The U.S. Department of Health and Human Services (HHS) has issued draft Guidance on Risk Analysis for covered entities and business associates. This guidance was issued, in part, to fulfill HHS's mandate under the Health Information Technology for Economic and Clinical (HITECH) Act to provide annual guidance on the most effective and appropriate technical safeguards for carrying out the HIPAA Security Rule standards. The draft Guidance on Risk Analysis is the first of a series of guidances that HHS will issue under the mandate.

Risk analysis is one of the four required implementation specifications under the HIPAA Security Rule's security management process standard. Importantly, the draft Guidance explains several elements that risk analysis "must incorporate." Briefly, these elements are:

  • Sufficient scope to encompass all e-PHI that is created, received, maintained or transmitted by the organization, regardless of the electronic media;
  • Identification of where e-PHI is stored, received, maintained or transmitted;
  • Identification and documentation of reasonably anticipated threats to e-PHI and vulnerabilities that create risks for the security of e-PHI;
  • Assessment and documentation of current security measures used to safeguard e-PHI;
  • Assessment of potential risks to the confidentiality, availability and integrity of e-PHI;
  • Assessment of the magnitude of the potential impact resulting from a threat or vulnerability that affects the confidentiality, availability and integrity of e-PHI;
  • Assignment of risk levels for all threats and vulnerability combinations identified;
  • Documentation of the risk analysis; and
  • Periodic review and update of the risk analysis.

The draft Guidance on Risk Analysis also includes definitions of vulnerability, threat and risk, terms that are used, but not defined, in the HIPAA security standards. These definitions are based on, or adapted from, the definitions of those terms in National Institute of Standards and Technology (NIST) publications.