The University of Washington Medicine (UWM) has agreed to pay $750,000, enter into a corrective action plan, and report its compliance annually in order to settle charges that it potentially violated the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule by failing to implement policies and procedures to prevent, detect, contain, and correct security violations for its affiliated entities. "Affiliated covered entities" are legally separate covered entities that are related and that designate themselves as a single covered entity for purposes of the Security Rule. Affiliated covered entities must have in place appropriate policies and processes to assure HIPAA compliance with respect to each of the entities that are part of the affiliated group. UWM is part of an affiliated covered entity, which includes designated health care components and other entities under the control of the University of Washington, including University of Washington Medical Center, the primary teaching hospital of the University of Washington School of Medicine.
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) initiated its investigation of the UWM following receipt of a breach report on November 27, 2013, which indicated that the electronic protected health information (e-PHI) of approximately 90,000 individuals was accessed after an employee downloaded an email attachment that contained malicious malware. The malware compromised the organization’s IT system, affecting the data of two different groups of patients: 1) approximately 76,000 patients involving a combination of patient names, medical record numbers, dates of service, and/or charges or bill balances; and 2) approximately 15,000 patients involving names, medical record numbers, other demographics such as address and phone number, dates of birth, charges or bill balances, social security numbers, insurance identification or Medicare numbers.
OCR’s investigation indicated UWM’s security policies required its affiliated entities to have up-to-date, documented system-level risk assessments and to implement safeguards in compliance with the Security Rule. However, UWM did not ensure that all of its affiliated entities were properly conducting risk assessments and appropriately responding to the potential risks and vulnerabilities in their respective environments.
To help avoid this sort of liability, covered entities (and particularly affiliated covered entities) should:
- Conduct regular risk assessments that include all affiliates and relevant parts of the entity;
- Address any material risks identified in the assessment through a risk management plan (the plan should include, for example, creation and distribution of appropriate policies and provision of training);
- Continually audit and monitor compliance with the risk management plan for all related parts of the entity and affiliates;
- Re-assess risks on a regular basis utilizing information from prior auditing and monitoring; and
- Create and maintain a robust vendor assessment program to assure that business associates and others with access to sensitive information are maintaining the security and privacy of the information and have sufficient security measures in place.
The Resolution Agreement and Corrective Action Plan can be found on the OCR website at:http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/uwm/index.html
The HHS Press Release can be found at: http://www.hhs.gov/about/news/2015/12/14/750000-hipaa-settlement-underscores-need-for-organization-wide-risk-analysis.html
HHS offers guidance on how your organization can conduct a HIPAA Risk Analysis: http://www.healthit.gov/providers-professionals/security-risk-assessment