HIPAA Privacy and Security Rule Summary: Key Requirements and What You Need to Know

This HIPAA Privacy and Security Rule Summary distills what you need to know to protect Protected Health Information (PHI) and Electronic Protected Health Information (ePHI). It explains how Covered Entities and Business Associates should structure policies, controls, and training across Administrative Safeguards, Technical Safeguards, and Physical Safeguards.

Overview of HIPAA Privacy Rule

Purpose and scope

The Privacy Rule governs how PHI in any form—paper, verbal, or electronic—is used and disclosed. It defines who may access PHI, for what purposes, and under what conditions, focusing on minimum necessary use and protecting individuals’ rights.

Individual rights

Individuals have rights to access and obtain copies of their PHI, request amendments, receive an accounting of certain disclosures, request restrictions, and ask for confidential communications. You must respond within required timeframes and document your responses.

Permitted uses and disclosures

Without an authorization, PHI may be used or disclosed for treatment, payment, and health care operations. Other uses—such as most marketing or sharing beyond these purposes—require a valid written authorization. Incidental disclosures must be limited through reasonable safeguards.

Organizational duties

Covered Entities must provide a Notice of Privacy Practices, designate a privacy official, maintain policies and procedures, and apply sanctions for violations. Business Associates must sign agreements that bind them to safeguard PHI and support Privacy Rule obligations.

Overview of HIPAA Security Rule

Scope and objectives

The Security Rule applies to ePHI and aims to ensure its confidentiality, integrity, and availability. It requires a risk-based program that matches controls to your environment, workforce, and technology.

Framework and flexibility

Safeguards fall into three categories—Administrative, Physical, and Technical. Some implementation specifications are “required,” while others are “addressable,” meaning you must implement them if reasonable and appropriate, or document an alternative that achieves equivalent protection.

Administrative Safeguards Requirements

• Security management process: Perform a risk analysis, manage identified risks, apply a sanctions policy, and establish security incident procedures to detect, report, and mitigate events.
• Assigned security responsibility: Appoint a security official accountable for developing, implementing, and overseeing the program.
• Workforce security: Authorize, supervise, and terminate access appropriately; promptly adjust access when roles change.
• Information access management: Grant role-based access aligned to the minimum necessary standard; review access regularly.
• Security awareness and training: Provide initial and periodic training, including phishing awareness, password hygiene, and secure device handling.
• Security incident procedures: Define detection, escalation, investigation, and breach response steps; document incidents and outcomes.
• Contingency planning: Maintain data backup, disaster recovery, and emergency mode operation plans; test and update them routinely.
• Evaluation: Conduct initial and periodic evaluations of your safeguards against organizational, technical, or regulatory changes.
• Business Associate management: Execute agreements that require Business Associates to protect ePHI and report incidents; monitor performance.
• Documentation: Maintain policies, procedures, decisions (including “addressable” rationale), training records, and evidence of control operation.

Technical Safeguards Requirements

• Access controls: Use unique user IDs, role-based permissions, emergency access procedures, automatic session timeouts, and, where reasonable, multi-factor authentication.
• Audit controls: Log access and activity across systems handling ePHI; retain, review, and investigate logs proportionate to risk.
• Integrity protections: Guard against improper alteration or destruction with hashing, application controls, change management, and anti-malware.
• Person or entity authentication: Verify the identity of users and systems before granting access to ePHI.
• Transmission security: Protect ePHI in transit with strong encryption (for example, TLS for network traffic), integrity checks, and secure messaging; avoid unsecured channels.
• Encryption at rest: While an addressable specification, encrypting ePHI at rest and managing keys securely is widely considered a reasonable and appropriate safeguard.

Physical Safeguards Requirements

• Facility access controls: Limit and log physical access to areas housing systems with ePHI; maintain maintenance records and emergency access processes.
• Workstation use: Define acceptable use and physical placement to prevent unauthorized viewing or use.
• Workstation security: Secure workstations with locks, privacy screens, and cable locks; use automatic screen locks.
• Device and media controls: Track hardware and media; back up data before movement; sanitize or destroy media before disposal or reuse; document custody.
• Environmental and visitor management: Control visitor access, escort when appropriate, and protect against hazards that could damage systems or records.

