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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

HIPAA-Compliance-Audit & Security-Risikoanalyse

Security-Risikoanalyse für OCR-Prüfungen

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.

Wo Projekte scheitern

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.

Compliance

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.

Was wir bauen

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).

Unser Prozess

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

Häufige Fragen

Ist eine HIPAA-Sicherheitsrisikoanalyse gesetzlich vorgeschrieben?

Ja. 45 CFR § 164.308(a)(1)(ii)(A) verpflichtet alle Covered Entities und Business Associates zu einer genauen und umfassenden Bewertung potenzieller Risiken und Schwachstellen für ePHI. Die OCR hat Strafen von über 1 Mio. USD speziell für das Auslassen dieses Schritts verhängt. Die Größe der Organisation spielt keine Rolle. Dies ist nicht optional.

Wie oft sollte eine HIPAA-Risikoanalyse durchgeführt werden?

Die Verordnung sieht keinen festen Zeitplan vor, aber § 164.308(a)(8) verlangt regelmäßige technische und nicht-technische Evaluierungen. OCR-Leitlinien und Durchsetzungsgeschichte deuten auf jährlich als erwartetes Minimum hin. Sie sollten auch nach erheblichen Systemänderungen, neuen Integrationen oder Sicherheitsvorfällen neu bewerten.

Welcher Unterschied besteht zwischen NIST 800-66 und dem OCR-Audit-Protokoll?

NIST 800-66 ist ein freiwilliger Implementierungsleitfaden, der HIPAA-Security-Rule-Anforderungen auf spezifische Bewertungsaktivitäten und Kontrollen abbildet. Das OCR-Audit-Protokoll ist die Durchsetzungs-Checkliste, die HHS während Compliance-Audits verwendet. Wir richten uns nach beiden — NIST 800-66 für technische Strenge, das OCR-Protokoll für Audit-Bereitschaft.

Können Sie eine Webanwendung mit einem anderen Tech-Stack bewerten?

Ja. Wir sind auf Next.js, Supabase und moderne JavaScript-Stacks spezialisiert, aber unsere HIPAA-Bewertungsmethodologie funktioniert unabhängig vom Framework. Wir bewerten die Sicherheitskontrollen, nicht die Sprache. Wir haben Anwendungen bewertet, die auf Rails, Django, Laravel, .NET und Legacy-PHP-Plattformen erstellt wurden.

Welche Ergebnisse erhalten wir nach der Bewertung?

Sie erhalten ein vollständiges Risk Register mit bewerteten Findings, ein ePHI-Datenfluss-Diagramm, ein NIST-800-66-Crosswalk-Dokument, einen Gap-Analysis-Bericht mit Zuordnung zu OCR-Audit-Protokoll-Elementen und eine priorisierte Remediation-Roadmap mit Implementierungsleitlinien. Alles ist für die Regulator-Überprüfung formatiert.

Beheben Sie auch die Schwachstellen, die Sie finden?

Ja. Im Gegensatz zu Compliance-Beratungen, die bei Berichten enden, sind wir ein Entwicklungsteam. Wir implementieren technische Abhilfemaßnahmen — Zugriffskontrolle, Verschlüsselung, Audit Logging, sichere API-Design — direkt in Ihrem Codebase. Jeder Fix wird gegen das ursprüngliche Finding überprüft, bevor er geschlossen wird.

HIPAA Security Risk Assessment from $8,000

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

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