HIPAA does not have a formal certification program — there is no "HIPAA certified" stamp from a government body. However, the HIPAA Security Rule requires covered entities and business associates to conduct regular risk assessments. Many organizations engage third-party auditors to perform comprehensive HIPAA assessments, gap analyses, and mock audits to prepare for OCR investigations or demonstrate compliance to customers and partners.
Healthcare cybersecurity specialist acquired by ClearDATA. Clearwater is widely recognized as a leader in HIPAA risk analysis and has worked with hundreds of health systems, hospitals, and digital health companies. They offer IRM|Pro software for ongoing compliance management.
Leading cybersecurity assessment firm with extensive HIPAA audit experience. Schellman can bundle HIPAA assessments with SOC 2 and HITRUST engagements for organizations that need multiple compliance reports.
Major cybersecurity firm with a dedicated healthcare practice. Coalfire performs HIPAA risk assessments, penetration testing, and compliance audits for health systems, health plans, and health-tech companies.
Full-service compliance firm offering HIPAA assessments alongside SOC 2, ISO 27001, and other frameworks. A-LIGN is popular with digital health startups and health-tech companies seeking multiple certifications simultaneously.
CPA firm offering HIPAA compliance assessments as part of their broader SOC 2 and compliance services. Johanson Group works with healthcare technology vendors and business associates.
Utah-based firm specializing in data security and compliance assessments. SecurityMetrics offers affordable HIPAA assessments with a focus on risk analysis, vulnerability scanning, and penetration testing.
A CPA firm specializing in cybersecurity and healthcare compliance. Zero Day CPA combines accounting credentials with deep technical expertise, offering HIPAA assessments alongside SOC 2 engagements for health-tech companies.
Healthcare-only cybersecurity firm serving hospitals, health systems, and health plans. Fortified Health Security provides managed security services, HIPAA risk assessments, and ongoing compliance monitoring tailored exclusively to the healthcare sector.
$15,000 – $90,000
Depending on organization size, scope, and complexity. First-time assessments may include readiness and gap analysis fees.
2-4 weeks for a gap analysis, followed by 4-8 weeks for a full risk assessment and remediation roadmap. Ongoing compliance monitoring is typically annual.
Walk into your audit with policies already drafted and evidence organized. PoliWriter generates HIPAA-specific policies customized to your infrastructure, saving weeks of preparation and reducing auditor billable hours.
No. HHS does not endorse or recognize any private HIPAA certification. However, third-party assessments are considered best practice and can demonstrate due diligence in the event of an OCR investigation or data breach.
The HIPAA Security Rule (45 CFR 164.308(a)(1)) requires covered entities and business associates to conduct a thorough risk analysis of their ePHI environment. This is the single most cited deficiency in OCR enforcement actions.
HIPAA requires an annual risk analysis at minimum. Best practice is to conduct a full third-party assessment every 1-2 years, with ongoing internal monitoring and quarterly vulnerability scans.
HIPAA is a US federal law. HITRUST CSF is a certifiable framework that incorporates HIPAA requirements along with other standards (ISO 27001, NIST, PCI DSS). HITRUST certification can demonstrate HIPAA compliance but goes beyond it.
Yes. Business associates (vendors that handle ePHI on behalf of covered entities) are directly liable under HIPAA and must comply with the Security Rule. Many covered entities require their business associates to provide third-party assessment reports.
HIPAA assessments typically range from $15,000 to $90,000 depending on organization size, complexity of ePHI environment, and scope (Security Rule only vs. Security + Privacy + Breach Notification rules).
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