Workforce Training and Responsibilities

Your workforce must understand how to handle PHI and ePHI securely and lawfully. Training should be role-based, assigned before granting access, refreshed periodically, and updated when systems or policies change.

• Privacy essentials: Minimum necessary use, permitted disclosures, authorizations, and handling of patient requests and complaints.
• Security awareness: Recognizing phishing and social engineering, creating strong passwords, reporting incidents, and securing devices and data.
• Acceptable use and BYOD: Clear rules for personal devices, remote work, storage, and transmission of ePHI.
• Access and accountability: Using unique credentials, avoiding sharing, and acknowledging responsibility for actions taken under one’s account.
• Documentation and sanctions: Record attendance and comprehension; apply and document sanctions for violations consistently.

Risk Assessment and Management Processes

Risk analysis and management are the foundation of HIPAA Security Rule compliance. You identify where ePHI resides and moves, evaluate threats and vulnerabilities, determine likelihood and impact, and implement reasonable and appropriate controls to reduce risks to acceptable levels.

How to conduct a risk analysis

• Define scope: Map all locations, systems, and workflows that create, receive, maintain, or transmit ePHI.
• Inventory and data flows: Catalog assets and vendors; chart how ePHI enters, moves, and leaves your environment.
• Identify threats and vulnerabilities: Consider technical flaws, human error, insider threats, third-party risks, and physical hazards.
• Assess likelihood and impact: Rate risks using a consistent methodology to prioritize remediation.
• Select safeguards: Choose Administrative, Technical, and Physical Safeguards; document rationale for addressable specifications.
• Implement and assign ownership: Set timelines, owners, and success criteria; integrate with change management.
• Monitor and re-evaluate: Track metrics, test controls, review logs, and update the analysis after material changes or incidents.

Ongoing risk management

• Vendor risk: Execute Business Associate Agreements, perform due diligence, and monitor vendors with access to PHI or ePHI.
• Operational resilience: Test backups and disaster recovery; practice emergency mode operations to protect availability of ePHI.
• Access governance: Recertify user access, remove unnecessary privileges, and review high-risk roles regularly.
• Continuous improvement: Use incidents, audits, and evaluations to refine safeguards and training over time.

Conclusion

By aligning policies, training, and controls with the Privacy Rule and implementing risk-based Administrative, Technical, and Physical Safeguards under the Security Rule, you can protect PHI and ePHI effectively. Treat risk analysis as a living process, document decisions, and hold your workforce and vendors accountable.

FAQs

What are the main differences between the HIPAA Privacy and Security Rules?

The Privacy Rule covers PHI in any form and governs when you may use or disclose it and what rights individuals have. The Security Rule focuses only on ePHI and requires a risk-based program of Administrative, Technical, and Physical Safeguards to ensure confidentiality, integrity, and availability. In short: Privacy defines the “when and why,” Security specifies the “how.”

What administrative safeguards are required under HIPAA?

You must conduct a risk analysis, manage identified risks, assign a security official, manage workforce access, provide security awareness training, define incident procedures, and maintain contingency plans. You also need periodic evaluations, appropriate Business Associate management, and thorough documentation of policies, decisions, and evidence that controls operate.

How do covered entities comply with risk assessment requirements?

Scope all systems and workflows that handle ePHI, identify threats and vulnerabilities, and rate risks by likelihood and impact. Select reasonable and appropriate safeguards, document rationale—especially for addressable items—assign owners and timelines, and monitor results. Update the assessment after significant changes or incidents to keep it current and effective.

What training is necessary for workforce members under HIPAA?

Provide role-based training before granting access and refresh it periodically. Cover privacy basics (minimum necessary, permitted disclosures), security awareness (phishing, passwords, device security), acceptable use and BYOD, incident reporting, and accountability. Keep records of attendance and comprehension, and apply sanctions consistently for violations.