International Trade Health

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Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

Health Alert (Australia) - 14 April 2014

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Reports: Queensland. Department of Health: - 1 April 2014 - Legislative change to address doctors’ concerns. The power of the Queensland...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

Health Alert (Australia) - 7 April 2014

In This Issue: Judgments; Legislation; and Reports. - Excerpt from Judgments: New Zealand 24 March 2014 - Wooton v Accident Compensation Corporation [2014] NZACC 77 [1]: This appeal concerns a treatment...more

Health Alert (Australia) - 31 March 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales - 4 March 2014 - Re JS [2014] NSWSC 302 - This was an application for declaratory relief made by the...more

The Elevator Speech Overview

The House and Senate were both in session this week, the President was traveling overseas. President Obama announced his backing for an overhaul of the NSA bulk phone data collection program, a plan that differs from the...more

Eye on Privacy Newsletter - March 2014

In this issue: - Kaiser Foundation Health Plan Settles California Attorney General Charges over Delayed Data Breach Notification - Status of the EU Regulation and the Safe Harbor Framework - FTC Steps...more

China Cracking Down On Pharmaceutical Corruption

Stricter Blacklist Regime - On December 25, 2013, the National Health and Family Planning Commission of China (“National Health Commission”, former Ministry of Health) issued the amended Provisions Regarding the...more

The Elevator Speech Overview

The House and Senate were both on recess this week. On Tuesday, the U.S. suspended the operations of Syria’s U.S. embassy and consulates as the Syrian civil war enters its fourth year. Also Tuesday, details of an NSA...more

How Much Are You Willing To Pay For Privacy?

How much are you willing to pay for personal privacy? 50% off a McDonald’s hamburger? 20% off groceries? Participation in the $1 Billion NCAA Tournament Bracket Challenge?...more

Your smartphone is NOT a medical device

Wearable technology issues relating to the potential qualification of such products as a medical devices have become popular on the press following the presentation of the first smartphone with a heart rate sensor, quickly...more

Health Alert (Australia) - 24 March 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Australia. Department of Health & Ageing - Media releases - 18 March 2014 - Latest PBS listings include medicines for...more

China Tightens Supervision and Enforcement in the Medical Device Sector

On March 13, 2014, the China Food and Drug Administration (the “CFDA”) announced an action plan titled “Rectifications of Five Common Types of Noncompliance Concerning Medical Devices” (the “Five Rectifications Campaign”). A...more

Health Alert (Australia) - 10 March 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: REPORTS: Australia. Department of Health & Ageing - - 6 March 2014 - Keynote address to the general practice...more

Avoid the Anti-Corruption “Blacklist:” Chinese Agency Guidance

On March 1, 2014, Circular No. 50, which the Chinese National Health and Family Planning Commission (NHFPC) recently promulgated to regulate the conduct of pharmaceutical and medical device companies that do business in...more

Privacy and Security Becoming More Increasingly Critical

Privacy and security continue to be critical considerations for all businesses. While such considerations in the healthcare industry have received a lot of attention over the past years with the increasing requirements under...more

National Cybersecurity Framework Released - Has Your Organization Considered the Implications?

On February 12, 2014, the National Institute of Standards and Technology ("NIST") released the final version of its Framework for Improving Critical Infrastructure Cybersecurity (the "Cybersecurity Framework" or "Framework")...more

China Solicits Comments on Good Supply Practices for Medical Devices

The China Food and Drug Administration recently published a draft regulation setting minimum standards for medical device distribution. The regulation sets forth requirements for procurement, delivery acceptance, storage,...more

China Compliance Update: Commercial Bribery Risks Remain Very Real in China

The enactment of new legislation, as well as new and continuing investigations, demonstrates that Chinese regulators have not slowed down their efforts to ferret out corruption in the pharmaceutical sector and related...more

Democratic House Leadership Does Not Want TPP to Undermine Public Health

Last month, in a letter sent to the U.S. Trade Representative, Ambassador Michael Froman, five Representatives reiterated the importance of incorporating the 2007 Bipartisan Agreement on Trade Policy into the Trans-Pacific...more

China Releases Fast Track Approval Process for Innovative Medical Devices

On February 7, 2014, the China Food and Drug Administration (“CFDA”) promulgated a notice titled The Fast Track Approval Process for Innovative Medical Device (Tentative), effective as of March 1, 2014. Unlike the draft...more

Healthcare Enforcement Actions and Trends: 2013 Overview

The Department of Justice (DOJ) and the Office of Inspector General for the U.S. Department of Health and Human Services continued aggressive enforcement of the healthcare industry in 2013. Officials employed a variety of...more

Will Your New Gold, Silver, or Bronze Health Plan Cover Your Care if You Travel to Sochi for the Winter Olympic Games?

Snowboarders flying down halfpipes. Bobsledders careening down tracks. Goalies making glove saves. Those are just a few of the spectacles to be seen at the 22nd Winter Olympic Games. Despite all the pomp and circumstance...more

Health Alert (Australia) - 10 February 2014

In This Issue: Judgments, Commentary, Legislation, and Reports. Excerpt from Commentary: Australian Professional Indemnity Blog - 3 February 2014 - Western Australia (WA) disciplinary tribunal...more

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