http://faegrebdc.com/articles Published Articles From FaegreBD Consulting en-us Copyright 2000-16 FaegreBD Consulting. All Rights Reserved. http://blogs.law.harvard.edu/tech/rss 11/28/2016 2:43:38 AM In an article for Law360, FaegreBD Consulting counsel Andrew Wheeler and advisor Nik Schoenherr shared how recent interest in the Public Utility Regulatory Policies Act (PURPA) could bring about changes by the Federal Energy Regulatory Commission... http://faegrebdc.com/purpa-changes-could-shake-up-clean-energy-market 06 Sep 2016 00:00:00:000 Studies show that half of the medicines sold online are counterfeit, and there are nearly 35,000 online drug sellers, 97 percent of which operate illegally. The Alliance for Safe Online Pharmacies – Global (ASOP Global), founded by FaegreBD... http://faegrebdc.com/internet-pharmacy-safeguards-we-salute-you 11 May 2016 00:00:00:000 On April 4, CMS published its annual Call Letter for the Medicare Advantage and Part D programs. In it, CMS shared its intention to “aggressively identify and pursue instances of non-compliance” with provider directory accuracy standards. This... http://faegrebdc.com/regulators-react-to-debate-over-narrow-networks 02 May 2016 00:00:00:000 When it goes into effect, the Trans-Pacific Partnership Agreement (TPPA) will bring together nations comprising nearly 40 percent of the world’s economy, making it the largest regional trade agreement ever. However, as FaegreBD Consulting senior... http://faegrebdc.com/several-factors-could-stand-in-the-way-of-the-tppas 23 Mar 2016 00:00:00:000 The Trans-Pacific Partnership (TPP) trade agreement promises to increase demand for U.S. agricultural products in markets throughout the world—but Congress has to approve it first. In an article published in Feed & Grain, FaegreBD Consulting senior... http://faegrebdc.com/grains-see-gains-from-tpp 08 Mar 2016 00:00:00:000 Internet access is essential to all elements of social participation, and it can have a particularly positive impact on rural communities. In an article published in Law360, FaegreBD Consulting principal Andy Ehrlich and director Josh Andrews... http://faegrebdc.com/broadband-challenges-remain-for-rural-communities 20 Jan 2016 00:00:00:000 The Office of the U.S. Trade Representatives recently included Rebel, a Canadian online domain register known as a “safe haven” for illegitimate Internet pharmacies, on its 2015 Notorious Markets List. In an article published in CircleID.com, Libby... http://faegrebdc.com/cheers-registries-and-registrars-doing-the-right-thing-by-patients 07 Jan 2016 00:00:00:000 As Congress continues debating 21st Century Cures and related medical Innovation legislation in the Senate and the Food and Drug Administration and industry continue to negotiate the next round of prescription drug user fees, a recurrent theme in... http://faegrebdc.com/what-does-the-future-hold-for-patient-focused-drug-development 08 Oct 2015 00:00:00:000 Today, health plans are doing all they can to hold down premiums against a backdrop of aging members and increasingly expensive therapies, particularly biologics and other specialty drugs. A widely used cost containment method is narrowing provider... http://faegrebdc.com/narrow-network-health-plans-new-approaches-to-regulating-adequacy-and 08 Oct 2015 00:00:00:000 For women seeking support and solutions when dealing with infertility, the Internet can be a great resource. It can also bring patients into contact with illegal online “pharmacies” selling treatments that are counterfeit, dangerous or both. In an... http://faegrebdc.com/infertility-and-the-age-of-the-internet 18 Aug 2015 00:00:00:000 The United States and the European Union are the world’s largest economies, accounting for more than 40 percent of world trade. The Transatlantic Trade and Investment Partnership (TTIP), a series of trade negotiations that were mandated for... http://faegrebdc.com/ttip-eu-and-us-perspectives 18 Jun 2015 00:00:00:000 FaegreBD Consulting principal and former Congresswoman Mary Bono co-authored an op-ed for USA Today on the growing epidemic of prescription painkiller abuse in the U.S. Bono—along with co-authors retired Major General Arthur T. Dean, CEO of... http://faegrebdc.com/when-painkillers-kill 11 Jun 2015 00:00:00:000 The U.S. Supreme Court will soon rule on King v. Burwell, deciding whether federally run health insurance exchanges can legally offer subsidies and tax credits to limited-income enrollees. If the Court ends this financial assistance, healthy people... http://faegrebdc.com/after-king-v-burwell-viable-exchanges-are-acas-next-challenge 05 Jun 2015 00:00:00:000 The Food and Drug Law Institute (FDLI) has released a new version of the book Bringing Your Pharmaceutical Drug to Market. Ralph Hall, counsel in Faegre Baker Daniels' health care and FDA group, co-published the book. Nick Manetto, FaegreBD... http://faegrebdc.com/bringing-your-pharmaceutical-drug-to-market 04 Jun 2015 00:00:00:000 The U.S. Department of Energy released its Quadrennial Energy Review on April 21, 2015, which includes a series of recommendations to upgrade the country’s aging energy infrastructure (from our natural gas infrastructure to rail and