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Stop Faxing

I’ve long thought that sending faxes was a pretty silly means of communication. Don’t send me a fax. I don’t want it. At some point I’m hoping that even my kids’ doctor’s office will get dragged into the 20th century and...more

The Regulator Knows Best: British Columbia Court of Appeal Upholds Bylaws Prohibiting Customer Incentive Programs

In Sobeys West Inc. v. College of Pharmacists of British Columbia, 2016 BCCA 41, the British Columbia Court of Appeal determined that it was reasonable for the College of Pharmacists to prohibit pharmacists from using...more

FDA Regulatory and Compliance Monthly Recap — February 2016

FDA publishes guidance on human factors review for devices, combination products - The FDA published two draft guidance documents and one final guidance document to address the incorporation of human factors studies in...more

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two...more

ALJ Upholds $239,800 In Civil Monetary Penalties For HIPAA Violations

Home health care provider Lincare, Inc. must pay $239,800 in civil monetary penalties for violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) Privacy Rule, according to a February 3, 2016...more

Why is the Government Interested in my Drone?

Everyone has heard of drones. Amazon is going to use them to deliver packages soon, right? What is a drone and what do individuals and businesses need to know about drone usage? Drones are defined simply an unmanned,...more

Izzet Sinan on What Telecom Antitrust Regulation Means For EU Integration [Video]

Izzet Sinan, partner in the Morgan Lewis's office in Brussels, talks about the interplay between antitrust regulations for the telecommunications industry and integration within the European Union....more

Reading the Section 5(a) Tea Leaves: What the end of 2015 may suggest about the FTC priorities in 2016

The end of 2015 represented a mixed bag for the Federal Trade Commission on privacy enforcement. In November, the FTC’s Chief Administrative Law Judge dismissed the FTC’s complaint against LabMD for a possible data breach of...more

No Harm, No Foul? Defining FTC’s Authority Over Data Security

Given the frequency of high-profile breaches, it’s reasonable for companies and consumers to be not only fearful but also realistic (or some would say fatalistic) about data security. It’s not a question of if a security...more

While Not Quite a Rash of Enforcement, FDA Takes Action in 2015 Against Cosmetic Products Making Unapproved Drug Claims

To paraphrase, admittedly horribly, the Cole Porter classic, “I’ve Got You Under My Skin,” a number of cosmetic companies got under the Food and Drug Administration’s (FDA) skin in 2015 for making unapproved new drug claims....more

All You Need to Know About LabMD’s Big Win in/over the FTC

We have been meaning for a while to write about LabMD’s epic data privacy fight against the FTC. We’re sure you have read about the action, and particularly about the administrative order dismissing the government’s...more

Government Forces Awaken: The Rise of Cyber Regulators in 2016

As the sun sets on 2015, but before it rises again in the New Year, we predict that, in the realm of cyber and data security, 2016 will become known as the “Rise of the Regulators.” Regulators across numerous industries and...more

FTC Appeals ALJ Ruling Dismissing Its Claims Against LabMD

The legal wrangling between the Federal Trade Commission and LabMD, Inc. over data security continues. On December 22, 2015, the FTC filed its appeal brief challenging Chief Administrative Law Judge (“ALJ”) D. Michael...more

Georgia Secretary of State’s office exposed 6 million voters’ SSNs

It is frustrating for citizens to continue to watch state and federal governmental agencies announcing massive data breaches of citizens’ personal information. Here is another one. On Tuesday, December 15, 2015, the...more

FDA Plans Workshop to Address Cybersecurity in Medical Devices

Two months after finalizing its first guidance on cybersecurity, the FDA has announced a public workshop entitled “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” to continue to address a growing...more

Task Force Makes Drone Registration Recommendations Expected to Be Adopted by the FAA, But on What Authority?

On November 21, 2015, the Unmanned Aircraft Systems Registration Task Force Aviation Rulemaking Committee, chartered by the FAA, issued its Final Report to the FAA containing the Task Force’s recommendations for how the FAA...more

Company prevails in challenge to FTC data security complaint

As we have previously observed, banks and other companies subject to the CFPB’s jurisdiction face the possibility that the CFPB could begin using its authority under Sections 1031 and 1036 of the Dodd-Frank Act (which...more

Company Prevails in Challenge to FTC Data Security Complaint

A recent decision by the Federal Trade Commission (FTC) Chief Administrative Law Judge (ALJ) dismissed the FTC’s complaint against LabMD, Inc. (LabMD) asserting the company’s alleged failure to protect consumer data in two...more

Stakeholders Say Biosimilars Names Should Be Meaningful and Memorable

FDA has received comments from more than 170 groups on its proposal for naming biosimilars. Biosimilar makers, insurers and pharmacies largely oppose distinct nonproprietary names (also known as proper names) for...more

ALJ Dismisses FTC Data Security Claims Against LabMD Due to Lack of Actual or Likely Substantial Consumer Harm

On November 13, a Federal Trade Commission administrative law judge dismissed the FTC data security complaint against medical laboratory LabMD, potentially vindicating LabMD’s vigorous two-year struggle to deny the FTC’s...more

Administrative Law Judge Dismisses FTC’s Complaint Against LabMD In Data Breach Case, Citing Lack Of Consumer Harm

On November 13, 2015, the Chief Administrative Law Judge (“ALJ”) Of the Federal Trade Commission (“FTC”) dismissed an Administrative Complaint against LabMD, Inc. (“LabMD”) regarding its data security practices. In a 92-page...more

FDA Approves Genetically Engineered Atlantic Salmon as Safe and Effective for Human Food and Releases Related Draft Guidance on...

On Thursday, November 19th, the Food & Drug Administration (FDA) announced that it had approved an application for AquAdvantage Salmon, a type of Atlantic Salmon that has been genetically engineered to grow to market size...more

ALJ Dismisses FTC Data Breach Action Against LabMD

In the first ruling rebuking the Federal Trade Commission’s cybersecurity enforcement efforts, the FTC’s head administrative law judge dismissed the FTC’s complaint against LabMD, Inc., on November 13, stating that...more

ALJ Issues Sweeping Decision Dismissing FTC’s Action Against LabMD

On November 13, 2015, the chief administrative law judge (“ALJ”) handling the Federal Trade Commission’s (“FTC” or “Commission”) complaint against LabMD Inc. (“LabMD”) dismissed the case in its entirety. As we previously...more

LabMD vindicated in FTC row

We have been following the fight between LabMD and the FTC for years. It has been a story of high emotions, principles, standoffs, aggression, lawsuits, court decisions, Congressional hearings and accusations, all outlined in...more

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