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FDA Reauthorization Act of 2017 passes the House

by Goodwin on

Earlier this month, the House of Representatives passed H.R. 2430: FDA Reauthorization Act of 2017 (FDARA) by voice vote. The FDARA seeks, among other things, to amend the Federal Food, Drug, and Cosmetic Act to revise and...more

State Governors Sign Cybersecurity Compact

by Williams Mullen on

The National Governors Association (NGA), recently announced that 38 governors had signed “A Compact to Improve State Cybersecurity.” In announcing the Compact, Virginia Governor Terry McAuliffe, outgoing chair of the NGA,...more

Governors Of 38 States Sign Cybersecurity Compact

by King & Spalding on

As Governor Terry McAuliffe (D-VA) completed his term as Chair of the National Governors Association, he announced on July 14, 2017, that 38 governors had signed a compact to improve state cybersecurity. The compact was the...more

Trump Administration Policy Statement Calls for FDA Premarketing Activities to be Funded Entirely by Industry Fees

by Knobbe Martens on

The Trump White House released a Statement of Administration Policy on Wednesday in response to the House of Representatives’ passage of H.R. 2430, a bill that would reauthorize the use of four FDA user fee programs: the...more

Recent Cases Demonstrate Need for Blockchain

by Goodwin on

A recent Delaware bill is poised to allow private Delaware corporations “use networks of electronic databases (examples of which are described currently as “distributed ledgers” or a “blockchain”) for the creation and...more

House Panel Approves Sweeping Proposal On Autonomous Vehicles, Putting Innovation Above Regulation

by Buchalter on

On July 19, 2017, a U.S. House panel took a significant step to clear the way for autonomous vehicles by approving a proposal allowing automakers to deploy up to 100,000 self-driving vehicles without meeting existing safety...more

House Panel Approves Groundbreaking Federal Autonomous Vehicle Legislation Draft

by Perkins Coie on

The House Subcommittee on Digital Commerce and Consumer Protection reached bipartisan agreement on July 19, 2017, regarding major aspects of legislation to address the testing and deployment of autonomous vehicles. The...more

US House Subcommittee Greenlights Proposal to Preempt State Regulations for Autonomous Vehicles

by Dentons on

A House panel on Wednesday unanimously advanced a sweeping proposal that would carve out new exemptions for thousands of experimental autonomous vehicles from existing federal auto safety standards, marking Congress's most...more

DOJ Places Website Rulemaking on the “Inactive” List

by Seyfarth Shaw LLP on

Seyfarth Synopsis: Trump Administration’s first Unified Agenda reveals DOJ has placed web accessibility, medical equipment, and furniture rulemakings under Title II and III of the ADA on Inactive List....more

Don’t give medical device makers more time before disclosing product woes

Pro-business and anti-consumer lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed...more

UK: The Biggest Shake Up of Employment Law in a Generation?

by Littler on

On July 11, 2017, the UK government published the Review of Modern Working Practices. The report was issued by Matthew Taylor, chief executive of the Royal Society of Arts and a former policy chief to Tony Blair. Current...more

President Trump Changes Course On Joint “Cyber Security Unit” With Russia

by King & Spalding on

On Sunday, July 9, 2017, coming out of the G20 Summit during which President Trump had met with Russian President Vladimir Putin for over two hours, Trump tweeted that he and Putin “discussed forming an impenetrable Cyber...more

DSM Watch: On your marks! Deadline for EU online Portability Regulation compliance is 20 March 2018

by Hogan Lovells on

In our 21 June blog we reported that the text of this, the first legislative proposal published by the Commission under the Digital Single Market strategy banner, had been finalised by the European Parliament and Council. ...more

CETA Draft Regulations Published on Patent Linkage and Term Restoration – 15 Day Public Comment Period

by Smart & Biggar on

The government has published the long anticipated draft regulations regarding: - changes to the Patented Medicines (Notice of Compliance) Regulations [“PMNOC Regulations”], and - proposed Regulations to implement...more

It’s That Time of Year Again: How Congress’ Proposed FAA Reauthorization Bills Could Impact the Commercial Drone Industry

by Hogan Lovells on

In the last few weeks, both houses of Congress have released draft FAA Reauthorization bills to continue FAA funding which runs out this fall. While the House bill’s proposal to privatize air traffic control in the United...more

Florida Enacts Law to Keep Local Governments from Regulating Drones

On July 1, 2017, a new law in the State of Florida became effective in order to keep “local governments from regulating drone and model aircraft operations” in the State, while in turn, “protecting those who fly safely and...more

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

A Federal Cyber Security Law Coming Your Way?

by Miles & Stockbridge P.C. on

On Thursday, June 29, 2017, Sens. Hatch and Markey introduced the “Promoting Good Cyber Hygiene Act” that would direct the National Institute of Standards and Technology (NIST) to establish a set of baseline voluntary best...more

Wrap-Up of Federal and State Chemical Regulatory Developments, July 2017

by Bergeson & Campbell, P.C. on

TSCA/FIFRA - EPA Releases Final Test Guideline For Performance Against Bed Bugs: On June 14, 2017, the U.S. Environmental Protection Agency (EPA) announced the availability of a final test guideline, Laboratory Product...more

Opportunity Foreclosed: The International Entrepreneur Parole Rule May Die Before it Gets Out of the Gate

The U.S. and worldwide entrepreneur community had been looking forward to July 17th with great anticipation. This was supposed to be the effective date of the new International Entrepreneur Parole immigration regulation....more

Is Telemedicine Change Coming to Congress? The Medicare Telehealth Parity Act of 2017 Among Several New Federal Bills

by Foley & Lardner LLP on

Congress is reconsidering a nationwide telehealth coverage bill, named the Medicare Telehealth Parity Act of 2017, designed to introduce an incremental, though significant, expansion of coverage for telehealth services under...more

Political Polarization in a Programmatic World

In an era of heightened political awareness and division, brands are more and more sensitive to the nature of the content where their online ads are displayed. In an era of ever-increasing dominance of programmatic...more

Supreme People’s Court Enhances Data Privacy Protection

In April of 2017, the Supreme People’s Court (“SPC”) and the Supreme People’s Procuratorate (“SPP”) passed and released a new judicial interpretation dealing with criminal infringement of citizens’ personal digital...more

Senate Passes Russia and Iran Sanctions Legislation

by Bass, Berry & Sims PLC on

On June 19, 2017, the U.S. Senate overwhelmingly passed a bill mandating sanctions against Russia and Iran and a 30-day congressional review period should the president attempt to reduce those sanctions....more

Giving Telemedicine More Room to Breathe: Recent and Pending State and Federal Actions in the World of Online Prescribing

On October 18, 2008, the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (the “Haight Act”) came into law as the federal government’s first attempt to address the public health risks associated with online...more

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Cybersecurity

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