Yesterday, the Alaska Department of Health and Social Services (DHSS), the state Medicaid agency, agreed to pay the U.S. Department of Health and Human Services (HHS) $1,700,000 to settle possible violations of the HIPAA Security rule. DHSS further agreed to a Corrective Action Plan (CAP) to properly safeguard the electronic protected health information (ePHI) of their Medicaid beneficiaries.

The HHS Office for Civil Rights (OCR) began its investigation following a breach report submitted by Alaska DHSS. The report indicated that on or about October 12, 2009, a portable electronic storage device (USB hard drive) possibly containing ePHI was stolen from a vehicle of a DHSS employee. On October 30, 2009, DHHS filed a breach report as required by the HITECH Act. On January 8, 2010, OCR began an investigation which included phone and email communications, documentation requests, and a site visit.

Over the course of the investigation, OCR found evidence that DHSS:

  1. Did not have adequate policies and procedures in place to safeguard ePHI
  2. DHSS had not completed a risk analysis (45 CFR 164.308(a)(1)(ii)(A))
  3. Did not implement sufficient risk management measures (45 CFR 164.308(a)(1)(ii)(B))
  4. Did not complete security training for its workforce members (45 CFR 164.308(a)(1)(ii)(A)(5)(i))
  5. Did not implement device and media controls (45 CFR 164.310(d)(1))
  6. Did not address device and media encryption (45 CFR 164.312(a)(2)(iv))

OCR Director Leon Rodriguez said that “covered entities must perform a full and comprehensive risk assessment and have in place meaningful access controls to safeguard hardware and portable devices. This is OCR’s first HIPAA enforcement action against a state agency and we expect organizations to comply with their obligations under these rules regardless of whether they are private or public entities.”

The Corrective Action Plan is 3 years in duration and requires that DHHS:

  1. Update its HIPAA policies, secure approval of HHS of the new policies, and adopt the new policies that include
    1. Procedure for tracking devices containing ePHI
    2. Procedure for safeguarding devices that contain ePHI
    3. Procedure for encrypting devices that contain ePHI
    4. Procedure for disposal and/or re-use of devices that contain ePHI
    5. Procedure for responding to security incidents, and
    6. Procedure for applying sanctions to work force members who violate these policies and procedures
  2. Distribute the new policies to all workforce members, and obtain signed documentation from all employees that they have read, understand, and shall abide by the policies,
  3. Update policies annually, and receive new signed documentation from all employees upon any policy revision
  4. Train all members of the workforce who have access to ePHI on HIPAA Security and the specifics of the DHHS policies, and maintain documentation that training was received
  5. Conduct a risk analysis
  6. Submit to HHS its risk analysis and any new risk management measures
  7. Hire a 3rd party monitor to audit DHHS compliance with this plan and submit quarterly reports to HHS
  8. Submit a detailed implementation report
  9. Submit detailed annual reports for regarding compliance activities in the CAP

The CAP may be viewed in its entirety at https://www.hhs.gov/sites/default/files/ocr/privacy/hipaa/enforcement/examples/alaska-agreement.pdf.

This enforcement action, and OCR statements make it clear that mobile device security is a priority issue in HIPAA enforcement.  Further, covered entities are advised to invest in a comprehensive risk analysis – this is the foundation of any good security program, would identify mobile device risks, and is one of the first things OCR would look for in any investigation.

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