HIPAA · HITRUST · Healthcare Data Security
HIPAA / HITRUST Compliance Services
Protecting Healthcare Data with Rigour and Legal Precision
Healthcare data compliance is among the most demanding in any regulated sector — combining stringent technical security requirements with strict patient privacy obligations and significant enforcement risk. SIRI Law LLP’s HIPAA/HITRUST practice serves Indian healthcare technology companies supplying to U.S. customers, Indian healthcare providers processing data of international patients, and organisations seeking HITRUST certification for competitive advantage.
What It Is & Why It Matters
HIPAA / HITRUST Compliance Services: The Essentials
HIPAA (Health Insurance Portability and Accountability Act) establishes national standards for protecting Protected Health Information (PHI). The HIPAA Security Rule specifies administrative, physical, and technical safeguards for electronic PHI (ePHI). The Privacy Rule governs the use and disclosure of PHI. The Breach Notification Rule requires notification to affected individuals, HHS, and media when unsecured PHI is compromised.
Business Associates — any organisation that creates, receives, maintains, or transmits PHI on behalf of a Covered Entity — must comply with the HIPAA Security Rule and Privacy Rule through a Business Associate Agreement (BAA). Indian technology companies processing U.S. patient data as Business Associates face direct HIPAA liability.
HITRUST CSF (Common Security Framework) is the most widely adopted healthcare security certification framework — combining HIPAA requirements with ISO 27001, NIST, PCI DSS, and GDPR into a single assessable framework. HITRUST certification is increasingly required by U.S. healthcare organisations from their technology vendors.
HIPAA Security Rule enforcement has intensified significantly — OCR (Office for Civil Rights) investigation and settlement amounts have increased substantially, with penalties ranging from $100 per violation for unknowing violations to $50,000 per violation for wilful neglect. A single breach can trigger multi-million dollar penalties.
Indian healthcare technology companies — EHR vendors, telemedicine platforms, medical device companies, and health data analytics firms supplying to U.S. customers — must comply with HIPAA as Business Associates. HIPAA applies to the data, not the geography of the organisation processing it.
HITRUST certification has become a de facto prerequisite for healthcare technology procurement in the U.S. market — replacing lengthy, individualised security questionnaires and assessments with a single, credible third-party validation. Achieving HITRUST certification can significantly accelerate enterprise healthcare sales cycles.
Scope of Services
What Our Engagement Covers
- HIPAA Security Rule gap assessment — all 54 implementation specifications
- HIPAA Privacy Rule gap assessment and advisory
- ePHI identification and data flow mapping
- Business Associate Agreement (BAA) review and negotiation
- Administrative safeguards — workforce training, access management
- Physical safeguards — facility access, workstation security
- Technical safeguards — access control, audit controls, encryption
- Risk analysis and risk management programme (Req. §164.308)
- HIPAA Breach Risk Assessment — 4-factor test
- Breach notification procedures — HHS, individual, and media notification
- Incident response plan development — HIPAA aligned
- HITRUST CSF readiness assessment — applicable control categories
- HITRUST e1/i1/r2 certification tier selection and preparation
- HITRUST validated assessment liaison
- Medical device security assessment — FDA and MDR context
- Healthcare AI compliance — clinical decision support advisory
Our Engagement Process
How We Work — Step by Step
Initial Scoping & Assessment
We conduct a gap assessment against the applicable framework, define the engagement scope, and produce a prioritised remediation roadmap with timeline and effort estimates.
Programme Design
We design the compliance programme — control framework, documentation structure, evidence requirements, and governance processes — tailored to your organisation.
Implementation Advisory
We advise on implementing each required control — working alongside your technical and operational teams to build controls that are practical and auditable.
Internal Audit & Validation
We conduct an internal audit or readiness assessment — identifying any remaining gaps before the formal certification or attestation process begins.
Certification / Attestation Support
We support the formal audit or assessment — managing auditor queries, providing evidence, and resolving findings on the day.
Post-Certification Advisory
After certification, we provide ongoing support — surveillance audit preparation, change management, and regulatory update advisory.
Typical engagement timeline varies by organisation size and existing control maturity.
