Massachusetts Eye and Ear Infirmary and Massachusetts Eye and Ear Associates Inc. (collectively referred to as “MEEI”) has agreed to pay the U.S. Department of Health and Human Services (HHS) $1.5 million to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule. MEEI also agreed to take corrective action to improve policies and procedures to safeguard the privacy and security of its patients’ protected health information.
The investigation by the HHS Office for Civil Rights (OCR) followed a breach report submitted by MEEI, as required by the Health Information Technology for Economic and Clinical Health Act (HITECH) Breach Notification Rule, reporting the theft of an unencrypted personal laptop containing the electronic protected health information (ePHI) of MEEI patients and research subjects. The information contained on the laptop included patient prescriptions and clinical information.
OCR’s investigation indicated that MEEI failed to take necessary steps to comply with certain requirements of the Security Rule, such as conducting a thorough analysis of the risk to the confidentiality of ePHI maintained on portable devices, implementing security measures sufficient to ensure the confidentiality of ePHI that MEEI created, maintained, and transmitted using portable devices, adopting and implementing policies and procedures to restrict access to ePHI to authorized users of portable devices, and adopting and implementing policies and procedures to address security incident identification, reporting, and response. OCR’s investigation indicated that these failures continued over an extended period of time, demonstrating a long-term, organizational disregard for the requirements of the Security Rule.
“In an age when health information is stored and transported on portable devices such as laptops, tablets, and mobile phones, special attention must be paid to safeguarding the information held on these devices,” said OCR Director Leon Rodriguez. “This enforcement action emphasizes that compliance with the HIPAA Privacy and Security Rules must be prioritized by management and implemented throughout an organization, from top to bottom.”
In addition to the $1.5 million settlement, the agreement requires MEEI to adhere to a corrective action plan, which includes reviewing, revising, and maintaining policies and procedures to ensure compliance with the Security Rule. An independent monitor will conduct assessments of MEEI’s compliance with the corrective action plan and render semi-annual reports to HHS for a 3-year period.
HHS OCR enforces the HIPAA Privacy and Security Rules, as well as the HITECH Breach Notification Rule. The Privacy Rule gives individuals rights over their protected health information and sets rules and limits on who can look at and receive that health information. The Security Rule protects health information in electronic form by requiring entities covered by HIPAA to adopt and implement physical, technical, and administrative safeguards to ensure that electronic protected health information remains private and secure. The HITECH Breach Notification Rule requires covered entities to report a breach of unsecured protected health information to affected individuals, the Secretary, and, in certain circumstances, to the media.
Individuals who believe that a covered entity has violated their (or someone else’s) health information privacy rights, or committed another violation of the HIPAA Privacy or Security Rules, may file a complaint with OCR at: http://www.hhs.gov/ocr/privacy/hipaa/complaints/index.html.
The HHS Resolution Agreement can be found on the OCR website at: http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/meei-agreement....
Additional information about OCR’s enforcement activities can be found at: http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/index.html.