OMP Domain Profile: Clinical AI Decision Accountability Under Joint Commission/CHAI Guidance, California SB 1120, and Emerging US State and Federal Healthcare AI Obligations
draft-veridom-omp-clinical-00
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| Last updated | 2026-04-05 | ||
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draft-veridom-omp-clinical-00
Internet Engineering Task Force T. Adebayo
Internet-Draft O. Apalowo
Intended status: Informational F. Makanjuola
Expires: 7 October 2026 Veridom Ltd
5 April 2026
OMP Domain Profile: Clinical AI Decision Accountability Under Joint
Commission/CHAI Guidance, California SB 1120, and Emerging US State and
Federal Healthcare AI Obligations
draft-veridom-omp-clinical-00
Abstract
This document defines a domain profile of the Operating Model
Protocol (OMP) for AI systems deployed in clinical and healthcare
decision contexts subject to qualified human reviewer requirements
under the US Joint Commission and Coalition for Health AI (CHAI)
Responsible Use Guide (September 2025), California Senate Bill 1120
(SB 1120, effective January 1, 2025), New York Assembly Bill A9149
(pending), and related US state and federal healthcare AI
accountability obligations.
The profile -- designated CareGuard -- specifies how OMP's
deterministic routing invariant, Watchtower enforcement framework,
and three-layer cryptographic integrity architecture satisfy the
qualified human reviewer documentation requirements, clinical
decision traceability obligations, and AI governance evidence
standards applicable to healthcare AI deployments. The profile
addresses four clinical deployment categories: medical necessity
determinations, clinical decision support, diagnostic AI assistance,
and prior authorisation AI systems.
The OMP core specification is defined in the Operating Model Protocol
Internet-Draft (draft-veridom-omp).
Status of This Memo
This Internet-Draft is submitted in full conformance with the
provisions of BCP 78 and BCP 79.
Internet-Drafts are working documents of the Internet Engineering
Task Force (IETF). Note that other groups may also distribute
working documents as Internet-Drafts. The list of current Internet-
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Table of Contents
1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . 3
2. Terminology . . . . . . . . . . . . . . . . . . . . . . . . . 4
3. Clinical AI Regulatory Framework Analysis . . . . . . . . . . 5
3.1. Joint Commission / CHAI Responsible Use Guide . . . . . . 5
3.2. California SB 1120 . . . . . . . . . . . . . . . . . . . 5
3.3. New York AB A9149 . . . . . . . . . . . . . . . . . . . . 6
3.4. Federal Context: ONC and CMS . . . . . . . . . . . . . . 6
3.5. EU AI Act Annex III Healthcare Category . . . . . . . . . 6
3.6. Convergent Requirements . . . . . . . . . . . . . . . . . 6
4. OMP CareGuard Profile . . . . . . . . . . . . . . . . . . . . 6
4.1. Routing States Under This Profile . . . . . . . . . . . . 6
4.2. Named Accountable Officer: The Qualified Human
Reviewer . . . . . . . . . . . . . . . . . . . . . . . . 7
4.3. Watchtower Definitions . . . . . . . . . . . . . . . . . 8
4.3.1. WT-CLINICAL-01: Qualified Human Reviewer Gate . . . . 8
4.3.2. WT-CLINICAL-02: Patient Safety Override Gate . . . . 8
4.3.3. WT-CLINICAL-03: Clinical Confidence Floor Gate . . . 9
4.3.4. WT-CLINICAL-04: Training Distribution Limitation
Gate . . . . . . . . . . . . . . . . . . . . . . . . 9
4.3.5. WT-CLINICAL-05: Anomalous Output Pattern Gate . . . . 9
4.3.6. WT-CLINICAL-06: SB 1120 Adverse Determination Gate . 10
4.4. Audit Trace Schema Extensions . . . . . . . . . . . . . . 10
5. Clinical Deployment Category Mapping . . . . . . . . . . . . 11
6. The CareGuard Invariant . . . . . . . . . . . . . . . . . . . 12
7. Patient Safety Override Architecture . . . . . . . . . . . . 12
8. Clinical Proof-Point as Regulatory Evidence . . . . . . . . . 13
9. Security Considerations . . . . . . . . . . . . . . . . . . . 13
10. IANA Considerations . . . . . . . . . . . . . . . . . . . . . 14
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11. References . . . . . . . . . . . . . . . . . . . . . . . . . 14
11.1. Normative References . . . . . . . . . . . . . . . . . . 14
11.2. Informative References . . . . . . . . . . . . . . . . . 15
Authors' Addresses . . . . . . . . . . . . . . . . . . . . . . . 16
1. Introduction
AI systems are now embedded across the clinical pathway: in medical
necessity determination, prior authorisation, clinical decision
support, diagnostic imaging analysis, sepsis prediction, and
medication management. The pace of deployment has substantially
outrun the development of regulatory frameworks that specify, with
technical precision, what accountability evidence these systems must
produce.
