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|OCR Addresses Business Associate Concerns for Cloud Services|
Rick L. Hindmand; McDonald Hopkins LLC;
October 28, 2016, previously published on October 7, 2016Today, the Department of Health and Human Services Office for Civil Rights (OCR) issued HIPAA guidance on cloud computing.
|Reminder to Health Care Providers: Are your ACA Section 1557 Notices and Taglines Up?|
Isabelle Bibet-Kalinyak, Rick L. Hindmand; McDonald Hopkins LLC;
October 28, 2016, previously published on October 19, 2016Section 1557 of the Affordable Care Act prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. As a reminder, under the final rule codifying Section 1557, all covered entities were required to comply with detailed...
|New California State Regulations for Cannabis Manufacturers and "Specialty Cottage" Farmers|
Neal Gidvani, Rachel K. Gillette, Joshua B. Goldstein, Lance Rogers, Phillip Silvestri; Greenspoon Marder;
October 25, 2016, previously published on October 3, 2016On Thursday, Governor Jerry Brown signed into law three bills affecting the state’s medical cannabis laws. The most significant of which will remove criminal penalties for cannabis manufacturers under Health & Safety Code § 11379.6, commonly referred to as the “meth house...
|Homeopathic Products Under Renewed Scrutiny Following FDA’s Consumer Warnings|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
October 20, 2016, previously published on October 17, 2016Last week, following up on a more general warning issued on September 30, FDA alerted the public that it had received at least 10 reports of baby deaths associated with the use of homeopathic teething products, as well as over 400 other adverse event reports over the past six years (since a 2010...
|Five Things to Know About the Mylan EpiPen “Settlement” - What It Is and What It Isn’t|
Ellyn Leslie Sternfield, Rodney Whitlock; Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
October 20, 2016, previously published on October 14, 2016Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen. The timing of the...
|Moving on From “Natural,” FDA Seeks Comments on What It Means to Be a “Healthy” Food|
Mintz Levin Cohn Ferris Glovsky Popeo P.C.;
October 20, 2016, previously published on October 13, 2016As it signaled it would be doing earlier this year, FDA has initiated a public process to redefine the implied nutrient content claim “healthy” when it is used on food labels and labeling. In addition, while the process is underway, the Agency intends to exercise enforcement discretion...
|Ontario Reintroduces Patients First Act, 2016 with Important Changes|
Meghan Lindo, Lydia Wakulowsky; Borden Ladner Gervais LLP;
October 20, 2016, previously published on October 13, 2016On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
|Telemedicine and the Health Care Industry|
Jillian N. Jagling, Gary R. Pannone; Pannone Lopes Devereaux & West LLC;
October 14, 2016The shift in the health care industry toward greater efficiency and a higher level of quality of care is leading to innovation and the popularity of new delivery methods, such as telemedicine. The challenge for telemedicine is that the innovation is outpacing the regulatory environment in many...
|What's In Your Provider Contract?|
Jillian N. Jagling; Pannone Lopes Devereaux & West LLC;
October 14, 2016In the commercial health insurance market, payers and providers enter into contracts that govern the provision of and payment for health care services delivered by providers to members of commercial health insurance plans (hereinafter, "Contract"). Payers consist mainly of insurance...
|Patient Engagement Results in Better Health and Lower Costs|
Pannone Lopes Devereaux West LLC;
October 14, 2016Patient engagement and access to relevant data are essential to achieving the primary goals of the Affordable Care Act (ACA), which include better health and lower costs. Reducing emergency room visits and readmissions are critical to reducing the overall costs of healthcare and in theory, if an...