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MoFocus: Our Insights into the Risk + Crisis Landscape - Vol.1 Issue. 1

by Morrison & Foerster LLP on

What Companies Should Be Doing to Prepare for the Next Ransomware Attack - The “WannaCry” cyberattack that struck in May paralyzed businesses, government entities, and Britain’s National Health Service, encrypting computer...more

Electric boogaloo: FDA releases sequel to 2003 guidance on use of electronic records and electronic signatures in clinical...

by Hogan Lovells on

On 21 June 2017, FDA announced the availability of a new draft guidance titled "Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11 — Questions and Answers." The draft guidance is...more

June Washington Update

This month’s Washington Update offers an extensive overview of the major legislation that has recently been introduced on Capitol Hill, as well as the big takeaways from this month’s congressional hearings related to energy...more

Round Two: Significant Telehealth Expansion Re-Proposed in Bipartisan Senate Bill

by McDermott Will & Emery on

On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the...more

Why do drug prices soar? Blame PBJs, PBMs, weak regulators, and CME

What do PBJs, PBM “black boxes,” industry friendly advisory panels, and CME (aka doctor training programs) all share in common? They’re blamed for contributing to Big Pharma’s skyrocketing prices—and it’s worth diving into...more

House member launches fintech lending investigation

by Ballard Spahr LLP on

Congressman Emanuel Cleaver, II announced last week that he had launched an investigation into small business financial technology (fintech) lending by sending a letter to the CEOs of several fintech small business lenders. ...more

Trade & Manufacturing - News of Note - June 2017

by King & Spalding on

President Trump Issues Two Additional Trade-Related Executive Orders - On April 29, 2017, President Donald Trump signed two executive orders (EOs) on issues related to international trade: (1) a Presidential Executive...more

Congressional Hearing on Driverless Cars: Tuesday, June 27

by Best Best & Krieger LLP on

The U.S. House Subcommittee on Digital Commerce and Consumer Protection will hold a hearing today on self-driving vehicle legislation at 10 am. ...more

Congress Faces Tough Questions on the Road to Governing Self-Driving Cars

by Foley & Lardner LLP on

Self-driving cars must also scare the hell out of Congress too. This past June 14 – long after states began their forays into regulating self-driving cars – the U.S. Senate Commerce, Science, and Transportation Committee...more

New Incentive for Data Centers in Florida

by Bryan Cave on

This session, Florida approved legislation that provides for a sales tax exemption for data centers and goes into effect on July 1, 2017. The exemption eliminates sales and use taxes for infrastructure, equipment, personal...more

Patent Legislation on the Hill: Senators Introduce the STRONGER Patents Act of 2017

by Ropes & Gray LLP on

Although the America Invents Act was enacted less than six years ago, the appetite for intellectual property legislation in D.C. has continued unabated over the last several years. In addition to the recent Defend Trade...more

President's Executive Order on Cybersecurity: Impact on Banks Unclear

President Donald Trump has signed an executive order addressing cybersecurity. But for financial institutions, is the executive order much ado about nothing? Not exactly....more

A Patchwork Quilt of Regulations for Self Driving Vehicles – No Way, Says Congress!

by Freeborn & Peters LLP on

Big news! Next week, on June 27th, a Subcommittee of the House Committee on Energy and Commerce will hold a hearing to discuss “Self-Driving Vehicle Legislation.” As reported by Wired, “last week, the Senate published...more

Queen Announces New UK Data Protection Bill

by Latham & Watkins LLP on

Following the commencement of the Brexit negotiations earlier this week, the Queen announced in her Speech [yesterday] a new law that will “ensure the United Kingdom retains its world-class regime protecting personal...more

Congressional Committees Advance Bipartisan FDA User Fee Agreements

by Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

Messaging Apps May Face New Obligations in Russia

by Latham & Watkins LLP on

The State Duma, Russia’s lower chamber of Parliament, has adopted amendments to the Federal Law on Information, Information Technologies and Information Protection of the Russian Federation (the Law) in its first reading....more

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

by Dorsey & Whitney LLP on

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

Bipartisan Group of Senators Releases Principles for Federal Autonomous Vehicle Laws

by Buchalter on

Last week, U.S. Senators John Thune (R-SD), Gary Peters (D-Mich), and Bill Nelson (D-Fla) released a framework for autonomous vehicle legislation based on these six principles...more

DSM Watch: EU online content services Portability Regulation will become law in its current form: Council adoption 8 June 2017

by Hogan Lovells on

DSM Watch has been tracking this, the first legislative proposal published by the Commission under the Digital Single Market strategy banner, since back in December 2015.  The Commission’s aim was to allow consumers who pay...more

Iran and Russia Sanctions Pass US Senate

by Hogan Lovells on

Last week, the U.S. Senate acted to pass both new Iran and Russia sanctions by large bipartisan margins. The House of Representatives has not yet acted on either piece of legislation. We anticipate that Congress will...more

Senators Announce Principles for Bipartisan Legislation on Self-Driving Vehicles

by Perkins Coie on

The U.S. Congress has started to explore potential legislation governing the testing and regulation of autonomous vehicles (AV). Last week, the U.S. Senate Committee on Commerce, Science, and Transportation held a hearing,...more

Trump Administration Highlights Limitations of CFIUS Process

In separate public statements last week, two Trump administration cabinet secretaries expressed concerns with the national security review process of the Committee on Foreign Investment in the United States (CFIUS). They also...more

Healthcare Weekly Preview from ML Strategies – June 2017 #3

Welcome back everybody. In general, this week insurers will submit their applications for participating in the Marketplace for 2018. After this we will begin to find out where the insurance deserts are and how much rates will...more

Nebraska Enacts Law To Allow Automatic Substitution Of Interchangeable Biosimilars

by Goodwin on

As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the...more

Washington becomes the third state with a biometric privacy law: five key differences

by DLA Piper on

The State of Washington has become the third state (after Illinois and Texas) to enact a law regulating biometric information (HB 1493). The new law, enacted in mid-May, goes into effect on July 23, 2017....more

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