A HIPAA risk assessment is performed by completing a documented HIPAA Security Rule risk analysis for electronic protected health information that identifies where electronic protected health information is created, received, maintained, or transmitted, evaluates reasonably anticipated threats and vulnerabilities, measures the likelihood and potential impact of adverse events, documents existing safeguards, and produces tracked risk management actions that reduce risk to an acceptable level.
Define scope by mapping electronic protected health information across the organization’s systems, devices, applications, networks, and workforce workflows, including electronic health records, patient portals, email and messaging, remote access, backups, cloud services, medical devices, and interfaces with vendors. Record where data resides, how it moves, who can access it, and which configurations and operational procedures control access and sharing. Maintain an inventory of assets and administrative accounts that touch electronic protected health information, including managed service provider access paths.
Evaluate threats, vulnerabilities, and safeguards using the documented environment. Assess unauthorized access scenarios, credential misuse, misconfiguration, malware, ransomware, loss or theft of devices, improper disposal, transmission exposure, and service provider failures. Document existing administrative, physical, and technical safeguards, including access control practices, audit controls, transmission security, device and media controls, patching, endpoint protections, backup and recovery, and facility and workstation controls. Assign likelihood and impact values using a consistent method and record the rationale, then calculate or otherwise rank risks to support decision-making.
Translate results into a risk management plan with assigned owners, target dates, and verification steps, and retain evidence that actions were implemented. Address HIPAA Security Rule addressable implementation specifications by documenting whether encryption, authentication controls, and other measures are implemented or replaced by equivalent protections supported by the risk analysis. Update the risk analysis when systems, vendors, workflows, or threat conditions change, and incorporate periodic review into governance processes. Distinguish this ongoing HIPAA Security Rule risk analysis from the HIPAA Breach Notification Rule breach risk assessment performed after an impermissible use or disclosure of unsecured protected health information, because the trigger, required factors, and output documentation differ.