The Health and Human Services Office for Civil Rights announced on March 21 that it has begun Phase 2 of its HIPAA Audit Program, which the agency is using to determine if health-care organizations and their contractors are complying with HIPAA privacy and security rules.
According to OCR, the audits are primarily a “compliance improvement activity” to determine what types of technical assistance should be developed and what types of corrective action would be most helpful. However, if an audit indicates a serious compliance issue, OCR may initiate a compliance review to further investigate.
OCR Director Jocelyn Samuels said that Phase 2 will consist of 200 desk and on-site audits of both covered entities and business associates. The desk audits are expected to be completed by December, while the more comprehensive on-site audits will begin later in the year, Samuels said during the National HIPAA Summit. (See related story, Next Phase of HIPAA Audits Has Begun, Official Says)
Phase 1, in 2011 and 2012, assessed the controls and processes of 115 covered entities to comply with HIPAA requirements. Phase 2 will audit both covered entities and business associates, including covered individual and organizational providers of health services, health plans of all sizes and functions, health care clearinghouses and a range of business associates of these entities.
OCR will first send out emails requesting address verification and contact information, and then a pre-audit screening questionnaire. OCR cautioned that communications sent by email may be incorrectly classified as spam. The agency recommended that entities check for email from OSOCRAudit@hhs.gov. Entities that don’t respond to an OCR email could still be subject to an audit.
Greta Cowart, a shareholder with Winstead PC in Dallas, told Bloomberg BNA, “I think it is curious after the IRS has made a point to warn people that it will not contact them via email to solicit information to warn them of identity theft scams, that HHS/OCR, that is charged with enforcing privacy and security requirements on our protected health information (PHI), is choosing to open their inquiries into information that should be protected and secure with an email letter.”
Covered entities and business associates selected for audit will be informed via email about their desk or on-site audit, and have 10 business days to respond. OCR will then review the information and provide the covered entity or business associate with draft findings, although the fact sheet does not give a limit to OCR’s time to review the findings. The covered entity or business associate then has 10 business days to review and return with written comments to OCR. OCR will complete a final audit report for each entity within 30 business days after receiving a response.
Joanna Kerpen, a partner at McDermott Will & Emery LLP, told Bloomberg BNA that covered entities should ensure they have current business associate agreements in place with all business associates. In addition covered entities and business associates should:
be prepared to provide records of compliance with HIPAA’s privacy, security and breach notification rules if audited;
ensure they have HIPAA policies and procedures in place; and
review and update existing HIPAA policies and procedures as necessary.
Cowart said, “In addition to being certain that covered entities have the HIPAA policies and procedures and business associate agreements in place, they should be certain that they have been doing periodic security analysis. In this day and age cybersecurity is critical and one must be proactive on defense. The best offense is a good defense.”
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