Administrative Agency Consumer Protection Science, Computers & Technology

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23andMe Receives FDA Approval for Genetic Diagnostic Test

Last Thursday the genetic diagnostic and DNA analysis company 23andMe announced that the FDA had granted the company approval to market a genetic diagnostic test for Bloom's Syndrome, the first such approval for this rare...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

White House Unveils New Federal Cybersecurity Agency

On February 10, the White House announced it will establish the Cyber Threat Intelligence Integration Center (CTIIC). In prepared remarks, Lisa Monaco, Assistant to the President for Homeland Security and Counterrorism,...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Privacy commissioner to audit 21 privacy policies for compliance: it may be you!

The Australian Privacy Commissioner (Commissioner) is preparing to conduct an assessment of 21 online privacy policies at random. The Commissioner also noted: "[we've] been talking for a long time about the need to build...more

Cybersecurity Executive Order: Not Much New

President Obama’s February 13 Executive Order, “Promoting Private Sector Cybersecurity Information Sharing” (the “EO”), turns out to be light on new measures to improve cybersecurity, but focused heavily on adjustments to...more

DOJ Releases Electrifying New Guidance on Standard-Essential Patent Policy

The Department of Justice (the “Department” or “DOJ”) continued its multi-pronged defense of standards-setting organizations (SSOs) who adopt patent policies to prevent hold-up during licensing negotiations. Last week’s...more

Citizen Petitions Aimed at Delaying Generic Competition Remain a Concern

Despite Congress enacting legislation in 2007 to curb misuse, citizen petitions submitted by pharmaceutical companies to the Food and Drug Administration (FDA) may still provide a mechanism for competitors to delay the...more

FDA Revises Approach to Presentation of Risk Information in Brief Summary

On February 6, 2015, the U.S. Food and Drug Administration (FDA) issued a revised draft guidance titled Brief Summary and Adequate Directions for Use: Disclosing Risk Information in Consumer-Directed Print Advertisements and...more

FTC Report Offers Privacy and Security Guidance for ‘Internet of Things’

On Tuesday, January 27, the FTC issued a 71-page Staff Report on the privacy and security issues with the Internet of Things. As we’ve noted in our previous blog posts, the Internet of Things (“IoT”) refers to the growing...more

FDA Issues Draft Guidance That Affects Health IT

The U.S. Food and Drug Administration (“FDA”) recently issued draft guidance that directly affects health information technology (“Health IT”), specifically medical device accessories and general wellness products. The new...more

DOJ Provides New Guidance on Required Licensing of Essential Patents in Standard-Setting

DOJ recently concluded that a standard-setting organization's proposal to update its policy regarding patents underlying its standards was pro-competitive. DOJ's analysis of the association's process and legal structure...more

UK's Information Commissioner's Office Enters Corrective Action Agreement With Shoe Retailer For Data Breach

On January 19, 2015, the United Kingdom’s Information Commissioner’s Office (“ICO”) — an independent UK body created to uphold information rights — published a corrective action agreement with shoe retailer Office Holdings...more

FDA Regulatory and Compliance Monthly Recap - January 2015

In This Issue: - FDA’s CDER, CDRH and CBER put out 2015 guidance agendas - FDA to study limiting major risk statements in direct-toconsumer TV ads amid concern that information is getting lost on consumers...more

NRC Report Reviews DPR’s Pesticide Risk Assessment Process

An ad hoc committee of the National Research Council (NRC) released a report, Review of California's Risk-Assessment Process for Pesticides, following its scientific and technical evaluation of the California Environmental...more

Privacy Update: Protecting Children From Cyber-Bullying

The Federal Government's Enhancing Online Safety For Children Bill 2014 Is A Significant Cyber Reform. The First Direct Response To Cyber-Bullying It May Also Herald A New And Targeted Approach To The Online Activity Of...more

NRDC Files Petition for Review To Ban Flea Collars and Pet Products Containing Pesticides

On January 5, 2015, the Natural Resources Defense Council (NRDC) filed a petition for review in the U.S. Court of Appeals for the Ninth Circuit challenging the November 6, 2014, decision of the U.S. Environmental Protection...more

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13,...more

Potentially Burdensome Reporting Obligations Ahead for Industry Interactions with APRNs in Connecticut

The Connecticut Department of Consumer Protection (Department) recently released its Expenditure Disclosure Form for manufacturers subject to section 75 of Public Act 14-217, which requires manufacturers of a covered drug,...more

Preemption and Primary Jurisdiction After Pom Wonderful

After the U.S. Supreme Court decision in Pom Wonderful LLC v. The Coca-Cola Co., __ U.S. __, 134 S.Ct. 2228 (2014), fear arose among national marketers that the decision would produce a wave of class actions challenging food,...more

Marriott Fined $600,000 For Wi-Fi Jamming

On October 3, 2014, Marriott International entered into a consent decree with the Federal Communications Commission (FCC) where Marriott agreed to pay a $600,000 fine for jamming conference guests' Wi-Fi hotspots at the...more

Congress Passes the National Cybersecurity Protection Act: Codifies National Cybersecurity Center & Creates Federal Agency Data...

The National Cybersecurity Protection Act of 2014 (NCPA) was passed by the House on December 8th, by the Senate on December 10th, and signed by the President on December 18th. Senate Committee on Homeland Security and...more

Advertising Law - December 2014 #2

Uber’s Privacy Mess Results in Legislative Inquiry - Providing a lesson in how not to handle a privacy policy, car service app Uber is now facing questions from the Senate Subcommittee on Privacy, Technology and the...more

Technology may reduce fraud but doesn’t fix regulatory confusion

President Barack Obama recently announced the administrtion’s BuySecure initiative. At a meeting at the Consumer Financial Protection Bureau Oct. 17, the president outlined the program, aimed at increasing the security of...more

Lawmakers Seek Details On Consumer Data Breaches From Financial Institutions

On November 18, 2014, several major financial institutions received requests from lawmakers for detailed information about recent data breaches and for briefings from their corporate data security officials. The lawmakers...more

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