Three instruments have begun to define that framework with sufficient
precision to support technical specification:
* The Joint Commission and CHAI Responsible Use Guide for Healthcare
AI (September 2025) establishes that healthcare organisations must
document human oversight of consequential AI clinical decisions,
maintain evidence that qualified human reviewers evaluated AI
recommendations before acting on them, and demonstrate that AI
systems used in clinical settings have governance structures with
named accountability.
* California Senate Bill 1120 (effective January 1, 2025) requires
health insurers and managed care plans to ensure that adverse
determinations based on AI-generated medical necessity decisions
are reviewed by a licensed physician or other qualified clinician
before the determination is communicated to the patient or
provider. The reviewing clinician must document their review, and
the insurer must retain that documentation.
* New York Assembly Bill A9149 (pending) proposes analogous
requirements for health plans operating in New York, including
mandatory disclosure to patients when AI was used in a coverage
determination and mandatory human reviewer documentation.
These instruments converge on a structural requirement that maps
directly onto OMP [I-D.veridom-omp]: every AI-assisted clinical
decision that produces a consequential outcome for a patient must be
either reviewed by a named, qualified human reviewer before it is
acted upon, or blocked from autonomous execution and escalated to
qualified human review.
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This document defines the CareGuard profile: the domain-specific
instantiation of OMP for clinical AI accountability. CareGuard
denotes that each AI-assisted clinical decision is cryptographically
marked against the operator's care accountability obligations,
producing a tamper-evident record before the decision affects a
patient.
Related OMP domain profiles include the AI Liability Insurance
profile [I-D.veridom-omp-aiins]. Audit Trace payloads are
canonicalized per [RFC8785]. The OMP specification is also archived
at [ZENODO-OMP].
The key words "MUST", "MUST NOT", "REQUIRED", "SHALL", "SHALL NOT",
"SHOULD", "SHOULD NOT", "RECOMMENDED", "MAY", and "OPTIONAL" in this
document are to be interpreted as described in [RFC2119] [RFC8174].
2. Terminology
This document uses the terminology defined in [I-D.veridom-omp]. In
addition:
* Qualified Human Reviewer (QHR): The licensed clinician or
credentialed healthcare professional designated to review AI
recommendations before they are acted upon. In OMP terms, the
Named Accountable Officer for ASSISTED and ESCALATED interactions
under this profile.
* Consequential Clinical Decision: An AI-assisted decision that, if
acted upon without human review, would directly affect a patient's
care pathway, coverage status, medication, diagnosis, or treatment
recommendation. All Consequential Clinical Decisions are subject
to the CareGuard Invariant.
* Adverse Determination: A determination resulting in denial,
limitation, or termination of coverage or benefits for a patient,
as defined in California SB 1120 and analogous state statutes. A
subset of Consequential Clinical Decisions subject to the most
stringent QHR documentation requirements.
* Patient Safety Override: An immediate, non-negotiable interruption
of an AI-assisted clinical process triggered when the AI system's
output creates an imminent patient safety risk, generating an
ESCALATED routing outcome, a HARD_BLOCK, and an immediate alert to
the Clinical Escalation Authority.
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* CareGuard Invariant: The two-property invariant defined in
Section 6: every Consequential Clinical Decision either generates
a sealed CareGuard Audit Trace documenting QHR review before the
decision is acted upon, or is blocked until QHR review is
completed and documented.
* Clinical Escalation Authority: The designated individual or team
responsible for Patient Safety Override response. Their response
is documented in the CareGuard Audit Trace.
