Big Ideas,
Real Impact.

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 & Innovation Pathway

Progress as of May 2026

NHS Innovation Service

United Kingdom

Needs Assessment
Support Org Assigned
Intake Call Complete
Technical Positioning Submitted May 18
Technical Positioning Review
Support Pathway Confirmed
Design Partner Deploy

UK Data Protection & GDPR

Information Commissioner's Office

Guidance Requested
Active Case Review
Response Received May 22
Trust DPIA
Compliance Certified

NHS Digital Technology Assessment

DTAC Classification

Pre-prototype Scoping
Classification Confirmed
Assessment Pathway
Full Compliance

US Regulatory Alignment

OHRP & Federal Framework

Federal Engagement
OHRP Determination
Outside 45 CFR Part 46 scope — written confirmation May 2026
Framework Design
Clinical Validation

US HIPAA & Federal AI Governance

Market Regulatory Environment

HIPAA Gap Identified — no AI attribution framework
Federal Framework Watch
NIST AI RMF Alignment
Federal Pilot
Compliance Certified

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
ANDHealth Office Hours
May 17, 2026
TGA Pre-submission Meeting
June 24, 2026
ARTG Alignment

EU — European AI Office

EU AI Act Article 14 Framework

Inquiry Submitted
Service Desk Guidance
Outside AI Act scope — Case SIP0001236
DG CONNECT Policy Inquiry
May 2026
AI Office Direct Engagement
Article 14 Alignment
EU Market Pathway
Milestone complete
In progress
Upcoming

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