Kusserow on Compliance: Recap of the OCR’s 2017 HIPAA enforcement

The HHS Office for Civil Rights (OCR) HIPAA Privacy Rule enforcement has been steadily increasing since it began the effort in 2003. Over the years, OCR has received over 175,000 HIPAA complaints and initiated nearly 1,000 compliance reviews. OCR investigations have resolved nearly 30,000 cases by requiring changes in privacy practices, taking corrective actions, or providing technical assistance to HIPAA covered entities and their business associates. OCR has been enforcing the HIPAA Rules where an investigation indicates noncompliance by the covered entity or their business associate. OCR investigations have ranged widely and included national pharmacy chains, major medical centers, group health plans, hospital chains, and small provider offices. To date, OCR has settled or imposed a civil money penalty in about 60 cases resulting in a total dollar amount of about $75,000,000. The average of enforcement penalties has been about $1.5 million per case. In another 12,000 cases, no violations were found. In another 25,000 cases, OCR intervened early and provided technical assistance to HIPAA covered entities, their business associates, and individuals exercising their rights under the Privacy Rule, without the need for an investigation. In the balance of over 100,000 cases, OCR determined that the complaint did not present an eligible case for enforcement, because of lack of jurisdiction; complaints were untimely or withdrawn by the filer; or the activity described didn’t violate HIPAA;


Cases that OCR closes fall into five categories:


  1. Resolved without investigation. OCR closes these cases after determining that OCR lacks jurisdiction, or that the complaint, referral, breach report, news report, or other instigating event will not be investigated. These include situations where the organization is not a covered entity or business associate and/or no protected health information (PHI) is involved; the behavior does not implicate the HIPAA Rules; the complainant refuses to provide consent for his/her information to be disclosed as part of the investigation; or OCR otherwise decides not to investigate the allegations.


  1. Technical assistance only. OCR provides technical assistance to the covered entity, business associate, and complainant through early intervention by investigators located in headquarters or a regional office.


  1. Investigation determines no violation. OCR investigates and does not find any violations of the HIPAA rules.


  1. Investigation results corrective action obtained. OCR investigates and provides technical assistance to or requires the covered entity or business associate to make changes regarding HIPAA-related privacy and security policies, procedures, training, or safeguards. Corrective action closures include those cases in which OCR enters into a settlement agreement with a covered entity or business associate.


  1. Other. OCR may investigate a case if (1) DOJ is investigating the matter; (b) it was as result of a natural disaster; (c) it was investigated, prosecuted, and resolved by state authorities; or (d) the covered entity or business associate has taken adequate steps to comply with the HIPAA Rules, not warranting deploying additional resources.


Order of frequency of issues investigated


  • Impermissible uses and disclosures of protected health information;
  • Lack of safeguards of protected health information;
  • Lack of patient access to their protected health information;
  • Use or disclosure of more than the minimum necessary protected health information; and
  • Lack of administrative safeguards of electronic protected health information.


Most common types of entities resulting in corrective actions


  • General hospitals;
  • Private practices and physicians;
  • Outpatient facilities;
  • Pharmacies; and
  • Health plans (group health plans and health insurance issuers).


Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

Recommendations for creating compliant security relationships with vendors

Recent regulatory changes have had an impact on what “covered entities” must do to create and maintain a compliant security relationship with their “business associates.” This impact, and how information technology (IT) and compliance departments can interact to improve business associate selection and management, were the topics of a recent Health Care Compliance Association (HCCA) webinar featuring Francois J. Bodhuin, Director, Information Security Officer, and Joseph A. Piccolo, Vice President, Corporate Compliance, at the Inspira Health Network. The presenters also offered a five-step life cycle approach to managing vendor security requirements.


The term “covered entity” is defined in 45 C.F.R. sec. 160.103 as either a health plan, a health care clearinghouse, or a health care provider who transmits any health information in electronic format. According to the presenters, the HITECH privacy provisions (Title XIII) of the American Recovery and Reinvestment Act (ARRA) (P.L. 111-5) resulted in the promulgation of the January 25, 2013 Final rule (78 FR 5566), which strengthen the privacy and security protections for health information established under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The rule also expanded the definition of “business associates” (BAs) to include subcontractors/vendors (and written assurance from subcontractors/vendors that they will uphold the security and privacy of protected health information (PHI)), increased reporting requirements, and enhanced penalties (see HIPAA final rule modifies Privacy, Security, and Enforcement Rules and establishes direct liability for business associates that violate certain rules, Health Law Daily, January 25, 2013).

