Health Communications & Media

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USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Final Blacklisting and Contractor Paid Sick Leave Rules Slated for Late Summer Publication, According to Spring Regulatory Agenda

Although this election season may feel endless, there are only six more months until voters decide the next president and members of Congress. Within this window, federal agencies are scrambling to finalize rules before the...more

Mass Appeal of Off Label Use

Hardly a week goes by without our blogging about accusations of off label promotion. This week is no exception. On Monday, we discussed a nice New York opinion rejecting a plaintiff argument that off label promotion saved a...more

Supreme Court Update: Zubik V. Burwell (14-1418) And Spokeo V. Robbins (13-339)

While a potential ninth justice made plans to give a high school commencement address, The Eight continued to demonstrate that, without a full complement of justices, this may be the Term Without Blockbusters. (Although, with...more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

Congress acts on opioid drug epidemic as judge unseals OxyContin files

Here are some developments worth watching in the nation’s battle against the epidemic of opioid drug misuse that killed 28,000 Americans in 2014 alone...more

Senate Committee Seeks Information on Rural Health Care and E-Rate Consultant Fees

On May 10, Senators John Thune (R-S.D.) and Cory Gardner (R-CO) of the U.S. Senate Committee on Commerce, Science, and Transportation sent a letter to FCC Chairman Tom Wheeler and USAC CEO Chris Henderson requesting...more

CMS Adds New Quality Measures To Nursing Home Compare Website

To help residents and their families find a quality Medicare or Medicaid certified nursing home and to encourage nursing homes to achieve high quality by public reporting of quality measures, in 1988 the Centers for Medicare...more

Joint Commission lifts ban on physicians texting patient orders

The Joint Commission, which is the national accrediting organization for health care organizations, has long banned physicians using text messages to place orders for patient care due to data security concerns. In 2011, the...more

Health Alert (Australia) - May 9, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: JUDGMENTS Commonwealth. Federal Court 29 April 2016 - Australian Competition and Consumer Commission v Reckitt...more

Joint Commission Ends Ban on the Texting of Physician Orders

In the Joint Commission Perspectives May 2016 edition, the Commission reversed its 2011 position prohibiting clinician texting of patient orders within accredited health care institutions, stating technological advancements...more

Telemedicine nursing licensure compact legislation enacted in 6 states and 7 more right behind

In another case of technology out pacing the law, telemedicine has continued to push the limits of state medical professional licensure laws. Generally, physicians and nurses must be licensed in the state in which they...more

Facebook, Healthcare Provider Websites and HIPAA

In a class action Complaint filed in the Northern District of California on March 15, 2016, Kiesel Law LLP, on behalf of primary plaintiff Winston Smith and a potential class of others, alleges that Facebook received...more

Wave of the Future: Government Releases New Tool to Aid Medical App Developers Comply with HIPAA

This month, the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Office of the National Coordinator for Health Information Technology (ONC), and the Federal Trade Commission (FTC)...more

Top Takeaways from IAPP

The world of privacy grows every day as more data goes through the cloud. The new trends and weekly data breaches make conferences like the Global Privacy Summit all the more relevant. Earlier this month we went to...more

News Flash: An Agreement Between Competitors to Limit Advertising/Marketing Violates the Antitrust Laws

For the second time in less than a year, the U.S. Department of Justice (DOJ) has filed an antitrust complaint against hospital systems that agreed to not advertise on billboards or in print in each other’s home county. Last...more

Mobile App Compliance for Dummies: New Tool Helps Developers Understand Their Legal Compliance Requirements

In a joint effort by the Federal Trade Commission (FTC), Office for Civil Rights (OCR), HHS Office of National Coordinator for Health Information Technology (ONC), and Food and Drug Administration (FDA), a new web-based tool...more

Anti-SLAPP Statute Raised in Planned Parenthood Protest Lawsuit

The DC anti-SLAPP statute has been invoked in a Superior Court lawsuit in which plaintiffs arguing that students need to be free from disruptions in the school environment are facing off against anti-abortion protestors....more

Sixth Circuit Court of Appeals Affirms "Prior Express Consent" in Health Care Collections Case

Baisden v. Credit Adjustments, Inc., No. 15-3411, 2016 WL 561735 (6th Cir. Feb. 12, 2016) - The U.S. Court of Appeals for the Sixth Circuit held that two hospital patients consented to a debt collection agency's...more

Federal Agencies Provide User-Friendly Guidance on Compliance with Data Privacy Laws

How federal privacy laws apply to mobile health applications has been an area of significant ambiguity. Recently, the Federal Trade Commission’s (FTC), the U.S. Department of Health and Human Services (HHS) Office of Civil...more

Regulators Offer Guidance on Privacy and Security for Health App Developers

This month, the Federal Trade Commission (FTC) issued guidance on privacy and security best practices for health-related mobile apps, such as fitness apps connected with wearables, diet and weight loss apps, and health...more

FCPA compliance and Ethics Report-Episode 249-Reflections on Cuba, with Adam Turteltaub [Video]

In this episode, I share some reflections and observations on Cuba with Adam Turteltaub who was coincidently on a tour in Cuba at the same time as myself. ...more

Abbott Laboratories Prevails in False Claims Act Case

On April 7, 2016, following a three-week trial and after only three hours of deliberations, a federal jury in Dallas, Texas found that Abbott Laboratories had not violated the False Claims Act (FCA) when it marketed bile duct...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

Summary Judgment for Defendants in FCA Action: No Admissible Evidence of False Claims

How much is “enough?” Will we have enough money to retire someday? Did the Drug and Device Law College Sophomore study enough for her computer science midterm? Is there enough salt in the matzo ball soup? In the realm of...more

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