Legal

Security Risk Assessment Framework

Effective Date: February 2026

Document Version: 1.0

1. Purpose

This Security Risk Assessment Framework ("Framework") establishes the methodology by which Rymeda, Inc. ("Rymeda," "we," "us") identifies, assesses, mitigates, and monitors security risks to the confidentiality, integrity, and availability of electronic Protected Health Information (ePHI) and all information systems under Rymeda's control. This Framework satisfies the requirements of HIPAA §164.308(a)(1)(ii)(A) (Risk Analysis) and is aligned with NIST SP 800-30 Rev 1.

2. Scope

This Framework applies to all systems, applications, data stores, and network components that create, receive, maintain, or transmit ePHI, including: cloud infrastructure (AWS VPC, S3, Cognito, KMS, CloudWatch, Shield), databases (MongoDB Atlas), the application layer (FastAPI, Next.js), AI/ML pipeline (OpenAI with ZDR, Google Gemini via LiteLLM, ORIS clinical AI), authentication (Cognito, RBAC, MFA), communication systems (telehealth, secure messaging), and all third-party subprocessors.

3. Framework Alignment

FrameworkVersionFunctions / Areas
NIST CSF2.0Govern, Identify, Protect, Detect, Respond, Recover
HIPAA Security Rule45 CFR Part 164Administrative, Physical, Technical Safeguards; Risk Analysis (§164.308(a)(1)(ii)(A))
NIST SP 800-53Rev 5Security and Privacy Controls (RA, CA, PM control families)

4. Risk Assessment Methodology

Rymeda uses a qualitative 5×5 risk matrix evaluating likelihood against impact. Scores range from 1 to 25.

4.1 Risk Matrix (Likelihood × Impact)

Likelihood / Impact1 Negligible2 Minor3 Moderate4 Major5 Catastrophic
5 Almost Certain510152025
4 Likely48121620
3 Possible3691215
2 Unlikely246810
1 Rare12345

4.2 Risk Levels

LevelScoreRequired Action
Critical20–25Immediate remediation; CISO notification within 24 hours; executive escalation
High15–19Remediation plan within 7 days; CISO review required; tracked in risk register
Medium8–14Remediation within 30 days; risk owner assigned; monitored quarterly
Low1–7Accept or remediate within 90 days; documented; reviewed annually

5. Asset Inventory Categories

CategoryRymeda SystemsClassification
Clinical Data SystemsCharts, SOAP notes, voice transcription, vitals, labs, diagnoses, ORIS AI outputsRestricted (PHI)
Authentication InfrastructureAWS Cognito (3 app clients, PKCE, RS256 JWT), bcrypt passwords, MFARestricted
AI/ML PipelineOpenAI (Whisper, GPT — ZDR), Google Gemini (via LiteLLM), ORIS with guardrailsRestricted (PHI)
Communication SystemsTelehealth video (100ms), secure messaging, patient portal, care team channelsConfidential
StorageMongoDB Atlas, Amazon S3 (voice, documents), AWS KMS (per-tenant keys)Restricted (PHI)
Network / APIAWS VPC, WAF, Shield, TLS 1.3, CORS, rate limiting (slowapi)Internal

6. Threat Identification

Rymeda uses the STRIDE threat model mapped to healthcare-specific threat scenarios:

STRIDE CategoryHealthcare ThreatsCountermeasures
SpoofingCredential theft, session hijacking, provider impersonation, forged NPICognito PKCE + RS256 JWT, MFA, NPI validation, provider verification
TamperingClinical record modification, AI note alteration, unauthorized chart amendmentsImmutable audit logs, HMAC-SHA256, append-only records, 6-year retention
RepudiationDenied clinical data access, disputed records, unattributed changesCentralized audit service, auto-capture middleware, user/role/IP/timestamp
Information DisclosureePHI breach, unauthorized access, AI data leakage, cross-tenant exposureAES-256 + per-tenant KMS, TLS 1.3, CLINICAL_PERMISSIONS RBAC, org_id isolation, ZDR
Denial of ServicePlatform unavailability, API exhaustion, brute-force auth attacksShield, WAF, slowapi (200/min global, 5/min auth, 3/min sensitive), multi-AZ
Elevation of PrivilegeRole escalation, admin bypass, cross-org access, AI guardrail bypass7 admin + 9 clinical sub-roles, least privilege, ORIS guardrails, trust scoring

