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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

Audit de Conformité HIPAA et Évaluation des Risques de Sécurité

Analyse des Risques de Sécurité Conçue pour le Contrôle de l'OCR

100%

ePHI Safeguards

Administrative, physical, technical

75+

Control Points

NIST 800-66 mapped

OCR Findings

Across client audits

48hr

Gap Report Delivery

After initial assessment

What Is a HIPAA Security Risk Assessment?

A HIPAA security risk assessment is a formal evaluation required under 45 CFR § 164.308(a)(1)(ii)(A). It identifies threats and vulnerabilities to electronic protected health information (ePHI), then checks your web application's technical, administrative, and physical safeguards against NIST 800-66 controls and the OCR audit protocol. The result is a clear picture of residual risk — plus a remediation plan that holds up to federal enforcement.

Où les projets échouent

Your web application handles ePHI but has never gone through a formal SRA OCR treats a missing risk analysis as a per-violation penalty — up to $2.13M per category.

Developers built authentication but skipped access controls mapped to workforce roles That violates § 164.312(a)(1) — the access control standard OCR cites more than anything else.

Audit logs exist but don't capture the six required data points per NIST 800-66 Incomplete audit trails fail the OCR audit protocol's Activity Review requirement.

You signed a BAA with your cloud provider but never actually verified their controls Covered entities are still on the hook for ePHI breaches caused by business associate negligence.

Your team treats HIPAA compliance as a one-time checkbox rather than ongoing risk management § 164.308(a)(8) requires periodic technical and non-technical evaluations — and OCR checks the timestamps.

Encryption gets applied inconsistently across data at rest and in transit Unencrypted ePHI breaches don't qualify for safe harbor under the Breach Notification Rule. That's a problem.

Conformité

Administrative Safeguard Mapping

We map every § 164.308 administrative safeguard directly to your application architecture — security management processes, workforce security, and information access management controls included.

Technical Safeguard Validation

Access controls, audit controls, integrity controls, and transmission security are all verified against § 164.312 requirements. Each control gets tested against your production environment.

NIST 800-66 Control Alignment

Every identified risk gets mapped to the corresponding NIST 800-66 Rev1 activity. You'll receive a crosswalk document that OCR auditors recognize and accept.

OCR Audit Protocol Readiness

We evaluate your application against all 180 OCR audit protocol elements covering Privacy, Security, and Breach Notification Rules. Gap findings are ranked by enforcement risk.

Encryption & Key Management Review

AES-256 at rest, TLS 1.3 in transit, key rotation policies — all assessed against NIST standards. We verify your implementation actually protects ePHI, not just that it looks good on paper.

Risk Register & Remediation Roadmap

The deliverable includes a scored risk register with likelihood, impact, and residual risk calculations. Each finding comes with a concrete remediation task your development team can act on immediately.

Ce que nous construisons

ePHI Flow Diagrams

A visual map of every ePHI touchpoint — from ingestion through storage, processing, transmission, and disposal — across your entire application stack.

Row-Level Security Audit

Verification that database access policies enforce minimum necessary access at the row and column level for every user role.

Penetration Testing

Targeted penetration tests against authentication, session management, and API endpoints that handle ePHI.

BAA Compliance Review

Analysis of all business associate agreements against actual subprocessor controls and data handling practices.

Incident Response Plan Validation

Testing your breach notification workflow against the 60-day reporting requirement and any applicable state notification laws.

Continuous Monitoring Architecture

Design and implementation of automated compliance monitoring that satisfies the periodic evaluation standard under § 164.308(a)(8).

Notre processus

Scope & ePHI Inventory

We identify every system, database, API, and third-party service that creates, receives, maintains, or transmits ePHI. That defines the assessment boundary.

Week 1

Threat & Vulnerability Analysis

Threats and vulnerabilities are identified systematically and mapped to each ePHI asset using NIST 800-30 methodology for consistent risk scoring.

Week 2

Control Assessment & Gap Analysis

Every existing safeguard gets tested against § 164.308, § 164.310, and § 164.312 requirements alongside NIST 800-66 activities. Gaps are documented with evidence.

Week 3

Risk Scoring & Remediation Plan

Residual risks are scored by likelihood and impact. You get a prioritized remediation roadmap with estimated effort, responsible parties, and target completion dates.

Week 4

Remediation & Verification

We implement technical fixes directly in your application — access controls, encryption, audit logging, secure configurations — and verify each remediation actually closes the identified gap.

Weeks 5-8

Next.jsSupabaseVercelRow-Level SecurityAES-256 EncryptionSOC 2 InfrastructureAudit Logging

Questions fréquentes

Une évaluation des risques de sécurité HIPAA est-elle légalement requise ?

Oui. 45 CFR § 164.308(a)(1)(ii)(A) exige que chaque entité couverte et associé commercial conduise une évaluation précise et complète des risques potentiels et des vulnérabilités pour les ePHI. L'OCR a imposé des amendes dépassant 1 M$ spécifiquement pour avoir omis cette étape. La taille de l'organisation n'a pas d'importance. Ce n'est pas optionnel.

À quelle fréquence une évaluation des risques HIPAA doit-elle être effectuée ?

La réglementation ne fixe pas d'échéance précise, mais § 164.308(a)(8) exige des évaluations techniques et non techniques périodiques. Les lignes directrices de l'OCR et l'historique des mises en œuvre pointent tous deux vers un minimum annuel. Vous devriez également réévaluer après des changements système significatifs, de nouvelles intégrations, ou des incidents de sécurité.

Quelle est la différence entre NIST 800-66 et le protocole d'audit de l'OCR ?

NIST 800-66 est un guide de mise en œuvre volontaire qui mappe les exigences de la Règle de Sécurité HIPAA à des activités d'évaluation et des contrôles spécifiques. Le protocole d'audit de l'OCR est la liste de vérification d'application que le HHS utilise lors des audits de conformité. Nous nous alignons sur les deux — NIST 800-66 pour la rigueur technique, le protocole OCR pour la préparation à l'audit.

Pouvez-vous évaluer une application web construite sur une pile technologique différente ?

Oui. Nous nous spécialisons dans Next.js, Supabase, et les piles JavaScript modernes, mais notre méthodologie d'évaluation HIPAA fonctionne quel que soit le framework. Nous évaluons les contrôles de sécurité, pas le langage. Nous avons évalué des applications construites sur Rails, Django, Laravel, .NET, et des plates-formes PHP héritées.

Quels sont les livrables reçus après l'évaluation ?

Vous recevrez un registre complet des risques avec des résultats notés, un diagramme de flux de données ePHI, un document de correspondance NIST 800-66, un rapport d'analyse des lacunes mappé aux éléments du protocole d'audit OCR, et une feuille de route de correction priorisée avec des conseils de mise en œuvre. Tout est formaté pour l'examen du régulateur.

Corrigez-vous également les vulnérabilités que vous trouvez ?

Oui. Contrairement aux cabinets de conformité qui s'arrêtent aux rapports, nous sommes une équipe de développement. Nous mettons en œuvre les corrections techniques — contrôles d'accès, chiffrement, journalisation d'audit, conception sécurisée des API — directement dans votre base de code. Chaque correction est vérifiée par rapport à la conclusion initiale avant sa fermeture.

HIPAA Security Risk Assessment from $8,000

Fixed-fee. Includes risk register, remediation roadmap, and 30-day post-delivery support.

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