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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

HIPAA 준수 감사 및 보안 위험 평가

OCR 감시에 대비한 보안 위험 분석

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.

프로젝트가 실패하는 이유

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.

컴플라이언스

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.

우리가 만드는 것

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).

우리의 프로세스

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

자주 묻는 질문

HIPAA 보안 위험 평가가 법적으로 필요합니까?

네. 45 CFR § 164.308(a)(1)(ii)(A)는 모든 대상 주체 및 업무 담당자가 ePHI에 대한 잠재적 위험 및 취약점에 대한 정확하고 철저한 평가를 수행할 것을 요구합니다. OCR은 이 단계를 건너뛴 특정 사건에 대해 $1M을 초과하는 벌금을 부과했습니다. 조직 규모는 중요하지 않습니다. 이는 선택사항이 아닙니다.

HIPAA 위험 평가는 얼마나 자주 수행해야 합니까?

규정은 고정된 일정을 설정하지 않지만 § 164.308(a)(8)은 정기적인 기술 및 비기술 평가를 요구합니다. OCR 지침 및 집행 이력 모두 연 1회를 최소한의 예상 횟수로 지적합니다. 또한 중대한 시스템 변경, 새로운 통합 또는 보안 사건 후에도 재평가해야 합니다.

NIST 800-66과 OCR 감사 프로토콜의 차이점은 무엇입니까?

NIST 800-66은 HIPAA 보안 규칙 요구사항을 특정 평가 활동 및 통제에 매핑하는 자발적 구현 가이드입니다. OCR 감사 프로토콜은 HHS가 준수 감사 중에 사용하는 집행 체크리스트입니다. 당사는 둘 다에 맞춰 진행합니다. — NIST 800-66은 기술적 엄격성을 위해, OCR 프로토콜은 감사 준비를 위해 사용됩니다.

다른 기술 스택으로 구축된 웹 애플리케이션을 평가할 수 있습니까?

네. 당사는 Next.js, Supabase 및 최신 JavaScript 스택을 전문으로 하지만 당사의 HIPAA 평가 방법론은 프레임워크와 관계없이 작동합니다. 당사는 보안 통제를 평가하지 언어를 평가하지 않습니다. 당사는 Rails, Django, Laravel, .NET 및 레거시 PHP 플랫폼에서 구축된 애플리케이션을 평가했습니다.

평가 후 어떤 결과물을 받게 됩니까?

완전한 위험 등록부(점수가 매겨진 발견사항 포함), ePHI 데이터 흐름 다이어그램, NIST 800-66 교차 참조 문서, OCR 감사 프로토콜 요소에 매핑된 격차 분석 보고서, 구현 지침이 포함된 우선순위 개선 로드맵을 받게 됩니다. 모든 문서는 규제 기관 검토를 위해 포맷됩니다.

발견된 취약점도 수정합니까?

네. 보고서에서 멈추는 준수 컨설턴시와 달리 당사는 개발팀입니다. 당사는 기술적 개선를 직접 코드베이스에 구현합니다. — 접근 제어, 암호화, 감사 로깅, 보안 API 설계. 모든 수정사항은 종료되기 전에 원래 발견사항에 대해 검증됩니다.

HIPAA Security Risk Assessment from $8,000

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

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