In its most recent cybersecurity newsletter, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) provided guidance regarding identifying vulnerabilities and mitigating the associated risks of software used to process electronic protected health information (“ePHI”). The guidance, along with additional resources identified by OCR, are outlined below: Continue Reading OCR Issues Guidance on Disclosures to Family, Friends and Others

The Department of Health and Human Services (“HHS”) recently published two advance notices of proposed rulemaking that address the accounting of disclosures and the potential distribution of civil monetary penalties to affected individuals.

Continue Reading HHS Publishes Advance Notices of Proposed Rulemaking on Accounting of Disclosures and Civil Monetary Penalties

On October 3, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement clarifying when protected health information (“PHI”) can be shared with family, friends and others. This announcement, prompted by the recent mass shooting in Las Vegas, outlines the purposes for which PHI can be disclosed to these parties pursuant to HIPAA and the conditions that apply, which are summarized below: Continue Reading OCR Issues Guidance on Disclosures to Family, Friends and Others

On September 7, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) issued an announcement containing disaster preparedness and recovery guidance in advance of Hurricane Irma. The announcement follows a bulletin issued in late August during Hurricane Harvey that addressed how protected health information (“PHI”) can be shared during emergencies. Together, these communications underscore key privacy and security issues for entities covered by HIPAA to help them protect individuals’ health information before, during and after emergency situations. Continue Reading OCR Releases Guidance on HIPAA Compliance During Emergencies

On May 10, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $2.4 million civil monetary penalty against Memorial Hermann Health System (“MHHS”) for alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule.  Continue Reading OCR Fines Texas Health System For Alleged HIPAA Privacy Rule Violation

On February 16, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into a resolution agreement with Memorial Healthcare System (“Memorial”) that emphasized the importance of audit controls in preventing breaches of protected health information (“PHI”). The $5.5 million settlement with Memorial is the fourth enforcement action taken by OCR in 2017, and matches the largest civil monetary ever imposed against a single covered entity. Continue Reading OCR Settlement Emphasizes Importance of Audit Controls

On February 1, 2017, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced a $3.2 million civil monetary penalty against Children’s Medical Center of Dallas (“Children’s”) for alleged ongoing violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules, following two consecutive breaches of patient electronic protected health information (“ePHI”). This is the third enforcement action taken by OCR in 2017, following the respective actions taken against MAPFRE Life Insurance of Puerto Rico and Presence Health earlier in January. Continue Reading OCR Issues Penalty for Noncompliance with HIPAA Privacy and Security Rules

On November 22, 2016, the Department of Health and Human Services (“HHS”)  announced a $650,000 settlement with University of Massachusetts Amherst (“UMass”), resulting from alleged violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy and Security Rules.  Continue Reading HHS Announces HIPAA Settlement with UMass

Recently, Aegerion Pharmaceuticals announced that it will enter into several settlements and plead guilty to two misdemeanors in connection with alleged violations of HIPAA, drug marketing regulations and securities laws. The criminal charges stem from the company’s marketing of a cholesterol drug called Juxtapid. Aegerion allegedly failed to comply with risk evaluation and management strategies and marketed Juxtapid (which is labeled with a warning about liver toxicity) without proper directions for use.  Continue Reading Pharmaceutical Company to Plead Guilty and Settle Drug Marketing Charges

The U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) recently announced resolution agreements with Raleigh Orthopaedic Clinic, P.A., (“Raleigh Orthopaedic”) and New York-Presbyterian Hospital (“NYP”) for HIPAA Privacy Rule violations. Continue Reading OCR Settles Two Key HIPAA Privacy Rule Cases Involving X-Rays and Medical Reality TV Show