Trust
Compliance posture
Last updated September 24, 2026
Kairos is a healthcare platform, and every part of it is designed against the frameworks a hospital's privacy officer, security team and counsel will ask about. Each control carries cross-framework keys, so one implementation produces evidence for all of them.
Honest status. Kairos is designed and evidenced against these frameworks; it is not yet certified. Live control status is published inside the product and summarised on the Compliance page.
How to read the status
Statuses use the legend of our compliance register.
- Designed & evidenced
- Implemented in the product; where a runtime check exists, it produces evidence continuously.
- Infrastructure
- Implemented by the cloud infrastructure stack: encryption, backups, TLS, image scanning.
- At pilot
- Required before real patient data enters the system. Tracked, and not needed for the synthetic demonstration.
Frameworks
HIPAA and HITECH
Privacy, Security and Breach Notification Rules · implemented per NIST SP 800-66 r2
Every Security Rule safeguard is mapped to where it lives: role-based access, a 15-minute automatic logoff, an encrypted identifier vault and an append-only audit trail.
- Control ids cite the NIST SP 800-66 activity each satisfies.
- Direct identifiers live only in an encrypted vault; one service may decrypt them, and every decrypt is logged.
- Breach workflow follows the 60-day HHS notice and the 500-plus media notice.
Designed & evidencedHITRUST CSF v11
e1 → i1 → r2
Controls carry HITRUST domain tags so one implementation produces evidence for the assessment hospitals ask vendors for. Target: e1 readiness at pilot, i1 in year one.
- Tagged domains include access control, transmission protection, password management, and data protection and privacy.
- r2 is planned alongside the first large health-system deployment.
At pilotSOC 2 Type II
Security · Availability · Confidentiality · Privacy
Controls map to the Trust Services Criteria and evidence is collected automatically where possible. No audit has been performed yet; the first window opens after the pilot.
- Change management runs through reviewed pull requests, CI gates and versioned database migrations.
- Boundary protection: security headers, an allow-listed CORS policy and rate limiting.
Designed & evidencedISO/IEC 27001, 27002 and 27799
ISMS · Annex A · health informatics
Annex A tagging yields a Statement of Applicability, and the health-informatics additions — patient-record audit trails, pseudonymisation, clinical-system availability — are built in.
- Data-leakage prevention: a log scrubber and no identifiers in URLs.
- Supplier relationships are tracked in a business-associate registry with agreement status per vendor.
Designed & evidencedISO/IEC 42001 and NIST AI RMF
AI management system · AI risk
An inventory of every AI use with its intended purpose, a human decision on every recommendation, stored tool traces, and a bias review of risk adjustment.
- Nothing the AI produces is applied automatically.
- Every answer stores the tool calls that produced it, so a reviewer can see exactly which queries ran.
Designed & evidencedNIST CSF 2.0 and HHS 405(d)
Govern · Identify · Protect · Detect · Respond · Recover
The executive view of the register, with the health-sector cybersecurity practices for vulnerability management, backups, access and incident response.
- Dependency scanning in CI and image scanning in the container registry.
- Encrypted automated database snapshots with cross-region copies and point-in-time recovery.
InfrastructureCalifornia CMIA, H&SC §1280.15 and CCPA/CPRA
Civil Code §56 · Health & Safety Code §1280.15 · Civil Code §1798.82
The pilot state's stricter medical-privacy law, the 15-business-day clock for reporting unlawful access to the state health department, and consumer privacy for non-medical personal data.
- The incident-response runbook has a California branch with the 15-business-day clock.
- No marketing use of medical information, ever.
At pilot21st Century Cures Act
ONC information blocking
Kairos never blocks export: every dataset is downloadable as a FHIR Bundle, NDJSON or CSV.
- Kairos is not an EHR and is not ONC-certified, and it still treats export as a right, not a feature.
Designed & evidencedFDA Clinical Decision Support guidance
Non-device CDS (2022)
Kairos stays non-device software: it shows the basis for every recommendation, supports rather than replaces clinician judgment, and never analyses medical images or physiological signals.
- Copy rules enforce this: "flagged for review", "recommended for release", never a clinical conclusion about a patient.
Designed & evidencedAnti-Kickback Statute, Stark Law and CMP gainsharing
OIG gainsharing safeguards
The safeguards are enforced in software: a safety gate, indicated-only stewardship, caps, independent validation, a documented method and attorney review before any program activates.
