What Is the HIPAA Privacy Rule? A Practical Guide for Organizations

Overview of the HIPAA Privacy Rule

The HIPAA Privacy Rule sets national standards for how organizations handle Protected Health Information (PHI). It governs when you may use or disclose PHI, what authorizations are required, and how to give individuals meaningful control over their health information.

The Rule applies to covered entities—health plans, health care clearinghouses, and most health care providers—and to business associates that create, receive, maintain, or transmit PHI on their behalf. It works alongside the HIPAA Security Rule, which focuses on Health Information Security for electronic PHI.

What counts as PHI?

PHI is individually identifiable information related to a person’s health, care, or payment for care. It can exist in any form—electronic, paper, or oral—and includes identifiers like names, addresses, full-face photos, device IDs, and medical record numbers when linked to health data.

Core objectives

• Enable essential care activities while limiting unnecessary use and disclosure.
• Give individuals clear rights to access, amend, and control their information.
• Require reasonable safeguards and accountability across the data lifecycle.

Requirements for Covered Entities

Covered entities must establish a compliance program that embeds privacy into daily operations. The following elements form the foundation of compliance.

Permitted and required uses/disclosures

• Treatment, payment, and health care operations without patient authorization, using the minimum necessary standard where applicable.
• Disclosures required by law or for specified public interest purposes (for example, certain public health and law enforcement activities).
• Uses/disclosures requiring written authorization, including most marketing and the sale of PHI.

Transparency and individual communication

• Provide a Notice of Privacy Practices that explains how you use PHI and the rights available to individuals.
• Offer reasonable, alternative means of communication upon request (for example, sending bills to a different address).

Business associates

Execute Business Associate Agreements that bind vendors to HIPAA requirements and specify permissible uses of PHI, safeguards, reporting obligations, and breach cooperation.

Minimum necessary standard

Limit PHI use, access, and disclosure to the least amount needed to accomplish the purpose, with role-based access and routine workflows pre-defined to support compliance.

Individual Rights under HIPAA

The Privacy Rule grants individuals actionable rights that you must enable through documented procedures and timely responses.

• Right of access: Provide copies or electronic access to designated record sets generally within 30 days, with one allowable 30-day extension and a reasonable, cost-based fee for copies.
• Right to request amendments: Evaluate and respond (approve or deny with rationale) and append statements of disagreement when appropriate.
• Right to request restrictions: Consider requests to limit certain uses/disclosures, including the special right to restrict disclosures to a health plan for items/services paid in full out of pocket.
• Right to confidential communications: Accommodate reasonable requests for alternative contact methods or locations.
• Right to an accounting of disclosures: Provide a record of certain disclosures made without authorization for a defined retrospective period.
• Right to receive a Notice of Privacy Practices and to file complaints without retaliation.

Safeguards for Protected Health Information

You must implement layered safeguards to protect PHI end to end. Align your program to the Rule’s expectations and to your risk profile.

Administrative Safeguards

• Conduct risk analyses to identify threats and vulnerabilities across people, processes, and technology.
• Adopt Written Privacy Policies and procedures, designate a Privacy Official, train the workforce, and apply sanctions for violations.
• Manage vendors through due diligence, contracts, and periodic reviews.

Technical Safeguards

• Use unique user IDs, strong authentication, and role-based access controls.
• Encrypt ePHI at rest and in transit, maintain audit logs, and enable automatic logoff where feasible.
• Implement data loss prevention, patching, and secure configuration baselines to strengthen Health Information Security.

Physical safeguards

• Control facility access, secure workstations and devices, and manage device/media disposal and reuse.
• Document hardware and media movement and apply chain-of-custody practices.

Breach Notification Procedures

The Breach Notification Rule requires you to notify affected individuals, the federal regulator, and, in some cases, the media after certain impermissible uses or disclosures of unsecured PHI.

