An entity’s gap analysis generally does not satisfy the risk analysis obligations because it typically does not demonstrate an accurate and thorough assessment of the risks to all of the ePHI an entity creates, receives, maintains, or transmits (See 45 C.F.R. Most HIPAA risk analyses are conducted using a qualitative risk matrix. A risk assessment … Conducting a risk analysis assists covered entities and business associates identify and implement safeguards that ensure the confidentiality, integrity, and availability of ePHI. That places them at risk of experiencing a costly data breach and a receiving a substantial financial penalty for noncompliance. It's not like you have to start all over from scratch, it’s adding on. which directs covered entities and business associates to conduct a thorough and accurate assessment of the risks and vulnerabilities to ePHI (See 45 CFR § 164.308(a)(1)(ii)(A)). There is no excuse for not conducting a risk assessment or not being aware that one is required. While a gap assessment is without question an effective tool at locating vulnerabilities, OCR clearly states that that a gap assessment is never a substitute for a bona fide risk analysis as required by the HIPAA Security Rule. This can lead to unknown compliance violations and risk exposure. 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]. When it comes to managing IT for your business. The #1 reason for failure is the absence of a full-spectrum healthcare risk assessment. What is a HIPAA Security Risk Analysis? 3. I’ve discovered that this is due to confusion caused by legislation, frameworks, and industry sources interchangeably (and often incorrectly) using terms like “risk assessment”, “risk analysis”, and “security assessment”. These are some reasons why a HIPAA Risk Assessment is not a one-time practice. Once you’ve conducted this risk analysis within your organization, you aren’t done yet. Yet, as we do HIPAA compliance audits and gap assessments for organizations, it is rare to find that a formal security risk analysis has been completed, and it is rarer still to find that the security risk analysis addresses what the authors of HIPAA intended. It depends on what your risk assessment looks like. The HIPAA risk analysis documents should include, at a minimum: A description of the purpose and scope of the risk analysis. Although it is a partial assessment of an entity’s enterprise, it may be a useful tool to identify whether certain controls and safeguards specified in the HIPAA Security Rule are met. The HIPAA Risk analysis is a foundational element of HIPAA compliance, yet it is something that many healthcare organizations and business associates get wrong. A risk assessment identifies the risks to HIPAA compliance, whereas a risk analysis assigns risk levels for vulnerability and impact combinations. The worksheets include an example of HIPAA security policy, a risk analysis completion form, a thorough threat-source list, and an inventory asset list. If an audit occurs, and you have not completed an assessment, you are most likely going to get fined tremendously. The risk analysis must be performed according to a documented procedure that can be repeated for future risk analysis. 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