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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

Auditoria de Conformidade HIPAA e Avaliação de Risco de Segurança

Análise de Risco de Segurança Desenvolvida para Escrutínio do OCR

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.

Onde os projetos falham

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.

Conformidade

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.

O que construímos

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).

Nosso processo

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

Perguntas frequentes

Uma avaliação de risco de segurança HIPAA é obrigatória por lei?

Sim. 45 CFR § 164.308(a)(1)(ii)(A) exige que toda entidade coberta e associado comercial conduza uma avaliação precisa e completa dos riscos e vulnerabilidades potenciais ao ePHI. O OCR impôs penalidades superiores a $1M especificamente por pular esta etapa. O tamanho da organização não importa. Isso não é opcional.

Com que frequência uma avaliação de risco HIPAA deve ser realizada?

O regulamento não estabelece um cronograma fixo, mas § 164.308(a)(8) exige avaliações técnicas e não-técnicas periódicas. A orientação do OCR e o histórico de execução apontam para anualmente como o mínimo esperado. Você também deve reavaliar após alterações significativas do sistema, novas integrações ou incidentes de segurança.

Qual é a diferença entre NIST 800-66 e o protocolo de auditoria do OCR?

NIST 800-66 é um guia de implementação voluntário que mapeia os requisitos da Regra de Segurança HIPAA para atividades e controles de avaliação específicos. O protocolo de auditoria do OCR é a lista de verificação de execução que o HHS usa durante auditorias de conformidade. Nos alinhamos a ambos — NIST 800-66 para rigor técnico, o protocolo do OCR para prontidão de auditoria.

Você pode avaliar uma aplicação web construída em um stack tecnológico diferente?

Sim. Nos especializamos em Next.js, Supabase e stacks modernos de JavaScript, mas nossa metodologia de avaliação HIPAA funciona independentemente do framework. Estamos avaliando os controles de segurança, não a linguagem. Avaliamos aplicações construídas em Rails, Django, Laravel, .NET e plataformas PHP legadas.

Quais são os entregáveis após a avaliação?

Você receberá um registro de risco completo com descobertas pontuadas, um diagrama de fluxo de dados ePHI, um documento de crosswalk NIST 800-66, um relatório de análise de lacunas mapeado para elementos do protocolo de auditoria do OCR e um roteiro de remediação priorizado com orientação de implementação. Tudo está formatado para revisão regulatória.

Vocês também corrigem as vulnerabilidades que encontram?

Sim. Diferentemente das consultadorias de conformidade que param em relatórios, somos um time de desenvolvimento. Implementamos remediações técnicas — controles de acesso, criptografia, registro de auditoria, design seguro de API — diretamente no seu código. Cada correção é verificada em relação à descoberta original antes de ser fechada.

HIPAA Security Risk Assessment from $8,000

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

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