HIPAA
US healthcare data privacy and security standard
§ Overview
HIPAA (Health Insurance Portability and Accountability Act) establishes national standards for protecting sensitive patient health information. The Security Rule requires administrative, physical, and technical safeguards for electronic Protected Health Information (ePHI). The Privacy Rule regulates the use and disclosure of PHI. Non-compliance can result in fines ranging from $100 to $50,000 per violation, up to $1.5 million per year.
§ Who needs this
Healthcare providers, health plans, healthcare clearinghouses (covered entities), and any business associate that creates, receives, maintains, or transmits PHI on their behalf — including SaaS companies, cloud providers, and IT vendors serving healthcare organizations.
§ Key requirements
Security Rule Compliance
Implement administrative, physical, and technical safeguards to ensure confidentiality, integrity, and availability of all ePHI you create, receive, maintain, or transmit.
Privacy Rule Compliance
Establish policies governing the use and disclosure of PHI. Implement minimum necessary standards and individual authorization requirements.
Risk Analysis
Conduct a thorough risk analysis identifying threats and vulnerabilities to ePHI. Document risk levels and implement mitigation measures.
Business Associate Agreements (BAAs)
Execute BAAs with all vendors and partners who handle PHI on your behalf. Ensure they meet HIPAA requirements.
Access Controls
Implement unique user identification, emergency access procedures, automatic logoff, and encryption/decryption mechanisms for ePHI.
Audit Controls
Implement hardware, software, and procedural mechanisms to record and examine activity in systems containing ePHI.
Breach Notification
Notify affected individuals within 60 days of discovering a breach. Notify HHS for breaches affecting 500+ individuals. Maintain a breach log.
§ Steps to compliance
Determine Scope
Identify all systems, applications, and workflows that create, receive, store, or transmit ePHI. Map data flows and system boundaries.
Risk Analysis
Conduct a comprehensive HIPAA risk analysis. Identify threats, vulnerabilities, current controls, and risk levels for all ePHI assets.
Policies & Procedures
Develop and implement all required HIPAA policies and procedures covering privacy, security, and breach notification requirements.
Technical Safeguards
Implement required technical controls: access controls, audit logging, integrity controls, transmission security, and encryption.
Physical Safeguards
Implement facility access controls, workstation security, and device/media controls for all locations where ePHI is accessed.
Training
Train all workforce members on HIPAA policies, their responsibilities, and sanctions for violations. Document all training.
Business Associate Management
Inventory all business associates, execute BAAs, and verify their HIPAA compliance status.
Ongoing Compliance
Conduct annual risk assessments, regular audits, and periodic policy reviews. HIPAA compliance is ongoing, not one-time.
§ What you get
Legal compliance with US healthcare data protection law
Ability to work with healthcare organizations as a business associate
Reduced risk of HHS investigations and fines
Protected patient trust and organizational reputation
Stronger overall security posture for sensitive health data
Market access to the $4 trillion US healthcare industry