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Healthcare & Compliance

Security RulePrivacy RuleHITECH Act

HIPAA Compliance Consulting for SaaS & Healthcare

Security Rule. Privacy Rule. HITECH. Handled.

100%

Audit Pass Rate

Across client assessments

$2M+

Fines Avoided

For our clients

< 30

Days to Compliance

Typical SaaS engagement

Breaches Post-Launch

Clean track record

What Is HIPAA Compliance Consulting?

HIPAA compliance consulting means we evaluate your web application, infrastructure, and org policies against the HIPAA Security Rule, Privacy Rule, and HITECH Act. For SaaS startups handling protected health information (PHI), that work surfaces real technical gaps—encryption holes, weak access controls, missing audit logs, unsigned BAAs—and gives you a concrete remediation roadmap to satisfy federal requirements before OCR shows up at your door.

프로젝트가 실패하는 이유

Your SaaS stores PHI but you've never done a formal risk assessment OCR can fine you $50K–$1.9M per violation category. No breach required.

Your engineers built auth but skipped audit logging and encryption at rest Skip those technical safeguards and your whole platform falls out of compliance—not just the parts they missed.

You signed a BAA with a covered entity but didn't cover your subprocessors When a downstream vendor gets breached, that's your liability under the HITECH Act.

You've got no documented workforce training policy and no incident response plan Administrative safeguard failures are the most commonly cited HIPAA violations—and the easiest ones for OCR to prove.

You're pitching enterprise health systems and they want proof of compliance We've seen startups lose $500K+ contracts because they couldn't produce a simple attestation letter.

Your infrastructure runs on standard cloud tiers without BAA-covered services AWS, GCP, and Azure all require specific configurations and signed BAAs before they qualify.

컴플라이언스

End-to-End Encryption

AES-256 encryption at rest, TLS 1.3 in transit, for every piece of PHI you handle. We trace every data path from browser to database to backup.

Access Control & RBAC

Role-based access control with minimum necessary permissions. That means MFA enforcement, automatic session timeouts, and unique user IDs—not optional, required.

Audit Trail Logging

Immutable audit logs that capture every PHI access, modification, and deletion. Tamper-proof storage with a 6-year retention policy baked in.

Risk Assessment & Gap Analysis

Formal SRA documentation that actually meets OCR requirements. We find every vulnerability and score it by likelihood and impact—nothing vague, nothing left out.

BAA Management

We review and execute Business Associate Agreements across your entire vendor chain. Every subprocessor touching PHI gets mapped and covered.

Incident Response Planning

Breach notification procedures built to hit the 60-day HITECH reporting window. We run tabletop exercises so your team isn't figuring it out during an actual incident.

우리가 만드는 것

Security Rule Technical Safeguards

All 22 technical safeguard specifications—encryption, integrity controls, transmission security—implemented and verified. Not just checked off a list.

Privacy Rule Policy Development

Custom privacy policies, Notice of Privacy Practices, and minimum necessary standards written around your application's actual data flows. Not boilerplate.

HITECH Act Breach Preparedness

Breach risk tools, notification templates, and OCR reporting workflows ready before you ever need them. You don't want to be building these under pressure.

Infrastructure Hardening

BAA-covered cloud configurations on AWS GovCloud, Azure Healthcare APIs, or GCP—with network segmentation and intrusion detection included.

Penetration Testing & Vulnerability Scanning

Third-party pen tests targeting PHI exposure vectors, with full remediation support and re-testing to confirm everything's actually fixed.

Compliance Documentation Portal

One central repository holding all your policies, risk assessments, training records, and BAAs. Hand it to any auditor in minutes.

우리의 프로세스

Discovery & Scoping

We start by mapping every system, vendor, and data flow that touches PHI. You get a full inventory and a clear scope before we do anything else.

Week 1

Security Risk Assessment

Then comes the formal SRA—every HIPAA Security Rule safeguard, scored and documented, with each finding tied to a specific remediation action.

