Health Science, Computers & Technology Antitrust & Trade Regulation

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

FDA Releases Guidance on Cybersecurity and Medical Devices

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of...more

Nexium Case Extends Actavis Ruling

Addressing a pay-for-delay and pharmaceutical-settlement antitrust jury trial for the first time since the 2012 Supreme Court of the United States decision in FTC v. Actavis (IP Update, Vol. 16, No. 7), the US Court of...more

Health Care Institutions

Originally published in Haig, Business and Commercial Litigation in Federal Courts, Fourth Edition §§ 87:1 et seq. © 2016 American Bar Association. This chapter discusses federal court litigation relating to health care...more

20 states, U.S. take aim at collusion claims, soaring prices for generic drugs

If there ever were naïve wishes that parts of Big Pharma might work in more enlightened ways for patients, the attorney generals in 20 states and federal prosecutors, have dashed optimism about “white hat” drug makers. Led by...more

Protecting Against Big Pharma's Tactics for Delaying Market Entry of Generics

Branded companies make millions of dollars each day that a generic version of a drug is held from the market. Therefore, the branded companies are highly motivated to obstruct the path of generic pharma companies. For some...more

UK Competition Regulator Targets Big Pharma Over Excessive Pricing

Compare and contrast the current excessive pricing debates occurring in the US with those in the UK. In both markets, pharmaceutical firms are being berated for double, triple and even quadruple digit rises in the prices of...more

Health Update - December 2016

Balancing Gene Therapy’s Promise and Price - Editor’s Note: Exciting advances in science have led to developing treatment breakthroughs, such as gene scripting therapies, that could represent the first potential cures...more

Telehealth for Healthy Competition

As providers look for more convenient and cost-effective means to reach patients, there has been much discussion about the potential benefits of telehealth services. Such services also are healthy from an antitrust...more

Health Alert (Australia) December 12, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: Commonwealth. Federal Circuit Court 5 December 2016 - Singh v Minister For Immigration & Anor [2016] FCCA 3061 - MIGRATION –...more

FTC Announces New Guidance on Ransomware

On November 10, 2016, the U.S. Federal Trade Commission (FTC) released new guidance for businesses and consumers on the impact of, and how to respond to ransomware. Ransomware is a form of malicious software that infiltrates...more

Guest Post — Do It If It Makes You Feel Good: FTC’s Report on Homeopathic Medicine Advertising

What follows is a guest post by John Feldman, a partner in Reed Smith’s Entertainment and Media Industry Group. John closely follows all things Federal Trade Commission and approached us when he saw the FTC weighing in a...more

FTC Addresses Homeopathic Drug Advertising

The Federal Trade Commission (“FTC”) recently released an enforcement policy statement regarding marketing claims for products in the over-the-counter (“OTC”) homeopathic drug market. Long permitted to fly under the FTC’s...more

FTC Issues Compliance Guidance for Organizations that Share and Collect PHI

The Federal Trade Commission (FTC) recently issued Guidance to remind HIPAA compliant organizations that share and collect protected health information (PHI) for commercial activities that they must also comply with FTC Act...more

NYSBA’s REMS and Other Drug Distribution Restrictions Program Provided an Excellent and Informative Discussion

On November 3, 2016, the New York State Bar Association’s Sections, Food, Drug and Cosmetic Law and Antitrust Law, held a program in New York City: “REMS and Other Drug Distribution Restrictions: When Does a Brand Company...more

ANDA Update - Volume 2, Number 3

On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more

Confusing Joint Guidance published by OCR and FTC on HIPAA Authorization Forms

There are arguments that there is a dearth of guidance by both the Office for Civil Rights (OCR) and Federal Trade Commission (FTC), so when guidance comes out, we listen. But the most recent guidance jointly issued by the...more

Cybersecurity and Data Privacy: Federal Agencies Issue New Guidelines and Rules for Data Breaches and Online Security (11/16)

After recent high profile data breaches and threats to online privacy—ranging from Yahoo Inc.’s data breach of approximately 500 million accounts to the hacking of Hillary Clinton’s campaign manager, John Podesta’s email...more

FDA Says BPCIA Poses No Fifth Amendment Taking for Innovator Biologics Submitted Prior to Its Enactment

On the same day that FDA approved the first biosimilar of Humira, the fourth biosimilar to be approved in the U.S., it also denied a citizen petition filed by Abbott Laboratories (now AbbVie) requesting that FDA not accept...more

Texas Medical Board Drops its Fifth Circuit Appeal To Bar Antitrust Challenge

On October 17, 2016, the U.S. Court of Appeals for the Fifth Circuit granted the Texas Medical Board’s (“Board”) motion to voluntarily dismiss its appeal of the District Court’s decision on sovereign immunity in its latest...more

DOJ/FTC Joint Guidance for Human Resources Professionals Suggests Broad Antitrust Risks

Provisions restricting the hiring of another company’s employees are often included in vendor agreements and a variety of corporate transactions and licenses. And it’s not unusual to see similar constraints adopted in...more

Price fixing not justified to protect pharmacies in rural areas

On 19 October 2016, the Court of Justice of the European Union (CJEU) issued an important judgment concerning the German law on fixing prices of retail prescription drugs. In the case before the Higher Regional Court of...more

Member States cannot impose uniform retail prices for prescription-only medicinal products, highest EU Court says

EU law precludes national legislation setting fixed retail prices for prescription medicinal products, as it unreasonably restricts imports - On 19 October 2016, the European Court of Justice issued a ruling concluding...more

Sharing Consumer Health Information? Look to HIPAA and the FTC Act

Does your business collect and share consumer health information? Check out these tips from the FTC for complying with HIPAA and the FTC Act....more

Health Update - October 2016

Defining and Resolving the Provider Data Dilemma - Editor’s Note: Provider data drives the most fundamental processes in the healthcare system. Inaccurate provider data puts patient care and billions of dollars at risk....more

Three Dozen States Sue Makers of Opioid Addiction Treatment Medications for Antitrust

With opioid abuse continuing to dominate national headlines, manufacturers of opioid overdose medications are facing intense scrutiny over pricing practices that threaten (or those perceived as threatening) public...more

210 Results
|
View per page
Page: of 9

Follow Health Updates on:

Popular Topics

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×