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:

  1. fully implement a permanent audit program;
  2. maintain complete documentation of corrective action;
  3. develop an efficient method in its case-tracking system to search for and track covered entities;
  4. develop a policy requiring OCR staff to check whether covered entities have been previously investigated; and
  5. 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.

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Photo of Michael R. Bertoncini Michael R. Bertoncini

Michael R. Bertoncini is a principal in the Boston, Massachusetts, office of Jackson Lewis. He is a member of the Healthcare industry group and a member of the Higher Education group.

With a background as a former Deputy General Counsel, Michael understands first-hand…

Michael R. Bertoncini is a principal in the Boston, Massachusetts, office of Jackson Lewis. He is a member of the Healthcare industry group and a member of the Higher Education group.

With a background as a former Deputy General Counsel, Michael understands first-hand the competing demands and unique challenges faced by in-house counsel. Before joining Jackson Lewis, he was responsible for all labor and employment law matters for the largest fully integrated community care hospital system in New England. Michael provides timely, practical advice that helps clients achieve their strategic goals while ensuring compliance with legal obligations.

With deep experience in a broad range of industries, Michael has a keen interest in the healthcare, higher education, museum, and arts & music sectors. He is dedicated to supporting clients in these areas, leveraging his extensive experience to address the specific challenges faced by institutions and organizations in these fields.

Michael regularly partners with clients to establish positive employee relations. In labor relations matters, he negotiates collective bargaining agreements on behalf of organized clients, represents clients in labor arbitrations and National Labor Relations Board proceedings, and counsels clients with respect to rights and obligations under collective bargaining agreements and applicable labor and employment laws. He also has extensive experience in advising organizations responding to corporate campaigns and negotiating neutrality agreements.

Michael’s privacy and data security practice focuses on advising clients on complying with HIPAA and other state and federal privacy and data security laws. He reviews and develops policies and procedures, written information security plans and integrated compliance programs to ensure his clients meet their obligations under privacy and data security laws. Michael represents clients in investigations of alleged data breaches and advises them on reporting obligations.. He also conducts workplace training programs on HIPAA compliance and related privacy and data security topics.