At a Glance
- Regulation: HIPAA (Health Insurance Portability & Accountability Act) Security Rule, Privacy Rule, Breach Notification Rule, plus HITECH
- Who needs it: Covered Entities and Business Associates handling US PHI: health-tech SaaS, BPO providers, telehealth, claims, RCM, medical device firms
- Typical timeline: 3-5 months from gap analysis to programme go-live and BAA-readiness
- Engagement model: Gap analysis + Security Rule build + Privacy Rule build + BAA template + breach playbook + annual risk analysis
- Indicative investment: INR 1.5L-4L for consulting depending on scope and PHI volume
- Response time: instant, no delay. Gap analysis scheduled same or next business day after scoping
What is HIPAA?
HIPAA is the United States federal regulation that protects the confidentiality, integrity and availability of Protected Health Information (PHI). It applies to Covered Entities (health plans, providers, clearinghouses) and Business Associates that create, receive, maintain or transmit PHI on their behalf. Indian health-tech firms, BPOs, RCM providers and telehealth platforms serving US clients are squarely in scope as Business Associates.
Codesecure delivers HIPAA as a managed compliance programme: full gap analysis against the Security Rule (administrative, physical and technical safeguards), Privacy Rule alignment, Business Associate Agreement (BAA) review and template authoring, breach notification playbook, evidence collection, and ongoing annual risk analysis. Our consultants are HIPAA Privacy and Security certified.
Why It Matters
For Indian Business Associates, HIPAA is a contractual gate. US Covered Entities cannot share PHI without an executed BAA, and they audit their vendors. Without demonstrable HIPAA controls, you lose US healthcare deals to competitors who have done the work. With them, you become an obvious choice.
HIPAA also has serious teeth. Civil penalties range up to USD 2 million per violation category per year, and HITECH added mandatory breach notification with state-AG involvement. Indian press has reported multi-million-dollar settlements involving Indian BPOs after PHI exposure incidents. HIPAA controls reduce that risk and demonstrate good faith if something does happen.
What's Included
Codesecure's HIPAA programme covers Security Rule, Privacy Rule and supporting controls:
Security Rule Gap AnalysisFull assessment against administrative, physical and technical safeguards in 45 CFR 164.308-312
Privacy Rule AlignmentMinimum-necessary use, patient rights, accounting of disclosures, notice of privacy practices
Risk AnalysisFormal HIPAA risk analysis per 164.308(a)(1)(ii)(A) with documented methodology
Administrative SafeguardsWorkforce training, sanctions, access management, contingency planning, evaluation
Physical SafeguardsFacility access, workstation use, device and media controls
Technical SafeguardsAccess control, audit controls, integrity controls, transmission security, encryption
BAA Templates & ReviewBusiness Associate Agreement template authoring and review of upstream BAAs
Breach Notification Playbook60-day notification readiness with documented investigation procedure
Workforce HIPAA TrainingRole-based HIPAA training and acknowledgement evidence
Annual Risk Analysis SupportYearly refresh of risk analysis and control evaluation
Indicative Pricing
HIPAA consulting fees vary by PHI volume, system count and whether you are a Covered Entity, Business Associate or sub-BA. Pricing covers Codesecure consulting only; certification is not part of HIPAA, compliance is demonstrated through documented controls.
Consulting fee, India
INR 1.5L – 4L+ taxes
Fixed-fee engagement covering Security Rule and Privacy Rule build, risk analysis, BAA template, breach playbook and 30-day post-launch support. Annual risk analysis support is quoted separately.
Request a Scoped Quote
StartupINR 1.5L – 2LSmall health-tech / BA, up to 25 staff
SMBINR 2L – 3L25-150 staff, single platform
Mid-MarketINR 3L – 4L+150+ staff or multi-product
Get a Free HIPAA Gap Analysis
45-minute call with our HIPAA lead. Bring your PHI flows, current controls and upstream BAA obligations, leave with a phased remediation roadmap. Instant response, no delay.
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Implementation Methodology
Every HIPAA engagement follows a 5-phase methodology from gap analysis through certification or attestation:
1
Discovery & Scoping
Scoping call, NDA, PHI inventory, system mapping, upstream BAA review, role designation (CE or BA).
2
Risk Analysis & Gap
Formal HIPAA risk analysis, gap assessment against Security Rule and Privacy Rule, prioritised remediation plan.
3
Safeguards Implementation
Administrative, physical and technical safeguards built. Encryption, access control, audit logging, workforce training.
