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New to HIPAA? Read these four pages first.

What the law is, who it binds, what counts as protected health information, and the ten-minute overview that makes the rest of this site click into place.

01

What is HIPAA?

HIPAA is a 1996 federal law — but the duties people mean when they say "HIPAA" come from regulations written under one of its titles.

The Health Insurance Portability and Accountability Act became law in 1996 (Public Law 104-191). Its original goals were to let people keep health coverage when they change or lose a job, and to make health care administration more efficient. The privacy and security standards arrived as a consequence of that second goal.

The statute has five titles. Title I protects coverage portability and renewability. Title II — Administrative Simplification — is the source of the privacy, security, transaction, identifier, and enforcement regulations that most people mean when they say HIPAA. Titles III, IV, and V cover tax provisions, group health plan rules, and revenue offsets.

The 2009 HITECH Act strengthened Title II: it added the breach notification rule, made business associates directly liable, and raised penalties for wilful neglect. When a policy cites "HIPAA," it is almost always pointing at Title II as amended by HITECH.

  • Privacy Rule

    When PHI may be used or disclosed, what patients are entitled to, and the paperwork every covered entity must keep.

    45 CFR Part 164, Subpart E

  • Security Rule

    Administrative, physical, and technical safeguards required for electronic PHI.

    45 CFR Part 164, Subpart C

  • Breach Notification Rule

    Who must be told, how, and how quickly when PHI is compromised.

    45 CFR Part 164, Subpart D

  • Enforcement Rule

    How OCR investigates complaints and what civil penalties can follow.

    45 CFR Part 160, Subparts C–E

See the full Title II breakdown
02

Who must comply

Duties attach to organizations: covered entities, business associates, and the hybrid organizations that run both covered and non-covered work.

A covered entity is a health plan, a health care clearinghouse, or a health care provider who transmits health information electronically in connection with a standard transaction — claims, eligibility checks, remittance advice, and the like. A provider who bills only on paper is generally outside the rules; the moment claims leave electronically, they are inside them.

A business associate is a person or company that performs functions or services for a covered entity involving PHI: claims processing, billing, data analysis, legal, actuarial, accounting, consulting, IT and cloud hosting, records destruction. Since HITECH, business associates carry direct duties under the Security Rule and the Breach Notification Rule, must sign a business associate agreement with the entity, and pass those duties on to their own subcontractors.

A hybrid entity performs both covered and non-covered functions — a university that runs a teaching hospital, or a company health plan sitting inside a larger business. Under § 164.105(a) it designates a health care component, and only that component is treated as the covered entity. The designation only holds if it is written down and the component is actually separated in practice.

  • Health plans

    Insurers, HMOs, employer-sponsored group health plans, Medicare, Medicaid, and similar payers.

    45 CFR § 160.103

  • Health care clearinghouses

    Entities that convert claims and other transactions between formats on behalf of others.

    45 CFR § 160.103

  • Health care providers

    Any provider who transmits PHI electronically for a standard transaction — most practices, hospitals, labs, and pharmacies today.

    45 CFR § 160.103

  • Business associates

    Vendors and service partners with PHI access, plus their subcontractors. Direct liability for security and breach duties.

    45 CFR §§ 164.308, 164.410, 164.504(e)

  • Hybrid entities

    Mixed organizations that formally designate a health care component and keep it separated.

    45 CFR § 164.105(a)

  • The workforce

    Employees and volunteers are not covered entities, but they must follow the organization's policies — and sanctions for violations are required.

    45 CFR § 164.308(a)(1)(ii)(C)

Who's who: Congress, HHS, and OCR
03

What counts as PHI / ePHI

PHI is health information that identifies a person. ePHI is the same information in electronic form — and it is what the Security Rule governs.

Protected health information is individually identifiable health information held or transmitted by a covered entity or business associate, in any form — paper, spoken, or digital. Health information means information about a person's physical or mental health, the care they received, or payment for that care. Individually identifiable means it names the person or could reasonably be used to identify them.

