HIPAA Privacy and Security Rule Explained: Key Requirements, Differences, and How to Comply

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HIPAA Privacy and Security Rule Explained: Key Requirements, Differences, and How to Comply

Kevin Henry

HIPAA

February 10, 2024

7 minutes read
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HIPAA Privacy and Security Rule Explained: Key Requirements, Differences, and How to Comply

The HIPAA Privacy and Security Rule Explained: Key Requirements, Differences, and How to Comply helps you understand how Protected Health Information (PHI) must be used, disclosed, and safeguarded. Whether you are a covered entity or a business associate, this guide clarifies core protections, outlines practical safeguards for Electronic Protected Health Information (ePHI), and shows how to build a sustainable compliance program.

HIPAA Privacy Rule Protections

The Privacy Rule governs how PHI—any individually identifiable health information in any form—is used and disclosed. It sets boundaries on sharing, grants individuals rights over their data, and requires you to implement policies that limit access to the “minimum necessary.”

What PHI Is Protected

  • PHI includes medical records, billing details, and identifiers (e.g., names, addresses, dates, account numbers) tied to a person’s health status, care, or payment.
  • PHI can exist on paper, verbally, or electronically; when electronic, it is ePHI and also falls under the Security Rule.

Permitted Uses and Disclosures

  • Treatment, payment, and healthcare operations without authorization, following minimum necessary standards.
  • Public interest and legal requirements (e.g., certain public health reporting) as specifically permitted by HIPAA.
  • All other uses require a valid, written authorization.

Individual Rights

  • Right of access and copies in requested format if readily producible, including electronic copies of ePHI.
  • Right to request amendments, restrictions, and confidential communications.
  • Right to an accounting of certain disclosures.

Organizational Obligations

HIPAA Security Rule Safeguards

The Security Rule requires you to protect the confidentiality, integrity, and availability of ePHI using Administrative, Physical, and Technical Safeguards. Risk management is ongoing and must be scaled to your size, complexity, and risk profile.

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Administrative Safeguards

  • Risk analysis and risk management to identify, evaluate, and reduce risks to ePHI.
  • Assigned security responsibility, workforce training, and sanctions for violations.
  • Information access management and role-based access aligned to minimum necessary.
  • Contingency planning: data backups, disaster recovery, and emergency operations.
  • Security incident procedures and periodic evaluations.

Physical Safeguards

  • Facility access controls (badging, visitor logs, secured server rooms).
  • Workstation use and security (screen positioning, automatic logoff, cable locks).
  • Device and media controls (inventory, secure disposal, media re-use, encryption for portable devices).

Technical Safeguards

  • Access controls: unique user IDs, multi-factor authentication, session timeouts, and emergency access procedures.
  • Audit controls: system logs, audit trails, and monitoring of access to ePHI.
  • Integrity controls to prevent improper alteration or destruction.
  • Authentication to verify users and entities accessing systems.
  • Transmission security: encryption in transit (TLS), secure messaging, and network protections.

Key Differences Between Privacy and Security Rules

  • Scope of information: the Privacy Rule covers PHI in any form; the Security Rule applies only to ePHI.
  • Focus: the Privacy Rule governs permissible uses/disclosures and individual rights; the Security Rule mandates safeguards to protect systems and data.
  • Mechanisms: the Privacy Rule relies on policies, notices, and process controls; the Security Rule emphasizes Administrative, Physical, and Technical Safeguards.
  • Actors: both affect covered entities and business associates, but the Privacy Rule centers on how PHI is shared, while the Security Rule centers on how ePHI is protected.

Compliance Strategies for Privacy Rule

Build Clear Policies and Workflows

  • Document uses/disclosures, minimum necessary standards, and role-based access for PHI.
  • Establish procedures for authorizations, revocations, and denial/approval of access requests.
  • Standardize de-identification (safe harbor) and limited data sets with Data Use Agreements where appropriate.

Empower Individuals

  • Provide timely access to records, including electronic copies of ePHI when requested.
  • Maintain processes for amendments, restrictions, and confidential communications.

Vendor and Associate Management

  • Identify all business associates and execute BAAs that specify permitted uses and safeguards for PHI.
  • Review vendors’ security practices and incident response capabilities before sharing PHI.

Training and Oversight

  • Train your workforce on PHI handling, minimum necessary, and reporting of potential privacy incidents.
  • Audit disclosures and spot-check compliance with policies and Notice of Privacy Practices.

