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Healthcare & HIPAA Compliance
45 CFR § 164.308NIST 800-66OCR Audit Protocol

HIPAA コンプライアンス監査 & セキュリティリスク評価

OCR 精査に対応したセキュリティリスク分析

100%
ePHI Safeguards
Administrative, physical, technical
75+
Control Points
NIST 800-66 mapped
0
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.

プロジェクトが失敗する理由

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.

コンプライアンス

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.

構築する内容

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).

私たちのプロセス

01

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
02

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
03

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
04

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
05

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

よくある質問

HIPAA セキュリティリスク評価は法律で要求されていますか?

はい。45 CFR § 164.308(a)(1)(ii)(A) は、すべてのカバード・エンティティとビジネス・アソシエイトに対して、ePHI への潜在的リスクと脆弱性の正確で徹底的な評価を実施することを要求しています。OCR はこのステップをスキップした場合、100万ドルを超える罰金を課しています。組織の規模は関係ありません。これは任意ではありません。

HIPAA リスク評価はどのくらいの頻度で実施すべきですか?

規制では固定スケジュールを設定していませんが、§ 164.308(a)(8) は定期的な技術的および非技術的評価を要求しています。OCR ガイダンスと執行履歴の両方は、年 1 回が最低限の期待値であることを示しています。重大なシステム変更、新しい統合、またはセキュリティインシデント後も再評価すべきです。

NIST 800-66 と OCR 監査プロトコルの違いは何ですか?

NIST 800-66 は、HIPAA Security Rule の要件を具体的な評価活動とコントロールにマップする任意の実装ガイドです。OCR 監査プロトコルは、HHS がコンプライアンス監査中に使用する執行チェックリストです。当社は両方に準拠しています — 技術的厳密性のための NIST 800-66 と、監査準備のための OCR プロトコルです。

異なるテクノロジースタックで構築されたウェブアプリケーションを評価できますか?

はい。当社は Next.js、Supabase、モダン JavaScript スタックを専門としていますが、当社の HIPAA 評価方法論はフレームワークに関係なく機能します。言語ではなくセキュリティコントロールを評価しています。Rails、Django、Laravel、.NET、レガシー PHP プラットフォームで構築されたアプリケーションを評価した経験があります。

評価後、どのような成果物を受け取りますか?

スコア付き所見を含む完全なリスクレジスタ、ePHI データフロー図、NIST 800-66 クロスウォーク文書、OCR 監査プロトコル要素にマップされたギャップ分析レポート、実装ガイダンス付きの優先順位付き改善ロードマップを受け取ります。すべて規制当局のレビュー用にフォーマットされています。

見つかった脆弱性も修正してくれますか?

はい。レポートで終わるコンプライアンスコンサルティングとは異なり、当社は開発チームです。アクセス制御、暗号化、監査ログ、セキュアな API 設計などの技術的改善をコードベースに直接実装します。すべての修正は、クローズされる前に元の所見に対して検証されます。

HIPAA Security Risk Assessment from $8,000
Fixed-fee. Includes risk register, remediation roadmap, and 30-day post-delivery support.
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Next.js DevelopmentCore Web Vitals Optimization GuideWordPress to Next.js Migration

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