Enterprise Security

Regulatory-grade security for healthcare AI

Skippy is built for environments where evidence is on the line. Our security architecture meets the rigorous demands of healthcare, finance, and regulated industries.

Regulatory Requirements

Three frameworks. Three active deadlines.

Healthcare AI now operates under enforceable regulatory frameworks that require what most AI architectures cannot provide: a traceable evidence chain from output to source. Skippy is built to satisfy these requirements structurally.

EU AI Act (Regulation 2024/1689)

Enforcing

High-risk obligations: August 2026

What it requires

Article 13: Technical documentation of knowledge base and how outputs are derived
Article 17: Quality management system with audit records for every decision
Article 14: Human oversight measures — knowledge boundary must be disclosed
Post-market monitoring with incident reporting to national authorities

How Skippy satisfies it

Skippy's architecture generates Article 13 and 17 documentation by construction — every output carries source lineage, confidence, and an immutable audit record. No post-processing required.

CMS Prior Authorization Rule (CMS-0057-F)

Active

PA API: January 2026 · Full compliance: January 2027

What it requires

PA denials must include a reason specific enough for the provider to understand which criterion was not met
AI-driven PA rationale must be traceable to specific clinical criteria — publicly available and versioned
Audit trail must reproduce the original denial rationale at appeal time
72-hour turnaround requirement for urgent PA decisions

How Skippy satisfies it

Skippy Auth returns a named clinical criterion, version date, and source citation with every decision. Every response is logged to an immutable audit record anchored to a versioned evidence snapshot — reproducible at appeal.

FDA Software as a Medical Device (SaMD)

Active

Ongoing — AI/ML Action Plan

What it requires

Predetermined Change Control Plan required for knowledge updates
CDS exemption requires clinician to independently review the evidence basis
Algorithm Change Protocol must gate all model updates affecting safety
Post-market monitoring with performance thresholds and incident reporting

How Skippy satisfies it

Skippy returns the full evidence chain underlying every recommendation — enabling independent clinician review, which is the structural requirement for the CDS exemption. Change gates run automatically on every evidence update.

Why LLMs can't satisfy these requirements →

Audit Trail Architecture

Cryptographically chained. 7-year retention. Tamper-evident by design.

Every API call produces an immutable audit record. Records are SHA-256 chained — any modification to a historical record invalidates every subsequent hash, detectable in a single linear scan.

Audit record schema

{
  "request_id":   "UUID per API call",
  "timestamp":    "UTC — NTP-synced",
  "query":        "submitted claim or query",
  "outcome":      "SUPPORTED | NOT_COVERED | ...",
  "confidence":   0.94,
  "sources_used": ["PubMed:12345", "ClinVar:67890"],
  "prev_hash":    "SHA-256 of previous record",
  "record_hash":  "SHA-256 of this record"
}

Chain integrity verification: any gap or modification detectable in a single linear scan. Export available for compliance review.

Regulatory compliance

Requirement	Framework	Implementation
Audit trail for all actions	FDA 21 CFR Part 11	Every API call logged
Tamper detection	FDA 21 CFR Part 11	SHA-256 hash chain
7-year retention	FDA 21 CFR Part 11	Active + compressed archive
Record & examine activity	HIPAA §164.312(b)	Full query + outcome + sources
Decision documentation	EU AI Act Art. 13	Source lineage per output
Decisions replayable	EU AI Act Art. 13	Versioned evidence snapshot

Security Architecture

Defense in depth, from data to deployment

Data Encryption

AES-256 encryption at rest (all persistent data)
TLS 1.3 encryption in transit (all API traffic)
Key management via AWS KMS with automatic rotation
Encrypted backups with separate key storage

Access Controls

Role-based access control (RBAC) for all admin interfaces
Single Sign-On (SSO) via SAML 2.0 for enterprise customers
Multi-factor authentication (MFA) required for all users
Audit logging of all access attempts and admin actions
Session timeouts after 15 minutes of inactivity

Network Security

VPC isolation for all production services
Web Application Firewall (WAF) with OWASP Top 10 rules
DDoS protection via Cloudflare Enterprise
Private endpoints for all data and monitoring services
No ports exposed to public internet (localhost only in dev)

Audit & Compliance

Immutable audit logs (7-year retention)
SOC 2 Type II certified
HIPAA Business Associate Agreement (BAA) available
GDPR-compliant data handling and deletion
Regular third-party security assessments

Shared Responsibility

What Skippy owns. What you own.

Skippy retains zero PHI after a request resolves. Audit records contain only metadata — hash, outcome, source IDs, confidence tier — enabling 7-year compliance retention without re-identification risk.

