🏥 Healthcare compliance · Free audit · Generate full stack

Compliance for Healthcare & Business Associates

Every provider, telehealth platform, billing service, and SaaS vendor touching PHI needs a real HIPAA program — not a 2-page template. ComplianceIQ generates Privacy Notices, Security Policies, BAAs, IRPs, and risk assessments tuned to your role.

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The Healthcare compliance stack

4 frameworks typically in scope. Click any to run the free framework-specific audit.

HIPAA Privacy + Security Rule
Core regulation — Privacy Rule (45 CFR §164.500-534) + Security Rule (§164.302-318)
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SOC 2 (Type 2)
De-facto requirement for healthcare SaaS selling to hospitals or payers
Free audit →
GDPR
Any patient data from EU/UK residents or EU clinical trial sites
Free audit →
ISO 27001:2022
Often paired with HIPAA for medical-device + global expansion
Free audit →

The 4-document Healthcare bundle

Generate any or all in PDF + DOCX. Maps to HIPAA, SOC, GDPR, ISO.

1
HIPAA Privacy Notice + Policies
HIPAA
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2
HIPAA Security Policy (45 CFR §164.308-312)
HIPAA / NIST
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3
Breach Notification + Incident Response Plan
HIPAA §164.404-410
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4
Website Privacy Policy (state law + GDPR coverage)
CCPA / GDPR
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Who buys this

  • Practice Administrator
  • Compliance Officer
  • CISO
  • CTO at digital-health startup
  • Privacy Officer

When teams reach for ComplianceIQ

  • OCR sent a corrective action plan after a complaint
  • Enterprise customer demanding signed BAA + Security Policy
  • Investor diligence flagged HIPAA gaps in data room
  • Launching telehealth, RPM, or AI-clinical product
  • Hospital system contract requires HITRUST or SOC 2 + HIPAA mapping

Real healthcare enforcement actions

$16M
Anthem (2018)
78.8M-record breach — largest HIPAA settlement in history
$6.85M
Premera Blue Cross (2020)
11M record breach + risk-analysis failure
$100K
Doctors' Management Services (2023)
First ransomware HIPAA settlement under OCR
$7.8M
BetterHelp (FTC, 2023)
Disclosed sensitive mental-health data to Meta/Snap ads

Why healthcare compliance projects fail

Marketing pixels on PHI pages
December 2022 OCR bulletin: third-party trackers (Meta Pixel, GA4) on patient portals, scheduling, or symptom-checker pages disclose PHI. Multiple hospital systems have settled $multi-million class actions in 2023-2024.
Subcontractor BAA chain breaks
Your BAs need BAAs with THEIR sub-processors. Common gaps: logging vendors, analytics, support tools, AI APIs. OCR audits walk the entire chain.
No documented risk analysis
§164.308(a)(1)(ii)(A) — the #1 OCR audit finding. 'We did one once' fails — they want recurring, dated, signed assessments.
Telehealth platform = covered entity OR business associate?
If you charge patients directly = often Covered Entity. If you sit between provider + patient = often BA. Get this wrong and your entire compliance model is wrong.

Healthcare compliance FAQ

Does my SaaS that touches PHI need HIPAA?
Yes — if you create, receive, maintain, or transmit PHI on behalf of a Covered Entity, you ARE a Business Associate by statute (45 CFR §160.103), regardless of how you market yourself. You need a signed BAA, a Privacy + Security Policy, and the §164.308-312 safeguards.
HITRUST vs SOC 2 vs HIPAA?
HIPAA = the regulation (mandatory). SOC 2 = audit framework (de-facto required by hospital + payer buyers). HITRUST = HIPAA-specific certification (deepest, most expensive). Most digital-health startups start with HIPAA policies + SOC 2 Type 2, add HITRUST when enterprise demand justifies it.
What does it cost to be HIPAA compliant?
Policies + procedures: $0-$10K (ComplianceIQ covers this). Risk analysis + remediation: $10K-$100K depending on scope. SOC 2 audit: $30K-$80K/year. Breach response: $200-$400 per PHI record (Ponemon 2024) if you fail.

Generate your Healthcare compliance stack

Bundle pricing: 4 documents, mapped to 4 frameworks, PDF + DOCX, custom-tailored to your org. From $49/mo (unlimited).

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