Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Reed Smith
Back in 2013, Ramirez v. Medtronic Inc., 961 F. Supp.2d 977 (D. Ariz. 2013), made it to #9 on our worst cases of the year list – which is pretty good (actually, pretty bad) for a trial court decision.
Wilson Elser Moskowitz Edelman & Dicker LLP
As the federal government continues to treat marijuana as a Schedule 1 controlled substance, attorneys across the nation face ethical concerns in providing professional services to cannabis-related businesses ...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app.
Horne LLP
The old adage, "Money can make you do crazy things," can easily be applied to both our personal and business lives.
Troutman Sanders LLP
With all the recent litigation, legislative efforts, and controversy centered around the U.S. Food and Drug Administration's Deeming Rule, perhaps there is now a more direct opportunity for stakeholders...
BakerHostetler
In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy's customer loyalty/discount program
Troutman Sanders LLP
Decisions remain pending on the adequacy of the FDA's defense in two cases challenging the Deeming Regulations.
Foley Hoag LLP
On September 8, 2017, following the mandated 30-day public comment period, the Baker Administration concluded its review of the pending MassHealth Section 1115 Demonstration Amendment Request.
Ropes & Gray LLP
In a new advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General clarified the scope of the Anti-Kickback Statute warranty safe harbor.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Similarly, OCR reminded covered entities and business associates that the HIPAA Security Rule is not suspended during a natural disaster or emergency.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Our colleagues at ML Strategies have provided their Health Care Weekly Preview for the week of September 18, 2017.
Jones Day
In June, the Food and Drug Administration ("FDA") published draft guidance on electronic privacy requirements for clinical trial records.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Each of the roundtable discussions was focused on a specific topic in the healthcare sector.
BakerHostetler
FDA still pouring over terminology decision...
BakerHostetler
Alleges advertising pumps up synthetic steroid health claims...
K&L Gates
On September 8, 2017, the Food and Drug Administration ("FDA") became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations...
Ostrow Reisin Berk & Abrams
Most Americans are not aware of a little-known drug pricing program called the 340B Drug Discount Program (340B).
BakerHostetler
The chairman of a Senate healthcare committee outlined a key test for stabilizing the Affordable Care Act's (ACA) shaky individual marketplace: Both Republicans and Democrats will have to give a little
Reed Smith
The FDA recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the DSCSA.
McDermott Will & Emery
Governments and their health care systems or operators are increasingly looking for improved, economically viable and more robust delivery of health care services.
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Morrison & Foerster LLP
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco City.
Day Pitney LLP
An August 17 article in Bloomberg BNA's Privacy Law Watch and other publications, "Wellmark's Iowa ACA Exchange Exit Prompts Civil Rights Complaint," discussed an administrative complaint filed with the Department of Health and Human Services' Office for Civil Rights (OCR) by three groups representing hemophiliacs. Day Pitney's Eric Fader was quoted in the article.
Ropes & Gray LLP
In the world of fee-for-service health care, most medical devices were sold to hospitals or other health care providers for use in the diagnosis or treatment of patients.
Day Pitney LLP
An August 21 article in Bloomberg BNA's Medical Devices Law & Industry Report and other publications, "Cyber Risks Mounting for Networked Medical Devices," discussed how recent cyberattacks that hit hospitals and pharmaceutical companies have spotlighted the risks of using medical devices that connect to the internet and transmit sensitive personal data.
Foley & Lardner
To date in 2017, nine actions have been settled and the average settlement amount continues to outpace 2016.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
EIP allows municipalities like the City to pay providers directly for EIP services and then seek reimbursement from other payors, like third party payors and New York Medicaid.
Holland & Knight
The requestor is a manufacturer of biologics and other pharmaceutical products (products) that require specific handling...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.
Foley Hoag LLP
The clock is ticking: on May 25, 2018, in less than a year from now, the General Data Protection Regulation ("the GDPR") will apply in all Member States of the European Union ("EU") and will replace...
Arnold & Porter Kaye Scholer LLP
The second issue has been the definition of CCI, and there is a disconnect between what the EMA and what industry considers should be withheld from disclosure.
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