3. Clinical AI Regulatory Framework Analysis
3.1. Joint Commission / CHAI Responsible Use Guide
The Joint Commission and CHAI Responsible Use Guide (September 2025)
[CHAI-2025] requires: contemporaneous documentation that qualified
clinical staff reviewed AI recommendations before acting on them;
named accountability for AI clinical system governance; auditability
of specific clinical decisions (what the AI recommended, whether a
qualified reviewer assessed the recommendation, what the final
outcome was); and documentation of failure mode handling when AI
confidence is low or the training distribution does not cover the
patient presentation.
The contemporaneity requirement is the specific property OMP's sealed
Audit Trace architecture satisfies. A QHR attestation created after
the fact is not contemporaneous evidence; an OMP CareGuard Audit
Trace sealed with an RFC 3161 [RFC3161] Qualified Timestamp at the
moment of QHR review is.
3.2. California SB 1120
California SB 1120 [CA-SB1120] (effective January 1, 2025) requires:
a physician or other licensed healthcare professional with relevant
clinical expertise must review AI-generated adverse medical necessity
determinations before they are communicated to the patient or
provider; the reviewing clinician must document independent clinical
review; health plans must retain the AI recommendation, the
reviewer's documentation, and the final determination; and health
plans must disclose to enrollees when AI was used in a coverage
determination resulting in a denial.
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3.3. New York AB A9149
New York AB A9149 [NY-A9149] (pending) proposes requirements
substantively identical to California SB 1120 for health plans
operating in New York, with additional provisions: patient
notification in writing when AI was used in a coverage determination;
patient right to request human review of any AI-assisted adverse
determination; and New York DFS audit rights over health plan AI
systems used in coverage determinations. The CareGuard profile is
designed to satisfy both instruments through a single evidence
framework.
3.4. Federal Context: ONC and CMS
The CMS Interoperability and Prior Authorization Rule (CMS-0057-F
[CMS-0057-F], effective January 2026) requires health plans subject
to CMS oversight to automate prior authorisation processes and
maintain documentation of prior authorisation decisions including AI-
assisted decisions. Section 5.4 addresses CMS-0057-F documentation
requirements.
3.5. EU AI Act Annex III Healthcare Category
The EU AI Act Annex III includes AI systems used in medical or health
services as high-risk AI systems subject to Article 12 logging
requirements addressed in [I-D.veridom-omp-euaia]. The CareGuard
profile is designed for use in conjunction with the EUAIA profile for
healthcare AI deployments subject to both EU AI Act and US clinical
accountability requirements. Section 4.5 defines a compatibility
field for joint deployments.
3.6. Convergent Requirements
The Joint Commission/CHAI guide, California SB 1120, and the pending
New York legislation define a structure that maps precisely onto
OMP's three routing states: AI clinical recommendations reviewed and
approved by a QHR before being acted upon correspond to ASSISTED;
recommendations triggering a Patient Safety Override or confidence
failure correspond to ESCALATED; fully autonomous AI clinical
decisions affecting patients are NOT PERMITTED under this profile for
Consequential Clinical Decisions.
4. OMP CareGuard Profile
4.1. Routing States Under This Profile
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* AUTONOMOUS: NOT PERMITTED for Consequential Clinical Decisions.
WT-CLINICAL-01 MUST be configured as a universal FORCE_ASSISTED
trigger for all interactions classified as Consequential Clinical
Decisions. AUTONOMOUS routing is permitted only for
administrative, scheduling, or non-clinical AI functions that do
not directly affect a patient's care pathway, coverage, diagnosis,
or treatment. Operators MUST maintain a written classification of
which interaction types are non-clinical (AUTONOMOUS eligible)
versus Consequential Clinical Decisions (QHR mandatory), reviewed
and approved annually by the operator's AI governance authority.
* ASSISTED: The standard routing state for all Consequential
Clinical Decisions. The AI generates a recommendation; the QHR
reviews, exercises independent clinical judgment, and documents
their review before the recommendation is acted upon. The QHR's
NPI, credential type, review timestamp, and clinical determination
are sealed in the CareGuard Audit Trace.
* ESCALATED: Triggered by: Patient Safety Override (WT-CLINICAL-02),
confidence failure below the clinical safety floor (WT-CLINICAL-
03), known training distribution limitation for the patient
presentation (WT-CLINICAL-04), or anomalous AI output pattern (WT-
CLINICAL-05). The AI recommendation MUST NOT be communicated to
the patient or used in a clinical decision until the Clinical
Escalation Authority has reviewed and documented a clinical
disposition.
