Antitrust & Trade Regulation Health Science, Computers & Technology

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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

FTC Enforcement in Schein: Misleading Statements about Encryption and Cybersecurity

On January 5, 2015, the Federal Trade Commission (FTC) entered into a consent order with dental software manufacturer Henry Schein Practice Solutions, Inc. ("Schein") in connection with allegations that Schein had made...more

Health Alert (Australia) - January 18, 2016

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: New South Wales 14 January 2016 - Health Care Complaints Commission v Athour [2016] NSWCATOD 5 The New South Wales...more

Henry Schein Settles FTC Charges of Deceptive Advertising of Dentrix G5

Data encrypted in accordance with the Advanced Encryption Standard (“AES”) gives dentists a “safe harbor” in the event of certain breaches of patient information. However, those relying on Henry Schein’s Dentrix G5 software...more

Lessons Learned from LabMD's Successful Challenge to the FTC's Cyber Authority and Wyndham's Monumental Settlement with the FTC

On the shifting sands of cyber security regulation, it is important to understand the outcome of two recent enforcement cases brought by the Federal Trade Commission (FTC) – one against clinical lab services company LabMD,...more

FTC settles with software provider over misleading customers about encryption of patient data

The Federal Trade Commission (FTC) announced on January 5, 2016, that it has agreed to settle an investigation with Henry Schein Practice Solutions, Inc. (Schein), an office management software provider for dental practices...more

As if a 20-Year Consent Order Wasn’t Enough Fun: FTC Brings First Monetary Settlement in Information Security Case

The FTC reached a $250,000 settlement with a 20-year consent order with Henry Schein Practice Solutions, Inc. over its use of allegedly subpar encryption technology in its offering to dental practices. This settlement is...more

Quest Defeats Claims that It Conspired with Health Insurers

On November 25, District Court Judge William Orrick (N.D. Cal.) dismissed all claims in Eastman v. Quest Diagnostics, finding that the plaintiffs, a class of Northern California consumers who had utilized Quest's services,...more

Second Circuit tells pharmacies the antitrust claims they cooked up need more than a little Morton Salt

Cash & Henderson Drugs, Inc. v. Johnson & Johnson, recently decided by the Second Circuit, concerns Robinson-Patman Act claims that retail pharmacies brought against pharmaceutical manufacturers. The retail pharmacies alleged...more

Antitrust Suit Continues to Stymie New Texas Telemedicine Regulation

A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its...more

Texas Telemedicine Provider Survives Another Round

Teledoc, a telehealth services provider looking to do business in Texas, continued its winning streak in Texas federal court: on Monday, a judge rejected the Texas Medical Board’s motion to dismiss Teledoc’s antitrust...more

Russian Government establishes procedure to determine interchangeability of medicines

The term "interchangeable medicine" was formally introduced to Federal Law No. 61-FZ on the Circulation of Medicines of April 12, 2010 (the "Law on the Circulation of Medicines") by amendments to it dated December 22, 2014,...more

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