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Increased FTC Enforcement as FDA Deregulates Low-Risk Health IT Devices

The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices. In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement...more

The FCC and the Uncertain Future of Privacy Oversight for Internet Service Providers

The Federal Communications Commission’s (“FCC”) net neutrality proceeding culminated this month with the release of an Order reclassifying broadband Internet access service as a common carrier Telecommunications Service...more

Can the U.S. – EU Safe Harbor Weather the Storm?

On 24 March, the Court of Justice for the European Union (CJEU) heard argument on a case that could significantly impact, if not invalidate altogether, the Safe Harbor framework that facilitates the flow of personal data from...more

Restrictions Eased for Communications-Related Items Exported to Sudan

On February 18, 2015, in a coordinated action, the Commerce Department's Bureau of Industry and Security (BIS) and Treasury Department's Office of Foreign Assets Control (OFAC) announced and implemented changes to the...more

EUROPE: EU-US data flows at risk? European Court of Justice today heard Facebook case.

Yesterday, the Schrems v. Irish Data Protection Commission case was brought before the Court of Justice of the European Union (‘CJEU’) for an oral hearing, following referral by the Irish High Court. While the final ruling by...more

Supreme Court Corner - Q1 2015

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. Patent – Decided: January 20, 2015 - Holding: When reviewing a district court’s resolution of subsidiary factual matters made during its construction of a patent claim,...more

FDA Issues Revised Draft Guidance on Disclosures of Risk Information in Consumer-Friendly Print Advertisements and Promotional...

The U.S. Food and Drug Administration (FDA) recently released its Revised Draft Guidance entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FCC Shifts Net Neutrality into High Gear

On March 12, 2015, the FCC published its long-anticipated Net Neutrality order. The Final Rules stem from the question asked by the FCC in its May Notice of Proposed Rulemaking: “What is the right public policy to ensure that...more

FCC Releases Open Internet Order

On March 12, 2015, the Federal Communications Commission (FCC or “Commission”) released the full text of its Open Internet Order (“Order”). The rules adopted in the Order will become effective 60 days after publication in the...more

State Regulation of Broadband

The Order attempts to minimize the possibility of state regulation of broadband Internet access service (BIAS), leaving only the most limited role for the states. The Order reaffirms that BIAS is an interstate service for...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

FDA's Evolving Policy Toward Health IT, Medical Apps, and Low Risk Devices

Between January 20 and February 9, 2015, the U.S. Food and Drug Administration (“FDA”) issued four guidances related to its policies toward low risk devices. These guidances were largely developed as an outgrowth from FDA’s...more

FDA Regulatory and Compliance Monthly Recap - February 2015

FY 2016 budget request reflects FDA’s broadening scope of activities - The regulator’s requested budget of $4.9 billion for the upcoming fiscal year represents a 9% increase from the enacted FY 2015 budget, with $147.7...more

Safety Labeling: Public Meeting Later This Month and Comment Period Extended – Key Dates Coming Up

On March 27, 2015, FDA plans to hold a public meeting entitled, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. The meeting was announced in a Federal Register Notice posted...more

Update: Hotel Industry Members Withdrawal FCC Wi-Fi Petition

This is an update to an article we posted on January 28, Can Hotels Legally Block Wi-Fi Hot Spots? The FCC Says No, and Fines a Hotel $600,000 For Doing It. On August 25, 2014, the American Hotel & Lodging Association,...more

White House Releases Cyber Threat Intelligence Integration Center Fact Sheet

On February 25, the White House issued a fact sheet regarding the establishment of the Cyber Threat Intelligence Integration Center (CTIIC), which outlines the purpose, authority, organizational structure, and how the CTIIC...more

Accessibility Standards for Equipment Covered By the Communications Act

New accessibility requirements could affect information and communications technology providers of computers, telecommunications equipment, software, and websites. In a notice of proposed rulemaking (NPRM) published in...more

FCC Adopts Open Internet (Net Neutrality) Rules

The order classifies broadband Internet access as a telecommunications service. The Federal Communications Commission (FCC or Commission) today voted, by a 3-2 margin, to adopt rules designed to promote an open Internet...more

Draft Available Only as a Password-Protected Download Is Not a Printed Publication - Samsung Electronics Co. Ltd. v. Rembrandt...

Addressing a petition to institute an inter partes review of a patent for communicating between different modem types, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB or Board) declined to institute...more

Generic top-level domains – the evolution of trademark protection

In early 2012 the Internet Corporation for Assigned Names and Numbers (ICANN) received over 1,900 applications for unlimited generic top-level domains (gTLDs). Since then, over 325 new TLDs have launched with a total of...more

Data Protection – Cookie sweeps and enforcement actions – Time for a common approach

There have been a lot of discussions about the results of the latest Cookie Sweep carried out in 8 EU member states (for more information see also the latest post of our Patrick van Eecke and Julie De Bruyn, and the Cookie...more

Colorado Bill Targets Internet Sweepstakes Cafés and Similar Establishments

Colorado House Bill 1047 would make internet sweepstakes cafés illegal under Colorado law. The law declares that internet sweepstakes cafés and similar establishments in which simulated gambling devices are used to award...more

FDA Issues Guidance for Mobile Medical Applications: What Will be Subject to FDA Oversight and Enforcement?

On February 09, 2015, the FDA issued final guidelines[1] to outline its regulatory enforcement approach to mobile medical applications (or “apps”). The FDA is taking a risk-based approach, focusing its oversight on apps that...more

FCC Should Use Scalpel, Not Ax to Preempt State Laws Limiting Muni-Broadband

On Feb. 26, the FCC plans to act to preempt state laws that retard development of municipally owned broadband networks. The breadth of the potential preemption is unclear. The decision will occur at the same meeting at which...more

AliveCor, Inc., Maker of Smart Phone-Based ECG Device, Receives FDA Clearance for Two New Algorithms that Provide Users Immediate...

San Francisco-based AliveCor,Inc. recently announced that the U.S. Food and Drug Administration (FDA) granted the company clearance for two new algorithms for its Smart Phone-based ECG device, the AliveCor Heart Monitor and...more

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