The Security Management Process standard in the Security Rule requires organizations to “[i]mplement policies and procedures to prevent, detect, contain, and correct security violations.” (45 C.F.R. § 164.308(a)(1).) Risk analysis is one of four required implementation specifications that provide instructions to implement the Security Management Process standard. Section 164.308(a)(1)(ii)(A) states: RISK ANALYSIS (Required). “Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the [organization].”
Elements of a Risk Analysis
There are numerous methods of performing risk analysis and there is no single method or “best practice” that guarantees compliance with the Security Rule.
A few elements of a Risk Analysis:
- It is part of the Security Rule
- It is a required element to perform in complying with HIPAA
- It helps identify vulnerabilities and weaknesses in your system
- It helps the development of you security policies and procedures once vulnerabilities and weaknesses have been found
In summary, a Risk Analysis is an initial and ongoing action in establishing your security policies.