HIPAA does not require a name. A date of birth combined with a ZIP code, a rare diagnosis in a small town, or a medical record number on a spreadsheet can all be PHI. The Privacy Rule's safe harbor lists 18 categories of identifiers, and data is de-identified only when all of them are removed and there is no actual knowledge that what remains could identify someone.

ePHI is PHI created, received, maintained, or transmitted electronically: EHR data, email, text messages, portal messages, backups, imaging, billing files, and the cloud services that hold them. The Security Rule applies only to ePHI, which is why the same record can be covered by the Privacy Rule on paper and by both the Privacy and Security Rules on a laptop.

  • The 18 identifiers

    Names, geographic data smaller than a state, dates tied to an individual except year, phone and fax numbers, email, SSN, medical record and health plan numbers, account and license numbers, device identifiers and serial numbers, URLs, IP addresses, biometric identifiers, full-face photos, and any other unique code.

    45 CFR § 164.514(b)(2)

  • Two de-identification paths

    A qualified expert determines the risk of re-identification is very small, or every identifier is stripped under the safe harbor with no actual knowledge left that the data could identify anyone.

    45 CFR § 164.514(a)–(b)

  • What is usually not PHI

    De-identified data, employment records a covered entity holds in its role as employer, education records covered by FERPA, and information about people deceased more than 50 years.

    45 CFR § 160.103

  • Where ePHI hides

    Backups, shared drives, personal phones, fax servers, and vendor systems all count — if the data is electronic and identifiable, the Security Rule applies to it.

    45 CFR § 164.312

Check the glossary of HIPAA terms
04

HIPAA in 10 minutes

Four rules do almost all of the day-to-day work. Read these summaries in order and you have a working map of the regulation.

This is the ten-minute version: what each rule is for, and the obligations that come up most often in real organizations. Every point below links to the full explanation elsewhere on the site.

  • Privacy Rule — what may be shared

    Treatment, payment, and health care operations are permitted without authorization; everything else needs authorization or a specific permission in the rule. It also sets the minimum necessary standard, requires a Notice of Privacy Practices, and gives patients rights of access (within 30 days), amendment, accounting of disclosures, restriction requests, and confidential communications.

    45 CFR Part 164, Subpart E

  • Security Rule — how ePHI is guarded

    Administrative safeguards: risk analysis, risk management, workforce controls, training, incident procedures, contingency planning, business associate contracts, periodic evaluation. Physical safeguards: facility access, workstation use, device and media controls. Technical safeguards: access control, audit logs, integrity, authentication, transmission security. Standards are either required or addressable — addressable means assess and document, not skip.

    45 CFR Part 164, Subpart C

  • Breach Notification Rule — what happens when it fails

    A breach is an impermissible use or disclosure that compromises privacy or security, presumed unless a risk assessment shows a low probability of compromise. Individuals are notified without unreasonable delay and no later than 60 days after discovery; HHS is notified (immediately at 500 or more people, annually otherwise), and media in the affected state when 500 or more residents are involved.

    45 CFR §§ 164.400–414

  • Enforcement — who answers for it

    OCR investigates complaints and compliance reviews. Civil money penalties are tiered by culpability, from lack of knowledge to wilful neglect, up to roughly $2 million per identical provision per year. DOJ can bring criminal charges — up to one year, five years, or ten years depending on intent and whether the information was sold — and state attorneys general can sue as well.

    45 CFR Part 160; 42 U.S.C. § 1320d-6

Understand the Rules

Know what matters and your obligations.

Protect Health Data

Apply safeguards to keep ePHI secure.

Reduce Risk, Stay Compliant

Follow best practices and avoid penalties.

Build Trust, Improve Care

Better data security leads to better care.

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Understand the rules. Protect people. Build trust. Clear, citation-backed HIPAA education for covered entities, business associates, and the workforce that keeps health data safe.

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Disclaimer

This site provides general educational information about HIPAA and is not legal advice. Always consult qualified compliance counsel for your specific circumstances, and refer to the official HHS guidance and the Code of Federal Regulations.

Strong Security. Smart Compliance. Better Outcomes. | HIPAA Made Simple.

© 2026 Simple HIPAA. Educational use only.

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