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|FDA Releases Draft Guidance on Internet/Social Media Product Promotion and Correction of Misinformation|
Laurie A. Clarke, Colleen Heisey, Mark Mansour, Christopher M. Mikson, Emily K. Strunk; Jones Day;
June 24, 2014, previously published on June 2014On June 18, the U.S. Food and Drug Administration ("FDA" or the "Agency") issued draft guidance documents addressing the presentation of risk and benefit information for prescription drugs and devices on internet/social media platforms permitting limited character usage, such as...
|High Court Says Federal Food, Drug, and Cosmetic Act No Bar to POM's Lanham Act Claim Against Coca-Cola|
John G. Froemming, Tracy A. Stitt, Meredith M. Wilkes; Jones Day;
June 24, 2014, previously published on June 2014In a unanimous decision authored by Justice Kennedy, the United States Supreme Court held that competitors can bring Lanham Act claims for misleading food and beverage labels, allowing POM Wonderful LLC's ("POM") false advertising claim against the Coca-Cola Co. ("Coca-Cola")....
|Recent Court Decision May Impact 340B Drug Pricing Program "Mega-Reg"|
Elizabeth S. Elson, Anil Shankar; Foley & Lardner LLP;
June 24, 2014, previously published on June 23, 2014A federal district court invalidated the first regulation published by the U.S. Department of Health and Human Services (HHS) addressing the 340B Drug Pricing Program (340B Program), on May 23, 2014, ruling that HHS had not been granted authority by Congress to issue the regulation. While the...
|Draft Guidelines for Telepathology Released|
Nathaniel M. Lacktman; Foley & Lardner LLP;
June 24, 2014, previously published on June 19, 2014The American Telemedicine Association released draft Clinical Guidelines for Telepathology and is seeking public comments through June 20, 2014.
|American Medical Association Offers New Telemedicine Recommendations|
Alexis Slagle Gilroy, Stephanie L. Resnik, Soleil E. Teubner; Jones Day;
June 24, 2014, previously published on June 2014During this week's annual meeting, the American Medical Association's ("AMA") House of Delegates approved its Council on Medical Service's report setting forth recommendations regarding the practice of telemedicine. The report, which comes on the heels of the Federation of State Medical...
|HRSA “Interprets” Its Enjoined 340 Orphan Drug Rule into Effect|
Ellyn L. Sternfield; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 23, 2014, previously published on June 18, 2014In January, I predicted that 2014 would be a game-changer for the 340B Drug Discount Program, in part because of HRSA’s announcement that, in June 2014, it would for the first time publish an omnibus rule governing 340B Program operations.
|The AMA Adopts New Telemedicine Guiding Principles|
Carrie A. Roll; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
June 23, 2014, previously published on June 18, 2014Last week, the American Medical Association (AMA) released new guiding principles on the provision of telemedicine services. The AMA’s guiding principles come on the heels of the Federation of State Medical Board’s (FSMB) adoption of its new model telemedicine guidelines and largely...
|Important Considerations Used to Select Facilities|
Timothy Spencer; Weltman, Weinberg & Reis Co., L.P.A.;
June 20, 2014, previously published on June 6, 2014One of the more difficult healthcare decisions an individual and his or her family will make is choosing which nursing home the in-need individual will stay. The selection process is important, personal, and often, very sensitive. Because of this, health care facilities benefit immensely from...
|Affordable Care Act Update: Quality Assessment and Performance Improvement Program - Still a Work in Progress|
Jason Mosbaugh; Weltman, Weinberg & Reis Co., L.P.A.;
June 20, 2014, previously published on June 6, 2014One year ago, WWR Health Matters introduced and examined the Quality Assessment and Performance Improvement program (QAPI). Since the initial introduction, WWR Health Matters has provided updates as the Centers for Medicare & Medicaid Services (CMS) provides further information, resources and...
|Safeguarding Personal Health Information: HIPAA's Privacy Rule|
James C. Warmbrodt; Weltman, Weinberg & Reis Co., L.P.A.;
June 20, 2014, previously published on June 6, 2014One of the cornerstones of the Health Insurance Portability and Accountability Act of 1996, commonly known by the acronym "HIPAA", is the "Privacy Rule", regulations issued by the Secretary of Health and Human Services which provide national standards to protect the...