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Behind the Curtain: Shkreli was NOT the Big Story on the Hill Today

Congress’s complex relationship with prescription drugs was on display today in the House of Representatives. In the House Committee on Oversight and Government Reform (OGR), Martin Shkreli pleaded the 5th at a hearing...more

Cybersecurity Act Of 2015 Aims To Bolster Cybersecurity In Health Care Industry

Section 405 of Title IV of the Cybersecurity Act is tailored specifically to cybersecurity matters affecting public and private health care entities. Section 405 of Title IV seeks to improve the cybersecurity landscape in...more

Safety of Both Devices and Drugs Need to Be Better Tracked, FDA Hears from Oversight Bodies

FDA lacks the appropriate data to effectively conduct postmarket surveillance and safety tracking activities, according to two reports released earlier this month. First, Senator Patty Murray’s Health, Education, Labor, and...more

Federal Spotlight Continues to Shine on Physician-Owned Distributorships

A recent Senate Finance Committee hearing investigated the effects of physician-owned distributorships (“PODs”) on costs of care and patient safety, suggesting that the momentum for greater oversight of such business...more

Omnibus funding bill creates healthcare cybersecurity task force

The $1.1 trillion spending and tax extender bill that is on President Obama’s desk awaiting signature creates a healthcare industry cybersecurity task force, which must be established within 90 days of enactment. This is...more

Washington Healthcare Update

This Week: Congress tries to put together a tax extender package, which may provide an opportunity for some Affordable Care Act changes... HHS releases final rule on bundled payment for Joint Replacement Comprehensive Care...more

FDA Commits to Moving Forward with LDT Regulation

Last Tuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration’s Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee’s Subcommittee on Health that...more

State Pharmaceutical Pricing Disclosure Laws: Old Story, New Refrain

As a veteran of the AWP litigation era, I am struck by the recent state efforts to legislate transparency into pharmaceutical pricing. Multiple states have introduced bills that would require pharmaceutical manufacturers to...more

Oregon Expands Data Breach Law

The modified law will expand the definition of personal information to include medical information and physical characteristics, and require notification to the state Attorney General. Businesses with customers in Oregon...more

Nevada and North Dakota amend state breach notification laws

Nevada has amended its breach notification law, effective July 1, 2015, to include a medical or health insurance identification number and a user name, unique identifier, or e-mail address in combination with a password or...more

Nevada Expands PI Definition under Data Breach Law

Becomes the fifth state to amend its data breach statute since January 2015 The definition of “personal information” (“PI”) just got a little bit bigger in the Silver State. On May 13, Nevada Governor Brian Sandoval signed...more

Legislation Proposed In New Jersey to Alert Patients to Out-of-Network Costs

On May 14, 2015, four New Jersey legislators introduced the Out-of-Network Consumer Protection, Transparency, Cost Containment and Accountability Act (the "Legislation"). If enacted, the Legislation would increase health care...more

North Dakota Focused on Privacy and Information Security; AG Wants to Know if You’ve Been Breached

Come August 1, North Dakota’s Attorney General will expect to hear from you if your company suffers a breach of computerized data affecting more than 250 persons. On April 13 North Dakota Governor Jack Dalrymple signed S....more

Surprise Bills Laws Enacted in California and New York

What Do They Mean for Providers? - Both California and New York have recently enacted so-called “Surprise Bills Laws” that require out-of-network providers to give notice to patients that a particular item or service...more

Wyoming amends data breach notification law

Continuing to add to the confusion surrounding provisions in 47 different state breach notification laws, Wyoming amended two laws last month which expand the definition of personal information requiring notification in the...more

U.S. House Committee on Agriculture - Mandatory Biotechnology Labeling Laws

Purpose - The purpose of this hearing was to examine the costs and impacts of mandatory biotechnology labeling laws. Members Present - Chairman Conaway, Ranking Member Peterson, and Representatives Davis (IL),...more

Tax Policy Update

NUMBER OF THE WEEK: $900 billion. The amount of additional taxes that would fall on businesses and families under Republicans’ budget plans, according to a “fact check” by the Associated Press in a story with a title made of...more

Montana Tweaks Data Breach Statute

The Big Sky Country’s data breach statute is going to see some small changes come October. On Feb. 27, 2015 Montana Governor Steve Bullock signed H.B. 74 into law, amending the state’s data breach notification statute. Among...more

News from the Health Law Gurus™

Millions Affected by Hackers’ Attack on Health Insurer Anthem, Inc. – “Anthem was the target of a very sophisticated external cyber attack,” announced Joseph Swedish, Anthem’s President and CEO. Anthem, Inc., formerly...more

Securing The Empire State: NYAG Proposes Tougher Data Breach Legislation

In the wake of the White House’s data breach proposal, New York Attorney General Eric Schneiderman announced his plan to propose new legislation to enhance New York’s data security regime. The NYAG’s January 15th press...more

New York Attorney General Announces Proposal to Revamp State Data Security Laws

On January 15, 2015, New York Attorney General Eric Schneiderman indicated that he plans to propose legislation to update New York’s information security laws, including by revising the definition of “private information”...more

Blog: Obama Advocates Federal Breach Reporting Law

On January 12, 2015, President Obama delivered a speech at the Federal Trade Commission during which he set forth several proposals, including the Personal Data Notification and Protection Act (the “Act”). ...more

Health Care Update - December 2014

In This Issue: - FDA Releases Menu Labeling Rule - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Upcoming Congressional Hearings - Excerpt from FDA...more

From Second and State: Capitol Wrap – Week of October 2014

As expected, this week blew through the Columbus Day holiday and into a flurry of legislative activity. Dozens of bills went back and forth between the chambers this week, and many have already landed on the governor’s desk....more

The Skinny on the White House Big Data Report

While the public debate on privacy has largely focused on how government, particularly the intelligence community, collects, stores, and uses data, President Obama earlier this year announced a comprehensive review of the...more

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