7. Current Security Controls

Control AreaImplementationRisk Addressed
Access ControlCognito PKCE + RS256 JWT (3 app clients), RBAC (7 admin + 9 clinical roles), MFA, bcrypt, NPI verificationSpoofing, Elevation of Privilege
EncryptionAES-256 at rest (KMS, per-tenant CMKs), TLS 1.3 in transit, HMAC-SHA256, RS256 tokensInformation Disclosure, Tampering
MonitoringCentralized audit service, auto-capture middleware, CloudWatch, 6-year immutable retentionRepudiation, Information Disclosure
Rate Limitingslowapi: 200/min global, 5/min auth, 10/min general, 3/min sensitiveDenial of Service, Spoofing
NetworkVPC isolation, WAF, Shield, security groups, CORS, CSP headersDenial of Service, Tampering

See the Information Security Policy for the complete controls inventory.

8. Risk Treatment Options

TreatmentDescriptionDecision Criteria
MitigateImplement controls to reduce likelihood or impactCost proportionate to reduction; preferred for Critical/High risks
TransferShare risk via insurance, BAAs, or contractsCannot fully mitigate internally; cyber insurance or vendor controls
AcceptAcknowledge and document residual riskWithin risk appetite; Low scores where mitigation cost exceeds impact; CISO approval required
AvoidEliminate by removing the activity or systemCannot reduce to acceptable level; alternative with lower risk available

HIPAA Requirement: ePHI risks cannot be accepted without documented justification per 45 CFR §164.306(b). All ePHI risk acceptance requires written CISO approval.

9. Assessment Schedule

TypeFrequencyScopeOwner
ComprehensiveAnnualAll systems, assets, threats, controls; full HIPAA §164.308(a)(1)(ii)(A) analysisCISO
TargetedQuarterlyHigh-risk areas, open register items, control effectivenessSecurity
Triggered — New SystemAs neededNew application, vendor, infrastructure, or AI model integrationEngineering
Triggered — IncidentPost-incidentSystems and controls involved in a breach or security incidentCISO
Triggered — RegulatoryAs neededNew HIPAA guidance, state privacy laws, or industry standardsCompliance

10. Risk Register Summary

The risk register is maintained by Compliance and reviewed quarterly by the CISO. Representative entries:

Risk IDDescriptionLIScoreTreatmentOwnerStatus
RSK-001Credential stuffing against auth endpoints3412MitigateSecurityControlled
RSK-002AI hallucinated clinical data in outputs3515MitigateAI TeamControlled
RSK-003Cross-tenant data leakage via API2510MitigateEngineeringControlled
RSK-004AI vendor data retention violation248TransferLegalControlled
RSK-005Ransomware targeting database backups2510MitigateInfraControlled
RSK-006Insider unauthorized clinical data access248MitigateCISOControlled

L = Likelihood, I = Impact. Full register maintained internally and available for audit.

11. Residual Risk Acceptance

After controls are implemented, Rymeda follows a formal process for residual risk:

11.1 Risk Owner Documentation

The risk owner documents the original score, implemented controls, residual score, and justification referencing specific control effectiveness.

11.2 CISO Approval

All residual risk acceptance requires written CISO approval. Critical and High residual risks additionally require executive leadership approval.

11.3 Ongoing Review

Accepted risks are reviewed quarterly and tracked with "Accepted" status and a review date no later than twelve (12) months from acceptance.

12. Continuous Monitoring

12.1 Real-Time Monitoring

CloudWatch for infrastructure alerting. Centralized audit service with auto-capture middleware. Trust scoring for anomaly detection. Brute-force detection after 5+ failures in 15 minutes.

12.2 Vulnerability Scanning

SAST on every commit. DAST weekly. Dependency scanning daily. Remediation SLAs: Critical 24h, High 7d, Medium 30d, Low 90d.

12.3 Penetration Testing

Annual external penetration testing by qualified third-party firm covering application, infrastructure, and API surfaces. Findings scored via risk matrix and tracked in the register.

13. Reporting

  • CISO Risk Report (Monthly): Open risks, register changes, control metrics, emerging threats.
  • Executive Summary (Quarterly): Risk posture, Critical/High status, treatment progress, resource needs.
  • Board Report (Annual): Comprehensive results, year-over-year trends, compliance status, strategic recommendations.
  • Regulatory Submissions: Documentation for OCR audits, SOC 2 Type II, state inquiries. Audit logs retained 6 years per HIPAA §164.530(j).

Contact

Security Team

Risk assessments, vulnerability reports, penetration testing

security@rymeda.com

Compliance Team

Regulatory compliance, audit requests, risk register

legal@rymeda.com

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