Week 2

Remediation & Implementation

We fix the technical gaps: encryption, access controls, audit logging, infrastructure config. Your team handles policy and training with our templates while we work.

Weeks 3–5

Validation & Documentation

Once everything's remediated, we re-assess to confirm all findings are closed. Then we compile your compliance package—policies, SRA, BAAs, training logs, and your attestation letter.

Week 6

Ongoing Monitoring

After that, it's quarterly vulnerability scans, annual SRA updates, and on-call support whenever you need breach response or new vendor onboarding.

Ongoing

Next.jsSupabaseVercelAWS GovCloudCloudflarePostgreSQLSOC 2 Tooling

자주 묻는 질문

SaaS 애플리케이션을 HIPAA 준수로 만드는 데 얼마나 걸립니까?

기존 애플리케이션을 보유한 일반적인 SaaS 스타트업의 경우 4–6주가 소요됩니다. 여기에는 전체 보안 위험 평가, 암호화 누락 및 감사 로깅과 같은 격차 해결, 정책 문서화 및 최종 검증이 포함됩니다. 당사 스택에서 처음부터 구축하는 경우 처음부터 준수할 수 있습니다.

익명화된 데이터만 저장하면 HIPAA 준수가 필요합니까?

데이터가 HIPAA의 Safe Harbor 방법에 따라 진정으로 익명화된 경우—18개의 식별자가 모두 제거됨—PHI가 아니며 HIPAA가 적용되지 않습니다. 하지만 대부분의 스타트업은 식별자로 간주되는 것을 과소평가합니다. 날짜, 우편번호, 기기 ID—모두 식별자로 적격일 수 있습니다. 당사가 익명화 프로세스를 감사하여 추측이 아닌 실제로 안전한지 확인하겠습니다.

HIPAA와 HITECH 준수의 차이점은 무엇입니까?

HIPAA는 건강 정보를 보호하기 위해 Security Rule과 Privacy Rule을 만들었습니다. 2009년 HITECH Act는 이러한 규칙을 업무 관련자에게 확대하고, 최대 벌금을 위반 범주당 190만 달러로 올렸으며, 위반 공시 요구사항을 추가했습니다. 그들은 함께 작동합니다—하나를 준수하고 다른 하나를 무시할 수 없습니다.

AWS 또는 GCP를 사용하면 자동으로 HIPAA 준수가 됩니까?

아닙니다. AWS, GCP 및 Azure는 HIPAA 적격 서비스를 제공하고 BAA에 서명하지만, 준수는 공동 책임입니다. 여전히 암호화, 접근 제어, 로깅 및 네트워크 분할을 직접 구성해야 합니다. 기본 설정에서 표준 S3 버킷 또는 Cloud SQL 인스턴스는 PHI를 노출시킵니다—클라우드 제공자가 서명한 것은 중요하지 않습니다.

내 SaaS 스타트업이 HIPAA 감사에 실패하면 어떻게 됩니까?

OCR 벌금은 위반당 $100에서 $50,000 범위이며, 연간 최대값은 위반 범주당 190만 달러에 달합니다. 벌금을 넘어서 필수 시정 조치 계획, 고의적 무시에 대한 잠재적 형사 송치 및 의료 영업 파이프라인을 조용히 죽이는 평판 손상을 보게 될 것입니다. 지금 준수를 갖추는 것이 그 중 어느 것이든 비용이 더 적습니다.

의료 엔터프라이즈 공급업체 보안 검토를 통과하도록 도와줄 수 있습니까?

네. 대규모 의료 시스템은 진지한 공급업체 평가를 실행합니다—종종 HITRUST 또는 NIST 프레임워크에 기반한 200개 이상의 질문 보안 설문지입니다. 당사가 문서를 준비하고, 설문지를 함께 작성하며, 보안 팀의 후속 기술 질문을 처리합니다. 당사 클라이언트는 일반적으로 첫 제출에서 이러한 검토를 통과합니다.

HIPAA Compliance Engagements from $8,000

Fixed-fee. Includes SRA, remediation, and 30-day post-launch support.

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