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Healthcare & HIPAA Compliance

45 CFR § 164.308NIST 800-66OCR Audit Protocol

Auditoría de Cumplimiento HIPAA y Evaluación de Riesgos de Seguridad

Análisis de Riesgos de Seguridad Diseñado para Escrutinio de 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.

Dónde fallan los proyectos

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.

Cumplimiento

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.

Qué construimos

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).

Nuestro proceso

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

Preguntas frecuentes

¿Es legalmente requerida una evaluación de riesgos de seguridad HIPAA?

Sí. 45 CFR § 164.308(a)(1)(ii)(A) requiere que toda entidad cubierta y asociado comercial realice una evaluación precisa y exhaustiva de riesgos potenciales y vulnerabilidades a ePHI. OCR ha impuesto sanciones superiores a $1M específicamente por omitir este paso. El tamaño de la organización no importa. Esto no es opcional.

¿Con qué frecuencia debe realizarse una evaluación de riesgos HIPAA?

La regulación no establece un cronograma fijo, pero § 164.308(a)(8) requiere evaluaciones técnicas y no técnicas periódicas. La guía de OCR y el historial de cumplimiento apuntan a anualmente como el mínimo esperado. También debes reevaluar después de cambios significativos del sistema, nuevas integraciones o incidentes de seguridad.

¿Cuál es la diferencia entre NIST 800-66 y el protocolo de auditoría OCR?

NIST 800-66 es una guía de implementación voluntaria que mapea los requisitos de la Regla de Seguridad HIPAA a actividades y controles de evaluación específicos. El protocolo de auditoría OCR es la lista de verificación de cumplimiento que HHS utiliza durante auditorías. Nos alineamos con ambos — NIST 800-66 para rigor técnico, el protocolo OCR para preparación de auditoría.

¿Pueden evaluar una aplicación web construida en un stack tecnológico diferente?

Sí. Nos especializamos en Next.js, Supabase y stacks modernos de JavaScript, pero nuestra metodología de evaluación HIPAA funciona independientemente del framework. Estamos evaluando los controles de seguridad, no el lenguaje. Hemos evaluado aplicaciones construidas en Rails, Django, Laravel, .NET y plataformas PHP heredadas.

¿Qué entregables recibimos después de la evaluación?

Recibirás un registro de riesgos completo con hallazgos puntuados, un diagrama de flujo de datos ePHI, un documento de mapeo NIST 800-66, un informe de análisis de brechas mapeado a elementos del protocolo de auditoría OCR, y una hoja de ruta de remediación priorizada con guía de implementación. Todo está formateado para revisión regulatoria.

¿También corrigen las vulnerabilidades que encuentran?

Sí. A diferencia de las consulterías de cumplimiento que se detienen en informes, somos un equipo de desarrollo. Implementamos remediaciones técnicas — controles de acceso, cifrado, registro de auditoría, diseño seguro de API — directamente en tu base de código. Cada corrección se verifica contra el hallazgo original antes de cerrarse.

HIPAA Security Risk Assessment from $8,000

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

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