Integrity Controls Policy

5. Procedures

1. DATA INTEGRITY AT REST

1.1 ePHI stored on servers, workstations, and media shall be protected through: file system permissions that restrict write, modify, and delete access to authorized users, use of database integrity features (e.g., referential integrity constraints, transaction logs), regular backup procedures that enable restoration to a known good state (see Contingency Plan), and file integrity monitoring where feasible.

1.2 The IT Manager shall ensure that storage systems use error-detection mechanisms (e.g., RAID, ECC memory, filesystem checksums) to detect and correct data corruption.

1.3 The EHR system shall maintain an audit trail of all record modifications, including the original value, the modified value, the user who made the change, and the date/time of the change.

2. DATA INTEGRITY IN PROCESSING

2.1 Applications that process ePHI shall implement input validation to prevent the entry of corrupted or malformed data.

2.2 System updates and patches shall be tested in a non-production environment before deployment to ePHI systems, where feasible, to prevent updates from introducing integrity issues.

2.3 Anti-malware protection shall be maintained on all systems to detect and prevent malicious software from altering or destroying ePHI (see Security Awareness & Training Policy for malware prevention training).

3. DATA INTEGRITY IN TRANSIT

3.1 ePHI transmitted electronically shall be protected using integrity verification mechanisms. See the Transmission Security Policy for detailed requirements.

3.2 At minimum, transmission integrity controls shall include: use of protocols that include built-in integrity checking (e.g., TLS, HTTPS, SFTP), verification of data completeness after file transfers, and digital signatures for sensitive or legally significant transmissions where applicable.

4. INTEGRITY VERIFICATION MECHANISMS

4.1 Where feasible, [PRACTICE NAME] shall implement mechanisms to authenticate ePHI and detect unauthorized alterations, including: hash values or checksums for files containing ePHI that are archived or transferred, EHR audit trail features that track all modifications, database transaction logs, and file integrity monitoring tools on servers hosting ePHI.

4.2 If [PRACTICE NAME] determines that a specific integrity mechanism is not reasonable and appropriate, the decision shall be documented along with the alternative measures implemented, per the addressable specification process at 45 CFR § 164.306(d).

5. INCIDENT RESPONSE FOR INTEGRITY VIOLATIONS

5.1 Any suspected unauthorized alteration or destruction of ePHI shall be reported and investigated per the Security Incident Response Policy.

5.2 If ePHI integrity has been compromised, the IT Manager shall assess the scope of the impact, restore data from the most recent clean backup, and document the incident and restoration.

6. Roles & Responsibilities

Security Officer ([SECURITY OFFICER NAME]): Defines integrity control requirements. Reviews integrity-related incidents. Ensures integrity controls are evaluated during annual assessments.

IT Manager/Vendor ([IT CONTACT NAME]): Implements technical integrity controls (permissions, checksums, monitoring). Maintains backup and restoration capabilities. Manages anti-malware and patch management. Responds to integrity incidents.

EHR Vendor: Provides built-in integrity features (audit trails, referential integrity, data validation). Supports integrity-related configuration and reporting.

All Workforce Members: Follow data entry procedures accurately. Report any suspected data corruption, unauthorized changes, or system errors to the IT Manager.

7. Review Schedule

This policy shall be reviewed at least annually. Integrity controls shall be evaluated as part of the annual security evaluation. The effectiveness of backup and restoration procedures in maintaining data integrity shall be tested at least annually per the Contingency Plan.

8. Regulatory References

45 CFR § 164.312(c)(1) — Integrity (Required) 45 CFR § 164.312(c)(2) — Mechanism to authenticate electronic protected health information (Addressable) 45 CFR § 164.312(e)(2)(i) — Integrity controls for transmission (Addressable) 45 CFR § 164.306(d) — Implementation specifications for addressable safeguards