Massachusetts Eye and Ear Infirmary (MEEI) and Massachusetts Eye and Ear Associates, Inc. (collectively referred to as "MEEI") have 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 HIPAA Breach Notification Rule, reporting the theft of an unencrypted personal laptop containing the electronically 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 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, and retaining an independent monitor who 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. 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 use physical, technical, and administrative safeguards to ensure that electronically protected health information remains private and secure. The HIPAA 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.