Recently, the Office of the National Coordinator for Health Information Technology (ONC) and the Office for Civil Rights (OCR) published new guidance on the privacy and security of electronic health information (the “Guide”). Although the Guide was drafted primarily for the benefit of smaller healthcare providers, it provides useful information … Read More
On December 3, 2014, the Federal Trade Commission (FTC) announced that it reached a settlement with PaymentsMD, an Atlanta-based medical billing company, and its former CEO, Michael C. Hughes, for alleged violations of Section 5(a) of the Federal Trade Commission Act for using deceptive tactics to collect sensitive health information. … Read More
On November 11, 2014, the Connecticut Supreme Court held in Emily Byrne v. Avery Center for Obstetrics and Gynecology, P.C. (“Avery Center”) (SC 18904) that the federal Health Insurance Portability and Accountability Act (“HIPAA”) does not preempt state common law negligence and emotional distress claims against medical providers who improperly … Read More
On Tuesday, April 22, 2014, the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) announced that Concentra Health Services Inc. (“CHS”) and QCA Health Plan Inc. (“QCA”) have agreed to pay a total of $1,975,220, collectively, to resolve potential violations of the Health Insurance Portability and … Read More
On February 3, 2014, the U.S. Department of Health and Human Services (HHS) released a long-awaited final rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy regulations to permit patients and their personal representatives to … Read More
The European Parliament’s Civil Liberties Committee (the “LIBE Committee”) has after several delays finally voted on the European Commission’s proposed EU Data Protection Regulation and adopted all amendments. The LIBE Committee also approved a mandate to start negotiations with the Council of Ministers (which represents EU Member States) and the … Read More
The European Parliament’s Civil Liberties Committee has published its draft report on the proposed EU Data Protection Regulation that is causing concern for many corporations. http://www.europarl.europa.eu/meetdocs/2009_2014/documents/libe/pr/922/922387/922387en.pdf.
The report sets out amendments to the draft EU data protection regulation published by the European Commission last January (the “Regulation”)… Read More
Scrip Regulatory Affairs
The EU Data Protection Regulation proposed by the European Commission in January will – if adopted in its current form – require pharmaceutical and medical device companies to adopt a new approach to data processing and data protection.
This article was published in the March 2012 issue … Read More