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
Government's Health Care Fraud "Cash Cow" Keeps Mooing
The Free Speech Clause of the First Amendment prevailed in the latest challenge to the FDA's prohibition against marketing FDA-approved drugs for off-label (or non-FDA-approved) uses. Applying the Second Circuit’s...more
On Friday, staff of the Federal Trade Commission’s Bureau of Consumer Protection, Office of Policy Planning, and Bureau of Economics submitted a written comment to FDA recommending that FDA reconsider its current regulatory...more
In a comment filed last Friday, the Federal Trade Commission (FTC) responded to its sister-agency’s request for comments by urging the Food and Drug Administration (FDA) to reconsider how homeopathic drugs are regulated. As...more
“I’m not a doctor, but I play one on TV” – shorthand for “I am pretending to know what I’m talking about, but I really don’t.” We have blogged frequently about experts inclined to such pretense and about courts’ varying...more
On August 13, 2015, the Federal Trade Commission (“FTC” or “Commission”), by a 4-1 vote, approved a bipartisan “Statement of Enforcement Principles” (“Statement of Enforcement”), which purports to shed light on the...more
The Maine Legislature ended its tumultuous session on July 16, 2015. After an advisory opinion by the Maine Supreme Court, we now know which bills actually became law. As usual, a number of significant tax issues were...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
The FTC announced late last week that it resolved its case against the final defendant, Avrom Lasarow, in the “Melanoma Detective” app matters. The FTC alleged that claims that the apps could detect and diagnose melanoma in...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
New Technology = New Threats -
With new technology comes new security concerns. But when that new technology is in the medical field, the cybersecurity vulnerabilities can be particularly devastating.
The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...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
Just two months before the U.S. Supreme Court hears argument in Campbell-Ewald Co. v. Gomez, two federal circuit court panels have ruled on jurisdictional issues presented in the case. Both the Seventh Circuit in Chapman v....more
Pharmaceutical manufacturers have likely taken note of Amarin Pharma Inc.’s recent success in a pre-enforcement legal challenge against the Food and Drug Administration (FDA or the Agency). On August 7, 2015, Amarin obtained...more
Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more
This week might have been the first time that an FDA regulatory issue hit the headlines on TMZ and other “celebrity watcher” websites. In an August 7 Warning Letter sent to the drug company Duchesnay, Inc., FDA complains...more
The U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) issued a Warning Letter this week to Duchesnay, Inc. related to celebrity Kim Kardashian’s social media posts on Instagram, Twitter and...more
Search for “homeopathy” on the Internet, and one quickly discovers that this particular form of “alternative medicine,” does not have the greatest reputation. Wikipedia, not always an unimpeachable source, but usually OK for...more
Major Medicaid Drug Payment Rule Under OMB Review: Last week a highly anticipated rule that could set the standards for the Medicaid Drug Rebate program arrived at the White House for final review. The Medicaid Outpatient...more
The health care industry is in the midst of rapid change as governments fight rising health care costs, providers look to comply with myriad new regulations, and technology continues to take a more prominent role in the...more
Last month, the Federal Communications Commission (FCC) released a long awaited declaratory ruling and order, FCC 15-72, addressing several petitions which sought clarification of or exemptions from Telephone Consumer...more
With health care breaches constantly on the rise, increasing access to electronic health records (EHRs) from mobile devices, and more prevalent “shadow” cloud use, health care organizations are getting a bit of help from the...more
The National Institute of Standards and Technology (NIST) cybersecurity center released a draft guide last week for health IT professionals to use to bolster security for the use of mobile devices in the health care industry....more
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