Navigating Data Privacy and Security in Telemedicine's Uncharted Territory
Insurance Limits and Case Value - A Clear Correlation?
Polsinelli Podcast - What Employers Need to Know About Dealing With Cash
Medical PL Risks in Retail Healthcare
Physician Considerations When Prescribing Medical Marijuana
Do I need an expert witness in my case?
Electronic Medical Records: Help or Hindrance?
How Does King v. Burwell Decision Affect the Affordable Care Act?
Antitrust Law Issues for Health Care Providers
Variables Affecting Medical PL Settlement Values
Polsinelli Podcast - Is a Single U.S. Food Agency a Reality?
The Biggest Obstacle to Value-Based Care
Technology in Healthcare
Do healthcare professionals have to report legal trouble to their licensing board?
Health Care Enforcement: The Impact on Private Equity Investments
Polsinelli Podcasts: Cloud Computing, From Cybersecurity to Confidentiality Issues
Polsinelli Podcast - Pharmacy Compounding: What's Next in Regulation?
Polsinelli Podcasts - The Latest on a Shift in Regulation in Dietary Supplements
PATIENT PRIVACY IN AN ERA OF SOCIAL MEDIA
A Moment of Simple Justice - Vaccines
The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more
When Kim Kardashian speaks, the FDA listens. Or, more precisely, when Kardashian, who has 46.8 million followers on Instagram, posts an enthusiastic endorsement—and advertisement—on the social media platform for Diclegis, a...more
On July 10, 2015, Congress passed H.R. 6, the 21st Century Cures Act, with a bipartisan vote of 344 to 77. The 352-page bill seeks to make the U.S. Food and Drug Administration (FDA) drug and device approval process less...more
A handful of recent court decisions, including one issued just last month, seems to have potentially cracked open the door for pharmaceutical manufacturers to have more leeway to promote off-label uses of their products....more
In keeping with the trend to strengthen its authority to deny an enrollment or revoke Medicare billing privileges, CMS has modified the appeals process in a manner that will significantly shorten the time allotted to mount an...more
Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business -
An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created an abbreviated pathway for the approval of biosimilar biological products, but is silent on how to name them. The nonproprietary naming of...more
On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”. The Common...more
The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more
For providers who have received inconsistent or varying reasons for denial while navigating through the Medicare appeals process, the Centers for Medicare & Medicaid Services (CMS) has provided much-needed relief in the form...more
The FDA has been gradually issuing guidances to implement the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”). One of the most eagerly awaited guidance documents has been that on nonproprietary names to be...more
On August 21, the United States Court of Appeals for the District of Columbia Circuit upheld the U.S. Department of Labor’s revisions to the “companionship exemption” under the Fair Labor Standards Act, and reversed two...more
On August 27, 2015, FDA released a long-awaited draft guidance entitled “Nonproprietary Naming of Biological Products” (the “Draft Guidance”). The Draft Guidance sets forth a naming convention for all biological products –...more
Healthcare providers and other HIPAA covered entities receive requests for protected health information (“PHI”) from a variety of sources on a daily basis. Such requests can range from informal requests made during the course...more
After almost fourteen months of legal challenges, the U.S. Department of Labor has emerged victorious in its attempt to modify the FLSA’s companionship exemption. On August 21, the U.S. Court of Appeals for the D.C. Circuit...more
As we reported in previous Payment Matters articles, the United States District Court for the District of Columbia has issued inconsistent opinions regarding Medicare's policy not to allow bad debt when that bad debt is still...more
Massachusetts regulators recently announced new rules that, if adopted, will change the requirements for nursing home sales and closures in the state. The proposed new rules require nursing home owners intending to sell a...more
A directive to establish nationwide policies and procedures aimed at speeding up the resolution of “whistleblower” complaints handled by the Occupational Safety and Health Administration (OSHA) was issued on August 19, 2015....more
On August 7, 2015, the FDA sent a warning letter to drug maker, Duchesnay, over Kim Kardashian’s endorsement of its pills for morning-sickness. Kardashian had made an Instagram and Facebook post which vouched for the...more
In a post published earlier this week this week our colleagues Brian Dunphy and Joanne Hawana examined key issues in the recent Amarin decision from the Southern District Court of the New York. The August 7th ruling provided...more
Irish and NI life sciences companies operating in the US likely are familiar with the concept of “off-label” promotion–providing information about drug/device uses that have not been cleared by the FDA (even where the FDA has...more
Mobile devices, including cell phones and tablets, have had a major impact on the practice of medicine, how patients interact with their doctors, receive or implement treatments, as well as how software developers view the...more
In the most recent court decision, Amarin Pharma, Inc. v. United States Food and Drug Administration, No. 15 Civ. 3588 (PAE) (S.D. N.Y. August 5, 2015), a U.S. District Court granted Amarin's preliminary injunction to...more
The Food and Drug Administration (FDA) recently issued a notice announcing the fiscal year (FY) 2016 medical device user fees, which apply to, among other things, applications for medical device approval. The National Law...more
Drugmaker Amarin Pharma, Inc. (Amarin), recently received a victory in its fight against the Food and Drug Administration (FDA). On August 7, 2015, the U.S. District Court for the Southern District of New York ruled that...more
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