In a recent speech outlining the Trump Administration’s healthcare regulatory reform efforts, Secretary of Health and Human Services (HHS) Alex Azar announced that the Administration will soon begin considering changes to federal health privacy regulations. (more…)
On Thursday, August 4, 2016, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) announced that Advocate Health Care Center (Advocate Health) agreed to pay $5.55 million to settle multiple violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is the largest HIPAA settlement to date against a single entity, and according to OCR, is due to the severity of the HIPAA violations and the length of time that those violations were allowed to persist. OCR alleged that in some instances, the purported violations date back to the effective date of the HIPAA Security Rule.
On June 24, 2016, Catholic Health Care Services of the Archdiocese of Philadelphia (“CHCS”) entered into a resolution agreement with the Department of Health and Human Services Office for Civil Rights (“OCR”) to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Security Rule after the theft of a CHCS mobile device compromised the protected health information (“PHI”) of 412 nursing home residents. This is OCR’s first settlement with a HIPAA business associate. As part of the settlement, CHCS agreed to enter into a two-year corrective action plan (“CAP”) and pay a monetary penalty of $650,000.
On October 16, the United States Attorney’s Office for the District of Massachusetts filed a criminal information against a former Warner Chilcott district manager alleging that he had obtained and used patient protected health information (PHI) in violation of the criminal provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The information alleges that this criminal violation occurred in connection with a scheme to promote Warner Chilcott’s osteoporosis drug Atelvia. The charge against former employee Landon Eckles is significant because it appears to be the first time a criminal prosecution under HIPAA has been brought against an employee of a pharmaceutical manufacturer for an alleged HIPAA privacy violation. Eckles pleaded guilty to the charges on November 12.
On Monday, October 5, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released an online platform for mobile health developers and others interested in the intersection of information technology and health information privacy and security. Interested parties can submit questions and comments on issues related to compliance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The White House is soliciting public comments on its Proposed Privacy and Trust Principles (the Proposed Principles) for the Precision Medicine Initiative (PMI). PMI is a federal initiative to support research, technology and policies that enable the development of individualized treatments, and is backed by a $215 million investment under President Obama’s 2016 Budget.