The U.S. Department of Health and Human Services (HHS) has issued draft Guidance on Risk Analysis for covered entities and business associates.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 The draft Guidance on Risk Analysis is the first of a series of guidances that HHS will issue under the mandate.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 Importantly, the draft Guidance explains several elements that risk analysis “must incorporate.”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...