netru
Frameworks/HIPAA
HIPAA
US Federal Law
Healthcare

HIPAA Compliance

The Health Insurance Portability and Accountability Act sets the standard for protecting sensitive patient health information. Any organisation handling Protected Health Information must comply.

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What is HIPAA?

The US standard for healthcare data protection

The Health Insurance Portability and Accountability Act (HIPAA) was enacted in 1996 and establishes national standards for the protection of Protected Health Information (PHI). It applies to covered entities (healthcare providers, health plans, healthcare clearinghouses) and their business associates.

HIPAA is enforced by the Office for Civil Rights (OCR) within the US Department of Health and Human Services (HHS). Penalties for non-compliance range from $100 to $50,000 per violation, with a maximum of $1.9 million per violation category per year.

For UK and European organisations providing services to US healthcare entities, HIPAA compliance is often a contractual requirement, even if not directly mandated by US law.

Enacted1996 (updated 2013 via Omnibus Rule)
Enforced byHHS Office for Civil Rights (OCR)
Applies toCovered entities and business associates
Key data typeProtected Health Information (PHI)
Maximum penalty$1.9M per violation category/year
Often paired withHITRUST, SOC 2

Compliance requirements

Key HIPAA obligations

HIPAA compliance spans administrative, physical, and technical safeguards across three primary rules.

Privacy Rule

Establishes national standards for the protection of individually identifiable health information, defining permitted uses and disclosures of Protected Health Information (PHI).

Security Rule

Sets standards for protecting electronic PHI (ePHI) through administrative, physical, and technical safeguards. Applies to covered entities and business associates.

Breach Notification Rule

Requires covered entities to notify affected individuals, HHS, and in some cases the media, following a breach of unsecured PHI within 60 days.

Business Associate Agreements

Written contracts with all business associates who handle PHI on your behalf, defining permitted uses, safeguards, and breach reporting obligations.

Risk Analysis & Management

A thorough and accurate assessment of potential risks and vulnerabilities to ePHI confidentiality, integrity, and availability, and a risk management plan to address them.

Workforce Training

All workforce members must receive HIPAA training appropriate to their role, with documented completion records maintained.

Compliance process

Building a defensible HIPAA programme

Netru builds HIPAA compliance programmes that satisfy OCR requirements and stand up to scrutiny.

01

Risk Analysis

We conduct a comprehensive HIPAA risk analysis, identifying all PHI flows, assessing threats and vulnerabilities, and producing a risk register.

02

Gap Assessment

Your current administrative, physical, and technical safeguards are assessed against HIPAA requirements, with a prioritised remediation roadmap.

03

Policies & Procedures

We develop or update your HIPAA policies, procedures, and workforce training programme to meet regulatory requirements.

04

BAA Review

All Business Associate Agreements are reviewed and updated to ensure they meet current HIPAA requirements.

05

Controls Implementation

Technical safeguards, encryption, access controls, audit logging, and transmission security, are implemented and documented.

06

Ongoing Compliance

Annual risk analysis updates, workforce training refreshers, and incident response support to maintain HIPAA compliance.

How Netru delivers it

Healthcare compliance expertise

Our team has deep experience in healthcare compliance. We build HIPAA programmes that are practical, defensible, and designed to scale with your organisation.

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Comprehensive HIPAA risk analysis and risk management plan
Administrative, physical, and technical safeguard implementation
HIPAA policy and procedure suite development
Business Associate Agreement (BAA) review and drafting
Workforce HIPAA training programme
Breach response procedure and notification support
Annual compliance review and risk analysis update

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