- The value program is the platform's highest legal-risk feature, so it is designed to fail closed.
Designed & evidencedWCAG 2.1 AA and Section 508
Accessibility
Keyboard navigation, 4.5:1 text contrast, visible focus and labelled controls on every page — a hospital procurement requirement.
- Charts carry text alternatives and data tables; status is never conveyed by colour alone.
Designed & evidenced
Not applicable by design
PCI DSS — Kairos never touches payment card data. 42 CFR Part 2 — substance-use-disorder program records are excluded from the episode model.
Selected controls
A selection from the control catalogue that is seeded into the product. Customers see every control with its latest evidence inside Kairos.
| Control | Implementation | Status |
|---|---|---|
| Access controlHIPAA-164.312(a)(1) | Roles, facility scoping and an explicit PHI grant | Designed & evidenced |
| Automatic logoffHIPAA-164.312(a)(2)(iii) | 15-minute idle timeout with a server-side session registry | Designed & evidenced |
| Encryption and decryptionHIPAA-164.312(a)(2)(iv) | Identifier vault, AES-256-GCM, versioned keys | Designed & evidenced |
| Audit controlsHIPAA-164.312(b) | Append-only, hash-chained audit and PHI access log | Designed & evidenced |
| Transmission securityHIPAA-164.312(e)(1) | TLS-only load balancer with HSTS | Infrastructure |
| Contingency planHIPAA-164.308(a)(7) | Encrypted snapshots, cross-region copy, point-in-time recovery | Infrastructure |
| Business associate contractsHIPAA-164.308(b) | Registry with agreement status per vendor | Designed & evidenced |
| De-identificationHIPAA-164.514(b) | De-identified context and an outbound guard for every AI call | Designed & evidenced |
| Vulnerability managementSOC2-CC7.1 | Dependency scanning in CI, image scanning in the registry | Infrastructure |
| Human oversight of AIISO42001-A.9 | Nothing auto-applied; recommendations need a person | Designed & evidenced |
| OIG gainsharing safeguardsAKS_STARK-gainsharing | Safety gate, indicated-only stewardship, caps, validation, legal-review flag | Designed & evidenced |
| Privacy programHITRUST-19.a | Privacy officer role and approved policies | At pilot |
| California authorisation rulesCMIA-56.10 | Privacy policy; no marketing use of medical information | At pilot |
AI governance commitments
Aligned with ISO/IEC 42001 and the NIST AI Risk Management Framework, and with HIPAA de-identification.
De-identified context only
The AI layer can only receive de-identified aggregates. A structural type and a guard on every outbound request block identifiers, and a blocked call is logged.
Tool traces you can read
Every answer stores the queries that produced it, one click from the answer.
Estimates you check
AI-generated numbers are labelled as estimates, shown in a distinct colour, and carry their basis.
Nothing auto-applied
Recommendations wait for a person. Releasing a block, booking a case or validating a saving is always a human action.
Data, not instructions
Free-text fields never enter system prompts; they are passed as tool results explicitly framed as data.
Gainsharing safeguards
The value program is the platform's highest legal-risk feature because it connects hospital savings to clinician pay. The Anti-Kickback Statute, the Stark Law and the Civil Monetary Penalties Law govern it, so the OIG safeguards are enforced in software.
Safety gate
No value payment in a period where a minimum safety or compliance threshold is missed.
Risk adjustment
Outcomes are adjusted for procedure, acuity (ASA) and patient factors outside the team's control.
No single-metric payment
Payment rests on a balanced scorecard; weights are configurable per hospital.
Indicated-only stewardship
Stewardship counts only tests and consults the protocol says were not indicated, so avoiding necessary care is never rewarded.
No payment without validation
Every savings line passes clinical review and finance review before it is shared.
Caps and a documented method
Payouts are capped, the method is written down, and every program carries an attorney-review flag that must clear before activation.
Governance cadence
Once a pilot is live, the register is reviewed on a fixed rhythm.
- Monthly
- Review failed evidence checks and break-glass use; recertify access for PHI-granted users.
- Quarterly
- Update the risk register; review vendors and business associate agreements; test a restore from backup.
- Annually
- HIPAA risk analysis, penetration test, policy re-approval, workforce training renewal, HITRUST and SOC 2 assessment window.
The live register is inside the product
Customers' administrators see every control with its implementation, cross-framework keys and the timestamp of its latest evidence check, run by the platform itself. Security questionnaires and the named sub-processor list are available on request — see the security page.