Compliance, Privacy & Security Glossary

Classify the entity and information first

Electronic protected health information, or ePHI, is PHI created, received, maintained, or transmitted in electronic form within HIPAA scope. Determine whether each activity involves a covered entity, business associate, subcontractor, hybrid component, or another role.

The HIPAA Security Rule establishes administrative, physical, and technical safeguard requirements for regulated ePHI. HHS's current Security Rule page continues to identify the January 2025 cybersecurity update as proposed. The current rule remains the baseline until a final rule and applicable date change it.

42 CFR Part 2 protects qualifying substance-use-disorder patient records held by covered Part 2 programs and recipients under its scope. HHS's HIPAA and Part 2 page provides current implementation resources. Classify Part 2 coverage separately from HIPAA.

Connect risk analysis to safeguards

A security risk analysis identifies where ePHI exists and evaluates potential risks and vulnerabilities. HHS risk-analysis guidance says covered entities and business associates must assess all ePHI they create, receive, maintain, or transmit.

A risk management plan is a practice artifact that assigns selected controls, owners, dates, resources, validation, residual risk, and review. The artifact can support required risk management while remaining distinct from the regulatory duty itself.

Role-based access control grants access according to defined job functions and need. An audit log records relevant system or user events for review. Access design needs unique accounts, timely provisioning and removal, privileged-role control, review, exception handling, and test evidence.

The minimum necessary standard generally requires covered entities and business associates to limit certain uses, disclosures, and requests for PHI to what is needed for the purpose. The rule has exceptions and should not be reduced to a universal “least data” slogan.

Triage incidents before classifying breach

A security incident includes attempted or successful unauthorized access, use, disclosure, modification, destruction, or interference with system operations under the HIPAA definition. A blocked credential-stuffing attempt can still be an incident.

A breach has a defined legal meaning. Under the HIPAA Breach Notification Rule, an impermissible acquisition, access, use, or disclosure of unsecured PHI is presumed to be a breach unless an exception applies or a documented assessment of the required factors shows a low probability of compromise.

HHS breach guidance describes distinct covered-entity and business-associate duties and timing. State, payer, licensing, insurer, and contract clocks may differ. Response, containment, evidence preservation, clinical continuity, and legal classification can proceed in parallel.

A fictional practice receives 15 alerts in a month. Twelve are triaged within the target, or 12/15, 80%. Eight become confirmed or suspected security incidents, and six reach the documented containment milestone on time, or 6/8, 75%. False-positive alerts stay in the first denominator because it measures triage, while alert-only cases stay out of the incident denominator.

Build a right-sized compliance program

A compliance program organizes standards, leadership, education, communication, reporting, enforcement, risk assessment, audit, investigation, corrective action, and monitoring. The OIG General Compliance Program Guidance is voluntary and nonbinding. It offers right-sized approaches for smaller entities as well as larger organizations.

HHS-OIG exclusion screening checks people and entities against the List of Excluded Individuals/Entities and verifies possible matches. OIG's exclusions FAQ explains federal program payment risks and recommends regular screening. State Medicaid and payer rules may add lists or cadence.

Keep reporting routes accessible to clients, families, staff, and contractors. Protect good-faith reporting, investigate consistently, refund or disclose when required, correct the cause, and validate the change.

Route fraud-and-abuse questions to counsel

Fraud, waste, and abuse is an umbrella phrase covering distinct intentional, inefficient, abusive, or improper conduct under applicable definitions. Do not treat the three words as interchangeable.

The False Claims Act addresses defined false or fraudulent claims and related conduct under federal law. The Anti-Kickback Statute concerns knowing and willful remuneration to induce or reward federal healthcare program referrals or business within its scope. Stark Law concerns certain physician referrals for designated health services and related billing under its definitions and exceptions.

These laws have different elements, covered programs, actors, services, exceptions, safe harbors, knowledge standards, and remedies. Counsel should review ownership, referral, marketing, discounts, gifts, management fees, leases, compensation, and transaction arrangements before implementation.

Maintain one source-linked control register

For each control, record the law or contract, entity and data scope, owner, procedure, evidence, frequency, exception, test, failure route, corrective action, and recheck trigger. A policy can satisfy documentation while the actual control fails.

Review after new sites, services, payers, vendors, devices, roles, interfaces, ownership, and incidents. Keep legal conclusions, risk acceptance, clinical decisions, and technical configuration attributable to the qualified role.

Archive superseded versions so an audit can reconstruct which control applied on the event date.

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