Science, Computers & Technology Updates

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Looking Back at Predictions That I Made Three Years Ago, Part 2: eDiscovery Predictions Revisited

Earlier, I took a look back at two posts that comprised six eDiscovery predictions for 2014 that I wrote three years ago. I thought it might be fun to look back at those posts to see how those predictions fared. I covered...more

HHS Finalizes Overhaul of Federal Human Subjects Research Protections

In Depth - On January 18, 2017, the Department of Health and Human Services (HHS) and 15 other federal agencies issued a final rule overhauling the federal human subjects research regulations known as the “Common Rule.”...more

FTC and States Reach $100 Million Antitrust Settlement with Mallinckrodt

On January 18, 2017, the Federal Trade Commission (“FTC”) announced that it reached a $100 million settlement with pharmaceutical company Questcor Pharmaartinceuticals, Inc. and its Irish parent company, Mallinckrodt plc. ...more

Day 18 of 30 Days to a Better Compliance Program-Email Sweeps [Video]

Ongoing monitoring is not limited to the financial component of compliance. The concept is straightforward; at regular intervals you can sweep through your company email database for identified key words that can be flagged...more

FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs

On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This...more

EU Legal Developments That May Impact Your Business in 2017

Sheppard Mullin’s EU team has created a list of major legal shifts that await General Counsel and Compliance Officers in the areas of competition, EU regulatory and trade in 2017. These challenges may have an impact on your...more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Vendor Causes Breach of Over 5,000 Patient Records

The continued risk that vendors pose to companies, including health care entities cannot be overemphasized. This week, Sentara Healthcare (Sentara) announced that one of its third-party vendors was the victim of a...more

Year in Review: The Most Popular Blog Posts of 2016

With President-Elect Donald Trump and his administration officially moving into the White House this Friday, the landscape of energy policy, investment, and incentives could see major changes in 2017. Given this backdrop, it...more

Longitudinal Study Finds that Post-Concussion Syndrome (PCS) May Be Permanent

University of Toronto researchers have just published an important longitudinal study following patients with Post-Concussion Syndrome (PCS) based on a diagnosis of concussion in conformity with the international sport...more

REDIAL: 2016 TCPA Year In Review – Analysis of Critical Issues and Trends

The Sutherland TCPA team has published its third annual REDIAL: 2016 TCPA YEAR IN REVIEW – ANALYSIS OF CRITICAL ISSUES AND TRENDS. This publication reflects our in-depth analysis of significant Telephone Consumer...more

FDA takes a half-step toward acknowledging manufacturers' right to disseminate truthful, non-misleading off-label information

The FDA has issued significant new Draft Guidance on January 17, 2017 that touches on the hot-button issues surrounding manufacturer dissemination of off-label information about approved drugs and medical devices, titled...more

FDA Clarifies “Intended Use” Regulations: Knowledge Alone ? Intent, But Knowledge Certainly Can Be One Element in Establishing the...

In its January 9, 2017 final rule addressing when tobacco products may be regulated as drugs, devices, or combination products, the Food and Drug Administration (“FDA” or “The Agency”) amended the intended use regulations for...more

No Stay Pending IPR in Brewing Patent Dispute | New England IP Blog

District court patent defendants often request a parallel inter partes review (“IPR”) proceeding at the U.S. Patent Office to challenge the validity of the patent at issue. As such IPR proceedings have the potential to kill...more

Obama FDA’s Parting Shot On Off-Label Promotion And The First Amendment

We haven’t digested it yet, so this isn’t a substantive post, but we wanted to make our readers aware that today the FDA made an announcement, which states in pertinent part...more

Privacy Tip #70 – Renters: Check out This Scam Thwarted by the FTC

I know a lot of people who have looked for and been successful in finding an apartment and/or a roommate on Craigslist. If you are looking for an apartment on Craigslist right now—listen up....more

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

Everything Compliance-Episode 5, year-end wrap up Part II [Video]

We turn to the 2016 year in review, in this Part II of a two-part series. Jonathan Armstrong leads a discussion on Privacy Shield, information and data privacy issues the past year. Mike Volkov relates what he saw as the top...more

Inherent Anticipation for Biotechnology Inventions

Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more

Obama Administration Issues a Fintech Policy Whitepaper

On January 13, 2017, the National Economic Council published a whitepaper that articulates the Obama Administration’s perspective on and vision for FinTech. The whitepaper builds upon the June 2016 White House FinTech Summit,...more

EPA Proposes Procedures to Prioritize Chemicals for Risk Evaluation under TSCA

The U.S. Environmental Protection Agency (EPA) proposed on January 17, 2017, procedures to establish the risk-based screening process and criteria that EPA will use to identify chemical substances under the Toxic Substances...more

New Jersey Senate Passes Law Requiring Notice Prior To Installation Of Remote Car Disabling “Payment Assurance Devices”

On December 19, 2016, the New Jersey Senate passed a bill requiring auto lenders to provide notice prior to installing “payment assurance devices” that can remotely disable an owner’s vehicle for failure to make a payment. ...more

Cybersecurity and Privacy Policy as a Board of Directors Issue

Cybersecurity and privacy of customer information have become such a critical issues that in-house counsel should treat them as board of directors-level issues. In-house counsel should do that with presentations for their...more

Only six months remain to register your database with the RNBD

Your Data Controller must register your databases in the RNBD according to the instructions in the user manual of the National Registration Database. The Superintendency of Industry and Commerce, Habeas Data Management...more

NYDFS: A Lawyer’s Responsibility

New York Financial Regulator to Enforce First-of-Its-Kind Cybersecurity Regulations in Coming Weeks - On December 28, 2016, the New York Department of Financial Services (NYDFS) issued revised cybersecurity regulations...more

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