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Compliance guide · ~11 min read · Updated June 2026

What is HIPAA?

HIPAA stands for the Health Insurance Portability and Accountability Act of 1996, a US federal law that lets people keep health coverage between jobs and sets national standards for protecting health information. Its Privacy, Security, and Breach Notification rules govern how protected health information (PHI) is used, secured, and disclosed, and are enforced by the HHS Office for Civil Rights.

Enacted
1996
Administered
HHS / OCR
Protects
PHI
Core rules
4
01 · Definition

What is HIPAA?

HIPAA is the Health Insurance Portability and Accountability Act of 1996, a US federal law administered by the Department of Health and Human Services (HHS). The name captures its two halves: portability, protecting people's health coverage when they change or lose a job, and accountability, setting national standards for handling health information.

Most compliance work concerns the accountability half. Under it, HHS issued a family of rules, the Privacy Rule, the Security Rule, the Breach Notification Rule, and the Enforcement Rule, that together control how protected health information is used, secured, and disclosed. The HHS Office for Civil Rights enforces them, and the law has been strengthened over time, notably by the 2009 HITECH Act and the 2013 Omnibus Rule.

"HIPAA required the Secretary to issue privacy regulations governing individually identifiable health information."

HHS Office for Civil Rights
Portability

Title I: protects health insurance coverage for workers and families when they change or lose jobs.

Accountability

Title II: national standards for health information and the Privacy, Security, and Breach rules.

Enforcement

The HHS Office for Civil Rights (OCR) investigates complaints and imposes penalties.

02 · Structure

The two titles of HIPAA

HIPAA is organised into titles, but two matter most. The name maps directly onto them: portability is Title I, accountability is Title II.

Title I: Health insurance portability

Protects health insurance coverage for workers and their families when they change or lose their jobs, and limits exclusions for pre-existing conditions. This is the half that gave the law its name but rarely features in day-to-day compliance projects.

Title II: Administrative Simplification

Directed HHS to create national standards for electronic health care transactions and the rules that protect health information, the Privacy, Security, and Breach Notification rules. This is the part virtually all HIPAA compliance work concerns.

03 · The rule family

The four HIPAA rules

Under Title II, HHS issued the rules that make up day-to-day HIPAA compliance. They share the same PHI and the same workforce, so most teams manage them as one programme.

Privacy Rule

Sets national standards for protecting PHI in any form and gives individuals rights over their health information. The foundational rule most people mean when they say "HIPAA."

Read the full guide

Security Rule

Requires administrative, physical, and technical safeguards to protect electronic PHI (ePHI). The "how" for keeping electronic health data confidential, available, and intact.

Breach Notification Rule

Requires covered entities to notify affected individuals, HHS, and sometimes the media after a breach of unsecured PHI, generally within 60 days of discovery.

Enforcement Rule

Establishes how the HHS Office for Civil Rights investigates complaints and imposes the tiered civil money penalties for violations.

04 · What it protects

Protected health information (PHI)

HIPAA protects protected health information: individually identifiable health information held or transmitted by a covered entity or business associate, in any form. That includes a person's health condition, the care they received, and payment for that care, when tied to identifiers such as name, address, dates, or medical record number.

The electronic subset, ePHI, is the focus of the Security Rule. Properly de-identified data, with all 18 HIPAA identifiers removed under the Safe Harbor method or certified by expert determination, falls outside HIPAA entirely. Employment records and FERPA-covered education records are also excluded from PHI.

For the full list of patient rights, permitted uses, the minimum necessary standard, and the 18 Safe Harbor identifiers, see our dedicated guide to the HIPAA Privacy Rule.

05 · Scope

Who must comply with HIPAA

HIPAA binds two groups. Scoping your status correctly is the first step of any compliance programme.

Covered entities

Health plans, health care clearinghouses, and health care providers who transmit health information electronically for a covered transaction (such as a claim).

Business associates

Vendors and subcontractors that create, receive, maintain, or transmit PHI on behalf of a covered entity, including cloud hosts, billing firms, and SaaS vendors. Directly liable since the 2013 Omnibus Rule.

06 · Enforcement

HIPAA penalties

The HHS Office for Civil Rights enforces HIPAA. Civil penalties are tiered by culpability, from a violation the entity did not know about up to willful neglect that was not corrected. Per-violation amounts and annual caps are adjusted for inflation each year and can reach into the millions of dollars for a category of violations.

The most serious knowing misuse of PHI can also be prosecuted criminally by the Department of Justice, with fines up to $250,000 and up to 10 years in prison. Beyond the dollars, OCR settlements usually require a multi-year corrective action plan, and large breaches appear on the public HHS breach portal.

Always confirm the live numbers. OCR republishes its inflation-adjusted penalty tiers annually, so treat any specific figure as a snapshot and check the current HHS guidance before quoting it.