4.2. Named Accountable Officer: The Qualified Human Reviewer
The Named Accountable Officer under this profile is the Qualified
Human Reviewer: the licensed clinician who reviews the AI
recommendation before it is acted upon. The QHR MUST hold the
licensure required by applicable law for the type of clinical
decision under review. For California SB 1120, the QHR MUST be a
physician or other licensed healthcare professional with relevant
clinical expertise.
Required fields in the QHR record:
* qhr_npi: National Provider Identifier (US) or equivalent national
professional registration identifier. MUST NOT be null for
Consequential Clinical Decisions;
* qhr_credential_type: licensure category (e.g., "MD", "DO", "NP",
"PA", "RN");
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* qhr_review_timestamp: ISO 8601 UTC timestamp of the QHR's review
action -- the contemporaneity anchor for SB 1120 and Joint
Commission/CHAI compliance;
* qhr_clinical_determination: one of APPROVED, MODIFIED, OVERRIDDEN,
ESCALATED_TO_SPECIALIST;
* qhr_independent_basis: REQUIRED for MODIFIED and OVERRIDDEN;
documents that the QHR exercised independent professional
judgment, not merely ratified the AI recommendation.
4.3. Watchtower Definitions
4.3.1. WT-CLINICAL-01: Qualified Human Reviewer Gate
*Trigger:* Any interaction classified as a Consequential Clinical
Decision.
*Action:* FORCE_ASSISTED. Cannot be disabled for Consequential
Clinical Decisions.
*Rationale:* California SB 1120 and the Joint Commission/CHAI guide
require documented human oversight of consequential AI clinical
decisions. This Watchtower gives these requirements structural
enforcement: it is architecturally impossible for a Consequential
Clinical Decision to proceed to patient impact without generating a
QHR review record.
4.3.2. WT-CLINICAL-02: Patient Safety Override Gate
*Trigger:* AI output contains or implies a condition the operator's
clinical safety detection framework identifies as creating an
imminent patient safety risk (e.g., recommendation conflicting with a
known allergy or contraindication; medical necessity denial for a
condition flagged as urgent; diagnostic output inconsistent with
vital signs indicating acute deterioration).
*Action:* HARD_BLOCK immediately. AI output MUST NOT be communicated
to the patient, provider, or any downstream clinical process.
Clinical Escalation Authority alerted immediately.
*Rationale:* Patient safety is non-negotiable. HARD_BLOCK ensures
Patient Safety Override conditions interrupt the AI pipeline rather
than merely flagging it, preventing the failure mode where an AI
safety concern is communicated as a recommendation rather than an
immediate interrupt.
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4.3.3. WT-CLINICAL-03: Clinical Confidence Floor Gate
*Trigger:* Composite Confidence Score falls below the operator's
configured clinical safety floor.
*Action:* FORCE_ESCALATED. The AI recommendation MAY be provided to
the Clinical Escalation Authority as context, clearly labelled as
below the clinical confidence floor, but MUST NOT be acted upon as an
AI recommendation.
*Rationale:* A recommendation generated below the clinical confidence
floor signals the AI system is operating outside its validated
performance envelope. The appropriate clinical response is
independent human judgment, not review of an unreliable
recommendation.
4.3.4. WT-CLINICAL-04: Training Distribution Limitation Gate
*Trigger:* Patient presentation matches a known training distribution
limitation documented in the AI system's clinical validation records
(e.g., demographic characteristics underrepresented in training data;
clinical features identified as associated with reduced performance).
*Action:* FORCE_ESCALATED. CareGuard Audit Trace records the
specific training limitation triggered.
*Rationale:* Known training distribution limitations create a
specific duty to escalate when those limitations are relevant to a
patient presentation, consistent with the Joint Commission/CHAI
requirement to document AI failure mode handling.
4.3.5. WT-CLINICAL-05: Anomalous Output Pattern Gate
*Trigger:* AI output deviates from expected operating parameters in
ways suggesting model degradation, data drift, or adversarial input
rather than a legitimate clinical edge case.
*Action:* FORCE_ESCALATED plus system anomaly alert for review by the
operator's AI governance authority.
*Rationale:* AI clinical systems can degrade as patient population
characteristics evolve away from the training distribution.
