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MEEI Breach Notification Prompts OCR Investigation and Settlement

Written by Dianne Bourque

The most recent, published Office for Civil Rights (OCR) HIPAA enforcement action serves as an important reminder that self-reported breaches can and do lead to investigations and enforcement.

Massachusetts Eye and Ear Infirmary (MEEI) was following the HITECH breach notification rules when it reported the theft of an unencrypted laptop in 2010.  The laptop contained the protected health information of MEEI patients and research subjects, including prescription and other health information.  OCR investigated the breach and brought an enforcement action, citing MEEI for a number of HIPAA security rule violations.  Not unexpectedly, OCR was focused on laptop security and the security of portable devices generally, which has been an enforcement priority of OCR.

The MEEI enforcement provides important reminders for covered entities:

1. Encrypt laptops and other portable devices.

2. Keep track of portable devices.

3. The OCR trend toward seven-figure fines is continuing (the MEEI settlement was $1.5 million).

To read the MEEI resolution agreement, click here.

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Authors

M. Daria Niewenhous

Member Emerita

Dianne specializes in counseling researchers and research sponsors in matters related to FDA and OHRP regulated clinical research, and counsels health care clients on the HIPAA Privacy Rule and Security Standards.