Antitrust & Trade Regulation Science, Computers & Technology Health

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Health Update - June 2016

Real-Time Data Analytics in Government Investigations and Reducing Exposure - It is not every day that the words “innovative” and “nimble” are used when referring to an agency of the federal government bureaucracy. Yet,...more

Practice Fusion and FTC Settle Complaint Over Deceptive Statements About the Privacy of Consumer-Generated Online Content

Last week, the Federal Trade Commission (FTC) announced (press release) that Practice Fusion, the largest cloud-based electronic health company in the United States, has agreed to settle FTC charges over deceptive practices...more

Update on Naming Biosimilars

In August 2015, FDA released a long-awaited draft guidance for the nonproprietary names of biologics and biosimilars. The draft guidance recommends that nonproprietary names for biologic products should consist of the “core”...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

Health Update - May 2016

Actions to Advance Infant and Early Childhood Mental Health - Editor's Note: Children's earliest experiences—both positive and negative—impact their brain formation and in turn their social and emotional, physical,...more

FTC Enters into Consent Agreement Regarding Company's Use of Exclusive Contracts

The Federal Trade Commission (FTC) recently announced that Invibio, which sells high-performance polymer for medical implants, has settled charges that the company monopolized sales to medical device makers through unlawful...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...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

Breaking: Third Circuit Dismisses Antitrust Suit Concerning Marketing of Lovenox

Earlier today, the Third Circuit Court of Appeals upheld the decision of the District of New Jersey trial court dismissing the antitrust claims lobbed against Sanofi-Aventis by its rival pharmaceutical company Eisai. The...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – May 2016

Special Focus on “Safe Harbor 2.0,” Privacy Shield and E.U. Data Transfers: Alston & Bird’s privacy team has been closely following the development of Privacy Shield, the proposed successor to the E.U.-U.S. Safe Harbor...more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...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

FTC Releases "Cheat Sheet" for Developing a Secure Mobile Health Application

The Federal Trade Commission (FTC), in partnership with other federal agencies, has released an online tool that provides developers legal guidance for the creation of mobile health applications (apps). Companies that are...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

Federal Trade Commission Releases New Mobile Health Apps Interactive Tool

The Federal Trade Commission (FTC) in conjunction with the Office for Civil Rights (OCR), the HHS Office of National Coordinator for Health Information Technology, and the Food and Drug Administration, have developed a new...more

FTC Releases Tool And Best Practices For Mobile Health App Developers

On April 5, the Federal Trade Commission (“FTC”) announced that it had created a web-based tool designed to assist developers of health-related mobile apps identify and understand what federal laws and regulations might apply...more

FTC Releases Mobile Health Apps Interactive Tool

Consider this: A 42-year-old man arrives at the emergency room showing signs of a heart attack. The ER doctors, using the patient’s activity tracker—in this case, a Fitbit® —are able to pinpoint when the patient’s normal...more

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies. My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The...more

FTC, ONC, OCR and FDA release online tool for mobile health app developers

While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more

Alert: FTC Challenges "No-AG" Agreement as Illegal Reverse Payment

On March 30 the US Federal Trade Commission filed suit in federal court alleging that settlements of patent litigation in the pharmaceutical industry in which a pioneer firm agrees not to market an "authorized generic"...more

FTC Launches First-Ever Attack on “No-AG Commitment” Pay-for-Delay Settlements

Today the FTC filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania against Endo Pharmaceuticals for entering into “pay-for-delay” agreements with two different generic manufacturers that...more

Health Update - March 2016

Liberating Data to Enable Healthcare Market Transparency: A Guide for Regulators and Policymakers - Editor's Note: We are on the cusp of a transparency revolution in which consumers will have the data and tools to make...more

Private Equity Market Intelligence: Physician/Hospital Quarterly Report - Q4

Key Findings - ..ACA enrollment reached 11.3 million by the end of the third open enrollment period, surpassing HHS expectations. Three-quarters of the enrollees were from the 38 states that use the healthcare.gov...more

Amidst the Raucous Debate in D.C., States Quietly Take Action on Rising Prescription Drug Prices

Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would...more

Texas Medical Board Appeals Immunity Ruling

In a notice of appeal filed on January 8, 2016, the Texas Medical Board appealed the Western District of Texas’s ruling that the Texas Medical Board was not entitled to state action immunity in an antitrust suit involving...more

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