Understanding HIPAA Requirements: A Guide to Compliance

HIPAA Privacy Rule Protections

What the Privacy Rule Covers

The HIPAA Privacy Rule protects Protected Health Information (PHI), which includes any individually identifiable health data held or transmitted by a covered entity or its business associate. It applies to PHI in any form—paper, oral, or electronic—and sets the baseline for how you may use and disclose that information.

Permitted Uses and Disclosures

You may use or disclose PHI for treatment, payment, and health care operations without patient authorization. Other disclosures—such as marketing or sale of PHI—generally require a valid authorization. Always apply the minimum necessary standard so staff access and share only what is needed for the task.

Individual Rights

Patients have rights to access, obtain copies, and request amendments to their PHI, as well as receive an accounting of certain disclosures. They may request restrictions and confidential communications; you must honor reasonable requests and document your responses.

Business Associates and BAAs

Vendors that create, receive, maintain, or transmit PHI on your behalf are business associates. You must execute Business Associate Agreements (BAAs) that define permitted uses, require safeguards, and mandate breach reporting. Subcontractors that handle PHI must also sign BAAs downstream.

HIPAA Security Rule Safeguards

Scope: Protecting ePHI

The Security Rule applies to Electronic Protected Health Information (ePHI). Your objective is to ensure the confidentiality, integrity, and availability of ePHI through risk-based controls that are reasonable and appropriate for your size, complexity, and capabilities.

Administrative Safeguards

• Perform an enterprise-wide Risk Assessment to identify threats, vulnerabilities, and likelihood/impact.
• Implement risk management plans, assign a security official, and enforce workforce security and sanction policies.
• Develop and maintain policies, procedures, and training; conduct periodic security evaluations.
• Execute and manage BAAs; oversee business associates and subcontractors.

Physical Safeguards

• Control facility access; protect workstations and portable devices from unauthorized viewing or theft.
• Use device and media controls for secure disposal, re-use, and transport of hardware and storage media.

Technical Safeguards

• Access controls with unique IDs, role-based access, and strong authentication.
• Encryption in transit and at rest where feasible; integrity controls to detect unauthorized alteration.
• Audit controls and activity review to log, monitor, and investigate access to ePHI.
• Transmission security to protect against unauthorized access to data sent over networks.

HIPAA Breach Notification Procedures

What Counts as a Breach

A breach is an impermissible use or disclosure of unsecured PHI that compromises the security or privacy of the information. PHI that is properly encrypted is generally considered secured, reducing notification obligations if compromised.

Risk Assessment for Breach Determination

You must assess the nature and extent of PHI involved, the unauthorized person who used or received it, whether the PHI was actually acquired or viewed, and the extent to which risks were mitigated. Document how you concluded whether notification is required.

Breach Notification Timeline

• Notify affected individuals without unreasonable delay and no later than 60 calendar days after discovery.
• Notify HHS; for breaches affecting 500 or more individuals in a state or jurisdiction, report without unreasonable delay (and within 60 days). Smaller breaches may be reported annually.
• Notify prominent media outlets when 500 or more individuals in a state or jurisdiction are affected.
• Business associates must notify the covered entity without unreasonable delay with details of the incident.

HIPAA Enforcement and Penalties

The HHS Office for Civil Rights (OCR) enforces HIPAA through investigations, audits, and resolution agreements that may include corrective action plans. Civil money penalties follow a tiered structure based on culpability and are adjusted for inflation, with potential totals reaching millions per year for persistent violations.

Willful misuse of PHI can trigger criminal penalties. Mitigating factors include prompt breach notification, comprehensive corrective actions, and demonstrated adherence to recognized security practices.

HIPAA Omnibus Rule Compliance

The Omnibus Rule strengthened HIPAA by expanding liability to business associates and their subcontractors, updating breach notification by presuming compromise unless a documented risk assessment shows low probability, and tightening rules on marketing, fundraising, and sale of PHI.

It also aligned HIPAA with genetic information protections, clarified requirements for Notices of Privacy Practices, and reinforced the need for robust BAAs with clear obligations for safeguarding PHI and reporting incidents.

Steps for HIPAA Compliance

Action Plan

• Confirm your status as a covered entity or business associate and map all PHI/ePHI data flows.
• Appoint a Privacy Officer and Security Officer to lead governance and accountability.
• Conduct an enterprise-wide Risk Assessment; prioritize remediation based on likelihood and impact.
• Implement risk management controls across Administrative Safeguards, Physical safeguards, and Technical Safeguards.
• Develop and maintain Privacy and Security policies, procedures, sanctions, and a data retention schedule.
• Execute BAAs with all vendors handling PHI; assess vendor security and monitor ongoing compliance.
• Deploy security controls such as encryption, access management, logging, and vulnerability management.
• Train your workforce initially and periodically; document attendance, content, and competency.
• Establish an incident response and breach management plan with a clear Breach Notification Timeline.
• Test contingency plans (backup, disaster recovery, emergency mode operations) and update after drills.
• Perform periodic evaluations, internal audits, and management reviews; adjust safeguards as your environment changes.

Documentation and Auditing Requirements

What to Document

• Risk Assessment and risk management plan, including remediation evidence and timelines.
• Privacy and Security policies, procedures, and change history; Notices of Privacy Practices.
• BAAs and vendor due diligence records; inventories of systems, devices, and data locations.
• Training materials, rosters, test results, and sanction actions.
• System activity logs, audit reports, access reviews, and incident/breach logs with investigation outcomes.
• Contingency plans, backup/restore tests, and results of periodic evaluations.

Audit Readiness

Maintain documentation for at least six years from the date of creation or last effective date, whichever is later. Organize evidence so you can quickly demonstrate how safeguards protect PHI and ePHI, how BAAs are enforced, and how your program continuously improves.

Conclusion

HIPAA requirements center on protecting PHI and ePHI through clear policies, robust safeguards, vigilant incident response, and disciplined documentation. By executing BAAs, performing ongoing Risk Assessments, and aligning operations with the Privacy, Security, and Breach Notification Rules, you build a defensible, resilient compliance program.

FAQs.

What entities are covered under HIPAA requirements?

Covered entities include health care providers that conduct standard electronic transactions, health plans, and health care clearinghouses. Business associates—and their subcontractors—that handle PHI on behalf of a covered entity are also directly regulated for many obligations through BAAs and the Security Rule.

How should breaches of unsecured PHI be reported?

Notify affected individuals without unreasonable delay and no later than 60 days after discovery, explain what happened and what you are doing in response, and provide mitigation steps. Report to HHS as required by breach size, notify media for large breaches, and ensure business associates promptly report incidents to covered entities with sufficient detail.

What are the penalties for HIPAA non-compliance?

OCR can impose tiered civil money penalties per violation with annual caps that are adjusted for inflation; severity depends on factors such as knowledge, negligence, and corrective actions. Serious misconduct can lead to criminal penalties. Resolution agreements may also require multi-year corrective action plans and ongoing monitoring.

How do business associates comply with HIPAA rules?

Business associates must implement the Security Rule for ePHI, follow relevant Privacy Rule requirements, and execute BAAs that define permissible uses and disclosures. They must conduct Risk Assessments, apply Administrative Safeguards and Technical Safeguards, train staff, maintain documentation, and report incidents and breaches to the covered entity without unreasonable delay.