Compliance Strategies for Security Rule

Strengthen Technical Controls

  • Encrypt ePHI at rest and in transit; enforce MFA; implement strong passwords and automatic logoff.
  • Centralize logging, enable audit trails, and review anomalous access to ePHI.
  • Harden systems: timely patching, vulnerability scanning, and endpoint protection.

Harden the Environment

  • Segment networks that store or process ePHI; limit administrative privileges.
  • Secure mobile and remote work via VPN, MDM, and remote wipe for lost or stolen devices.

Plan for Disruptions

  • Implement backups with periodic restore tests; define Recovery Time and Recovery Point Objectives.
  • Document and exercise an incident response plan and disaster recovery procedures.

Operationalize Security Governance

  • Assign a security official, define accountability, and run regular security evaluations.
  • Integrate change management so new systems handling ePHI are assessed before go-live.

Roles and Responsibilities in HIPAA Compliance

  • Executive leadership: set tone, allocate resources, and approve HIPAA policies.
  • Privacy official: oversees Privacy Rule compliance, NPP, authorizations, and individual rights.
  • Security official: drives Security Rule compliance, risk management, and safeguard implementation.
  • IT and security teams: implement Technical and Physical Safeguards, monitoring, and incident response.
  • Clinical and operational staff: follow minimum necessary, verify identity, and report incidents.
  • Compliance/legal: manage BAAs, training, audits, and investigations.
  • Business associates: protect PHI per BAAs, limit uses/disclosures, and support incident handling.

Risk Assessment and Mitigation Techniques

A disciplined Risk Assessment is the engine of HIPAA Security Rule compliance and informs Privacy Rule controls. You identify where ePHI lives, evaluate threats and vulnerabilities, and prioritize treatment to reduce risk to acceptable levels.

Methodology

  • Inventory assets: systems, applications, databases, devices, and data flows containing ePHI.
  • Map threats and vulnerabilities: human error, unauthorized access, ransomware, loss/theft, misconfigurations.
  • Analyze likelihood and impact to rate risks; consider confidentiality, integrity, and availability.
  • Document existing safeguards and gaps; track findings to remediation owners and due dates.

Mitigation Plan

  • Apply Administrative Safeguards: policies, training, sanctions, vendor oversight, and contingency planning.
  • Enhance Physical Safeguards: restricted facilities, workstation security, and device/media controls.
  • Implement Technical Safeguards: encryption, MFA, access controls, audit logs, and secure configurations.
  • Address high-risk items first; define measurable outcomes (e.g., “100% MFA on EHR by Q2”).

Ongoing Monitoring

  • Schedule periodic evaluations, tabletop exercises, and incident post-mortems.
  • Continuously review access, logs, and alerts; verify deprovisioning when roles change.
  • Update the Risk Assessment when systems or vendors change or after significant incidents.

Conclusion

The HIPAA Privacy and Security Rule Explained: Key Requirements, Differences, and How to Comply comes down to understanding PHI and Electronic Protected Health Information (ePHI), enforcing minimum necessary, and implementing Administrative, Physical, and Technical Safeguards. With clear roles, strong vendor management, and a living Risk Assessment, you can protect individuals’ information and maintain trust while meeting regulatory obligations.

FAQs.

What is the main purpose of the HIPAA Privacy Rule?

The Privacy Rule protects individuals’ PHI by setting limits on uses and disclosures, establishing the minimum necessary standard, and granting rights such as access, amendments, and confidential communications. It requires covered entities to publish a Notice of Privacy Practices and to manage Business Associates through BAAs.

How does the HIPAA Security Rule protect electronic health information?

The Security Rule safeguards ePHI through Administrative, Physical, and Technical Safeguards. You must perform a Risk Assessment, implement controls like encryption, MFA, and audit logging, train your workforce, plan for contingencies, and continuously evaluate the effectiveness of these measures.

What are the key differences between the Privacy and Security Rules?

The Privacy Rule applies to PHI in any form and governs when and how information may be used or disclosed and what rights individuals have. The Security Rule applies only to ePHI and focuses on how systems and processes must protect confidentiality, integrity, and availability via defined safeguards.

How can organizations ensure compliance with HIPAA regulations?

Start with a documented Risk Assessment, implement minimum necessary access, enforce Administrative/Physical/Technical Safeguards, maintain BAAs with business associates, train your workforce, monitor access to ePHI, and regularly review and update policies, procedures, and controls to address emerging risks.

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