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Cuba Si! Trade With Cuba … Not Quite Yet

There has been much fanfare surrounding the reestablishment of diplomatic relations with Cuba, starting with President Obama’s announcement of the resumption of bilateral relations, and followed by the formal establishment of...more

Federal Data Breach Bill Stalled in Congress

A key distinguishing feature of U.S. data privacy laws is their patchwork nature. There are industry-specific data privacy laws at the federal level (think HIPAA or the GLBA), yet there are no comprehensive federal standards...more

Oregon Amends Data Breach Law — Companies Can Expect More Enforcement Actions

Oregon Gov. Kate Brown recently signed into law amendments to the state’s data breach law. These amendments recognize the growing definition of data, expand the role of the Attorney General in addressing data breaches,...more

21st Century Cures Act – Provisions Relating to Digital Health: Interoperability and Information Blocking

On July 10, 2015, the House of Representatives approved the 21st Century Cures Act (HR 6) (the “bill”) by a vote of 344-77. In addition to increasing medical research funding and expediting the process of making breakthrough...more

Cures Are on the House: House Passes 21st Century Cures Act, but Senate Awaits

On July 10, 2015, the House of Representative passed H.R. 6, the 21st Century Cures Act (“Cures Act”), with strong bipartisan support, by a vote of 344-77. This medical innovation reform legislation represents the culmination...more

Medicare, Medicaid, and Enforcement Implications of the 21st Century Cures Act Recently Passed by the House

On July 10th, the U.S. House of Representatives passed the 21st Century Cures Act – medical innovation reform legislation that has been in the works for over a year – by a wide margin (344-77). As Ropes & Gray previously...more

Small Business Committee holds hearing to explore commercial drone operations

On Wednesday, July 15, the House Committee on Small Business (the Committee) held a hearing, titled “Taking Flight: Small Business Utilization of Unmanned Aircraft,” aimed at exploring small business use of drones. The...more

Arnall Golden Gregory Series Explains Provisions in the 21st Century Cures Act

On July 10, 2015, the House of Representatives passed the 21st Century Cures Act by a vote of 344-77. The bill is intended to promote drug and device development, support research and expedite patients’ access to new...more

Debate over the Exclusivity Period for Biologics in the Trans-Pacific Partnership

A group of Democratic lawmakers and advocacy organizations criticized protections for brand-name biologics in the current draft of the Trans-Pacific Partnership, or TPP, a free-trade agreement among a dozen Pacific Rim...more

Georgia Senator Introduces The Combination Product Regulatory Fairness Act of 2015

On July 17, 2015, Georgia’s U.S. Senator Johnny Isakson (R-GA), along with co-sponsors, Robert Casey (D-PA), and Pat Roberts (R-KS), introduced a Senate bill entitled, “The Combination Product Regulatory Fairness Act of...more

White House Provides Update on 2015 Cybersecurity Initiatives

On July 9, the White House released a fact sheet regarding the Administration’s 2015 cybersecurity efforts “both domestic and international, to improve our cyber defenses, enhance our response capabilities, and upgrade our...more

State Breach Notification Laws – Updates From the 2015 Legislative Sessions, 6 Action Steps for Companies

This is proving to be a banner year for new breach notice requirements. In the period between 2006 and 2009, most US states enacted data breach notice laws. This year, we are seeing a wave of “second-generation” breach notice...more

Washington Healthcare Update

This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more

State Attorneys General Ask Congress Not To Preempt Breach Notification Laws

In the wake of recent, large-scale data breaches, several pieces of legislation have been introduced in Congress to establish a national data breach notification law, including a House bill that would preempt the current...more

White House Releases Proposed Precision Medicine Initiative Privacy Framework

Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each...more

Connecticut Updates its Data Security Laws, Imposing Stringent New Requirements

On June 30, 2015, the Governor of Connecticut signed into law S.B. 949, “An Act Improving Data Security and Agency Effectiveness." The new law updates Connecticut’s data security laws, including by adding a 90-day hard...more

Food Labeling, Food Safety & Nutrition - July 2015

The Obama Administration’s robust use of executive authority on issues related to food labeling, food safety, and nutrition continue to position these issues as a priority for the remainder of the President’s term in office....more

Alert: Is an Innovation Box Coming to the US?

United States lawmakers are facing increasing pressure from technology and life science industry leaders to adopt an "innovation box" regime to level the playing field with foreign counterparts and prevent significant US job...more

Rand Paul And The Expiration Of The Patriot Act

During the last weekend in May, Kentucky Senator Rand Paul did something that is not easy to do – he managed to anger most Republicans and Democrats, the Senate Majority Leader (who is also the senior senator from Kentucky),...more

A significant milestone in the path towards the adoption of the General Data Protection Regulation

On 15 June 2015, the Ministers of the Council of the European Union (the "Council") agreed upon a global approach to the European Commission's proposal for a Regulation of the European Parliament and of the Council on the...more

NAAG Urging Congress to Refrain From Passing Federal Data Breach Legislation Preempting State Authority

On July 7, as Congress considers proposed legislation on data breach notification and security, the National Association of Attorneys General (NAAG) sent a letter to leaders of both houses of Congress urging them to refrain...more

GMOs in the Hotseat: White House to Overhaul Regulatory Framework on Biotechnology

Last week, the White House waded into the GMO regulatory fray with the Office of Science and Technology Policy’s (OSTP) announcement of a major overhaul of GMO regulation. In a statement released July 2, OSTP noted that...more

State Attorneys General Tell Congress: “Back-Off Our Data Breach Authority”

Every week, we learn about new data breaches affecting consumers across the country. Federal government workers and retirees recently received the unsettling news that a breach compromised their personal information,...more

Revamped Telehealth Bill Referred to the House and Energy Commerce Committee and the House Committee on Ways and Means

On July 7, 2015, U.S. Reps. Mike Thompson, Gregg Harper, Diane Black, and Peter Welch announced the introduction of a new version of the July 2014 telehealth legislation (H.R. 5380) called the Medicare Telehealth Parity Act...more

TSCA Reform: House Passes TSCA Modernization Act: Senate to Consider TSCA Soon

On June 23, 2015, the House passed the TSCA Modernization Act of 2015 (H.R. 2576) by a vote of 398-1. The House Committee on Energy and Commerce issued a press release on June 22, 2015, noting that the bill "would bring...more

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