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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.

Waar projecten falen

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.

Compliance

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.

Wat we bouwen

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.

Ons proces

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

Veelgestelde vragen

Hoe lang duurt het om een SaaS-applicatie HIPAA-compliant te maken?

Voor een typische SaaS-startup met een bestaande applicatie kun je rekenen op 4–6 weken. Dit omvat de volledige security risk assessment, herstel van hiaten zoals ontbrekende encryptie en audit logging, beleidsdocumentatie en definitieve validatie. Als je helemaal nieuw bouwt op onze stack, ben je direct compliant.

Heb ik HIPAA-compliance nodig als ik alleen geanonimiseerde gegevens opslag?

Als jouw gegevens echt geanonimiseerd zijn volgens HIPAAs Safe Harbor-methode—alle 18 identificeerbare elementen verwijderd—is het geen PHI en is HIPAA niet van toepassing. Maar de meeste startups onderschatten wat als identificeerder telt. Datums, postcodes, apparaat-ID's—dit alles kan kwalificeren. We controleren jouw geanonimiseeringsproces om er zeker van te zijn dat je echt veilig zit, niet alleen aanneemt.

Wat is het verschil tussen HIPAA en HITECH-compliance?

HIPAA creëerde de Security Rule en Privacy Rule ter bescherming van gezondheidsgegevens. De HITECH Act van 2009 breidde deze regels uit naar business associates, verhoogde maximale boetes naar $1,9M per schendingscategorie en voegde meldingsplichten voor inbreuken toe. Ze werken samen—je kunt niet één volgen en de ander negeren.

Maakt het gebruik van AWS of GCP mijn app automatisch HIPAA-compliant?

Nee. AWS, GCP en Azure bieden HIPAA-geschikte services en ondertekenen BAA's, maar compliance is gedeelde verantwoordelijkheid. Je moet zelf encryptie, toegangscontrole, logging en netwerkindeling configureren. Een standaard S3-bucket of Cloud SQL-instantie met standaardinstellingen laat PHI blootgesteld—het maakt niet uit wat je cloudprovider heeft ondertekend.

Wat gebeurt er als mijn SaaS-startup een HIPAA-audit niet doorstaat?

OCR-boetes lopen van $100 tot $50.000 per schending, met jaarlijkse maxima tot $1,9M per schendingscategorie. Afgezien van boetes, kijk je naar verplichte corrigerende maatregelplannen, mogelijke strafrechtelijke verwezen voor opzettelijke nalatigheid en het soort reputatieschade dat je sales-pipeline voor gezondheidszorg stiekem doet verdwijnen. Nu compliant worden kost minder dan dit alles.

Kunt u ons helpen een security review van een grote zorgsysteem door te komen?

Ja. Grote gezondheidssystemen voeren grondige leveranciersbeoordelingen uit—vaak meer dan 200 veiligheidsvragen op basis van HITRUST- of NIST-kaders. We bereiden je documentatie voor, helpen je bij vragenlijsten en behandelen vervolgvragen van hun security teams. Onze cliënten slagen deze reviews routinematig in bij de eerste indiening.

HIPAA Compliance Engagements from $8,000

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

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