4
BAA & Breach Readiness
BAA template authored, breach notification playbook documented, tabletop exercise run.
5
Annual Risk Refresh
Year 2 and Year 3 risk analysis refresh, control evaluation, training cadence maintained.
What You Get
Every HIPAA programme ships with the same audit-ready handoff:
HIPAA Risk Analysis ReportDocumented risk analysis per 164.308(a)(1)(ii)(A) with methodology
Security Rule Control MatrixAdministrative, physical, technical safeguards with evidence
Privacy Rule Policy PackNotice of Privacy Practices and supporting policies
BAA TemplateReviewable Business Associate Agreement template
Breach Notification Playbook60-day investigation, notification and documentation runbook
Annual Risk Analysis SupportYear 2 and Year 3 risk analysis refresh
Programme Timeline
Most HIPAA programmes reach BAA-ready status within 3-5 months. Instant response, no delay, kickoff scheduled same or next business day after scoping.
Month 1
Risk Analysis
Scoping, PHI inventory, formal HIPAA risk analysis, remediation plan.
Month 2
Security Rule Build
Administrative, physical and technical safeguards implemented with evidence.
Month 3
Privacy & BAA
Privacy Rule alignment, BAA template, workforce training, breach playbook.
Month 4-5
Validation
Internal walkthrough, tabletop exercise, BAA-readiness review, sign-off.
// Frameworks & Standards We Cover
HIPAA Security Rule
HIPAA Privacy Rule
HIPAA Breach Notification
HITECH Act
45 CFR 164
HHS OCR
NIST 800-66
SOC 2 mapping
ISO 27001 mapping
DPDP Act 2023
Talk to a HIPAA Compliance Lead
30-minute call with our HIPAA lead. Discuss your role (CE / BA / sub-BA), PHI scope and upstream contractual obligations with no sales pressure.
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Frequently Asked Questions
Do Indian companies actually need HIPAA?
Yes, if you handle PHI for US-based Covered Entities or Business Associates. You are a Business Associate (or sub-BA) under HIPAA, and your US clients are required to have a BAA with you. Without HIPAA-aligned controls and a BAA, your US clients legally cannot share PHI with you, which means you cannot serve them.
What does HIPAA actually cost?
Codesecure consulting fees are typically INR 1.5L-2L for early-stage Business Associates, INR 2L-3L for SMBs with established PHI workflows, and INR 3L-4L+ for mid-market or multi-product Indian health-tech firms. HIPAA does not have certification, so there is no certification body fee. Annual risk analysis support is quoted separately.
How is HIPAA different from ISO 27001 or SOC 2?
HIPAA is a US regulation specific to healthcare data with mandatory provisions; ISO 27001 is a global voluntary security standard; SOC 2 is a US attestation framework. They overlap significantly on security controls but differ in scope: HIPAA is narrow (PHI only) and prescriptive; ISO 27001 is broad and risk-based; SOC 2 is service-organisation focused. Many health-tech firms run combined HIPAA + SOC 2 programmes to satisfy both clinical and SaaS buyer requirements.
How quickly can you start?
Instant response, no delay. We respond within an hour during business hours, send a fixed-fee scoped proposal in 24-48 hours under NDA, and start gap analysis the same day or next business day after sign-off.
Do you handle HIPAA breach response?
Yes. The breach notification playbook covers the 60-day clock, documented investigation, risk-of-compromise analysis, notification to HHS OCR, notification to affected individuals, and state-AG notifications if required. We can also act as breach-response advisor on retainer.
Can HIPAA evidence satisfy SOC 2 or ISO 27001 audits?
Largely yes. Most HIPAA technical safeguards map directly to SOC 2 Trust Service Criteria CC6 (logical access), CC7 (system monitoring) and CC8 (change management), and to ISO 27001 Annex A controls in technological and people themes. Running these together is faster and cheaper than running them serially.
Is HIPAA still relevant if I also follow DPDP Act?
Yes, they are not substitutes. DPDP Act 2023 governs personal data of Indian data principals; HIPAA governs PHI of US individuals. If your health-tech firm serves both Indian and US patients, you need both. The controls overlap on encryption, access management and incident response, so combined programmes are common.
Ready to Become HIPAA-Ready?
Codesecure runs your HIPAA programme: risk analysis, Security Rule and Privacy Rule build, BAA readiness and breach playbook. Free 30-minute gap analysis call, instant response, no obligation.
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