Science, Computers & Technology Updates

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Legislation Tracker: PRICED Act Proposes to Shorten Biologic Exclusivity Period from 12 to 7 Years

A bill introduced in the House of Representatives yesterday proposes “[t]o amend the Public Health Service Act to shorten the exclusivity period for brand name biological products from 12 to 7 years.” Titled the “Price...more

Knee Implant MDL Judge Enters Aggressive Lone Pine Order

We love Lone Pine orders. First of all, we love the name. Makes us think of a cowboy eating beans under a scraggly tree. On the prairie. Listening to Dolly Parton. We also love Dolly Parton, whom we saw in concert last week...more

IPR Tracker: IPR2016-00383 (U.S. Patent No. 6,331,415) (Genzyme) (Cabilly II patent) – Denying Institution of IPR

The PTAB has denied IPR on U.S. Patent No. 6,331,415. On June 8, the PTAB instituted a separate Genzyme petition against this patent (IPR20016-00460), which was joined to an earlier Sanofi-Aventis and Regeneron IPR...more

NTIA Multistakeholder Process Finalizes General Privacy Guidelines for Commercial Facial Recognition Use

We’ve previously blogged about the National Telecommunications and Information Administration (NTIA) privacy multistakeholder process to address concerns associated with the emerging commercial use of facial recognition...more

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

CMS Overhauls Clinical Laboratory Fee Schedule with Long-anticipated Final Rule

On June 17, 2016, CMS released a long-anticipated final rule revising the Medicare payment system for clinical diagnostic laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) (the Final Rule). In 2018,...more

Autonomous Vehicle Manufacturers Do Not Need to be Shielded from Lawsuits

Full disclosure # 1: I, the author of this blog post, am a trial lawyer. Full disclosure # 2: The law firm that allows the publication of this blog post has many, many, many more trial lawyers. Without disputes that could go...more

Drone on Drones: FAA Commercial Drone Regulations Finalized

The FAA finalized the first operational rules for routine commercial use of small unmanned aircraft systems this week, beginning the process towards full integration of drones into domestic airspace. The regulations, which in...more

New Data Protection Obligations In Europe: Data Protection Officers and Impact Assessment under the New General Data Protection...

The full text of the General Data Protection Regulation (GDPR) was published on 4 May 2016. Although the GDPR will not be effective until 25 May 2018, it is worth looking into it right now given the major changes it makes to...more

Senate Creates Cybersecurity Caucus

On June 14, 2016, Senators Mark Warner (D-VA) and Cory Gardner (R-CO) announced the creation of the Senate Cybersecurity Caucus to help coordinate cybersecurity efforts across Senate committees and keep lawmakers and staffers...more

FAA Releases Long-Awaited Rule for Commercial Operations of Small Unmanned Aircraft Systems

A key milestone in regulating the commercial use of small unmanned aircraft systems (sUAS), the Federal Aviation Administration’s (FAA) final rule overhauls the current case-by-case exemption regime, establishes an...more

Illinois data breach law amended and includes new twists

Governor Bruce Rauner signed several new provisions into law amending Illinois’ Personal Information Privacy Act, including health insurance and medical information into the definition of personal information that triggers...more

Toxic Substances Control Act Overhauled Chemical Risk Regulation in the U.S. Joins the 21st Century

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Act). Passed with significant bipartisan support, the Act is the first major update to a federal...more

Courts: We Hear No Suit Based on Cyber Crime Before its Time

Two recent decisions out of the U.S. District Court for the District of Maryland illustrate the difficulty that cyber breach victims can have in establishing standing to sue. In both cases, the court dismissed the cyber...more

NIH Signals “Paradigm Shift” with Policy on Multi-Site Studies

Federally-funded clinical trials conducted at multiple sites will move to a single Institutional Review Board (IRB) review scheme under a new National Institutes of Health (NIH) Policy. The NIH has finalized its policy to...more

Predictions for Alberta’s Renewable Electricity Program

In March 2016, the Alberta government tasked the Alberta Electric System Operator (AESO), the independent system operator for Alberta’s electricity system, with developing and implementing a plan to significantly increase...more

TSCA Reform: EPA Web Page on the Frank R. Lautenberg Chemical Safety for the 21st Century Act Includes FAQs Addressing PMNs and...

On June 22, 2016, President Obama signed into law the Frank R. Lautenberg Chemical Safety for the 21st Century Act. Later that day, the U.S. Environmental Protection Agency (EPA) announced the creation of a web page on the...more

President Signs TSCA Legislation Modernizing Nation’s Chemical Safety Program

On June 22, 2016, the President signed the “Frank R. Lautenberg Chemical Safety for the 21st Century Act,” a landmark law containing major reforms to the Toxic Substances Control Act (“TSCA”). As noted in Balch &...more

Significant Hospital Related Mid-Year Updated OIG Review Activities

This is the second of three alerts discussing the mid-year update to the Fiscal Year 2016 Work Plan issued by the Office of Inspector General (OIG). In the first alert we discussed the top management performance challenges...more

MAG Aerospace Industries, Inc. v. B/E Aerospace, Inc. (Fed. Cir. 2016) - Equitable Assignor Estoppel Doctrine Expanded by Federal...

Arcane aspects of the law are frequently analogized as constituting "traps for the unwary," and patent law seems to have more than its share of minutiae that fall within that characterization. The equitable principle of...more

Reputation Matters: Don’t Lose Opportunities Due to Inaccurate Personal Data

Consumers may be injured by inaccurate data that they cannot review or correct. There’s a hole in the bucket, dear Congress. The children’s song, “There’s a Hole in the Bucket,” exemplifies the conundrum many consumers...more

Implications of New Lautenberg Act’s Sweeping Changes to Toxic Substances Control Act

President Obama signed HR 2576, the Frank Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), into law on June 22, 2016. The Lautenberg Act makes significant changes to the Toxic Substances Control Act...more

Patent Litigation for the Non-Specialist: How it Works and What to Expect

On June 15, 2016, we presented a webinar on Patent Litigation for the Non-Specialist: How it Works and What to Expect. A replay of our webinar is available here. The audience raised several great questions, some of which we...more

Embry-Riddle Aeronautical released guide for novice drone operators

Everywhere you look there is another news story about drones. Now, Embry-Riddle Aeronautical University’s Worldwide Campus has released the first comprehensive consumer guide to buying and using small unmanned aircraft...more

Is The Most Frightening Cyber Trend Numbness Leading to Complacency?

Today’s new cyber world necessitates protection of what is most important to you. The cyber landscape continues to change on a near daily basis and shows no signs of slowing. K2 Intelligence’s Jeremy Kroll and Austin...more

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