---
type: source
title: "Liability Risks of Ambient Clinical Workflows With Artificial Intelligence for Clinicians, Hospitals, and Manufacturers"
author: "Sara Gerke, David A. Simon, Benjamin R. Roman"
url: https://ascopubs.org/doi/10.1200/OP-24-01060
date: 2026-01-01
domain: health
secondary_domains: [ai-alignment]
format: journal-article
status: processed
processed_by: vida
processed_date: 2026-04-02
priority: high
tags: [ambient-AI-scribe, liability, malpractice, clinical-AI, legal-risk, documentation, belief-5, healthcare-law]
extraction_model: "anthropic/claude-sonnet-4.5"
---

## Content

Published in *JCO Oncology Practice*, Volume 22, Issue 3, 2026, pages 357–361. Authors: Sara Gerke (University of Illinois College of Law, EU Center), David A. Simon (Northeastern University School of Law), Benjamin R. Roman (Memorial Sloan Kettering Cancer Center, Strategy & Innovation and Surgery).

This is a peer-reviewed legal analysis of liability exposure created by ambient AI clinical workflows — specifically who is liable (clinician, hospital, or manufacturer) when AI scribe errors cause patient harm.

**Three-party liability framework:**

1. **Clinician liability:** If a physician signs off on an AI-generated note containing errors — fabricated diagnoses, wrong medications, hallucinated procedures — without adequate review, the physician bears malpractice exposure. Liability framework: the clinician attests to the record's accuracy by signing. Standard of care requires review of notes before signature. AI-generated documentation does not transfer review obligation to the tool.

2. **Hospital liability:** If a hospital deployed an ambient AI scribe without:
   - Instructing clinicians on potential mistake types
   - Establishing review protocols
   - Informing patients of AI use
   Then the hospital bears institutional liability for harm caused by inadequate AI governance.

3. **Manufacturer liability:** AI scribe manufacturers face product liability exposure for documented failure modes (hallucinations, omissions). The FDA's classification of ambient scribes as general wellness/administrative tools (NOT medical devices) does NOT immunize manufacturers from product liability. The 510(k) clearance defense is unavailable for uncleared products.

**Specific documented harm type from earlier generation speech recognition:**
Speech recognition systems have caused patient harm: "erroneously documenting 'no vascular flow' instead of 'normal vascular flow'" — triggering unnecessary procedure; confusing tumor location → surgery on wrong site.

**Emerging litigation (2025–2026):**
Lawsuits in California and Illinois allege health systems used ambient scribing without patient informed consent, potentially violating:
- California's Confidentiality of Medical Information Act
- Illinois Biometric Information Privacy Act (BIPA)
- State wiretapping statutes (third-party audio processing by vendors)

**Kaiser Permanente context:** August 2024, Kaiser announced clinician access to ambient documentation scribe. First major health system at scale — now multiple major systems deploying.

## Agent Notes

**Why this matters:** This paper documents that ambient AI scribes create liability exposure for three distinct parties simultaneously — with no established legal framework to allocate that liability cleanly. The malpractice exposure is live (not theoretical), and the wiretapping lawsuits are already filed. This is the litigation leading edge of the clinical AI safety failure the KB has been building toward.

**What surprised me:** The authors are from MSK (one of the top cancer centers), Illinois Law, and Northeastern Law. This is not a fringe concern — it is the oncology establishment and major law schools formally analyzing a liability reckoning that they expect to materialize. MSK is one of the most technically sophisticated health systems in the US; if they're analyzing this risk, it's real.

**What I expected but didn't find:** Any evidence that existing malpractice frameworks are being actively revised to cover AI-generated documentation errors. The paper describes a liability landscape being created by AI deployment without corresponding legal infrastructure to handle it.

**KB connections:**
- npj Digital Medicine "Beyond human ears" (archived this session) — documents failure modes that create the liability
- Belief 5 (clinical AI novel safety risks) — "de-skilling, automation bias" now extended to "documentation record corruption"
- "ambient AI documentation reduces physician documentation burden by 73%" (KB claim) — the efficiency gain that is attracting massive deployment has a corresponding liability tail
- ECRI 2026 (archived this session) — AI documentation tools as patient harm vector

**Extraction hints:**
1. "Ambient AI scribe deployment creates simultaneous malpractice exposure for clinicians (inadequate note review), institutional liability for hospitals (inadequate governance), and product liability for manufacturers — while operating outside FDA medical device regulation"
2. "Existing wiretapping statutes (California, Illinois) are being applied to ambient AI scribes in 2025–2026 lawsuits, creating an unanticipated legal vector for health systems that deployed without patient consent protocols"

**Context:** JCO Oncology Practice is ASCO's clinical practice journal — one of the most widely-read oncology clinical publications. A liability analysis published there reaches the operational oncology community, not just health law academics. This is a clinical warning, not just academic analysis.

## Curator Notes

PRIMARY CONNECTION: Belief 5 clinical AI safety risks; "ambient AI documentation reduces physician documentation burden by 73%" (KB claim)
WHY ARCHIVED: Documents the emerging legal-liability dimension of AI scribe deployment — the accountability mechanism that regulation should create but doesn't. Establishes that real harm is generating real legal action.
EXTRACTION HINT: New claim candidate: "Ambient AI scribe deployment has created simultaneous malpractice exposure for clinicians, institutional liability for hospitals, and product liability for manufacturers — outside FDA oversight — with wiretapping lawsuits already filed in California and Illinois."
