Health Science, Computers & Technology

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Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

CMS, FDA Establishing Interagency Task Force on LDT Quality Oversight

CMS and FDA are establishing an interagency task force to reinforce their collaboration regarding the oversight of laboratory-developed tests (LDTs), which are tests intended for clinical use and designed, manufactured, and...more

Court Report - April 2015 #4

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Medicis Pharmaceutical Corp. v. Taro Pharmaceuticals U.S.A., Inc. et el. 3:15-cv-02841; filed April 22, 2015 in the...more

Still No Duty To Supply Drugs - In 22 States

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we usually see in product liability...more

Blog: Medical Device Tax Repeal Shows Signs of Life

Despite making it a priority following the 2014 elections, Congress has not been able to move legislation repealing the medical device tax. However, recent developments show that Congress may finally be making progress....more

Blog: HIPAA FAQ Series: Do You Need a BAA with Your Cloud Storage Provider?

This week, the HIPAA FAQ series continues with another topic about business associate agreements (BAAs). As most Covered Entities and Business Associates know, in the event that a Covered Entity utilizes a service provider...more

MACRA’s Advancement of EHR Interoperability and Telehealth

This is the fourth and final post in our series on the Medicare Access and CHIP Reauthorization Act (MACRA). Pub.L. No. 114-10. We’ve previously covered the repeal of the Sustainable Growth Rate (SGR) in our April 20th post,...more

FDA Releases Draft Guidance on Acceptance of Medical Device Clinical Data from Studies Conducted Abroad

On April 21, 2015, the Food and Drug Administration (FDA) issued a notice announcing the availability of a draft guidance document clarifying the Agency’s acceptance of medical device clinical data from studies conducted...more

Pharmacists: Aren’t You Really Providers Already? – Part Two

The first part of this article discussed pharmacist provider status and argument both for and against it. Today’s post now turns to regulatory hurdles, developments towards provider status and the acknowledgment of changing...more

SGR Legislation Includes Gainsharing Fix and More Anti-Fraud Measures

The legislation repealing the Medicare sustainable growth rate formula (SGR), signed by President Obama on April 16, 2015, contained several anti-fraud related provisions that affect the health care industry. The provision...more

Five Things to Know About the Medicare SGR Fix

H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), was signed into law by President Obama on April 16, 2015. A broad bipartisan compromise measure, MACRA repeals the much-maligned sustainable growth rate (SGR)...more

Federal Courts in the Third Circuit are Following the National Trend and Dismissing Data Breach Cases for Lack of Standing

Data breaches are becoming increasingly common. These incidents have spawned considerable litigation, including class action lawsuits brought by individuals whose personal information has been compromised. But many of these...more

Amicus Briefs on Biosimilar Patent Litigation

Amgen has appealed the district court decision denying its motion for a preliminary injunction to keep Sandoz’ biosimilar version of Neupogen® off the market. The appeal is on an expedited briefing schedule at the Federal...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Regulators Examining Cybersecurity Policies and Practices for the Insurance Industry

Shortly after the discovery of a cybersecurity breach at the health insurance company Anthem, Inc., the National Association of Insurance Commissioners (NAIC) called for a multi-state examination of Anthem’s cybersecurity...more

Cardinal Health Agrees to Settle Monopolization Claims

The Federal Trade Commission ("FTC") announced on April 20, 2015 that it had entered into a stipulated consent order ("Order") with Cardinal Health, Inc. ("Cardinal"). The Order, which is pending court approval, requires...more

Blog: Fraud Watch: Laboratory Referrals Under Government Scrutiny

Significant recent regulatory and enforcement activity related to laboratory fees and services continues to demonstrate an increased focus on this industry. Government enforcers are active in cases involving both the...more

Data Breach Class Actions: Don’t Overlook Standing Defense Just Because Plaintiff Alleges Identity Theft

A New Jersey federal district court recently dismissed the putative class action claims of four plaintiffs against a health care defendant following the theft of two password-protected laptops allegedly containing personal...more

TMB Limits Telemedicine in Texas

The Texas Medical Board has issued limits on telemedicine, stating that a physician-patient relationship can be established through a “face-to-face” visit held either in person or via telemedicine. ...more

CMS Announces Recompete of Round 1 of the Medicare DMEPOS Competitive Bidding Program for 2017

On April 21, 2015, CMS announced its plans to recompete the supplier contracts awarded under the Round 1 Recompete of the Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding...more

Latest Spike in Prescription Drug Spending Prompts OIG Investigation

A new report released by the IMS Institute for Healthcare Informatics shows that U.S. spending on pharmaceuticals increased in 2014 by 13.1 percent, reaching $373.9 billion. This is the highest increase since 2001 when drug...more

Following FDA’s First Biosimilar License, CMS Issues Guidance on Reimbursement for Biosimilars

On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number of guidance documents addressing reimbursement for biosimilars under the...more

The FDA Gets an EARful on Label Changes

We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014...more

Breaking News - Caplinger Infuse Preemption Dismissal Affirmed

We thought our readers would like to know that today the InFuse preemption decision in Caplinger was affirmed by the 10th Circuit in a 2-1 opinion (here’s a link). Our non-Reed Smith bloggers will undoubtedly have more to...more

FTC Settles Radioactive Allegations Against Cardinal Health with a Near Record-Breaking Disgorgement Agreement

In a 3-2 decision, as part of its aggressive antitrust enforcement in health care industries, the Federal Trade Commission (FTC or the Commission) announced that Cardinal Health, Inc. (Cardinal) agreed to pay $26.8 million to...more

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