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UK Government Consults on Mandatory Supply of IT Services to Insolvent Customers

The UK Government has released a long awaited consultation document proposing new controls on IT suppliers’ dealings with customers facing insolvency. To a degree this brings the termination provisions of the UK’s...more

e-IDs: the Future of Secure Digital Identification?

Over the past decade, the EU has made significant technological and legal strides toward the widespread adoption of electronic identification cards. An electronic ID card, or e-ID, serves as a form of secure identification...more

Cyber Security: Forewarned is Fair-Warned

When Wei Wong, owner of Sushi Mushi, a popular Japanese food bistro in Texas, installed a phone add-on to take credit and debit card payments straight from his employees’ phones, his revenues skyrocketed. Yesterday the Feds...more

UK anti-piracy campaign set for launch

In an effort to combat digital piracy, the film and music industries have reached an agreement with the UK’s leading ISPs to launch the ‘Voluntary Copyright Alert Programme’ next year. The programme will send up to four...more

California Appellate Court Requires Actual Viewing of Confidential Information in Data Breach Case Under the California Medical...

In a case against Sutter Health involving records from a stolen office computer, the California Court of Appeal recently issued a decision limiting plaintiffs’ ability to state a claim and obtain statutory damages under the...more

Corruption Risks in Pharma Manufacturing in Russia

The Russian government has targeted the pharmaceutical industry for growth and development, adopting a program Pharma 2020 Strategy. This program aims to improve the competitiveness of the Russian pharmaceutical industry and...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

New York Proposes First State Bitcoin Regulations

One might have thought the biggest news in the digital currency world lately was Dell announcing that it was now accepting bitcoin. However, after a series of highly-publicized hearings in January, New York State rolled out...more

Bitcoin In The News: International Reports, California Makes It Legal

Virtual and digital currencies continue to be the focus of policy makers around the globe. In addition to new reports from international bodies addressing both the benefits and risks of the currencies, California...more

Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir.)

Case Name: Gilead Sciences, Inc. v. Natco Pharma Ltd., 2013-1418, 2014 U.S. App. LEXIS 7494 (Fed. Cir. Apr. 22, 2014) (Circuit Judges Rader, Prost, and Chen presiding; Opinion by Chen, J.; Dissent by Rader, C.J.) (appeal from...more

Health Headlines: Also in the News - July 2014 #3

CMS Revises Medicare Advantage and Part D Prescription Drug Plan Prior Authorization Requirement for Hospices – On July 18, 2014, CMS released a revised a memorandum outlining responsibility for drug payments for hospice...more

Drugs and the Internet: draft guidance on social media platforms and prescription drugs

The Food and Drug Administration (FDA) recently promulgated two much-anticipated draft guidance documents on the use of social media to present information about prescription drugs and medical devices. The draft guidance...more

Recent FDA Draft Guidance Addresses Social Media Challenges Faced by Drug and Device Companies

The first draft guidance discusses how drug and medical device companies may promote their products using character space limited social media (e.g., Twitter) and Internet advertisements (e.g., Google search engine...more

FDA Accepts the First Biosimilar Application under the BPCIA

Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more

Global Boardroom Risk Solutions Newsletter

Now more than ever, there is a need for risk solutions in the boardroom. Any organization can be faced with a significant crisis, whether a fraud investigation, a regulatory infringement, allegations of anticompetitive...more

New York AG Reports that Data Breaches Cost New York Businesses over $1B Last Year

The current headline in data security is a just-released report from the New York Attorney General's Office (the "AG Report") announcing that the number of reported data breaches more than tripled between 2006 and 2013,...more

Update on Google Unauthorized Children’s In-App Purchase Class Action: THE SHOW MUST GO ON!

U.S. District Court Judge Ronald M. Whyte has issued an order granting in part and denying in part Google’s Motion to Dismiss the class action filed against the Company on ­March 7 in the U.S. District Court for the Northern...more

CMS Proposes Elimination of CME Exemption From Sunshine Act

Teaching hospitals and physicians who speak at continuing medical education (CME) programs should be interested in a July 11, 2014, announcement by the Centers for Medicare & Medicaid Services (CMS). The announcement proposes...more

Governance, Risk, And Compliance Platforms, Q1 2014

In this Issue: - GRC Technology Decisions are Getting More Difficult - It’s Not worth Defining submarkets For GRC Platforms - Governance, Risk, and Compliance Platform evaluation Overview -...more

Honing in on the new rules for the transfer of personal data outside of the EEA

Although no major legislative milestones for the EU Data Protection Regulation have occurred since March 2014 (see status update here), there has been some progress over the late spring and early summer of 2014. One key item...more

HHS Relabels Invalidated 340b Regulation As “Interpretative Rule”

Earlier this week HHS came out swinging in the latest round of its battle with the Pharmaceutical Research & Manufacturers of America (PhRMA) over the Affordable Care Act’s provisions on 340B and orphan drugs. HHS reasserted...more

Delaware Adopts Law Requiring the Destruction of Consumers’ Personally Identifiable Information

On July 1, 2014, Delaware Governor Jack Markell signed into law Delaware House Bill 295, which amends Section 6 of the Delaware Code relating to trade and commerce. The new law, 6 Delaware Code §§50C-101 thru 50C-401, places...more

HHS Says It Has Authority to Issue Interpretive Guidance on Contested 340B Orphan Drug Rule Despite Court Order Vacating Final...

According to a recent court filing by HHS, the agency should not be precluded from issuing interpretative guidance regarding a provision of the 340B Drug Pricing Program even though a federal district court previously vacated...more

No news doesn’t mean it’s gone away: Timing Update for the EU Data Protection Regulation

With no major legislative milestones since the March 2014 EU Parliamentary vote endorsing the LIBE draft of the new Data Protection Legislation, observers from outside the EU might understandably wonder whether the...more

Stewart Title Guaranty Co. v. Segin Software, LLC (PTAB 2014)

On April 12, 2013, Segin Software sued Stewart Title and several other parties for infringement of U.S. Patent No. 8,165,939. The defendants filed a petition with the U.S. Patent and Trademark Office requesting post-grant...more

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