23rd May 2019

Medical Informatics Engineering, Inc. (MIE) has paid $100,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services, and has agreed take corrective action to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. MIE is an Indiana company that provides software and electronic medical record services to healthcare providers.

 

On July 23, 2015, MIE filed a breach report with OCR following the discovery that hackers used a compromised user ID and password to access the electronic protected health information (ePHI) of approximately 3.5 million people. OCR’s investigation revealed that MIE did not conduct a comprehensive risk analysis prior to the breach. The HIPAA Rules require entities to perform an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of an entity’s electronic protected health information.

“Entities entrusted with medical records must be on guard against hackers,” said OCR Director Roger Severino. “The failure to identify potential risks and vulnerabilities to ePHI opens the door to breaches and violates HIPAA.”

In addition to the $100,000 settlement, MIE will undertake a corrective action plan to comply with the HIPAA Rules that includes a complete, enterprise-wide risk analysis.

The resolution agreement and corrective action plan may be found at https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/mie/index.html.

24th May 2019

The HHS Office for Civil Rights (OCR) has issued a new fact sheet that provides a clear compilation of all provisions through which a business associate can be held directly liable for compliance with certain requirements of the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (“HIPAA Rules”), in accordance with the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.  In 2013, under the authority granted by the HITECH Act, OCR issued a final rule that, among other things, identified provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable. 

OCR has the authority to take enforcement action against business associates only for those requirements and prohibitions of the HIPAA Rules that appear on the following list. 

1. Failure to provide the Secretary with records and compliance reports; cooperate with complaint investigations and compliance reviews; and permit access by the Secretary to information, including protected health information (PHI), pertinent to determining compliance.
2. Taking any retaliatory action against any individual or another person for filing a HIPAA complaint, participating in an investigation or other enforcement processes, or opposing an act or practice that is unlawful under the HIPAA Rules.
3. Failure to comply with the requirements of the Security Rule.
4. Failure to provide breach notification to a covered entity or another business associate.
5. Impermissible uses and disclosures of PHI.
6. Failure to disclose a copy of electronic PHI to either the covered entity, the individual, or the individual’s designee (whichever is specified in the business associate agreement) to satisfy a covered entity’s obligations regarding the form and format, and the time and manner of access under 45 C.F.R. §§ 164.524(c)(2)(ii) and 3(ii), respectively.
7. Failure to make reasonable efforts to limit PHI to the minimum necessary to accomplish the intended purpose of the use, disclosure, or request.
8. Failure, in certain circumstances, to provide an accounting of disclosures.
9. Failure to enter into business associate agreements with subcontractors that create or receive PHI on their behalf, and failure to comply with the implementation specifications for such agreements.
10. Failure to take reasonable steps to address a material breach or violation of the subcontractor’s business associate agreement.

“As part of the Department’s effort to fully protect patients’ health information and their rights under HIPAA, OCR has issued this important new fact sheet clearly explaining a business associate’s liability,” said OCR Director Roger Severino.  “We want to make it as easy as possible for regulated entities to understand, and comply with, their obligations under the law.”

The new fact sheet may be found at https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/business-associates/index.html along with OCR’s guidance on business associates.

May 6, 2019

Touchstone Medical Imaging (“Touchstone”) has agreed to pay $3,000,000 to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), and to adopt a corrective action plan to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Security and Breach Notification Rules. Touchstone, based in Franklin, Tennessee, provides diagnostic medical imaging services in Nebraska, Texas, Colorado, Florida, and Arkansas.

In May 2014, Touchstone was notified by the Federal Bureau of Investigation (FBI) and OCR that one of its FTP servers allowed uncontrolled access to protected health information (PHI).  This uncontrolled access permitted search engines to index the PHI of Touchstone’s patients, which remained visible on the Internet even after the server was taken offline. 

Touchstone initially claimed that no patient PHI was exposed.  However, during OCR’s investigation, Touchstone subsequently admitted that the PHI of more than 300,000 patients was exposed including, names, birth dates, social security numbers, and addresses.  OCR’s investigation found that Touchstone did not thoroughly investigate the security incident until several months after notice of the breach from both the FBI and OCR.  Consequently, Touchstone’s notification to individuals affected by the breach was also untimely.  OCR’s investigation further found that Touchstone failed to conduct an accurate and thorough risk analysis of potential risks and vulnerabilities to the confidentiality, integrity, and availability of all of its electronic PHI (ePHI), and failed to have business associate agreements in place with its vendors, including their IT support vendor and a third-party data center provider as required by HIPAA.

In addition to the monetary settlement, Touchstone will undertake a robust corrective action plan that includes the adoption of business associate agreements, completion of an enterprise-wide risk analysis, and comprehensive policies and procedures to comply with the HIPAA Rules. 

The resolution agreement and corrective action plan may be found at http://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/tmi/index.html.