Healthcare App Security Checklist (PHI, Access, Audits)

TL;DR: If your app touches PHI, audit readiness comes down to three things: clear PHI flows, tight access controls, and complete audit trails. Start by mapping where ePHI is created, stored, and transmitted. Then enforce least privilege, strong authentication, and session controls. Finally, log every access and change to ePHI in a tamper-evident system with alerting. Use HHS and NIST guidance as your baseline and keep evidence ready for audits.

Who this checklist is for

This is for founders, product leaders, security teams, and engineers building healthcare apps or platforms that handle Protected Health Information (PHI). If you create, receive, maintain, or transmit electronic PHI (ePHI), the HIPAA Security Rule applies and you should treat this as a living program, not a one-time task.

Know your baseline: HIPAA Security Rule and technical safeguards

HIPAA requires administrative, physical, and technical safeguards to protect confidentiality, integrity, and availability of ePHI. For app teams, the technical safeguards are where your security posture will stand or fall:

• Access control
• Audit controls
• Integrity
• Person or entity authentication
• Transmission security

These standards are flexible and scalable, but auditors still expect concrete, consistent controls and evidence. Use official sources as your baseline:

• HHS Security Rule guidance: Security Rule Guidance Material
• HHS Technical Safeguards summary: Technical Safeguards PDF
• NIST implementation guidance: NIST SP 800-66 Rev. 2

Step 1: Map PHI flows before you secure them

You cannot secure what you cannot trace. Start with a PHI data inventory and flow map. This is also the foundation for risk analysis and audit evidence.

Checklist

• Identify every feature that creates, reads, updates, or exports ePHI.
• Map storage locations (databases, object storage, backups, analytics, logs).
• Map transmission paths (mobile clients, web apps, APIs, vendor integrations).
• Identify every third party that touches ePHI and verify BAAs.

Deliverables to keep audit-ready:

• Data flow diagram (what → where → who)
• Data inventory (systems, fields, owners)
• Risk analysis tied to each PHI flow

Step 2: Access control and least privilege

Access control is the most common audit gap. Build roles around clinical and operational workflows, not org charts.

Checklist

• Enforce unique user IDs for every user and service account.
• Use role-based access control (RBAC) with least privilege defaults.
• Support break-glass access with tight time limits and elevated logging.
• Require regular access reviews and removal of stale accounts.
• Automate provisioning and deprovisioning through your IAM system.

If you support admin actions (exports, bulk edits, user management), isolate those permissions and require stronger authentication.

Step 3: Authentication and session security

HIPAA requires “person or entity authentication.” In practice, that means identity proof and strong session controls.

Checklist

• Require MFA for privileged or clinical admin accounts.
• Enforce strong password policies and avoid legacy password resets.
• Shorten session duration for apps that display or export ePHI.
• Bind sessions to device fingerprints when feasible.
• Block logins from unexpected geographies or risky IPs.

If you offer patient access, balance security with usability by making MFA available and using adaptive step-up verification for sensitive actions.

Step 4: Audit controls and logging

Audit controls must record and examine activity in systems that contain or use ePHI. Your audit story should link directly to your PHI flow map.

Checklist

• Log all read, write, export, and delete actions on ePHI.
• Log changes to access permissions and role assignments.
• Include who, what, when, where, and how (user ID, resource ID, IP, device).
• Centralize logs in a tamper-evident system (SIEM or write-once storage).
• Monitor for suspicious access patterns (bulk exports, off-hours access).
• Retain logs for the required documentation period.

Align this with the OCR audit protocol so you can show evidence quickly during reviews: HHS OCR Audit Protocol.

Step 5: Integrity controls for ePHI

Integrity safeguards require that ePHI is not altered or destroyed improperly. This is about both technical protection and evidence.

Checklist

• Use database constraints and application-level validations.
• Track edit history for clinical records.
• Use checksums or versioning for files with ePHI.
• Implement write permissions for specific roles only.
• Monitor for data tampering and unexpected changes.

Step 6: Transmission security and encryption

Transmission security protects ePHI in transit. Encryption protects ePHI at rest. Both are non-negotiable for healthcare apps.

Checklist

• Enforce TLS 1.2+ on all API and web traffic.
• Encrypt ePHI at rest in databases and object storage.
• Use managed key services and rotate keys on a regular cadence.
• Avoid logging raw ePHI in analytics, error reports, or traces.
• Secure backups with encryption and access controls.

Step 7: Mobile app security controls

Mobile devices are a common weak point. HHS provides a concise checklist that should be part of your baseline.

Checklist

• Enforce device-level encryption and secure storage.
• Require strong authentication and automatic lock on inactivity.
• Limit app permissions and avoid storing ePHI locally when possible.
• Disable data exposure through screenshots and clipboard when feasible.
• Keep OS and app updates current with patch management.
• Use remote wipe and device management for enterprise deployments.

Reference: HHS Mobile Device Security Checklist

Step 8: API and integration security

Most healthcare apps are integration hubs. Every integration is a potential exposure point for ePHI.

Checklist

• Scope access tokens tightly (least privilege by API endpoint).
• Require OAuth or signed tokens for all integration access.
• Rate-limit and monitor API abuse patterns.
• Validate input for all ePHI fields to prevent injection attacks.
• Maintain BAAs and security reviews for vendors handling ePHI.

Step 9: Secure SDLC for healthcare apps

Compliance becomes much easier when security is built into your delivery pipeline.

Checklist

• Threat model any feature that reads or exports ePHI.
• Run SAST and dependency scanning in CI.
• Maintain a vulnerability triage and remediation workflow.
• Require code review for changes touching PHI logic.
• Keep evidence of testing and security sign-offs.

Step 10: Incident response and breach readiness

HIPAA expects you to be ready for incidents. Response planning is part of compliance, not an optional add-on.

Checklist

• Maintain an incident response plan with roles and escalation paths.
• Document forensic steps and evidence preservation.
• Test backups and recovery procedures regularly.
• Define breach notification workflows with legal and compliance input.

Step 11: Audit-ready documentation (what reviewers ask for)

Audits are about evidence. You need documentation that proves controls are designed and operating.

Checklist

• Risk analysis and ongoing risk management plan
• PHI flow maps and data inventory
• Access control policies and access review records
• Audit log retention and monitoring evidence
• Vendor security reviews and BAAs
• Security training records
• Incident response drills and recovery tests

If you can show these quickly, audits become a verification exercise instead of a scramble.

Business impact / bottom line

Strong healthcare app security is not just a compliance requirement. It also drives business outcomes:

• Faster security reviews: Clear evidence reduces back-and-forth with enterprise buyers.
• Lower breach risk: Strong controls lower the likelihood and impact of incidents.
• Operational efficiency: Security built into the SDLC reduces rework and fire drills.
• Trust and retention: Patients and partners stay when they see responsible data practices.

Final checklist (printable)

Use this as a quick reference for launch readiness:

1. Map PHI flows and maintain a live data inventory
2. Enforce least privilege with RBAC and access reviews
3. Require strong authentication and session controls
4. Log all ePHI access and changes in a tamper-evident system
5. Encrypt ePHI at rest and in transit with key management
6. Implement integrity controls and change history for records
7. Apply HHS mobile security controls for all device access
8. Secure APIs and vendor integrations with tight scopes
9. Embed security checks into CI/CD and code review
10. Maintain incident response, backups, and recovery evidence
11. Keep documentation audit-ready and aligned to HHS guidance

Conclusion

Healthcare app security is a program, not a checklist you run once. If you get PHI flows, access controls, and audit trails right, the rest becomes much easier. Use HHS and NIST guidance as your baseline, keep evidence organized, and treat compliance as part of product reliability and trust.

References

• HHS Security Rule guidance: https://www.hhs.gov/hipaa/for-professionals/security/guidance/index.html
• HHS Technical Safeguards: https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/administrative/securityrule/techsafeguards.pdf
• HHS OCR Audit Protocol: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/audit/protocol-edited/index.html
• NIST SP 800-66 Rev. 2: https://csrc.nist.gov/pubs/sp/800/66/r2/final
• HHS Mobile Device Security Checklist: https://www.hhs.gov/sites/default/files/hph-mobile-device-security-checklist-tlpclear.pdf