Anomalous output detection provides early warning to prevent
systematic patient harm from a degraded AI system operating at scale.
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4.3.6. WT-CLINICAL-06: SB 1120 Adverse Determination Gate
*Trigger:* For health insurer and managed care plan deployments
subject to California SB 1120: AI output constitutes or implies an
adverse determination.
*Action:* FORCE_ESCALATED. MUST be reviewed by a physician or other
licensed healthcare professional with relevant clinical expertise
before the adverse determination is communicated to the patient or
provider.
*Rationale:* California SB 1120 creates a specific, legally
enforceable requirement for QHR review of AI-generated adverse
determinations. WT-CLINICAL-06 gives this requirement structural
enforcement for the SB 1120 context, in addition to the general QHR
Gate (WT-CLINICAL-01).
4.4. Audit Trace Schema Extensions
The following fields are REQUIRED under the CareGuard profile, in
addition to core fields in [I-D.veridom-omp] Section 7:
* qhr_npi: string, REQUIRED for Consequential Clinical Decisions.
National Provider Identifier (US) or equivalent national
professional registration identifier.
* qhr_credential_type: string, REQUIRED. RECOMMENDED values: "MD",
"DO", "NP", "PA", "RN", "PharmD", "clinical_specialist".
* qhr_review_timestamp: string, ISO 8601 UTC, REQUIRED for ASSISTED
and ESCALATED. The contemporaneity anchor for SB 1120 and Joint
Commission/CHAI compliance.
* qhr_clinical_determination: string, REQUIRED for ASSISTED and
ESCALATED. One of: APPROVED, MODIFIED, OVERRIDDEN,
ESCALATED_TO_SPECIALIST.
* qhr_independent_basis: string, OPTIONAL for APPROVED; REQUIRED for
MODIFIED and OVERRIDDEN. Documents independent clinical judgment,
not merely ratification of the AI recommendation.
* patient_safety_override: boolean, REQUIRED. True if WT-
CLINICAL-02 triggered a Patient Safety Override.
* clinical_confidence_floor_breached: boolean, REQUIRED. True if
WT-CLINICAL-03 triggered for this interaction.
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* training_limitation_triggered: string, OPTIONAL. Identifier of
the specific training distribution limitation that triggered WT-
CLINICAL-04, if applicable.
* deployment_category: string, REQUIRED. One of:
"medical_necessity", "clinical_decision_support",
"diagnostic_assistance", "prior_authorisation", "administrative".
* sb1120_adverse_determination: boolean, REQUIRED for health insurer
and managed care plan deployments in California. True if WT-
CLINICAL-06 triggered.
* euaia_joint_deployment: boolean, OPTIONAL. True if this
deployment is also subject to EU AI Act Article 12 requirements
addressed in [I-D.veridom-omp-euaia].
* profile_version: string, REQUIRED. MUST be "VERIDOM-CAREGUARD-
v1.0".
5. Clinical Deployment Category Mapping
For medical necessity determinations: WT-CLINICAL-01 and WT-
CLINICAL-06 MUST be active. deployment_category MUST be
"medical_necessity". For California deployments,
sb1120_adverse_determination MUST be evaluated for every interaction.
The QHR MUST hold the SB 1120-required credential. Audit Traces MUST
be retained for a minimum of three years from the determination date
for California SB 1120 compliance.
For clinical decision support: WT-CLINICAL-01 through WT-CLINICAL-05
MUST be active. deployment_category MUST be
"clinical_decision_support". The QHR is the treating clinician who
acts on the AI recommendation at the point of care; their NPI MUST be
recorded. WT-CLINICAL-04 MUST be configured with the training
distribution limitations documented in the AI system's clinical
validation records and FDA 510(k) clearance documentation where
applicable.
For diagnostic AI assistance: WT-CLINICAL-01 through WT-CLINICAL-05
MUST be active. WT-CLINICAL-02 is particularly critical: a
diagnostic AI recommendation conflicting with clinical findings
indicating acute deterioration MUST trigger HARD_BLOCK.
deployment_category MUST be "diagnostic_assistance". The QHR is the
licensed clinician who interprets the AI output and issues the
diagnostic report.
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For prior authorisation AI systems: WT-CLINICAL-01 and WT-CLINICAL-06
MUST be active. deployment_category MUST be "prior_authorisation".
