; Google adds AI health trends

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An Epic Systems alert for pediatric sepsis caught 36% of cases across eight New York emergency departments, researchers from Columbia University and NewYork-Presbyterian reported Oct. 5 in JAMA Pediatrics; Epic disputed parts of the study.

The Food and Drug Administration issued an early alert Oct. 9 tying a software and cable problem in Philips' Lumify handheld ultrasound to four deaths and eight serious injuries, with the greatest risk in ambulances and other places with poor connectivity. Stryker agreed Oct. 12 to invest about $400 million in CMR Surgical and become the exclusive U.S. seller of its Versius soft-tissue robot, and Google introduced a Fitbit tracker that reports AI-derived blood pressure and insulin resistance trends under a general wellness label.

The FDA also cleared Click Therapeutics' Motivista, a prescription smartphone app and the first authorized treatment for the negative symptoms of schizophrenia. The Epic, Lumify and Motivista items were first reported last week and run here as catch-up items.

In this episode

• Epic's pediatric sepsis alert flags 36% of sepsis cases in 166,943 visits to eight New York emergency departments, JAMA Pediatrics study finds
• FDA early alert ties Philips Lumify handheld ultrasound software and cable faults to four deaths and eight serious injuries
• Stryker invests about $400 million in CMR Surgical and becomes exclusive U.S. seller of its Versius soft-tissue robot, with an option to buy
• Google's $179.99 Fitbit Edge adds AI blood pressure and insulin resistance trend alerts, labeled for general wellness only
• FDA clears Click Therapeutics' Motivista app, the first authorized treatment for negative symptoms of schizophrenia

CMS chat room gave tech firms access to officials, report says; device makers seek wider RAPID path; FDA grants pacemaker identifier; GPT-5 misreads images

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Technology and AI companies lobbied federal health officials for about a year in a 1,700-member Slack workspace run by the Centers for Medicare & Medicaid Services, KFF Health News reported Oct. 9.

Only a handful of the members were patient advocates, physicians or hospital representatives, according to the report, which drew on thousands of messages, meeting transcripts and recordings. Vendors in the workspace pushed for broader access to patients' records for vetted apps, and CMS officials indicated that apps the agency promotes would be prioritized for a new program paying for AI chatbot advice and wearable tracking, the outlet reported. CMS did not answer questions about whether the group complies with federal advisory committee law.

The weekend was quiet. Device makers pressed CMS to widen its proposed RAPID coverage pathway before comments close Oct. 13, the Food and Drug Administration granted a De Novo to a handheld identifier for implanted cardiac devices, and a study of GPT-5 found image misreadings and unreliable web search in real-world diagnosis.

In this episode

• CMS-run Slack workspace of about 1,700 members gave AI and tech firms direct access to Medicare and FDA officials, KFF Health News reports
• Device makers ask CMS to widen its RAPID pathway to more breakthrough devices and diagnostics before comments close Oct. 13
• FDA grants De Novo to BridgeSource's SmartRead, a handheld device that names a pacemaker or defibrillator maker in about 20 seconds
• GPT-5 configurations misread images and stumble with web search on 161 real-world diagnostic cases, npj Digital Medicine study finds
• Bridge Neurotech launches with $13.5 million to read brain activity through the skull with Butterfly Network's ultrasound chips

A chatbot's differential or a smartwatch alert belongs in the history, as a record of what worried the patient; physicians should treat it neither as a diagnosis nor as a threat.

Read the special topic and its sources: https://physicianintheloop.org/specials/patients-ai-got-there-first/

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Safety prompt cuts harmful AI choices in 19 of 20 models; Oracle breach tally nears 20 million; device coverage comments close Oct. 13; Mayo AI grades side effects

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A short safety reminder cut potentially harmful clinical choices by 20 open-weight language models from 16.6% to 10.1% across more than 10 million responses, Mount Sinai researchers reported in Communications Medicine.

The models still picked a harmful option in about 1.18 million responses, and the reminder helped least on cases drawn from real hospital records, where harmful choices fell from 46.6% to 24.5%, the authors reported. They called the work a proof of concept that does not estimate how often harm would occur in deployed systems.

Elsewhere, filings with state attorneys general put the toll of Oracle Health's 2025 breach of legacy Cerner servers at nearly 20 million people, according to Fierce Healthcare and SecurityWeek. Comments on Medicare's proposed fast coverage pathway for breakthrough devices close Tuesday. The weekend was otherwise quiet, and the post runs shorter.

In this episode

• Short safety reminder cuts harmful clinical choices from 16.6% to 10.1% across 20 AI models and 10 million responses, Mount Sinai reports
• Oracle Health's 2025 breach of legacy Cerner servers reached nearly 20 million people, state filings show; about 3 million are Texans
• Comments close Oct. 13 on Medicare's RAPID pathway, which would propose coverage of some breakthrough devices on the day FDA authorizes them
• Mayo Clinic system grades radiation side effects from recorded visits with 82.6% exact agreement, near the range of expert raters
• MMI raises $125 million to expand its Symani robotic microsurgery system, used in about 3,500 procedures on some 50 installed units

FDA clears Epic deterioration model; Bayer sells Blackford radiology AI; chest X-ray AI flags osteoporosis; Houston Methodist ties OR AI to more cases

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The Food and Drug Administration has cleared Epic Systems' Deterioration Index Version 2, a model in Epic's record that predicts which hospitalized adults will decline, in a 510(k) decided Sept. 18, agency records show.

The model is Epic's first AI clearance from the agency's device center, according to a review of September clearances by the consultancy Innolitics. Its validation showed lower sensitivity for Black and Hispanic patients than for white patients at the medium-risk threshold, Becker's Hospital Review reported.

In radiology, Sopris Capital closed its purchase of Blackford Analysis from Bayer, and Korean researchers reported a chest X-ray model that identified osteoporosis in three outside cohorts. In surgery, Houston Methodist's innovation chief described an operating-room camera system linked to 7% more cardiothoracic cases a month, and a Northwell Health team published a skills score built from robotic console data.

In this episode

• FDA clears Epic's Deterioration Index Version 2, an inpatient decline model hospitals have run inside Epic for years
• Sopris Capital buys Blackford Analysis, a platform carrying more than 130 radiology AI apps, from Bayer and plans to merge it with Azra AI
• Chest X-ray model identifies osteoporosis with AUROCs of 0.88 to 0.93 in three Korean validation cohorts of more than 150,000 exams
• Houston Methodist links operating-room camera AI to 7% more cardiothoracic cases a month; the hospital holds equity in the vendor
• Robotic console data separate attending surgeons from trainees in inguinal hernia repair with an outside-cohort AUC of 0.84

A small rural hospital should buy the few AI tools that fill a gap in its staffing or clearly pay their way, and leave alone whatever it has no one to check.

Read the special topic and its sources: https://physicianintheloop.org/specials/ai-for-the-25-bed-hospital/

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Software is gaining the power to prescribe, triage and code faster than anyone is checking its results. It should earn that power by publishing its errors.

Read the letter and its sources: https://physicianintheloop.org/letters/2026-10-05/

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