Compliance for
Healthcare & Health Tech

If you store, process, or transmit Protected Health Information (PHI) for US patients or US healthcare clients, you are almost always a Business Associate and must meet the HIPAA Security Rule, regardless of where your team sits. Indian healthtech firms, EHR vendors, medical-billing companies, and telemedicine platforms serving US covered entities routinely sign Business Associate Agreements (BAAs) that contractually bind them to HIPAA safeguards. TCSA runs a HIPAA Security Risk Assessment, closes the gaps, and prepares BAA-ready policies and technical safeguards.

HIPAA has no certificate or independent attestation — a BAA is only a promise. SOC 2 is the independent CPA attestation US hospitals, payers, and digital-health platforms use to verify the safeguards you committed to. Because the SOC 2 Trust Services Criteria overlap heavily with the HIPAA Security Rule, we map each control to both frameworks so a single engagement satisfies the BAA promise and the buyer's vendor-security review.

For domestic patient data the DPDP Act 2023 is the legal baseline — consent, purpose limitation, security safeguards, and breach notification. For enterprise credibility and to win larger contracts, ISO 27001 is the international information-security standard most healthcare buyers recognise. If you serve US clients, add HIPAA and SOC 2. Most of our healthcare clients sequence DPDP plus ISO 27001 first, then layer HIPAA and SOC 2 as US business grows.

A HIPAA Security Risk Assessment and remediation typically runs 4–6 months; ISO 27001 6–9 months; SOC 2 10–16 weeks for the consulting phase plus the auditor's observation window; DPDP readiness 3–5 months. Indicative consulting fees sit under ₹5 Lakh for a single framework and reduce per-framework when bundled, because overlapping controls are implemented once. CPA or certification-body audit fees are billed separately.

We scope every engagement to the systems that actually touch PHI, then implement encryption, granular role-based access control, audit logging, breach-notification workflows (HIPAA 60 days, DPDP without undue delay), and vendor-risk controls for labs, billing, and cloud providers. With 500+ audits delivered across India, USA, UK, Australia and UAE, our auditors translate the standards into engineering tasks your team can ship without slowing down care delivery.