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Health International Trade

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.

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

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

Update on Regulatory Compliance in the Global Health Care Industry

by Baker Ober Health Law on

A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

What Can We Tell About the Trump Administration’s Focus on Compliance?

There are a few early signs that the Trump administration will continue to hold companies to the “way of compliance,” as our colleague Jane Lewis-Raymond put it recently on this blog. But after the first four months of his...more

All or Nothing at All: Brexit Update for Life Sciences Companies

by Arnall Golden Gregory LLP on

A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more

“Fireball” Malware a Threat to Health Care Industry

A new report released by Check Point has security personnel working in the health care industry particularly concerned and they are warning their colleagues about the existence of “Fireball.”...more

Data Privacy + Cybersecurity Insider - June 2017

by Robinson & Cole LLP on

The American Institute of CPAs (AICPA), has released a risk management reporting framework intended to "establish a common, underlying language for Cybersecurity risk management reporting — almost akin to US GAAP or IFRS...more

Health and Science Projects in Iran

by Dentons on

The Iranian pharmaceutical and healthcare products market has had steady growth during the last decade. There have been significant improvements in living standards in Iran, in particular adequate access to healthcare...more

EMA accepts adalimumab biosimilar applications from Fujifilm Kyowa Kirin and Sandoz, and an infliximab biosimilar application from...

by Goodwin on

Two companies have announced that the European Medicines Agency (EMA) has accepted for regulatory review their Marketing Authorisation Applications (MAA) for proposed biosimilar candidates. Fujifilm Kyowa Kirin Biologics...more

(Un)Protected Health Information Held for Ransom

by Snell & Wilmer on

Recent experiences of major health care companies offer a reminder of the importance of data security and following a well-written policy for compliance with the HIPAA Privacy Rule....more

What’s New in Washington: 10 Things You Need to Know

Despite the headlines coming out of Washington, Congress continues to move forward in regular fashion, discussing and acting upon key issues, such as funding the government, addressing the need to raise the debt ceiling and...more

Recent Healthcare Data Breaches

by Revision Legal on

Healthcare computer systems harbor the most useful three pieces of personal identifying information that can be used for fraud and identity theft – names, Social Security numbers, and dates of birth. With these three pieces...more

European Competition Law Newsletter – June 2017

by McGuireWoods LLP on

EU Regulators Open Pharma Pricing Investigations Focusing on Abuse of Dominance - The European Commission and UK Competition and Markets Authority (CMA) have both opened new investigations into alleged abuses of...more

EMA Releases Informational Guide on Biosimilars for Healthcare Providers

by Goodwin on

The European Medicines Agency (EMA) and the European Commission have jointly released an informational guide on biosimilars for healthcare providers. The guide aims to inform healthcare providers about the benefits of...more

Rx IP Update - May 2017

by Smart & Biggar on

Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

Health Alert (Australia) 29 May 2017

by DLA Piper on

In This Issue: - Judgments; Legislation; and Reports. - Excerpts from Judgments: 12 May 2017 - White v State of Queensland (Central Queensland Hospital and Health Service) [2017] QIRC 41 - INDUSTRIAL LAW –...more

New European Medical Device Regulations Will Become Effective on May 25, 2017

by King & Spalding on

On May 5, 2017 the European Union legislator published Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - the EU-Medical Devices Regulations (MDRs) in the...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 9

by Clark Hill PLC on

Agriculture - Lawmakers to Introduce Organic Research Funding Bill: A bipartisan trio of House lawmakers were set to introduce legislation late May 16 that would boost Department of Agriculture funding for research into...more

Washington, D.C. Update – May 2017

by Baker Donelson on

April saw the debate in Congress heat up as Justice Neil Gorsuch was confirmed for a seat on the Supreme Court, House Republicans suspended, restarted and then ultimately succeeded in their effort to repeal and replace the...more

Global Inquiries into Drug Price Increases

European competition authorities announced this week an investigation into Aspen Pharmacare’s recent price hikes of five cancer drugs. The European Commission said in a press release that it had “information indicating that...more

Dr. Reddy’s to Install GE Healthcare’s FlexFactory

by Goodwin on

GE Healthcare announced today that Dr. Reddy’s will install GE Healthcare’s FlexFactory in Dr. Reddy’s facility in Hyderabad, India. According to the press release, “FlexFactory will help Dr. Reddy’s increase its capacity to...more

WannaCry Global Ransomware Attack

A global ransomware attack began early last Friday and has affected businesses and government entities in 150 countries, including Britain’s national health system, FedEx, Spain’s Telefónica, and the Russian Interior...more

Take-Aways from WannaCry

We have read multiple reports on WannaCry and if you are reading this and don’t know what WannaCry is, Google it for the background story. The clear message is this is not the last major attack we will see, and future attacks...more

Privacy Tip #88 – The Challenge of Keeping Up with Patches

Over the past week, many clients and individuals have asked me why some companies and health care facilities were devastated by the WannaCry ransomware, and why others made it through the weekend without a blink of an eye....more

The Pricing of Patented Drugs in Canada: Stakeholder Consultation Period Open Until June 28, 2017

by Smart & Biggar on

The Patented Medicine Prices Review Board (PMPRB) regulates the price of patented medicines in Canada by determining whether a price is excessive. The Board is revisiting its approach to pricing, and has now released a...more

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