07 · Implementation

How to comply with HIPAA

Six steps that take a covered entity or business associate from uncertain to defensible. The documented risk analysis is the artifact OCR asks for first.

  1. 1

    Confirm your status

    Determine whether you are a covered entity, a business associate, or both. Your obligations and your Business Associate Agreements flow from this.

  2. 2

    Inventory your PHI

    Map every system, vendor, and workflow that creates, receives, maintains, or transmits PHI, in any form. You cannot protect data you have not located.

  3. 3

    Run a Security Rule risk analysis

    Conduct and document a risk analysis of threats to your electronic PHI. This is the single most-requested artifact in an OCR investigation.

  4. 4

    Write policies and appoint officers

    Document Privacy and Security policies, publish a Notice of Privacy Practices, and designate a Privacy Officer and a Security Officer.

  5. 5

    Execute Business Associate Agreements

    Put a written BAA in place with every vendor that touches PHI, and flow the same obligations down to subcontractors.

  6. 6

    Train, remediate, and stay audit-ready

    Train the workforce, track remediation of every gap to closure, and keep a timestamped evidence trail. Required HIPAA documentation must be retained for six years.

Make it audit-ready
Run HIPAA on a platform, not a spreadsheet.

RiskWatch ships pre-built HIPAA Privacy and Security Rule assessments on a shared control library, runs the risk analysis, tracks remediation to closure, manages Business Associate Agreements, and keeps the timestamped evidence trail OCR asks for.

08 · Frequently asked

HIPAA, answered

The questions people search most when they first encounter the law.

What does HIPAA stand for?
HIPAA stands for the Health Insurance Portability and Accountability Act of 1996. It is a US federal law with two main goals: to let people keep their health insurance coverage when they change or lose jobs (portability), and to set national standards for protecting sensitive health information (accountability). It is administered by the US Department of Health and Human Services (HHS) and enforced by its Office for Civil Rights (OCR).
What is HIPAA in simple terms?
HIPAA is the US law that protects your medical information and makes sure your health insurance follows you between jobs. For organisations, it sets rules on how protected health information (PHI) can be used, disclosed, and secured, and it gives patients rights to see and control their own records. Breaking the rules can lead to significant fines and, in serious cases, criminal charges.
What are the main HIPAA rules?
There are four core rules. The Privacy Rule limits how PHI is used and disclosed and grants patient rights. The Security Rule requires safeguards for electronic PHI. The Breach Notification Rule requires notifying individuals and HHS after a breach. The Enforcement Rule sets out investigations and penalties. The 2009 HITECH Act and the 2013 Omnibus Rule strengthened these, notably by making business associates directly liable.
What are the two titles of HIPAA?
Title I protects health insurance coverage for workers and their families when they change or lose their jobs (the "portability" half). Title II, known as Administrative Simplification, is the part most compliance work focuses on: it directed HHS to create national standards for electronic health care transactions and the Privacy, Security, and other rules that protect health information (the "accountability" half).
What information does HIPAA protect?
HIPAA protects "protected health information" (PHI): individually identifiable health information held or transmitted by a covered entity or business associate, in any form, oral, paper, or electronic. That covers a person's health condition, the care they received, and payment for that care when tied to identifiers like name, address, dates, or medical record number. The electronic subset is called ePHI and is the focus of the Security Rule.
Who has to comply with HIPAA?
Covered entities (health plans, health care clearinghouses, and health care providers who transmit health information electronically) and their business associates (vendors and subcontractors that handle PHI on their behalf). Since the 2013 Omnibus Rule, business associates are directly liable for compliance, not merely bound by contract.
What are the penalties for violating HIPAA?
Civil penalties are tiered by culpability, from a violation the entity did not know about up to willful neglect that was not corrected, with per-violation amounts and annual caps that OCR adjusts for inflation each year and that can reach into the millions of dollars per category. Criminal violations can carry fines up to $250,000 and up to 10 years in prison for the most serious knowing misuse of PHI.
What is the difference between the Privacy Rule and the Security Rule?
The Privacy Rule applies to all PHI in any form and governs who may use or disclose it and the rights patients hold. The Security Rule is narrower: it applies only to electronic PHI and requires administrative, physical, and technical safeguards to protect it. The Privacy Rule sets the "what" and "who"; the Security Rule sets the "how" for electronic data. For a deeper look, see our guide to the HIPAA Privacy Rule.
Does HIPAA apply to employers?
Generally not in their role as employers. Employment records an employer holds are excluded from PHI, and HIPAA applies to covered entities and business associates in their health-care capacity. However, an employer that sponsors a self-insured group health plan must protect the PHI it handles for that plan, and it must keep that information separate from employment decisions.
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