Skippy's responsibility

✓Encryption in transit (TLS 1.3) and at rest (AES-256)
✓API authentication and rate limiting
✓Audit trail integrity — SHA-256 Merkle chain, tamper-evident
✓7-year audit log retention on immutable storage (S3 Object Lock)
✓Zero PHI retention after request resolves
✓Verifier gate enforcement — no response issued on critical violation
✓PCCP gate compliance — blocks deployment on calibration failure
✓Incident detection, triage, and breach notification

Customer's responsibility

User authentication and identity management within your environment
Network perimeter and access controls between your systems and the API
Audit log access authorization (who in your org can read exports)
API key rotation and credential management
PHI de-identification before submitting queries (for additional assurance)
User training and acceptable use policy enforcement

No customer data is used for model training or improvement. Customer submissions are not shared across tenants.

Compliance & Certifications

Meeting the world's toughest standards

Framework	Status	Target Date	Details
SOC 2 Type II	Certified	Active	Comprehensive audit of security, availability, and confidentiality controls — certified.
HIPAA	Ready	Available Now	Full BAA available. Infrastructure configured for HIPAA-compliant deployments.
GDPR	Compliant	Active	Data residency options for EU customers. Right to deletion implemented.
Penetration Testing	Annual	Last: Q1 2026	Third-party pen test by accredited firm. Zero critical findings. Executive summary available in security package.
FedRAMP	In Progress	2027	FedRAMP Moderate authorization in progress. FISMA Moderate architecture available now on Government plan.
ISO 27001	In Progress	Q2 2027	Information security management system certification.

Request Security Documentation

Data Residency

Where your data lives matters

Skippy offers data residency options to meet regional compliance requirements:

US East (Virginia)

Primary region. HIPAA-compliant infrastructure. SOC 2 Type II certified.

EU West (Ireland)

GDPR-compliant. EU data residency. Enhanced encryption controls.

On-Premises

For organizations with strict data sovereignty requirements. Full control of infrastructure.

Subprocessors

Third-party services and their compliance posture

Skippy notifies customers 30 days before adding or changing a subprocessor. No subprocessor receives PHI — audit logs are metadata-only. All subprocessors are bound by Data Processing Agreement.

Subprocessor	Purpose	PHI access	Certifications
Amazon Web Services (AWS)	Compute, storage, primary infrastructure	No — metadata only	SOC 2, ISO 27001, HIPAA BAA, FedRAMP High
AWS KMS	Encryption key management	No	FIPS 140-2, SOC 2
Cloudflare Enterprise	DDoS protection, WAF, CDN	No	SOC 2 Type II, ISO 27001
Datadog	Infrastructure monitoring and alerting	No — metrics and traces only	SOC 2 Type II, HIPAA BAA available

Complete subprocessor list with DPA references available in the security documentation package. Request it →

Independent Verification

Verify Skippy responses without trusting our servers

Every Skippy response carries a cryptographic signature. skippy-verify is an open-source Python package that performs offline verification — checking Ed25519 signatures, Merkle root integrity, key revocation, and optional transparency-log inclusion proofs. No Skippy infrastructure required.

Signature present

Rejects any response missing the signature block — no fallback

Key lookup

Fetches the Ed25519 public key from your configured registry with TTL caching

Key revocation check

Confirms the signing key has not been revoked before accepting the signature

Merkle root recomputation

Canonically reconstructs the signing payload and verifies the Merkle root hash

Ed25519 signature

Cryptographically validates the signature against the recomputed payload

Response hash

Confirms the response text has not been modified after signing

Install

pip install skippy-verify

Verify a response

from skippy_verify import ResponseVerifier

verifier = ResponseVerifier(

key_registry_url="https://keys.your-org.com"

)

result = verifier.verify(signed_response)

if result.verified:

# response is cryptographically intact

else:

# result.failures lists each failed step

Signing payload schema

spec_version: "skippy-sig/v1"

key_id · issued_at · skippy_version

request_id · audit_log_id

response_hash (SHA-256)

citations (pass-through)

All open source packages →

Incident Response

Breach notification and incident response

Skippy maintains a documented incident response plan covering detection, triage, containment, eradication, recovery, and post-incident review. Customers are notified before applicable regulatory deadlines.

Customer notificationWithin 24 hours of confirmed breach

HIPAA breach notificationWithin 60 days (per HHS requirements)

GDPR breach notificationWithin 72 hours to supervisory authority

Critical incident triage SLAAcknowledged within 1 hour

Security contact

Responsible disclosure & urgent incidents:

security@skippy.ai

Bug bounty program in progress. Responsible disclosure acknowledged within 24 hours.

Penetration testing

Annual third-party pen test by accredited firm. Last engagement: Q1 2026. Zero critical findings. Executive summary available on request.

Need security documentation for your evaluation?

We'll send you our complete security whitepaper, SOC 2 progress report, and HIPAA BAA template.

Request Security Package