For CMS-regulated health plans, CareGuard Audit Traces for prior
authorisation decisions MUST be retained and producible for CMS audit
within the timeframes specified by CMS-0057-F. Audit Traces MUST
record whether the prior authorisation request was subject to a
required response timeline and whether QHR review was completed
within that timeline.
6. The CareGuard Invariant
Implementations of this profile MUST satisfy the following two-
property invariant:
* Property 1 (QHR review completeness): Every Consequential Clinical
Decision MUST generate a sealed CareGuard Audit Trace documenting
QHR review before the AI recommendation is acted upon,
communicated to a patient or provider, or used in a coverage
determination. No Consequential Clinical Decision may affect a
patient without a contemporaneous, sealed QHR review record.
* Property 2 (Immutable trail): The CareGuard Audit Trace MUST be
sealed with the three-layer integrity architecture defined in
[I-D.veridom-omp] Section 7. Any modification to any historical
Audit Trace record MUST be detectable by any third party --
including a state regulator, CMS, the Joint Commission, or a court
-- without access to the operator's or OMP implementer's
infrastructure.
An operator satisfying the CareGuard Invariant can demonstrate, for
any Consequential Clinical Decision: the AI recommendation as
generated; the QHR's identity (NPI), credential type, and review
timestamp establishing contemporaneity for SB 1120 and Joint
Commission/CHAI purposes; the QHR's clinical determination and
independent basis where required; Watchtower evaluation results;
whether a Patient Safety Override was triggered; and that the record
has not been altered since sealing.
7. Patient Safety Override Architecture
When WT-CLINICAL-02 triggers a Patient Safety Override: (a) the AI
system's output is immediately blocked -- no further processing of
the AI recommendation occurs; (b) a Patient Safety Override Audit
Trace is generated immediately with patient_safety_override set to
true, the specific safety condition identified, and a UTC timestamp
sealed with an RFC 3161 TimeStampToken; (c) the Clinical Escalation
Authority is alerted immediately; (d) the Clinical Escalation
Authority's response -- including the responding clinician's
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identity, response timestamp, and clinical disposition -- MUST be
recorded in the CareGuard Audit Trace within the operator's
configured maximum response time; (e) no further AI-assisted
processing of this interaction MAY occur until the Clinical
Escalation Authority has documented a clinical disposition.
The Patient Safety Override architecture prevents the failure mode
documented in published adverse event reports involving AI clinical
systems: a patient safety concern detected by an AI system that was
communicated as a recommendation rather than as an immediate
interrupt, resulting in delayed clinical response. OMP's HARD_BLOCK
mechanism ensures Patient Safety Override conditions interrupt the AI
pipeline, not merely flag it.
8. Clinical Proof-Point as Regulatory Evidence
The OMP Proof-Point artefact for a clinical deployment MUST include,
for each Consequential Clinical Decision: the full CareGuard Audit
Trace including the AI recommendation as generated; the QHR review
record; the Watchtower evaluation log; chain integrity proof (SHA-256
Merkle root and chain path); and the RFC 3161 TimeStampToken
verification output from the OMP Reference Validator [OMP-OPEN-CORE],
confirming the temporal anchor that establishes contemporaneity.
This artefact is self-contained: a state insurance regulator, CMS
auditor, Joint Commission reviewer, plaintiff's attorney, or expert
witness can verify its integrity using only the OMP Reference
Validator and the Timestamp Authority's public key material, without
access to the operator's infrastructure. For SB 1120 adverse
determination appeals, the CareGuard Audit Trace provides:
documentation of independent QHR review (SB 1120 requirement); RFC
3161 timestamp proving contemporaneity; qhr_independent_basis
documenting independent clinical judgment; and the three-layer
integrity architecture proving the record has not been altered.
9. Security Considerations
The security considerations of [I-D.veridom-omp] apply in full.
Patient data sensitivity: CareGuard Audit Traces will routinely
contain or be associated with Protected Health Information (PHI)
under HIPAA. Operators MUST implement HIPAA-compliant safeguards for
Audit Trace storage, access, and disclosure.
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QHR identity integrity: The qhr_npi field MUST reflect the NPI of the
actual clinician who reviewed the AI recommendation. Operators MUST
implement technical controls to prevent NPI assignment without the
clinician's authenticated action. The review_timestamp MUST be set
by the OMP pipeline at the time of the QHR's authenticated review
action.
