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Health Science, Computers & Technology Antitrust & Trade Regulation

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

Health Update - April 2017

CMS Issues Self-Referral Disclosure Protocol for Stark Law Violations - On March 28, 2017, the Centers for Medicare & Medicaid Services (CMS) issued a new voluntary self-referral disclosure protocol (SRDP) for disclosing...more

Appeal for Legislative Action to Address REMS Concerns

by Goodwin on

Last month, during the Biosimilar and Generics User Fee Acts (BsUFA II and GDUFA II) reauthorization hearing, a subject of considerable discussion was Risk Evaluation and Mitigation Strategies (REMS). REMS is a provision...more

Geotargeting Medical Facilities? Massachusetts Says ‘No Snoop For You!’

by Morgan Lewis on

Geotargeting—delivering content to users based on their geographic location—has become a popular and effective marketing tool. Yet proper implementation may be more nuanced than originally contemplated because certain...more

New York Attorney General Settles Claims against Three Health Apps

by Morgan Lewis on

Health app developers must be vigilant not only of federal laws, but of state laws as well. On March 23, New York Attorney General Eric T. Schneiderman announced a settlement with developers of three health-related...more

New York Attorney General Enters Digital Health App and Privacy Enforcement Fray: Announces Three Settlements with Health and...

by Ropes & Gray LLP on

On March 23, the New York Office of the Attorney General (“NY OAG”) announced Assurances of Discontinuance (“Settlements”) with three developers of health and fitness mobile apps. The Settlements appear to mark the NY OAG’s...more

NY AG Enters Mobile Health App Enforcement Arena with Settlements Targeting Health Claims and Privacy Practices

by Kelley Drye & Warren LLP on

New York Attorney General Eric Schneiderman recently announced settlements with three mobile health app developers resolving allegations that they made deceptive advertisements and had irresponsible privacy practices. The...more

Health Alert (Australia) April 10, 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 5 April 2017 - Reckitt Benckiser (Australia) Pty Ltd v Australian Competition and Consumer Commission [2017] HCASL 86 - The High...more

Healthcare Law Update: March 2017

by Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion Allowing Free or Reduced-Cost Lodging and Meals - On March 3, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG) issued...more

DELAYED: The FDA’s Intended Use Rule

by Strasburger & Price, LLP on

The effective date of FDA’s Intended Use Rule has been extended until March 19, 2018. The comment period will remain open until May 19, 2017....more

Advertising Law - March 2017

FTC Fights Back in LabMD Suit - The Federal Trade Commission demonstrated its intention to fight for the power to regulate data security by filing a 111-page brief with the U.S. Court of Appeals for the Eleventh Circuit...more

Health Update - February 2017

Securing the Safety Net for America's Vulnerable Populations - Editor's Note: America's population is aging rapidly. By 2029, 75 million baby boomers will have reached age 65 and older, and older adults will represent...more

Tokyo Dispute Resolution & Crisis Management Newsletter – February 2017

by King & Spalding on

Product Pricing and Antitrust Law in the United States - A recent US court action by a Japanese company in respect of a competitor’s volume discounts - Introduction - The current position in the US on the rules...more

Advocating for Patient Safety: Coalition for Patient Vision Care Safety submits comments in response to FTC Proposed Rule...

The Coalition for Patient Vision Care Safety (“Coalition”) is a group of health care providers, medical device manufacturers and academic institutions dedicated to ensuring the safe and appropriate use of contact lens so that...more

Competition Appeal Tribunal Refuses Interim Relief in Pharma Pricing Case

by Latham & Watkins LLP on

The Competition Appeal Tribunal (the “CAT”) in the UK heard on 17 January 2017 an application by Flynn Pharma Ltd and Flynn Pharma (Holdings) Ltd (together “Flynn”) to suspend the Competition and Markets Authority’s (the...more

Health Update - January 2017

Top Five Healthcare Antitrust Trends to Watch in 2017 - Antitrust enforcement and litigation had a big year in 2016. In this article, we look back at the most significant cases for the healthcare industry over the last...more

Uncertainty rises about leadership in nation’s top health posts

Although attention has focused on the GOP-promised repeal and replacement of the Affordable Care Act, other big changes also are afoot in the federal government that will have significant effects on health care in this...more

An Increased Cooperation in Enforcement Activity: The Italian Competition Authority and the Italian Medicines Agency Sign a...

by McDermott Will & Emery on

On 19 January 2017, the Italian Competition Authority (AGCM) and the Italian Medicines Agency (AIFA) signed a memorandum of understanding in order to increase enforcement in the pharmaceutical sector by strengthening their...more

FTC and States Reach $100 Million Antitrust Settlement with Mallinckrodt

by King & Spalding on

On January 18, 2017, the Federal Trade Commission (“FTC”) announced that it reached a $100 million settlement with pharmaceutical company Questcor Pharmaartinceuticals, Inc. and its Irish parent company, Mallinckrodt plc. ...more

REDIAL: 2016 TCPA Year In Review – Analysis of Critical Issues and Trends

The Sutherland TCPA team has published its third annual REDIAL: 2016 TCPA YEAR IN REVIEW – ANALYSIS OF CRITICAL ISSUES AND TRENDS. This publication reflects our in-depth analysis of significant Telephone Consumer...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

by DLA Piper on

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

FDA Releases Guidance on Cybersecurity and Medical Devices

by Reed Smith on

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

by McDermott Will & Emery on

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

by K&L Gates LLP on

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

by Tarter Krinsky & Drogin LLP on

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

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