HIPAA is a risk-based security framework and the production of a Risk Analysis is one of primary requirements of the HIPAA Security Rule’s Administrative Safeguards. In fact, a Risk Analysis is the foundation for the entire security program. It identifies the locations of electronic Protected Health Information (ePHI,) vulnerabilities to the security of the data, threats that might act on the vulnerabilities, and estimates both the likelihood and the impact of a threat acting on a vulnerability. The Risk Analysis helps HIPAA Covered Entities and Business Associates identify the locations of their protected data, how the data moves within, and in and out of, the organization. It identifies what protections are in place and where there is a need for more. The Risk Analysis results in a list of items that must be remediated to ensure the security and confidentiality of ePHI. The value of a Risk Analysis cannot be overstated. Every major data breach enforcement of HIPAA, some with penalties over $1 million, have cited the absence of, or an ineffective, Risk Analysis as the underlying cause of the data breach. The Risk Analysis must be run or updated at least annually, more often if anything significant changes that could affect ePHI.
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