Patient Safety Override integrity: The patient_safety_override field
MUST be set by the OMP Watchtower framework, not by the operator's
application layer. Operators MUST NOT implement mechanisms allowing
the patient_safety_override flag to be unset after being set by WT-
CLINICAL-02.
Confidence floor integrity: Changes to the clinical confidence floor
MUST be treated as configuration changes requiring the same
governance approval as clinical protocol changes, and MUST generate a
WT-CLINICAL-05 anomaly record.
10. IANA Considerations
This document has no IANA actions.
11. References
11.1. Normative References
[I-D.veridom-omp]
Adebayo, T., Apalowo, O., and F. Makanjuola, "Operating
Model Protocol (OMP): A Deterministic Decision-Enforcement
Protocol with Externalized Proof-of-Integrity", Work in
Progress, Internet-Draft, draft-veridom-omp-00, March
2026, <https://datatracker.ietf.org/doc/html/draft-
veridom-omp-00>.
[RFC2119] Bradner, S., "Key words for use in RFCs to Indicate
Requirement Levels", BCP 14, RFC 2119, March 1997,
<https://www.rfc-editor.org/info/rfc2119>.
[RFC3161] Adams, C., Cain, P., Pinkas, D., and R. Zuccherato,
"Internet X.509 Public Key Infrastructure Time-Stamp
Protocol (TSP)", RFC 3161, August 2001,
<https://www.rfc-editor.org/info/rfc3161>.
[RFC8174] Leiba, B., "Ambiguity of Uppercase vs Lowercase in RFC
2119 Key Words", BCP 14, RFC 8174, May 2017,
<https://www.rfc-editor.org/info/rfc8174>.
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[RFC8785] Rundgren, A., Jordan, B., and S. Erdtman, "JSON
Canonicalization Scheme (JCS)", RFC 8785, June 2020,
<https://www.rfc-editor.org/info/rfc8785>.
11.2. Informative References
[CA-SB1120]
California Legislature, "Senate Bill 1120: Health care
coverage: utilization review: artificial intelligence",
2024.
[CHAI-2025]
Joint Commission and Coalition for Health AI (CHAI),
"Responsible Use Guide for Healthcare AI", September 2025.
[CMS-0057-F]
Centers for Medicare and Medicaid Services, "CMS
Interoperability and Prior Authorization Final Rule (CMS-
0057-F)", January 2024.
[I-D.veridom-omp-aiins]
Adebayo, T., Apalowo, O., and F. Makanjuola, "OMP Domain
Profile: AI Liability Insurance Underwriting and
Parametric Claims Evidence", Work in Progress, Internet-
Draft, draft-veridom-omp-aiins-00, April 2026,
<https://datatracker.ietf.org/doc/html/draft-veridom-omp-
aiins-00>.
[I-D.veridom-omp-euaia]
Adebayo, T., Apalowo, O., and F. Makanjuola, "OMP Domain
Profile: EU AI Act Article 12 Logging and Traceability
Requirements for High-Risk AI System Operators", Work in
Progress, Internet-Draft, draft-veridom-omp-euaia-00,
April 2026, <https://datatracker.ietf.org/doc/html/draft-
veridom-omp-euaia-00>.
[NY-A9149] New York State Assembly, "Assembly Bill A9149: Relates to
health insurance coverage and artificial intelligence",
2025.
[OMP-OPEN-CORE]
Veridom Ltd, "OMP Open Core: Reference Validator and
Schema Library", Apache 2.0,
https://github.com/veridomltd/omp-open-core, 2026.
[ZENODO-OMP]
Adebayo, T., Apalowo, O., and F. Makanjuola, "OMP --
Operating Model Protocol: A Deterministic Routing
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Invariant for Tamper-Evident AI Decision Accountability in
Regulated Industries", Zenodo DOI 10.5281/zenodo.19140948,
March 2026.
Authors' Addresses
Tolulope Adebayo
Veridom Ltd
London
United Kingdom
Email: tolulope@veridom.io
Oluropo Apalowo
Veridom Ltd
Awka
Nigeria
Email: ropo@veridom.io
Festus Makanjuola
Veridom Ltd
Toronto
Canada
Email: festus@veridom.io
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