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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

HIPAA Compliance Audit & Security Risk Assessment

Security Risk Analysis Built for OCR Scrutiny

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.

Waar projecten falen

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.

Wat we bouwen

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).

Ons proces

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

Veelgestelde vragen

Is a HIPAA security risk assessment legally required?

Yes. 45 CFR § 164.308(a)(1)(ii)(A) requires every covered entity and business associate to conduct an accurate and thorough assessment of potential risks and vulnerabilities to ePHI. OCR has imposed penalties exceeding $1M specifically for skipping this step. Organization size doesn't matter. This isn't optional.

How often should a HIPAA risk assessment be performed?

The regulation doesn't set a fixed schedule, but § 164.308(a)(8) requires periodic technical and non-technical evaluations. OCR guidance and enforcement history both point to annually as the expected minimum. You should also reassess after significant system changes, new integrations, or security incidents.

What is the difference between NIST 800-66 and the OCR audit protocol?

NIST 800-66 is a voluntary implementation guide that maps HIPAA Security Rule requirements to specific assessment activities and controls. The OCR audit protocol is the enforcement checklist HHS uses during compliance audits. We align to both — NIST 800-66 for technical rigor, the OCR protocol for audit readiness.

Can you assess a web application built on a different tech stack?

Yes. We specialize in Next.js, Supabase, and modern JavaScript stacks, but our HIPAA assessment methodology works regardless of framework. We're evaluating the security controls, not the language. We've assessed applications built on Rails, Django, Laravel, .NET, and legacy PHP platforms.

What deliverables do we receive after the assessment?

You'll receive a complete risk register with scored findings, an ePHI data flow diagram, a NIST 800-66 crosswalk document, a gap analysis report mapped to OCR audit protocol elements, and a prioritized remediation roadmap with implementation guidance. Everything's formatted for regulator review.

Do you also fix the vulnerabilities you find?

Yes. Unlike compliance consultancies that stop at reports, we're a development team. We implement technical remediations — access controls, encryption, audit logging, secure API design — directly in your codebase. Every fix gets verified against the original finding before it's closed.

HIPAA Security Risk Assessment from $8,000

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

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