Read Health Law updates, alerts, news, and legal analysis from leading lawyers and law firms:
PODCAST - Inside Law - HIPAA Changes Overview by Emily Wey
GranuFlo and NaturaLyte Accused in Heart Attacks
Lawsuits Claim SSRIs Can Cause Severe Birth Defects
Hernia Patients in Pain as Skin Procedure Fails
Going on the Offense: Proactive Strategies to Reduce Uncertainty
Craft Beer Boom in Michigan
Medicaid Receiving Startlingly Little Attention As Everyone Discusses Medicare
Digital Health: Revolutionizing Healthcare
The Biggest Changes in HIPAA/HITECH Omnibus Rule & Recommended Action Steps—Ted Kobus
Hot Companies in Digital Health
Digital Health: Where is the Action for Entrepreneurs?
Corporate Law Report: Cybersecurity, CEO Social Media, New Workplace Laws, Healthcare Reform in 2013
Jennifer Abril on The Story of Fragrances
Obamacare May Be Headed Back to Supreme Court As Contraception Mandate Comes Under Fire
Supreme Court to Decide Whether or Not Human Genes Are Patentable
Election results and the Affordable Care Act – What can employers do now?
Corporate Law Report: Obamacare Deadlines, $13M for Exotic Dancer Misclassification, 2013 Medicare Taxes, More...
Will New Marijuana Laws Go Up In Smoke?
Stealth Lawyer: Tama Matsuoka Wong, Forager for Restaurant Daniel
Polsinelli Shughart Election Analysis and Legal Insight
On March 7, 2013, the United States Food and Drug Administration (FDA) issued a warning letter to compounding pharmacy Medi-Fare Drug & Home Health Center (Medi-Fare Drug), taking the FDA's most aggressive position to date...more
In 2012, the Center for Drug Evaluation and Research’s (CDER) Office of Prescription Drug Promotion (OPDP) issued a total of 28 enforcement letters to pharmaceutical manufacturers, two fewer than in 2011. Of the 28 letters,...more
In This Issue: - NLRB Protects Workers' Rights to Post About Job on Facebook - 6 States Ban Companies from Asking for Social Media Passwords - Health Law Requires Employers to Offer Family Care to All - Fiscal...more
Mobile device use is becoming more commonplace in health care. Health care professionals use text messaging to communicate with each other about patient status. Medical schools now provide residents tablets to use as...more
The Federal Communications Commission (FCC) has created a new Healthcare Connect Fund (Fund), designed to expand health care provider (HCP) access to broadband technologies and to encourage the creation of broadband health...more
As physicians, nurses, therapists and health care providers continue to utilize new smart phones, tablets, and laptops in caring for patients, the Department of Health and Human Services (“HHS”) has responded with educational...more
On Dec. 21, the FCC released its long-awaited Report and Order reforming its funding mechanisms for rural health care by creating a Healthcare Connect Fund (HCF) of $400 million annually....more
The U.S. Department of Health and Human Services recently posted a website focusing on mobile devices and health information privacy and security at http://www.healthit.gov/mobiledevices. The website includes five videos on...more
As we’ve previously discussed, Prop 37 has two important labeling components: (1) a requirement that foods made with genetic engineering are labeled as genetically engineered, and (2) a restriction on labeling genetically...more
Originally published in Law360, New York on October 19, 2012. On Aug. 23, 2012, the U.S. Food and Drug Administration published a notice announcing proposed research titled “Communicating Composite Scores in...more
In an aggressive step against businesses selling drugs online, the U.S. Food and Drug Administration, in conjunction with the U.S. Department of Homeland Security, took legal action earlier this month against more than 4,100...more
In a move he says will improve the quality of health care and cut health system costs, FCC Chairman Julius Genachowski announced the Commission will work toward implementing recommendations proposed by the mHealth Task Force,...more
In its first judgment on Regulation 1924/2006 on nutrition and health claims made on foods, the Court of Justice of the EU adopted a broad interpretation of the definition of “health claim” by ruling that claims for merely...more
Mobile health technologies are increasingly becoming a valuable tool for improving the quality and efficiency of healthcare. A current example of work in this area involves The Robert Wood Johnson Foundation's Project...more
On July 27, 2012, in Friedman et al. v. Sebelius, the United States Court of Appeals for the D.C. Circuit held that the Department of Health & Human Services may exclude from participation in federal health care programs...more
On July 9, 2012, President Obama signed legislation that reauthorizes the U.S. Food and Drug Administration (FDA) to assess user fees to support the agency’s review of marketing applications for drugs (including biologics)...more
Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...more
On November 27, 2009, the Italian Government notified a draft regulation on the use of substances other than vitamins and minerals in food supplements before the European Commission, pursuant to the procedure laid down in...more
As a general matter FDA regulates all medical devices and FCC regulates devices that utilize electromagnetic spectrum - i.e. broadcast devices. So with regard to mobile health devices - sensors, applications, systems - FDA...more
The Office of the National Coordinator (ONC) frequently speaks about the "ubiquitous connected platform" that is being created by the ongoing use of private electronic devices, like smart phones and tablets, in a medical...more
The United States Department of Justice announced recently that Walgreens had agreed to settle federal False Claims Act allegations arising out of a prescription gift card program. The $9.2 million settlement concluded an...more
The Office of Inspector General (OIG) issued a favorable advisory opinion to a company that proposed to provide Internet-based coupons and advertisements to health care providers. Advisory Opinion 12-02 [PDF] concluded that...more
The Food and Drug Administration Amendments Act of 2007 authorizes the U.S. Food and Drug Administration (FDA) to “require the submission of any television advertisement for a drug … not later than 45 days before...more
The FTC requires that healthcare advertisements be substantiated with “competent and reliable scientific evidence.” What constitutes such evidence, however, is hotly debated. Not surprisingly, the FTC’s position is that...more
On March 14, 2012, the Centers for Medicare and Medicaid Service (CMS) issued a Final Rule (Final Rule) revising and relaxing four of the 30 Medicare supplier standards applicable to suppliers of durable medical equipment,...more
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