SOC 2 for Healthtech &
Healthcare SaaS

Because HIPAA has no certificate. HIPAA is a US legal obligation you self-attest to — there is no recognised body that “certifies” HIPAA compliance. US hospitals, payers, and digital-health platforms therefore ask for SOC 2, an independent CPA attestation they can rely on, as proof your safeguards actually operate. The two overlap heavily, so we map your SOC 2 controls to the HIPAA Security Rule and run one body of work that satisfies both your customers and your Business Associate obligations.

Substantially. HIPAA’s Security Rule covers administrative, physical, and technical safeguards — access control, audit controls, encryption, integrity, and contingency planning — which map directly onto the SOC 2 Security, Availability, and Confidentiality criteria. We build a control set once and cross-reference each control to both the relevant Trust Services Criterion and the HIPAA Security Rule citation, so a single engagement evidences your SOC 2 report and demonstrates the safeguards your Business Associate Agreements commit you to.

Security (the Common Criteria) is mandatory and carries most of the HIPAA overlap. For healthtech we almost always add Confidentiality, because PHI is confidential by law, and Availability, because clinical systems carry uptime and contingency obligations. The Privacy criterion is added where you collect health information directly from individuals, and Processing Integrity where data accuracy is clinically material. We scope criteria to your customer BAAs rather than over-scoping.

Plan on 10–16 weeks of consulting work: Type I in 10–12 weeks, Type II in 14–16 weeks plus a 3–12 month observation window. TCSA’s consulting fee is ₹2–4 Lakh (indicative until a scoping call), covering scoping, gap assessment, control design across your PHI systems, policy drafting, evidence preparation, and audit coordination. The CPA firm’s attestation fee is billed separately and varies with scope.

Most start with Type I to put a report in a health customer’s hands quickly — it attests that controls are designed correctly at a point in time, in roughly 10–12 weeks — then roll into the Type II observation window, which tests operating effectiveness over 3–12 months. Many hospitals and payers ultimately require Type II, so if a specific customer demands it we scope the observation period up front and aim for the fastest path to your deal.

Yes. AWS and GCP both offer HIPAA-eligible services and will sign a Business Associate Agreement, and they already hold their own SOC reports, so you inherit their infrastructure controls. You focus on application-level controls — access, encryption, audit logging, and minimum-necessary access over PHI. We document the complementary user-entity controls and carve out the subservice organisations, and ensure BAAs are in place across your subprocessor chain so the shared-responsibility boundary is explicit and the auditor finds no gaps.