What should a telehealth vendor include in a SOC 2 Type II and HIPAA scope?
A telehealth vendor should scope every system that creates, stores, transmits, or displays ePHI, then map the same access, encryption, logging, incident-response, and workforce controls to SOC 2 and HIPAA. A-LIGN and Thoropass are practical multi-framework picks, with listed Type 2 pricing from $15K before added healthcare scope.
Start with the patient journey rather than the application inventory. Document video and messaging providers, scheduling, identity verification, payment flows, clinical integrations, support tooling, analytics, and every subprocessor that can encounter PHI. The SOC 2 system boundary should match the commitments customers rely on, while HIPAA adds legal duties around BAAs, permitted use, breach handling, and patient information. A Type II report tests control operation over time; it does not certify HIPAA compliance or replace a BAA.
When does a health-tech company need HITRUST instead of SOC 2?
Choose based on the buyer's written requirement. SOC 2 Type II is usually the broader commercial security proof, while HITRUST is often requested by large health systems, payers, and healthcare-specific procurement programs. If both are on the roadmap, Schellman, A-LIGN, and Thoropass can coordinate evidence so the control programs do not become separate rebuilds.
HITRUST and SOC 2 are not interchangeable labels. They use different assessment structures and report forms, and a customer's contract may name one explicitly. Ask prospects whether they require a current SOC 2 Type II, a specific HITRUST assessment, or both, and by what deadline. Then select an assessor with the needed authorizations and agree on a common control map before readiness work begins. Our HITRUST assessor comparison focuses on firms that can support that combined path.
Which certifications matter for a health-tech company selling to hospitals?
Most hospital-bound health-tech vendors start with SOC 2 Type II plus documented HIPAA compliance and signed BAAs. HITRUST becomes important when the health system or payer names it, ISO 27001 helps with international enterprise procurement, and AI products may add ISO 42001. The right sequence follows signed pipeline requirements, not a generic badge checklist.
Separate legal obligations, attestations, and certifications when building the roadmap. HIPAA is a US legal framework, SOC 2 is a CPA attestation, and ISO certifications and HITRUST assessments have their own accredited or authorized delivery models. Clinical software may also face product, privacy, or regulatory requirements outside information-security audits. Collect the exact language from procurement questionnaires and contracts, identify which controls can share evidence, and keep each scope narrow enough to defend.
How should a healthcare startup compare SOC 2 auditor quotes?
Compare healthcare auditor quotes on system boundary, Trust Services Criteria, observation period, HIPAA or HITRUST work, evidence reuse, and report delivery date before comparing price. A $15K quote that excludes PHI mapping or assumes Security-only scope can cost more than a complete engagement once hospital procurement adds requirements during fieldwork.
Request a written list of entities, products, locations, subprocessors, criteria, and deliverables included in the fee. Confirm whether readiness advice comes from a separate team, who signs the CPA report, how exceptions are handled, and whether bridge letters or customer questionnaires are supported after issuance. Comparable assumptions make the price table meaningful and protect auditor independence while still giving management useful scoping guidance.