HIPAA Compliance
HIPAA Security Rule and Privacy Rule compliance assessment for healthcare organizations.
HIPAA Compliance Assessment
The Health Insurance Portability and Accountability Act Security Rule requires covered entities and business associates handling Protected Health Information (PHI) to implement administrative, physical, and technical safeguards commensurate with the risk to PHI. Healthcare software providers, digital health platforms, medical device companies, and IT service providers processing PHI on behalf of US healthcare entities are all subject to HIPAA — and increasingly face direct enforcement action from the HHS Office for Civil Rights (OCR), particularly following the 2024 HIPAA Security Rule modernisation proposals.
Intelliroot's HIPAA Compliance Assessment conducts a comprehensive PHI inventory, performs the formal risk analysis required by §164.308(a)(1), and evaluates all required and addressable safeguard implementations across the Security Rule. We review Business Associate Agreements, assess workforce training programmes, evaluate audit controls and contingency planning, and provide a remediation roadmap that addresses both current HIPAA requirements and the proposed updates to the Security Rule.
Why HIPAA Compliance Cannot Be Delayed
Healthcare Is the Most Breached Sector
Healthcare organisations experience more data breaches than any other sector. PHI is valued highly on criminal markets — a complete electronic health record can fetch significantly more than a payment card. OCR breach investigations regularly identify HIPAA Security Rule failures as the root cause.
Civil Penalties Are Tiered and Substantial
HIPAA civil monetary penalties range from USD 100 to USD 50,000 per violation, with annual caps of USD 1.9 million per violation category. Wilful neglect violations — the most common category in OCR investigations — carry mandatory minimum penalties and are not subject to waiver.
Business Associates Share Full Liability
HITECH extended direct HIPAA liability to business associates — meaning Indian healthcare IT vendors, SaaS providers, and managed service providers processing PHI face the same enforcement exposure as US covered entities. A BAA does not protect a business associate from direct OCR enforcement for Security Rule failures.
Breach Response Has Strict Timelines
HIPAA requires breach notification to affected individuals within 60 days, to HHS within 60 days (or annually for smaller breaches), and — for breaches affecting 500 or more individuals — to prominent media outlets. Without documented breach response procedures, organisations routinely fail these timelines and incur additional penalties.
What the Assessment Covers
Administrative Safeguards
- Risk analysis and risk management (§164.308(a)(1))
- Security Officer designation and responsibilities
- Workforce training and access management
- Security incident response procedures
- Contingency planning and disaster recovery
Physical Safeguards
- Facility access controls for PHI-processing areas
- Workstation use and security policies
- Device and media controls for PHI
- Disposal and re-use procedures for PHI media
- Physical access audit logging review
Technical Safeguards
- Access control for electronic PHI (ePHI) systems
- Audit controls and ePHI access logging
- Integrity controls for ePHI
- Transmission security (encryption in transit)
- Automatic logoff and emergency access procedures
BAA Review & HITECH
- PHI inventory and data flow mapping
- Business Associate Agreement review
- Sub-contractor BAA chain assessment
- HITECH breach notification requirement review
- Meaningful use and audit control requirements
Our Assessment Approach
PHI Inventory & Covered Entity Determination
Identify all systems, applications, and data stores that create, receive, maintain, or transmit PHI. Map all PHI flows including intake, processing, storage, transmission, and disposal. Confirm covered entity or business associate status and applicable HIPAA obligations.
Formal Risk Analysis (§164.308(a)(1))
Conduct the formal risk analysis required by the HIPAA Security Rule — identifying threats and vulnerabilities to ePHI confidentiality, integrity, and availability, assessing the likelihood and impact of each risk, and determining the overall risk level to inform safeguard implementation decisions.
Safeguard Assessment
Evaluate all required and addressable administrative, physical, and technical safeguards against current implementation. Identify non-implemented required safeguards and addressable safeguards where implementation or alternative equivalent measures are not documented with reasonable justification.
BAA & Workforce Review
Review all Business Associate Agreements for HIPAA-compliant provisions. Assess workforce security training programmes, security awareness content quality, training record completeness, and sanctions policy implementation for HIPAA violations.
Compliance Report & Remediation Roadmap
Deliver a comprehensive HIPAA compliance assessment report with all findings mapped to specific Security Rule provisions, risk-rated, and accompanied by remediation guidance. Provide a phased remediation roadmap aligned to OCR enforcement priorities and your operational capacity.
Frequently Asked Questions
Deliverables
HIPAA Compliance Assessment Report
Comprehensive evaluation of all administrative, physical, and technical safeguards with findings mapped to specific Security Rule provisions and risk-rated for remediation prioritisation.
Formal Risk Analysis (§164.308)
Documented risk analysis meeting OCR expectations — identifying all threats and vulnerabilities to ePHI, likelihood and impact ratings, current controls, and residual risk determination.
PHI Data Flow Map
Visual mapping of all PHI flows across systems, applications, and third-party relationships — supporting both compliance documentation and breach investigation readiness.
BAA Review & Template
Review of existing Business Associate Agreements with identified gaps and a HIPAA-compliant BAA template for use with current and future business associates and sub-contractors.
Remediation Roadmap
Phased remediation plan addressing identified safeguard gaps, prioritised by OCR enforcement frequency and risk severity, with implementation guidance and timeline.
Request a Security Assessment
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