Pre-seed team.

Global regulatory traction.

Attribution infrastructure that must exist.

The Problem

Clinical AI is already influencing decisions — ambient scribes, radiology LLMs, copilots in every workflow. Model monitoring platforms watch whether the AI is drifting. EHR audit trails capture the signed record. Nobody captures what happened between the AI output and the signature — what was surfaced, whether the clinician found it admissible, what was decided. That moment currently disappears.

The Solution

CAVAL is the open governance standard that captures the attribution record at the moment AI influences a clinical decision. Vendor-agnostic, FHIR R4 compatible, tamper-evident, and designed to sit underneath any AI tool already deployed.

CAVAL is not a decision support tool. It does not suggest or direct care. It documents what happened at the decision point.

The CAVAL Clinical AI Attribution Schema (CAAS) v0.1.2 is published as an open standard under CC BY 4.0.

The Regulatory Reality

UK — NHS DTAC, ICO, and NHS AI governance are moving toward requiring demonstrable audit trails.

EU — The AI Act's Article 14 requires human oversight for high-risk AI. Full enforcement August 2027.

UAE — The National Policy for AI-Driven Smart Healthcare identifies governance, transparency, and accountability as core pillars. Clinical AI is deploying at national scale across NABIDH and Malaffi. The attribution layer doesn't exist yet.

Australia — The TGA requires continuous monitoring for AI scope creep into medical device territory.

US — HIPAA has no framework for AI-influenced clinical decisions. There is no federal requirement to document what AI surfaced, no standard for capturing the clinician's response, and no audit trail requirement at the encounter level. The Trump administration's March 2026 National Policy Framework asked Congress to establish a single federal approach — but until that framework exists, the gap is structural. A health law attorney advising a hospital on HIPAA compliance today cannot point their client to any federal standard for AI attribution.

Kairoc Systems Inc. is a Delaware healthcare AI governance company. CAVAL™ is published as an open standard under CC BY 4.0. github.com/cavallayer

Meet the Team

Regulatory pathway updated · HTML

Regulatory & Innovation Pathway

Progress as of September 2026

September 10, 2026 — The UK's National Commission into the Regulation of AI in Healthcare (established by MHRA) published its formal recommendations for a future regulatory framework, naming continuous lifecycle monitoring, transparency, and accountability as foundational requirements — directly validating the provenance gap CAVAL is built to close.

NHS Innovation Service

United Kingdom

Needs Assessment
Support Org Assigned
Health Innovation Yorkshire & Humber
Intake Call Complete
Technical Positioning Submitted May 18
Technical Positioning Review
Completed Aug 20

UK Data Protection & GDPR

Information Commissioner's Office

Guidance Requested
Active Case Review
Response Received May 22
Trust DPIA
Follow-up sent — response overdue
Compliance Certified

NHS Digital Technology Assessment

DTAC Classification

Pre-prototype Scoping
Classification Confirmed

US Regulatory Alignment

OHRP & Federal Framework

Federal Engagement
OHRP Determination
Outside 45 CFR Part 46 scope — written confirmation May 2026

UAE — Dubai Health Authority

National AI Healthcare Framework

Inquiry Submitted
DHA Dept Review
Classification Guidance
Framework Alignment

Australia — TGA

Therapeutic Goods Administration

Pre-submission Inquiry
Guidance Received
Pre-submission Guidance
May 2026
TGA Pre-submission Meeting
June 2026
Written Confirmation Received
July 2026 — Not a medical device; ARTG not required

United States — ASTP/ONC

USCDI ONDEC Submission

Account Registered
Submission Prepared
Submission Filed
July 2026 — new USCDI data element proposed
ONC Level Determination
Public comment expected October 2026
USCDI Version Consideration

EU — European AI Office

EU AI Act Article 14 Framework

Inquiry Submitted
Service Desk Guidance
Closed Jun 2026 — favorable classification signal
Policy Inquiry
Resolved May 2026
Article 14 Alignment
Milestone complete
In progress
Upcoming

Kairoc Systems Inc.  ·  CAVAL™  ·  www.cavallayer.ai