SOC 2 Type II and HITRUST r2 are the independent validations that answer enterprise security reviews — and the difference between a deal that closes and one that stalls at procurement. We build toward certification from readiness assessment through the audit period.
Talk to our team about your current control environment and certification goals. We reply within 24 hours.
Enterprise healthcare customers don't take vendors' word on security. SOC 2 Type II and HITRUST are the two independent validation frameworks that answer the question — and a current report is what removes the friction from enterprise sales.
An independent CPA-firm audit evaluating whether security and related controls were suitably designed and operated effectively over a defined period — typically 6–12 months. Enterprise healthcare customers require Type II, not Type I, because it proves sustained operational effectiveness rather than a point-in-time design review.
A comprehensive healthcare-specific certification consolidating HIPAA, NIST, ISO 27001, and PCI DSS requirements into one control set. HITRUST r2 certification — the most rigorous level — is explicitly required by some large health systems and payers as their standard for business associate due diligence.
SOC 2 evaluates controls across five criteria: Security, Availability, Processing Integrity, Confidentiality, and Privacy. Most healthcare-focused audits begin with Security — covering logical and physical access, change management, risk assessment, and incident response — and add criteria based on customer requirements.
A readiness assessment identifies gaps between current practices and the controls required for certification before the audit period begins. Addressing gaps and establishing consistent control operation takes 3–6 months for organizations starting from scratch — beginning proactively prevents year-long delays when enterprise customers ask for a report.
Both SOC 2 and HITRUST require penetration test results as part of the control evidence package. Enterprise healthcare customers review these alongside audit reports during vendor security reviews — and request them independently in procurement questionnaires.
SOC 2 Type II reports must be renewed annually to remain current. HITRUST r2 certification is valid for two years with an interim assessment at year one. The certification is evidence that controls exist — the controls themselves must be maintained continuously between audit cycles.
A five-step program from readiness assessment to audit-ready control evidence — designed so that the first time an enterprise customer asks for a SOC 2 report, the answer is ready.
Enterprise healthcare security reviews stall deals at procurement when vendors rely on self-attestation. A current SOC 2 Type II report or HITRUST certification replaces months of back-and-forth with a document customers' security teams can review directly.
Book a Certification Readiness ConsultationThe right certification depends on your target customer segment, deal size, and stage. Most digital health companies start with SOC 2 Type II and layer in HITRUST when large health system or payer deals require it.
The five domains that SOC 2 auditors evaluate — most healthcare audits begin with Security and add criteria based on customer requirements.
Three certification levels with increasing rigor — r2 is the level enterprise healthcare customers recognize.
Customer segment drives certification strategy — understand what your buyers require before choosing.
HITRUST r2 is significantly more resource-intensive than SOC 2 — plan accordingly.
Both frameworks require the same underlying control evidence — the audit just evaluates it differently.
Certification is not a one-time event — controls must operate consistently between audit cycles.
Compliance tooling, audit evidence platforms, and security infrastructure — selected to support SOC 2 Type II and HITRUST r2 audit cycles and provide the continuous control evidence enterprise customers expect.
V
Vanta
D
Drata
S
Secureframe
T
Tugboat Logic
H
HITRUST MyCSF
A
AWS IAM
A
Azure AD / Entra
O
Okta
A
Auth0
R
Role-Based Access
A
AWS CloudTrail
A
Azure Monitor
D
Datadog
S
Splunk
A
AWS Security Hub
P
Penetration Testing
N
Nessus / Qualys
O
OWASP ZAP
B
Burp Suite
D
Dependency Scanning
We build toward SOC 2 Type II and HITRUST r2 from the readiness assessment through the audit period — so the first time an enterprise customer requests a security report, the answer is a current, independently validated one.
Book a Certification Readiness Consultation
100 Fastest Growth Companies
Global Spring Winner
Top App Development Company
AWS Partner Network
Google Cloud Partner
Highly Rated on Trustpilot
Verified Agency
Top App Development Company
ASSOCHAM Member
Most digital health compliance advisors recommend beginning SOC 2 preparation before or shortly after a company starts handling real patient data in production. A readiness assessment identifies gaps between current practices and audit-ready controls. Addressing those gaps and establishing consistent control operation typically takes 3–6 months. The audit period then runs for 6–12 months before the report is issued. A startup that begins this process after an enterprise customer requests a SOC 2 report faces a delay of a year or more. Beginning proactively means the report is available when enterprise customers ask for it.
No. SOC 2 Type II evaluates controls against the AICPA's Trust Services Criteria, which overlap significantly with HIPAA security requirements but are not identical to them. A SOC 2 Type II report does not constitute a HIPAA compliance assessment or a guarantee that the organization meets all HIPAA requirements. Many healthcare customers accept a SOC 2 Type II report as evidence of a mature security program and use it to streamline their HIPAA business associate due diligence, but it does not replace a proper HIPAA risk analysis or the implementation of all required HIPAA Security Rule safeguards.
SOC 2 Type II is recognized and accepted by most Canadian healthcare organizations as evidence of security maturity — it is a well-known international standard. HITRUST certification is primarily a U.S.-focused framework and while recognized by Canadian organizations with U.S. operations or partnerships, it is less commonly required by Canadian-only healthcare buyers. Digital health companies serving primarily Canadian customers typically find that SOC 2 Type II satisfies security validation requirements, while those serving U.S. markets should evaluate HITRUST based on their specific customer segment.
HITRUST offers three certification levels with increasing rigor. e1 is a foundational level covering a limited control set, assessed through a validated self-assessment. i1 is an independently validated certification covering a broader control set, suitable for organizations that need external validation but are not yet ready for the full r2 process. r2 — formerly called HITRUST CSF Certification — is the most comprehensive level, involving detailed independent testing and validation of the full CSF control set and HITRUST's own review and certification process. r2 is the level that enterprise health systems and payers recognize when they specify HITRUST as a vendor requirement.
