Electronic Protected Health Information (ePHI) Under HIPAA: Definition, Examples, and Compliance Requirements
Definition of Electronic Protected Health Information
Electronic Protected Health Information (ePHI) is any protected health information that is created, received, maintained, or transmitted in electronic form. If the data can identify an individual and relates to past, present, or future health, care, or payment—and it exists in electronic media—it is ePHI.
Electronic media includes servers, desktops, laptops, mobile devices, removable drives, medical devices, cloud services, and networks that transmit data. De-identified data, education records under FERPA, and employment records held by an employer are not ePHI. Once PHI is printed, it remains PHI but is no longer “electronic.”
What ePHI includes and excludes
- Includes: identifiable clinical, demographic, financial, and operational data in EHRs, patient portals, secure messaging, backups, and system logs.
- Excludes: fully de-identified datasets (no reasonable basis to identify an individual) and records outside HIPAA’s scope as noted above.
Examples of ePHI Data Types
- Patient identifiers tied to health data: names, addresses, phone numbers, emails, dates, Social Security numbers, medical record numbers, plan member IDs.
- Clinical content: diagnoses, lab and imaging results, allergies, medications, care plans, progress notes, operative reports, pathology reports.
- Financial and administrative: claims, billing details, remittance advice, eligibility checks, authorizations, Explanation of Benefits.
- Communications: secure emails, patient portal messages, telehealth chat logs, VoIP recordings when they contain PHI.
- Images and signals: DICOM images, photographs, waveforms, device outputs, and metadata that can identify a patient.
- Device and app data: wearable metrics, remote patient monitoring feeds, mobile health app records when handled by Covered Entities or Business Associates.
- Operational records: audit logs, access logs, help-desk tickets, and backups if they include or reference PHI.
HIPAA Security Rule Overview
The HIPAA Security Rule sets national Compliance Standards to protect the confidentiality, integrity, and availability of ePHI. It uses a risk-based, scalable model so you implement “reasonable and appropriate” controls for your organization’s size, complexity, and risks.
Safeguards are grouped into Administrative Safeguards, Physical Safeguards, and Technical Safeguards. Some implementation specifications are “required,” while others are “addressable,” meaning you must implement them as written or adopt an equivalent alternative and document your rationale.
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- Applies to Covered Entities (providers, health plans, clearinghouses) and their Business Associates that create, receive, maintain, or transmit ePHI.
- Requires ongoing risk analysis, policies and procedures, workforce training, monitoring, and documentation.
Required vs. addressable
- Required: unique user identification, audit controls, security incident response, risk analysis, and contingency planning.
- Addressable: encryption and decryption, automatic logoff, integrity mechanisms, and certain transmission protections—still expected when reasonable.
Administrative Safeguards for ePHI
Security management process
- Conduct and document a Risk Assessment to identify threats, vulnerabilities, likelihood, and impact to ePHI.
- Implement risk management plans, apply sanctions for violations, and review system activity (logs, alerts, access reports).
Workforce and access management
- Assign a security official; define roles; grant minimum necessary access; use onboarding, transfer, and termination procedures.
- Deliver security awareness training, phishing education, and periodic refreshers with measurable outcomes.
Incident response and contingency planning
- Establish security incident procedures, breach triage, evidence preservation, and escalation paths.
- Maintain a contingency plan: data backup plan, disaster recovery plan, and emergency mode operations; test and update them regularly.
Governance, evaluation, and documentation
- Perform periodic evaluations to confirm controls remain effective as technologies and workflows change.
- Execute Business Associate Agreements (BAAs); manage vendor risk; retain policies, procedures, and evidence for at least six years.
Physical and Technical Safeguards
Physical Safeguards
- Facility access controls: restricted areas, visitor management, environmental protections, and emergency access procedures.
- Workstation use and security: screen placement, privacy screens, automatic locking, and secure remote work standards.
- Device and media controls: asset inventories, encryption, secure disposal and media reuse, device sanitization, and chain-of-custody records.
Technical Safeguards
- Access control: unique IDs, role-based access, Multi-Factor Authentication, emergency access procedures, and automatic logoff.
- Audit controls: centralized logging, immutable log storage, regular review of access, admin actions, and anomalous events.
- Integrity and authentication: tamper detection, hashing and digital signatures where appropriate, and user/entity authentication.
- Transmission security: encryption in transit (e.g., TLS) and protections against unauthorized alteration; encryption at rest is strongly recommended.
- Additional practices: endpoint protection, patch and vulnerability management, network segmentation, and secure configuration baselines.
Risk Assessment and Management
Effective Risk Assessment begins with an asset and data-flow inventory: where ePHI is stored, processed, and transmitted; who accesses it; and which systems depend on it. Map third-party connections and cloud services to capture full exposure.
Analyze threats and vulnerabilities, estimate likelihood and impact, and record findings in a risk register. Prioritize remediation using a clear plan with owners, timelines, and acceptance criteria. Validate through testing and adjust as conditions change.
Practical cadence and evidence
- Perform a comprehensive assessment at least annually and whenever major changes occur (new EHR, cloud migration, mergers, or new integrations).
- Use tabletop exercises, backup restore tests, and incident simulations to prove control effectiveness and support continuous improvement.
Compliance Obligations for Covered Entities and Business Associates
Covered Entities must implement the HIPAA Security Rule across people, processes, and technology, enforce the minimum necessary standard, train the workforce, and monitor compliance. They must notify affected individuals, HHS, and sometimes the media of breaches without unreasonable delay and no later than 60 days after discovery.
Business Associates are directly liable for safeguarding ePHI. They must sign BAAs, flow down obligations to subcontractors, conduct Risk Assessments, implement Administrative, Physical, and Technical Safeguards, and report incidents to the Covered Entity promptly.
Both parties should align controls to recognized security practices to demonstrate diligence, reduce risk, and support enforcement discretion. Maintain thorough documentation—policies, assessments, training records, vendor due diligence, incident reports, and test results—to substantiate compliance.
Conclusion
ePHI protection under the HIPAA Security Rule hinges on a risk-based program: know your data, assess threats, implement fit-for-purpose safeguards, and prove they work. Clear governance, strong vendor management, disciplined operations, and continuous testing keep compliance effective and sustainable.
FAQs.
What constitutes electronic protected health information under HIPAA?
Any individually identifiable health information in electronic form—created, received, maintained, or transmitted by a Covered Entity or Business Associate—counts as ePHI. It includes clinical, demographic, financial, and operational records tied to a person. Fully de-identified datasets are not ePHI.
How must covered entities protect ePHI?
Covered Entities must apply a risk-based program that implements Administrative, Physical, and Technical Safeguards, trains the workforce, manages vendors via BAAs, monitors systems, responds to incidents, and documents policies and proof of control effectiveness.
What are the major safeguards required by the HIPAA Security Rule?
The Security Rule requires Administrative Safeguards (risk analysis, risk management, training, incident and contingency planning), Physical Safeguards (facility, workstation, and device/media controls), and Technical Safeguards (access control, audit controls, integrity, authentication, and transmission security).
How often should risk assessments for ePHI be performed?
Perform a comprehensive Risk Assessment at least annually and any time significant changes occur—such as system replacements, cloud migrations, new integrations, or organizational restructuring—to ensure controls remain reasonable and appropriate for current risks.
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