Enforcement themes and challenges

The presenters noted several themes present in recent government enforcement actions, including accusations of inadequate risk assessment plans, outdated vendor agreements, the lack of risk analysis, and inadequate oversight (lack of communication). The presenters also laid out several new logistical challenges, including (1) insuring that vendor agreements are current (and incorporate the 2013 rule changes); (2) the need to educate board members, employees, and vendors; and (3) the monitoring of vendor agreements.

Interaction of IT and compliance

The presenters stressed the need for IT and compliance to jointly develop a process that makes use of (1) HHS Office of Civil Rights (OCR) guidance, audit criteria, and recent settlements; and (2) that sets guidelines for vendors, including a vendor code of conduct, specific policies and procedures for vendors, and vendor education requirements.

The presenters see the IT role as performing annual security assessments, frequent vulnerability scans, and the integration of risk analysis. In addition, in support of compliance, they believe that IT must: (1) be represented on the compliance committee; (2) have software that tracks vendors; (3) develop security questionnaires; and (4) evaluate the security programs of vendors.

Compliance, according to the presenters, must support IT by: (1) being a conduit for communication in understanding vendor relationships; (2) collaborating with IT on new and unique projects; (3) educating the board on the compliance/IT partnership; (4) developing and updating policies; and (5) including audits as part of the annual work plan.

Collaborative management of vendors

The presenters recommend language in vendor agreements that will allow for the covered entity to conduct a survey or questionnaire of the vendor. They suggest that the questionnaire incorporate the organizational values of the covered entity, not just government requirements. The questionnaire should be required of both new and existing vendors.

The presenters also recommend that the covered entity create an oversight group to review vendor responses, extrapolate risk levels, review actions taken with the vendor, tweak questionnaires, and report results to executives though the compliance committee.

Five-step approach

The presenters concluded by describing their five-step life cycle approach to managing vendor security requirements. Their approach centers on the following elements: (1) patient satisfaction; (2) quality outcomes; (3) electronic data security; (4) patient engagement/population management; and (5) stewardship and reputation.

Trump Administration appoints controversial figure to HHS’ anti-discrimination office

The Trump Administration appointed Roger Severino as Director of the HHS Office for Civil Rights (OCR). Previously, Severino worked for the Heritage Foundation as the director of the DeVos Center for Religion and Civil Society in the Institute for Family, Community, and Opportunity. Prior to his work with the Heritage foundation, he was a trial attorney in the Department of Justice’s Civil Rights Division. Severino was also the Chief Operations Officer and Legal Counsel for the Becket Fund for Religious Liberty.


The OCR enforces federal laws designed to prohibit discriminatory practices in health care by providers who receive HHS funds. The OCR also protects the privacy and security of health information through its investigatory and enforcement actions related to the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191).


Senator Patty Murray (D-Wash) spoke out in opposition to the Trump Administration’s appointment, calling it an “appalling hire.” Murray criticized Severino’s work with the Heritage foundation and the Becket Fund, where he “fought against transgender equality in health care, against the separation of church and state, and in support of defunding Planned Parenthood.” Severino has previously worked to oppose the OCR’s implementation of Section 1557 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148)—a law which prohibits discrimination in health care on the basis of race, color, national origin, sex, age, or disability.

Free Webinar! Personal Health Information: Hospitals, Health Plans, and Human Resources

Headlines screaming about the mishandling of personal health information have become ubiquitous in the media. Employers handling health records are rightly concerned about their liability for the protection of such data. So where should an anxious employer begin?

This webinar will provide employers with an overview of their legal obligations, focusing significantly on health care providers, covered entities, and business associates under HIPAA, as well as the handling of health information from health insurance, medical leave, or disability, and will cover GINA, the FMLA, and the ADA.

Join this webinar to get real answers to questions like:

  • What obligations do organizations have to secure protected health information (PHI) under HIPAA?
  • What can HIPAA-covered entities and business associates expect from OCR audits and compliance investigations?
  • What other laws must employers consider when dealing with health information?


Thursday, October 13, 2016
2:00-3:00 p.m. EDT
1:00-2:00 p.m. CDT
12:00-1:00 p.m. MDT
11:00-12:00 p.m. PDT

Registration is open to the first 1,000 approved registrants and requires a complete name, title, organization, and valid business email address.