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

HIPAA 合規性稽核與安全風險評估

針對 OCR 審查而設計的安全風險分析

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.

專案失敗的原因

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.

合規

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.

我們構建的內容

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).

我們的流程

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

常見問題

HIPAA 安全風險評估在法律上是否為必需？

是的。45 CFR § 164.308(a)(1)(ii)(A) 要求每一個受保護實體和業務夥伴進行準確且徹底的 ePHI 潛在風險和漏洞評估。OCR 因跳過此步驟而課處超過 100 萬美元的罰款。組織規模無關緊要。這不是選項。

應多久進行一次 HIPAA 風險評估？

法規並未規定固定時間表，但 § 164.308(a)(8) 要求進行定期的技術和非技術評估。OCR 指南和執法歷史都指向每年至少一次作為預期最低標準。系統發生重大變更、新整合或安全事件後，您也應重新評估。

NIST 800-66 與 OCR 稽核協議之間有何差異？

NIST 800-66 是一份自願性實施指南，將 HIPAA 安全規則要求對應至特定評估活動和控制措施。OCR 稽核協議是 HHS 在合規性稽核期間使用的執法檢查清單。我們與兩者相一致 — NIST 800-66 用於技術嚴謹性，OCR 協議用於稽核準備。

您能否評估基於不同技術堆疊構建的網路應用程式？

可以。我們專精於 Next.js、Supabase 和現代 JavaScript 堆疊，但我們的 HIPAA 評估方法論適用於任何框架。我們評估的是安全控制措施，而非語言。我們已評估在 Rails、Django、Laravel、.NET 和舊版 PHP 平台上構建的應用程式。

評估後我們會收到什麼交付物？

您將收到完整的風險登記簿（含評分結果）、ePHI 資料流程圖、NIST 800-66 交叉對照文件、對應至 OCR 稽核協議元素的差距分析報告，以及優先級排序的補救路線圖和實施指南。所有內容均格式化以供監管機構審查。

您是否也會修復發現的漏洞？

是的。與在報告階段停止的合規顧問公司不同，我們是開發團隊。我們直接在您的程式碼庫中實施技術補救 — 存取控制、加密、稽核日誌、安全 API 設計。每個修復在結案前都會針對原始結果進行驗證。

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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