A prospective client asked for our help after receiving a HIPAA audit letter from the Office of Civil Rights (OCR). OCR sent the client the letter after one of the client’s business associates experienced a HIPAA related breach. I won’t give any additional information on the client, the business associate or details of the security incident. The only additional information is that the prospective client was a covered entity with less than 10 employees. Note: the breach was NOT caused by the covered entity but by one of their business associates.
OCR asked the covered entity to supply the following information within 20 days of the receipt of the OCR audit letter
- Please submit a response to the allegations made in the complaint. Please describe the circumstances leading to the alleged incident to include the date of the incident and the date of discovery of the incident. Please list in detail the protected health information (PHI) that was made available to unauthorized individuals.
- Copies of any notes, documents and reports relating to any internal investigation including of any forensic analysis, conducted by the covered entity, or its designated contractor or agent, of the alleged incident. Please detail any corrective measures taken as a result of this alleged incident.
- Please indicate whether you conducted a breach risk assessment for the alleged incident. If so, please provide a copy of the breach risk assessment.
- If you determined that a breach of patients’ PHI occurred as a result of this incident, please indicate, as applicable, whether you notified the affected individuals, the media, and the HHS Secretary.
- If you notified the affected individuals, the media, and the HHS Secretary, please provide OCR with documentation of said notifications.
- A copy of the covered entity’s policies and procedures with respect to uses and disclosures of PHI and safeguarding PHI developed pursuant to HIPAA.
- Please provide a copy of the covered entity’s business associate agreement with the vendor that was in effect at the time of this incident.
- A copy of any risk analysis performed pursuant to 45 C.F.R 164.308(a)(1)(ii) prior to the date of the incident and any risk management plans developed as a result of the risk analysis.
- Any revisions or updates made to the risk analysis to include malware infection or hacking attacks as a risk item.
- Evidence of all implemented security measures to reduce the risk of malware infection or hacking (e.g. screenshots, configuration settings).
- Evidence of information system activity reviews (e.g. user access, user activity, network security, etc.).
- Evidence of any network scans or penetration tests performed before and/or after the incident.
- A copy of the covered entity’s approved access management policy pursuant to 45 C.F.R. 164.308(a)(4).
- A copy of the covered entity’s security awareness and training materials prior to the incident. Please include evidence of workforce attendance to the training.
- Evidence of malicious software protection (antivirus system) installed at the time of the incident. Please also include evidence of patching on the affected systems.
- A copy of the covered entity’s approved data backup procedures. Please include evidence of data backup mechanism/process.
- Evidence of technical access controls that the covered entity implemented. Please include a copy of the covered entity’s approved password management policy and procedure.
- Evidence of implemented network security devices such as firewalls, intrusion detection systems, etc. Please include evidence of any network scans performed on the network/computer before and/or after the incident.
- Details of network security monitoring to identify network related threats and vulnerabilities.
For each data request item listed above, specify the name and title of each individual who furnished information in response to the request.
We ask that the information requested above be provided within 20 days of the receipt of this letter.
Again it is important to remember that the breach was not caused by the covered entity but by one of their business associates. Regardless of who caused the breach, OCR was looking directly at the covered entity. The sum of the information requested is clearly looking to see if the covered entity was complying with HIPAA regulations and more specifically the HIPAA Security Rule. 20 days is not a lot of time to produce all of this information. If the covered entity did not already have the information it would be very difficult to create and compile the information in the requested timeframe.
OCR was looking for the following:
- Evidence the covered entity (CE) performed a Risk Assessment prior to the incident. In addition OCR is looking for evidence of a Risk Management plan or in other words that the CE performed a Risk Assessment and put together a work plan to implement additional security safeguards. Just performing a Risk Assessment and not implementing additional safeguards is not acceptable.
- Evidence of HIPAA policies and procedures on safeguarding PHI.
- Evidence of employee training.
- Evidence of breach procedures including a breach risk assessment and breach notification procedures.
- Evidence of network vulnerability and penetration scans along with evidence of anti-virus/anti-malware software.
- Evidence of system activity review – who accessed PHI, what PHI was accessed and when was the PHI accessed.
When we perform a risk assessment for a client we always make it clear that it is critical to not only perform or implement security safeguards but you MUST have documentation that you can produce that shows you are performing or have implemented the safeguard.
Many covered entities don’t feel the risk of an audit is real. They point to the lack of HIPAA enforcement and have a false sense of security. This case shows that CEs and BAs need to not focus on random audits but understand that they can be audited if one of their subcontractors (in the case of a CE or BA) or one of their clients (in the case of BA) have a security breach. And not being able to produce the above requested items by OCR may lead to OCR finding the organization in willful neglect of HIPAA regulations.
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