CompliWiseAI
Data Protection · US

HIPAA documentation generator

HIPAA sets US federal requirements for protecting individuals' health information. Covered entities and business associates must implement administrative, physical and technical safeguards (the Security Rule), honour patient privacy rights (the Privacy Rule) and follow defined breach-notification duties. CompliWiseAI generates the policies, risk analysis and procedures auditors and customers expect, tailored to your role and the PHI you handle.

HIPAA — the Health Insurance Portability and Accountability Act — governs how covered entities (health plans, providers, clearinghouses) and their business associates protect Protected Health Information (PHI). Compliance rests on three rules: the Security Rule (administrative, physical and technical safeguards for electronic PHI), the Privacy Rule (patients' rights and permitted uses/disclosures), and the Breach Notification Rule. The Security Rule's cornerstone is a documented risk analysis and risk-management process. CompliWiseAI generates the complete HIPAA documentation set — security and privacy policies, the safeguards policies, risk analysis, breach-notification procedure, Business Associate Agreement management and a contingency plan — tailored to whether you are a covered entity or a business associate and the type of PHI you process.

Documents we generate for HIPAA

10 required documents, each tailored to your company and structured for audit.

Information Security Policy (HIPAA Security Rule)

Required

Overarching policy for protecting electronic PHI in line with the Security Rule.

Policy · 45 CFR §164.306

Risk Analysis & Risk Management

Required

Documented analysis of risks to ePHI and the plan to reduce them to a reasonable level.

Risk register · §164.308(a)(1)

Administrative Safeguards Policy

Required

Workforce, access management, training and security-management administrative controls.

Policy · §164.308

Physical Safeguards Policy

Required

Facility access, workstation use and device/media controls protecting ePHI.

Policy · §164.310

Technical Safeguards Policy

Required

Access control, audit controls, integrity, authentication and transmission security for ePHI.

Policy · §164.312

HIPAA Privacy Policy & Notice of Privacy Practices

Required

Permitted uses and disclosures of PHI and individuals' privacy rights.

Data protection · 45 CFR Part 164 Subpart E

Breach Notification Policy & Procedure

Required

How suspected breaches of PHI are assessed, and notifications made to individuals, HHS and media.

Incident response · 45 CFR §164.400–414

Business Associate Agreement (BAA) Management

Required

Process and template for executing and tracking BAAs with vendors handling PHI.

Policy · §164.308(b) / §164.502(e)

Workforce Security & Awareness Training

Required

Security and privacy awareness training and sanctions for the workforce.

Training · §164.308(a)(5)

Contingency Plan (Backup, DR & Emergency Mode)

Required

Data backup, disaster recovery and emergency-mode operation for ePHI systems.

Incident response · §164.308(a)(7)

Access Control & Audit Controls Procedure

Operational procedure for provisioning access and reviewing audit logs.

SOP · §164.312(a)/(b)

HIPAA readiness checklist

  • Security and privacy official(s) appointed
  • Security Rule risk analysis completed and current
  • Administrative, physical and technical safeguards documented
  • Privacy policy and Notice of Privacy Practices in place
  • Breach notification procedure with timelines defined
  • Business Associate Agreements executed and tracked
  • Workforce security and privacy training delivered
  • Contingency plan (backup, DR, emergency mode) tested

HIPAA — frequently asked questions

Who must comply with HIPAA?+

Covered entities (health plans, health-care clearinghouses, and providers who transmit health information electronically) and their business associates — any vendor that creates, receives, maintains or transmits PHI on their behalf, such as SaaS and cloud providers in healthcare.

What is a HIPAA risk analysis?+

A required, documented assessment of the risks and vulnerabilities to the confidentiality, integrity and availability of electronic PHI (Security Rule §164.308(a)(1)). It is the foundation of HIPAA security compliance and a frequent audit focus.

Do I need a Business Associate Agreement (BAA)?+

Yes — covered entities and business associates must have a written BAA in place with each downstream business associate that handles PHI. CompliWiseAI generates a BAA template and a process for managing them.

Start your HIPAA documentation free

Create a workspace, add HIPAA, and generate your first audit-ready document in minutes.