They expertly mapped the overlapping controls between SOC 2 and ISO 27001, which saved us from duplicating work.
Jasreet Kaur B.Silicon Physical Design Engineer · Small-BusinessSOC 2 + ISO 27001 · August 2026
Industries · Healthcare
Compliance for
Healthcare & Health Tech
Protect patient data and achieve compliance faster. We help hospitals, clinics, and health tech companies across Mumbai, Delhi, Bangalore, Hyderabad, Gurgaon, and Pune meet HIPAA, ISO 27001, and DPDP requirements.
40+Healthcare clients
1,000+Audits delivered
20+Frameworks covered
HIPAA · ISO 27001 · SOC 2 · DPDP — mapped together so one engagement covers multiple frameworks
40+Healthcare Clients
4-6moAvg. HIPAA Timeline
20+Frameworks Covered
300+SOC 2 Engagements
Direct Answer
What compliance does a healthcare organisation need?
Healthcare organisations need a layered compliance program: the DPDP Act 2023 for Indian patient data, ISO 27001 for enterprise-grade information security, and HIPAA plus SOC 2 when serving US patients or US healthcare clients. Tranquility Cybersecurity (TCSA) scopes each engagement to the systems that actually hold PHI, maps overlapping controls so one project serves multiple frameworks, and prepares you for audit.
Key Takeaways
- Indian healthtech firms handling US patient data are usually Business Associates and must meet the HIPAA Security Rule under their BAAs.
- HIPAA has no certificate — US health buyers ask for SOC 2 as the independent CPA attestation of the safeguards you promised.
- DPDP Act 2023 is the legal baseline for domestic patient data. ISO 27001 adds the enterprise credibility most healthcare buyers recognise.
- TCSA maps SOC 2, HIPAA, ISO 27001, and DPDP controls together so a single engagement covers multiple frameworks. Indicative fees sit under ₹5 Lakh per framework, except DPDP for an enterprise at ₹5–7 Lakh.
What You Need
Healthcare compliance requirements
Key frameworks and standards for protecting patient data and meeting regulatory requirements
HIPAA Security Rule
Critical for US Market4-6 months
US healthcare data protection standard required for health tech companies serving US clients or handling PHI.
ISO 27001
Enterprise Requirement6-9 months
International information security standard demonstrating robust security controls for patient data.
DPDP Act 2023
Legal Requirement8-10 weeks small, 12-14 MSME, over 16 enterprise
India's data protection law governing patient data, consent management, and breach notification.
SOC 2 Type II
SaaS Essential14–16 weeks end to end, including the 12-week minimum window
Trust service criteria for health tech SaaS platforms handling sensitive patient information.
What We Solve
Common healthcare security challenges
Healthcare organizations face unique cybersecurity challenges that require specialized expertise
Electronic Health Records (EHR) Security
Protecting patient medical records, treatment histories, and diagnostic data from unauthorized access and breaches.
Multi-Stakeholder Access Control
Managing access for doctors, nurses, administrative staff, patients, insurance companies, and third-party labs.
Medical Device Integration
Securing IoT medical devices, diagnostic equipment, and ensuring data integrity across connected systems.
Telemedicine Platform Security
Protecting video consultations, remote patient monitoring, and ensuring HIPAA-compliant communication channels.
Patient Consent Management
Implementing granular consent mechanisms for data sharing with specialists, labs, insurance, and research.
Breach Notification Requirements
Meeting strict timelines for breach notification to patients, regulators (HIPAA: 60 days, DPDP: patients and the Board without delay, the Board’s detailed report within 72 hours).
“SOC 2 Services were excellent.”
— Anand Singh, Google review
Proof
In their words.
Quotes verbatim from G2. Company names added where the client confirmed them.
Instead of simply providing generic templates or checklists, their team took the time to understand our environment and requirements.
Anand .Market Risk Analyst · Mid-MarketCompliance readiness · September 2026
The team’s willingness to work with us and ease of communication.
sam v.CEO · Small-BusinessSOC 2 Type I + ISO 27001 · August 2026
They delivered the project with speed, accuracy, and cost-effectiveness.
Maneet P.Mid-MarketSOC 2 · August 2026
My only regret is that we didn’t engage them sooner in our compliance journey, which would have saved us even more time.
Mahesh Raju C. · XonarSmall-BusinessSOC 2 · GRC · August 2026
They were always responsive and willing to go the extra mile whenever we had questions or needed guidance.
Chandan J. · DsiderSmall-BusinessSOC 2 Type I · August 2026
Managing the auditor relationship on our behalf was especially valuable — it took a lot of pressure off our internal team.
Achyut B.Senior Software Engineer · Small-BusinessSOC 2 + ISO 27001 · September 2026
Their focus on ensuring that we were genuinely audit-ready rather than simply completing documentation.
Ravi V.Founder & CEO · Mid-MarketSOC 2 Type II · August 2026
The guidance was not generic or simply based on a standard checklist — they suggested practical approaches that made sense for our business.
Verified UserInternational Trade and Development · Small-BusinessSOC 2 + ISO 27001 · September 2026
What I like best is the hands-on support and clear guidance throughout the SOC 1 and SOC 2 process.
Sai Sudha S. · ExcersSmall-BusinessSOC 1 + SOC 2 · September 2026
Healthcare Compliance — Frequently Asked Questions
HIPAA, SOC 2, ISO 27001, and DPDP answers from the team behind 1,000+ audits.
Does an Indian healthtech company or hospital need HIPAA compliance?
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.
Why do US health customers ask for SOC 2 if HIPAA already applies?
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.
Which compliance framework should an Indian hospital or clinic start with?
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.
How long does healthcare compliance take and what does it cost?
A HIPAA Security Risk Assessment and remediation typically runs 4–6 months, and ISO 27001 6–9 months. SOC 2 takes 6–8 weeks to audit-ready, with the Type 1 report after that and Type 2 in 14–16 weeks end to end, including the 12-week minimum observation window. DPDP readiness takes 8–10 weeks for a small company, 12–14 weeks for an MSME and more than 16 weeks for an enterprise, at indicative DPDP fees of ₹1.5–2 Lakh, ₹2–4 Lakh and ₹5–7 Lakh. For the other frameworks, indicative consulting fees sit under ₹5 Lakh for a single framework and reduce per-framework when bundled, because overlapping controls are implemented once. SOC 2 is all-in, including the independent CPA attestation, and ISO certification-body audit fees are billed separately.
How does TCSA protect EHR and patient data during implementation?
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 1,000+ 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.
Keep Exploring
Keep Exploring
Related Reading
HIPAA
HIPAA Compliance
US health-data rules for healthtech and business associates.
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HIPAA Knowledge Hub
Privacy Rule, Security Rule, BAAs, cloud guides and penalties.
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SOC 2 for Healthtech
Where SOC 2 meets HIPAA for healthcare SaaS selling into the US.
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ISO 27001 Overview
The ISMS standard — the baseline certificate global buyers ask for.
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SOC 2 Overview
The AICPA attestation US and global enterprise buyers ask for.
Read moreTrust
Proof & Track Record
Every number we publish — explained, sourced and verifiable.
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