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Eastern District of Wisconsin Grants Summary Judgment on Hip Component Manufacturer’s Negligence Claims But Denies Summary...

by Reed Smith on

Last week, like most weeks during the past year, we spent a lot of our time on airplanes. One of those trips fell on a day with “lots of weather.” All of our flights were delayed, although we were luckier than many. When we...more

Health Update - June 2017

HIPAA and Emerging Technologies - Editor’s Note: According to a HIMSS Mobile Technology Survey of healthcare provider employees, about 90% say they are using mobile devices to engage patients in their healthcare—and 36%...more

HHS Subjects Human Research to an Updated Common Rule

by Alston & Bird on

The Department of Health and Human Services has taken a step toward harmonizing the complex regulatory requirements for federal human subjects research. Our Health Care Group breaks down the changes to the Common Rule due to...more

The State AG Report Weekly Update

by Cozen O'Connor on

Charities- New York Attorney General Reaches Settlement with Breast Cancer Charity over Fraud Allegations- New York AG Eric Schneiderman reached a settlement with the Breast Cancer Survivors Foundation, Inc. (“BCSF”)...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

Indiana Reverses Course on Telemedicine Prescribing and Controlled Substances Laws

by Foley & Lardner LLP on

Indiana has taken another step towards expanding the meaningful use of telemedicine in connection with clinical services and prescribing. HB 1337, signed by Governor Eric Holcomb and effective July 1, 2017, will allow...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

The Past, Present, and Future of Government Regulation of Off-Label Communications – Part 3

This is Part 3 in my series exploring the history of FDA’s regulation of off-label communications, which has become newly relevant in light of the recent events highlighted in Part 1. In this installment, I continue...more

Outsourcing in the Pharmaceutical and Life Sciences Sectors – A UK Perspective

Pharmaceutical and Life Sciences companies operate in a demanding environment and face diverse challenges such as pricing pressure, increased regulatory requirements and mounting costs. With this backdrop, they have, starting...more

Healthcare Providers Beware: HIPAA Isn’t Your Only Concern Following a Data Breach–State Law Matters

by McGuireWoods LLP on

Healthcare service provider CoPilot Support Services (“CoPilot”) recently agreed to pay a $130,000 settlement after it waited over a year to notify patients of a data breach, in violation of New York’s breach notification...more

FDA Requires Reprocessing Validation Data for Certain Reusable Devices

by Hogan Lovells on

On June 9, 2017, the U.S. Food and Drug Administration (“FDA”) published a Federal Register Notice announcing that new 510(k) notices for a number of reusable medical devices will now require the support of validated...more

OIG Reports More Than $731 Million in Inappropriate Medicare Meaningful Use Payments

by McDermott Will & Emery on

The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US...more

Ninth Circuit En Banc Panel Holds that Central Hudson Survives Sorrell

by Reed Smith on

Last week we bashed a Ninth Circuit Daubert decision. We feel a little bit bad about that, not because the decision wasn’t bashworthy – no, Wendell really is a rotten precedent – but because we hate contributing to the...more

FDA to Create New Digital Health Unit

by Knobbe Martens on

The FDA has announced that it will create a new unit responsible for overseeing digital health products. According to Bakul Patel, the Associate Center Director for Digital Health at FDA, the agency is working to define...more

OFAC Enforcement Trends in the Health Care, Agriculture and Tech Industries

by Baker Donelson on

The United States Department of the Treasury's Office of Foreign Assets Control (OFAC), the U.S. governmental agency tasked with administering and enforcing economic sanctions against hostile targets in furtherance of U.S....more

MedPAC Takes Anti-POD Stance in Report to Congress, Echoing an Increasingly Uniform Consensus

by Ropes & Gray LLP on

On June 15, 2017, the Medicare Payment Advisory Commission (MedPAC), a non-partisan group that advises Congress on Medicare policy, released its annual Report to the Congress on Medicare and the Health Care Delivery System...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

FDA Commissioner Forecasts New, Modernized Digital Health Regulatory Framework

by Ropes & Gray LLP on

In his first public statement as Commissioner of the Food and Drug Administration (“FDA”) on the regulation of digital health technologies, Scott Gottlieb, M.D., signaled that FDA is contemplating significant changes. In a...more

Unfair and Unbalanced-Episode 20, Roy's Retirement Announcement Edition

by Thomas Fox on

In this episode, I visit with Roy Snell about his recent announcement that he is stepping down as head of the SCCE. We review the current state of the SCCE and how the Roy has seen the compliance evolve from its start after...more

Gottlieb Announces New Regulatory Paradigm for Digital Health Software

by Hogan Lovells on

Recognizing both the opportunities and the potential regulatory challenges presented by such rapid development, the FDA – under the leadership of recently confirmed Commissioner Dr. Scott Gottlieb – is spearheading a new...more

Health Alert (Australia) 19 June 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 9 June 2017 - Health Services Union v St John of God Health Care [2017] FWC 2981 - Alleged dispute arising under an enterprise...more

Rallying Cry: Health Care Cybersecurity a Key Public Health Concern

by Sedgwick LLP on

On June 2, 2017, the Health Care Industry Cybersecurity Task Force published its Report on Improving Cybersecurity in the Health Care Industry. The lengthy and comprehensive Report serves as a wake-up call to the medical...more

Breaking News - Bristol-Myers Squibb Slams The Door On Litigation Tourism

by Reed Smith on

The Supreme Court decided “the big one” today – and not to keep anyone in suspense [the big one is a major earthquake in California mass tort litigation], the result is that the California Supreme Court finding of personal...more

Cybersecurity Task Force Issues Report on Improving Cybersecurity in the Health Care Industry

by Dorsey & Whitney LLP on

The Cybersecurity Act of 2015 established the Health Care Industry Cybersecurity Task Force to respond to severe cyber-attacks within the rapidly-expanding information technology (“IT”) aspect of health care. Section 405(c)...more

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