International Trade Health Communications & Media

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Health Company Fined by UK’s Information Commissioner Office

Last week, the UK’s Information Commissioner’s Office (ICO) published a monetary penalty notice which fined a private healthcare company, HCA International, £200,000 for its failure to keep sensitive data secure....more

Restrictions on Advertising with Nutrition and Health Claims Apply to Both Communications Addressed to Consumers and to...

The Court of Justice of the European Union (ECJ) held that the restrictions on promoting foodstuffs with nutrition and health claims not only apply to communications addressed to the general public but also to communications...more

Borderline products: Marketing food supplements in the UK following the glucosamine case

In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of...more

Privacy and Data Security: 2017 Year in Preview

Few issues keep executives awake at night more than Privacy and Data Security. New regulations and threats alike are plentiful, varied, and evolving. The rate of change for cybersecurity and information governance continues...more

Post-Election Outlook: A New, Unpredictable World

In a shock to investors and political analysts around the world, Donald J. Trump won the 2016 Presidential election, putting the Republican Party in charge of the White House and Congress for the first time in a decade. Even...more

Review of International Regulation of Social Media Promotions at the 2016 RAPS Conference

The Regulatory Affairs Professionals Society (RAPS) held its annual Convergence conference last week in San Jose. The event certainly illustrated RAPS’s global influence given that the attendees represented many of the...more

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Top Takeaways from IAPP

The world of privacy grows every day as more data goes through the cloud. The new trends and weekly data breaches make conferences like the Global Privacy Summit all the more relevant. Earlier this month we went to...more

FCPA compliance and Ethics Report-Episode 249-Reflections on Cuba, with Adam Turteltaub [Video]

In this episode, I share some reflections and observations on Cuba with Adam Turteltaub who was coincidently on a tour in Cuba at the same time as myself. ...more

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare...more

Cuba: The Risks and Rewards for U.S. Businesses

Background - Last week, the Obama Administration announced that the President intends to visit Cuba next month. He will find a political mixed bag of optimism and resignation. American businesses will find an equally...more

Do the Restrictions on Advertising with Nutrition and Health Claims also Apply to Communications Addressed Exclusively to Health...

The Court of Justice of the European Union (ECJ) will soon decide on the issue of whether the restrictions on promoting foodstuffs with nutrition and health claims also apply to communications addressed exclusively to health...more

U.S. to China Health Care Arrangements: New Rules for Medical Institution and Service Advertisements

As U.S. hospitals and health care providers continue to explore China’s market for international health care business opportunities, including telemedicine, they often consider providing services or products to consumers...more

Telemedicine or just a gadget for fitness addicts? Mobile Health Apps and the law

Mobile health (mHealth) apps are becoming more and more popular. Back in 2013, more than 97,000 health apps were already on the market. According to the European Commission (EC), this figure now amounts to around 100,000...more

Medicinal Product Regulation and Product Liability in Australia: Overview

The Therapeutic Goods Act 1989 (Cth)(TG Act): - Provides a national framework for the regulation of medicinal products. - Provides a national system to control the quality, safety, efficacy and timely availability...more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

This post is the fourth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market....more

Focus on Regulatory Law - December 2014

In This Issue: - Regulatory Authorities - Energy - Public Economy Law - Contracts - Public Health - Comparative Law - Excerpt from Regulatory Authorities: French...more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...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

‘Country of Origin’ Compliance: The Top 10 Things Pharmaceutical Companies Need to Know

What is the “country of origin” for the drugs you manufacture? This question arises every time a pharmaceutical company labels a drug, imports it, exports it, markets it, or sells it to the U.S. government. Unfortunately, the...more

China Solicits Comments on Post-Market Study Guidelines

The Center for Drug Evaluation (“CDE”) in China recently published the draft Guidelines for the Administration of Post-Market Studies on Chemical Drugs and Therapeutic Biologics (“Draft Guidelines”) for public comments...more

China Life Sciences Health Industry Client Briefing – May/June 2013 (July 12, 2013)

Pharmaceuticals, Medical Devices, Health Care & Life Sciences - .. Medical Devices Regulations and News - