HIPAA Compliance Checklist
Risk Analysis and Management
Map every system that creates, receives, stores, or transmits ePHI — application databases, S3 buckets, log aggregators, backup snapshots, analytics warehouses, support ticket systems. Diagram the flows between them. Shadow stores in dev/staging are the most common audit finding.
Score threats × vulnerabilities × impact for each ePHI system identified in the inventory. HHS expects a documented methodology — NIST SP 800-30 is the safe choice. Attach the completed assessment so it lives in the evidence repository for the next audit.
For each high or medium risk, name an owner, a target completion date, and the chosen treatment (mitigate, accept, transfer). Track tickets in Jira or Linear so progress is visible — a treatment plan that lives only in a Word doc is the failure mode auditors flag.
Policies and Procedures
Review the administrative, physical, and technical safeguard policies against §164.308–.312. Vanta, Drata, and Secureframe ship template policies; they still need to match how your team actually operates or auditors will catch the gap.
Push the approved versions to Notion, Confluence, or whichever handbook tool the team already uses. Version-control the policy source in git so changes have an audit trail.
Every workforce member — employees, contractors, interns — signs the acknowledgment within their onboarding window or 30 days of policy revision. Compliance platforms automate this; otherwise track signed forms in the HR system.
Workforce Training
Required for all workforce members, not just engineers who touch ePHI. Cover minimum-necessary access, phishing recognition, sanction policy, and breach reporting channels. KnowBe4 and Curricula are common LMS choices.
Backend, SRE, and on-call engineers need deeper coverage: secrets handling, break-glass production access, audit-log expectations, encryption requirements, and the scrubbing rules for support tickets and bug reports. Generic awareness training does not satisfy this for technical roles.
Pull the completion roster and chase the laggards. Workforce members who have not completed training within the policy window need a documented sanction action — auditors check that the sanction policy is actually applied, not just written down.
Business Associate Agreements
Cover infrastructure (AWS, GCP, Azure), data (Snowflake, MongoDB Atlas), observability (Datadog, Sentry), email (SendGrid, Postmark), support (Zendesk, Intercept), and any AI/ML APIs. Anything that processes or stores ePHI on your behalf needs a BAA — including Slack and Notion if PHI ever ends up in tickets or runbooks.
AWS, GCP, and Azure all require an active BAA flag on the account before HIPAA-eligible services may be used — and only specific services qualify. A BAA on the parent contract does not cover a non-eligible service.
Pull the latest Type II report for each in-scope vendor; check the audit period covers your reporting window with no gap. Note any qualified opinions or carve-outs in the vendor risk file.
Incident Response and Breach Notification
The runbook lives next to the on-call docs in the team's runbook tool. It names the incident commander, the privacy officer, the legal contact, and the four-factor risk assessment used to decide whether an impermissible disclosure is a reportable breach.
Pick a realistic scenario — an exposed S3 bucket, a stolen laptop with cached PHI, a misconfigured IAM role granting a vendor access. Walk the on-call rotation and the privacy officer through the response. File the tabletop notes as evidence.
Apply the §164.402 four-factor analysis to each suspected impermissible use or disclosure logged this cycle. Capture the affected count tier — the 500-individual threshold drives different downstream notification obligations.
Written notice by first-class mail (or email if the individual agreed). The 60-day clock starts at discovery, not at confirmation — auditors look closely at the gap between first signal in your ticketing system and the notice timestamp.
For breaches affecting fewer than 500 individuals, file via the HHS OCR portal annually within 60 days of year-end. For breaches affecting 500 or more, file within 60 days of discovery — same portal, different timeline.
Required only for breaches affecting more than 500 residents of a single state or jurisdiction (§164.406). Coordinate with legal and PR before issuing the press release; the wording must include the same elements as the individual notice.
Technical Safeguards
Quarterly access review covering AWS IAM, k8s RBAC, database roles, and the application's own admin tier. Engineers who left the team or changed roles are the typical findings — SCIM via the SSO provider closes most of the gap but never all of it.
KMS-backed encryption on RDS, S3, EBS, and any backup destination. ALB/CloudFront listeners enforce TLS 1.2 or higher with modern cipher suites — run an SSL Labs scan against the public endpoints and capture the report as evidence.
CloudTrail, k8s audit, application access logs, and database audit streams all flow into the SIEM (Splunk, Datadog, or similar) with at least six years of retention to match the §164.316 documentation requirement. Verify the log integrity check actually runs — silent ingestion failures are common.
Physical Safeguards
Jamf, Kandji, or Intune enforces full-disk encryption, screen lock, OS patch level, and remote wipe. Devices that fail compliance lose SSO access via the conditional access policy — the device-trust pattern, not just an honor-system policy doc.
NIST SP 800-88 sanitization for any device that held ePHI. Keep the certificate of destruction for laptops returned through the IT asset offboarding flow — auditors ask for samples.
For cloud-hosted ePHI you inherit physical controls from AWS, GCP, or Azure. File the relevant section of their SOC 2 Type II as evidence; note the carve-out clearly so your auditor sees the inheritance is intentional.
Documentation and Recordkeeping
Risk assessments, policies, training rosters, BAAs, access reviews, vulnerability scans, and incident logs all land in one place — Vanta, Drata, or a tightly-permissioned bucket. Auditors ask for the artifact, not the description of the artifact.
§164.316(b)(2) sets the floor at six years from creation or last-effective date, whichever is later. Lifecycle policies on S3 and equivalent stores enforce the minimum without manual tracking — verify the rule is actually configured, not just drafted.
The privacy officer and security lead walk the evidence repository quarterly to catch stale artifacts before the auditor does. Stale access reviews and expired BAAs are the most common findings at this checkpoint.
Use this template in Manifestly
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- Regulatory Compliance Checklist
- Quarterly Internal Control Review Checklist
- Sales Tax Reporting Checklist
- Legal Entity Management Checklist
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- Anti-Money Laundering Compliance Checklist
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- GDPR Compliance Review Checklist
- IT Security Audit Checklist
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- Payroll Processing Checklist
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- Employee Records Management Checklist
- Legal Document Storage Checklist
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- Property Risk Assessment Checklist
- Property Safety Inspection Checklist
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- Fair Housing Compliance Checklist
- Legal Compliance Checklist for New Properties
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- Software Licensing Compliance Checklist
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- Real Estate Legal Compliance Checklist
- MLS Listing Review Checklist
- Real Estate License Renewal Checklist
- GDPR Compliance Checklist
- Real Estate Contract Review Checklist
- Fair Housing Compliance Audit
- Listing Agreement Intake Checklist
- ISO/IEC 27001 Compliance Checklist
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- Real Estate Ethics & Compliance Review
- Brokerage Trust Account Management Checklist
- Real Estate Professional Development Checklist
- Brokerage Technology Inventory Audit
- Real Estate Website Audit Checklist
- Continuing Education Checklist
- Employee Termination Checklist
- Employee Records File Audit
- Regulatory Compliance Checklist
- Brokerage HR Policy Compliance Checklist
- Employee Handbook Annual Review
- Employee Termination Checklist
- Data Privacy Compliance Checklist
- Risk Management Checklist
- Insurance Compliance Checklist
- Complaint Resolution Checklist
- Financial Audit Checklist
- Data Security Checklist
- Risk Mitigation Checklist
- Claims Auditing Checklist
- Quarterly Industry Standards Compliance Review
- Insurance Training and Development Checklist
- Anti-Money Laundering Checklist
- Training Evaluation Checklist
- Manufacturing Regulatory Compliance Checklist
- Training Needs Assessment Checklist
- Skills Development Checklist
- Audit Preparation Checklist
- Network Security Checklist
- Employee Offboarding Checklist
- IT Asset Inventory Management Checklist
- Regulatory Reporting Checklist
- Compliance Audit Checklist
- Insurance Program Initiation Checklist
- Insurance Program Launch Project Monitoring Checklist
- Training Materials Checklist
- Quarterly Risk Monitoring Checklist
- System Backup Checklist
- Employee Benefits Checklist
- Insurance Program Launch Execution Checklist
- Insurance Marketing Campaign Checklist
- Email Compliance Checklist
- Law Firm Compliance Checklist
- Anti-Money Laundering Compliance Checklist
- Law Firm Compliance Checklist
- Professional Responsibility Compliance Review
- Data Privacy Compliance Checklist
- Law Firm Risk Management Checklist
- HR Audit Checklist
- HR Compliance Checklist
- Email Deliverability Checklist
- Law Firm Ethics Compliance Review
- Document Retention Policy Checklist
- Employee File Audit Checklist
- Law Firm Risk Management Checklist
- Cloud Security Checklist
- User Access Review Checklist
- IT Regulatory Compliance Review
- Compliance Audit Checklist
- Security Audit Checklist
- Business Continuity Checklist
- Employee Termination Checklist
- Quarterly Operations and Compliance QA Review
- Expense Management Checklist
- Advisor and Employee Onboarding Checklist
- Client Satisfaction Survey Checklist
- Operational Risk Checklist
- Know Your Customer (KYC) Checklist
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- Contract Review Checklist
- New Hire Onboarding Checklist
- Client Onboarding Checklist
- Contract Review Checklist
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- Monthly Financial Reporting Checklist
- Regulatory Reporting Checklist
- Intellectual Property Management Checklist
- Internal Audit Checklist
- Lead Generation Checklist
- Annual Financial Reporting Checklist
- Annual Compliance Program Review
- Annual Risk Assessment Checklist
- Data Security Review Checklist
- Quarterly Performance Measurement Checklist
- Financial Services Project Initiation Checklist
- IT Policy Review Checklist
- Data Protection Checklist
- E-commerce Sales Tax Reporting Checklist
- Project Execution Checklist
- Project Planning Checklist
- Project Monitoring Checklist
- Financial Statement Review Checklist
- Quarterly Compliance Monitoring Checklist
- Cybersecurity Risk Assessment Checklist
- Project Closure Checklist
- Financial Services IT Security Audit Checklist
- PCI DSS Compliance Checklist
- Advisor and Staff Onboarding Checklist
- Cybersecurity Incident Response Checklist
- E-commerce Risk Management Checklist
- CRM Data Entry Checklist
- Business Continuity Plan Checklist
- E-commerce Legal Compliance Checklist
- Vendor Contract Review Checklist
- Annual Risk Management Review Checklist
- Risk Assessment Checklist
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- Annual School Compliance Audit
- School First Aid and Emergency Medication Audit
- Motor Carrier TSA Security Compliance Checklist
- Internal Controls Checklist
- Client Communication Checklist
- Restaurant Permit and Licensing Renewal Checklist
- New Hire Paperwork Checklist
- Restaurant Policy Update Checklist
- Restaurant New Hire Checklist
- Annual Attorney Professional Conduct Review
- International Fuel Tax Agreement (IFTA) Quarterly Filing Checklist
- Restaurant Licensing Renewal Checklist
- Marketing Strategy Checklist
- Department of Transportation (DOT) Audit Checklist
- Retail Policy Update and Compliance Checklist
- Employee Data Security Checklist
- Security Review Checklist
- Security Testing Checklist
- Security Best Practices Checklist
- PCI DSS Compliance Checklist
- Incident Response Checklist
- Quarterly Security Review Checklist
- Engineer Offboarding Checklist
- Password Management Checklist
- Server Security Checklist
- IT Emergency Response Checklist
- Security Audit Checklist
- Quarterly Network Security Review
- Quarterly DevOps Security Review
- Database Security Checklist
- Security and Privacy Review Checklist
- E-commerce IT Security Checklist
- Website Security Checklist
- Security System Check Checklist
- School Security and Safety Checklist
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