Determining whether an incident is a breach

• Assume a breach unless a documented risk assessment shows a low probability that PHI was compromised, considering factors such as: the nature and sensitivity of PHI, unauthorized person, whether PHI was actually acquired/viewed, and the extent to which risk was mitigated.
• Recognize narrow exceptions (for example, good-faith, unintentional access within scope and authority).

Notifying the right parties

• Individuals: Provide written notice without unreasonable delay and no later than 60 days after discovery, in plain language with required content (what happened, types of PHI, steps individuals should take, what you are doing, and contact information).
• Regulator: Report to the federal authority; timing and method depend on the number of affected individuals.
• Media: Notify prominent media outlets when a breach affects more than 500 residents in a state or jurisdiction.

Response and documentation

• Activate incident response, contain and eradicate the issue, and mitigate harm.
• Preserve evidence, complete the risk assessment, and document decisions, timelines, and notifications.
• Review root causes and update safeguards and training accordingly.

Compliance Responsibilities and Documentation

Strong governance turns policy into practice. Build a documented program that leadership sponsors and regularly reviews.

• Appoint a Privacy Official to oversee the program and serve as the point of contact for complaints and inquiries.
• Maintain Written Privacy Policies that cover uses/disclosures, individual rights, minimum necessary, incident response, and vendor management.
• Train all workforce members upon hire and periodically; track attendance and competency.
• Apply a sanctions policy for violations and maintain a complaint handling process with timely investigation and resolution.
• Execute, inventory, and periodically reassess Business Associate Agreements.
• Retain required documentation for at least six years from the date of creation or last effective date, whichever is later.
• Perform periodic audits and risk assessments; remediate gaps with prioritized action plans.

Resources for HIPAA Compliance

Leverage authoritative guidance and proven frameworks to operationalize compliance and strengthen Health Information Security.

• Federal guidance and FAQs from the health privacy regulator to interpret requirements and learn from enforcement actions.
• Audit protocols and checklists to benchmark your program and prepare for investigations or assessments.
• NIST resources such as SP 800-66 and the Cybersecurity Framework to align Security Rule controls and risk management.
• Professional associations and training providers for workforce education, policy templates, and practical workshops.
• Legal counsel and privacy consultants for complex use cases, data sharing arrangements, and state-law interplay.
• Secure technology solutions for access control, encryption, auditing, data minimization, and breach response coordination.

Conclusion

The HIPAA Privacy Rule gives individuals clear rights and sets expectations for how you handle PHI. By defining permissible uses, honoring requests promptly, implementing Administrative Safeguards and Technical Safeguards, and following the Breach Notification Rule, you can protect privacy, reduce risk, and build patient trust.

FAQs

What information is protected under the HIPAA Privacy Rule?

The Rule protects PHI—individually identifiable health information related to a person’s health, care, or payment for care. PHI includes data such as diagnoses, test results, treatment notes, insurance details, and identifiers like names, addresses, dates, and medical record numbers when linked to health information, in any form (electronic, paper, or oral).

Who must comply with the HIPAA Privacy Rule?

Health plans, health care clearinghouses, and most health care providers that conduct standard electronic transactions are covered entities. Business associates—vendors and partners that create, receive, maintain, or transmit PHI for a covered entity—must also comply through contract and are directly liable for many requirements.

What are the consequences of non-compliance with HIPAA?

Consequences can include corrective action plans, civil monetary penalties tiered by culpability, reputational damage, and operational disruption. Significant breaches may trigger external notifications, investigations, and long-term monitoring requirements, in addition to internal remediation and retraining.

How can organizations securely handle PHI?

Adopt Written Privacy Policies, designate a Privacy Official, and train your workforce. Apply minimum necessary access, encrypt ePHI, enforce strong authentication, and monitor with audit logs. Use Administrative Safeguards and Technical Safeguards, manage business associates diligently, and maintain an incident response plan aligned to the Breach Notification Rule.