fleets)... http://faegrebdc.com/a-bipartisan-bill-on-energy-policy 08 May 2015 00:00:00:000 FaegreBD Consulting principal and former Congresswoman Mary Bono authored an article for The Hill on the United States’ renewable energy strategy. Bono explained that though people have been able to fill up their gas tank at around $2 per gallon... http://faegrebdc.com/is-renewable-energy-part-of-the-all-of-the-above 19 Mar 2015 00:00:00:000 News of data breaches have become commonplace as our society and economy increasingly move towards technology to help citizens and companies manage accounts and organize and store information. FaegreBDC senior director Kathleen Rice, who was former... http://faegrebdc.com/data-breach-no-company-immune 17 Mar 2015 00:00:00:000 On Jan.29, 2015, the U.S. Senate passed S. 1, the Keystone XL Pipeline Approval Act, by a vote of 62-47, with all Republicans and eight Democrats voting for the legislation. While the president pledged to veto the legislation, the debate over the... http://faegrebdc.com/keystone-xl-will-shape-energy-debate-for-114th-congress 11 Feb 2015 00:00:00:000 In January 2015, after almost a year of hearings and events throughout the U.S. to garner interest and input from key stakeholders, the U.S. House Energy and Commerce Committee released its first draft of its 21st Century Cures package. FaegreBD... http://faegrebdc.com/can-congress-coalesce-around-the-21st-century-cures-bill 06 Feb 2015 00:00:00:000 In the wake of several high-profile cyber-attacks in the U.S., President Obama has announced a need for nationalized regulations on companies exposed to data breaches. Business leaders largely support such legislation as they could focus on a single... http://faegrebdc.com/the-need-for-a-national-data-breach-notification-law 20 Jan 2015 00:00:00:000 In November 2014, the U.S. Environmental Protection Agency announced that it would again delay the release of a final rule on the 2014 Renewable Fuel Standard volumetric blending requirements. Andrew Ehrlich, David Lyons and Andrew Wheeler of... http://faegrebdc.com/epa-delay-on-renewable-fuel-puts-ball-in-congress-court 12 Jan 2015 00:00:00:000 Former congresswoman Mary Bono is senior vice president at FaegreBD Consulting where she leads a technology, privacy and cybersecurity practice. In an article authored for The Hill, Bono details the importance of building a nationwide interoperable... http://faegrebdc.com/lets-get-firstnet-right-now 06 Jan 2015 00:00:00:000 Congress has responded to fears from employers over the theft of trade secrets by proposing legislation to address the issue on a federal level, rather than leaving lawmaking up to the states, which has been the historical approach to trade secret... http://faegrebdc.com/inside-pending-federal-trade-secrets-legislation 10 Dec 2014 00:00:00:000 New big data programs in the agricultural sector have raised a number of privacy concerns among farmers about the types of information being collected and how that information is being used. In an article authored for Food & Drink, FaegreBD... http://faegrebdc.com/is-there-room-for-privacy 13 Nov 2014 00:00:00:000 In the wake of high profile cyber-attacks targeting retailers and banks, pressure is on Congress to pass legislation addressing this problem before the next big cyber-attack occurs. Kathleen Rice, Mary Bono and Robert Ehrich of FaegreBD Consulting... http://faegrebdc.com/congress-must-pass-cyber-legislation-before-next-attack 06 Nov 2014 00:00:00:000 Patient advocates in Washington have faced tough times over the past few years. Tight federal budgets and limits on legislation for specific conditions have been frustrating for patient advocates, but signs indicate that change is coming as... http://faegrebdc.com/are-brighter-days-ahead-for-patient-advocates-in-washington 18 Sep 2014 00:00:00:000 In March 2014, the Environmental Protection Agency (EPA) released guidance on steps to reduce methane gas emissions. The EPA guidance document noted that methane accounts for an estimated nine percent of greenhouse gas emissions and is far more... http://faegrebdc.com/as-climate-changes-so-does-focus-on-methane-emissions 08 Sep 2014 00:00:00:000 Little progress has been made on the Transatlantic Trade and Investment Partnership (TTIP), the proposed free trade agreement between the U.S. and the European Union, following the most recent round of negotiations in Brussels. The fact that... http://faegrebdc.com/whats-the-hold-up-in-the-us-fast-track-presidential 08 Aug 2014 00:00:00:000 Ralph Hall of FaegreBD Consulting discussed the advent of the International Medical Device Regulators Forum (IMDRF) and analyzed its potential for playing a significant role in the marketplace in the March 2014 issue of BioFutures (page 24), the... http://faegrebdc.com/the-new-regulator-the-rise-of-imdrf 25 Apr 2014 00:00:00:000 FaegreBD Consulting vice president Nick Manetto and public policy specialist Allison Durham wrote an article appearing in Law360 explaining the ways the government shutdown is affecting health care policy. With the shutdown in its third week, the... http://faegrebdc.com/govt-shutdown-impacts-health-care-edition 15 Oct 2013 00:00:00:000