Certified Engineers
Our Team Holds
CCSPCISMCIPPECEHOSCPCISSPCPENTISO 27001 LAIntegration Advantage
Our compliance engagements are backed by qualified legal counsel — ensuring your programme satisfies both technical certification requirements and legal obligations under DPDPA, IT Act, and sector-specific regulation.
Benefits & Deliverables
What You Get from This Engagement
HIPAA Risk Analysis
Comprehensive risk analysis of your ePHI environment — the foundational HIPAA Security Rule requirement and the starting point for every HIPAA compliance programme.
Gap Assessment
Control-by-control gap assessment against HIPAA Security Rule implementation specifications — with prioritised remediation roadmap.
BAA Review
Review and negotiation of Business Associate Agreements with your Covered Entity customers — ensuring appropriate risk allocation and contractual protections.
Safeguards Implementation
Advisory on implementing all three categories of HIPAA safeguards — administrative, physical, and technical — with practical, proportionate guidance.
HITRUST Readiness
Gap assessment against applicable HITRUST CSF control categories and selected certification tier (e1, i1, or r2) — with a realistic programme to readiness.
Breach Response
HIPAA-compliant breach response procedures — including the 4-factor breach risk assessment, notification timelines, and HHS reporting requirements.
Training Programme
HIPAA workforce training programme — addressing Privacy Rule, Security Rule, and Breach Notification Rule obligations for all workforce members.
HIPAA Risk Analysis Report
Documented risk analysis satisfying §164.308(a)(1)(ii)(A) — identifying threats, vulnerabilities, likelihood, and impact for all ePHI.
HIPAA Gap Assessment Report
Control-by-control assessment against all 54 implementation specifications with remediation roadmap.
Policies and Procedures
Complete HIPAA-required policy and procedure documentation — privacy policies, security policies, breach notification policy, and workforce training materials.
BAA Template Library
Standard and enhanced BAA templates for different vendor risk tiers — ready for immediate use with Covered Entity customers.
HITRUST Readiness Report
Gap assessment against HITRUST CSF with certification tier recommendation and implementation roadmap.
Breach Response Playbook
HIPAA-aligned breach response procedures with notification templates and HHS reporting guides.
Frequently Asked Questions
We are an Indian company building healthcare software for U.S. hospitals. Do we need to comply with HIPAA?
Yes — if you process Protected Health Information (PHI) of U.S. patients on behalf of a Covered Entity (hospital, health plan, healthcare clearinghouse), you are a Business Associate under HIPAA. You are required to comply with the HIPAA Security Rule and Privacy Rule, enter into a Business Associate Agreement with your Covered Entity customers, and notify them of any breaches of unsecured PHI. HIPAA applies to the data you handle, not where your company is based.
What is the difference between HITRUST e1, i1, and r2 certification?
HITRUST now offers three certification tiers: e1 (essential) — 44 foundational controls, typically completed in 90 days; i1 (implemented) — approximately 182 controls for organisations wanting a more comprehensive certification; r2 (risk-based) — the full HITRUST CSF assessment, the most rigorous and credible tier, required by many U.S. healthcare enterprise customers. We advise on the appropriate tier for your market requirements and compliance maturity.
What are the penalties for HIPAA non-compliance?
HIPAA penalties are tiered by culpability: Tier 1 (unknowing violation) — $100–$50,000 per violation; Tier 2 (reasonable cause) — $1,000–$50,000; Tier 3 (wilful neglect, corrected) — $10,000–$50,000; Tier 4 (wilful neglect, uncorrected) — $50,000 per violation with an annual cap of $1.9 million per violation category. Criminal penalties also apply in egregious cases. A single breach event can involve thousands of violations.
How does HIPAA interact with India’s DPDPA?
HIPAA and DPDPA both apply to health data — but HIPAA is specific to U.S. healthcare sector entities and their business associates, while DPDPA applies broadly to any personal data of Indian data principals. Indian healthcare technology companies with both Indian and U.S. operations may need to comply with both. We design integrated compliance programmes that satisfy both frameworks — building a single, coherent approach rather than two parallel programmes.
Ready to Start Your HIPAA Journey?
All engagements begin with a complimentary scoping call. Let us understand your environment and propose the right approach.
Also see: Cybersecurity GRC · Privacy Compliance