Responding to a Department of Health and Human Services Office of Inspector General (OIG) report recommending stronger oversight of covered entities’ compliance with the HIPAA Privacy Rule, the Office for Civil Rights (OCR) stated that in early 2016 it will launch Phase 2 of its audit program measuring compliance with HIPAA’s privacy, security and breach notification requirements by covered entities and business associates.
After conducting a study to assess OCR’s oversight of covered entities’ compliance with the HIPAA Privacy Rule, OIG issued a report finding that OCR should strengthen its oversight of covered entities and making several recommendations. Specifically, OIG recommended that OCR:
- fully implement a permanent audit program;
- maintain complete documentation of corrective action;
- develop an efficient method in its case-tracking system to search for and track covered entities;
- develop a policy requiring OCR staff to check whether covered entities have been previously investigated; and
- continue to expand outreach and education efforts to covered entities.
OCR concurred with each of OIG’s recommendations. In its response to the report, OCR stated it is moving forward with a permanent audit program and will launch Phase 2 of that program in early 2016. The program will target common areas of noncompliance and will include business associates as well as covered entities. Phase 2 “will test the efficacy of the combination of desk reviews of policies as well as on-site reviews.” Accordingly, both covered entities and business associates should be reviewing their HIPAA policies and practices and developing a plan for working with OCR in on-site reviews.
OCR also indicated it is working on improving its ability to document and track corrective actions taken by covered entities and business associates in response to an OCR investigation. In addition, OCR revealed that it now has the ability to search for and track covered entities’ compliance history. OCR will now require investigators to check for prior investigations at the outset of new investigations of covered entities and business associates. This may mean a greater likelihood of on-site visits if a covered entity’s history indicates a potential for systemic compliance issues.
Finally, OCR agreed with OIG’s recommendation that it should continue to expand its outreach and education efforts. Information about those efforts can be found in Appendix C to OIG’s report.
As we previously reported, having the right documents in place can go a long way toward helping an organization survive an OCR HIPAA audit. Now that it is clear that these audits are coming early next year, it is important that covered entities and business associates invest the time in identifying and closing any HIPAA compliance gaps before an OCR investigator does this for them.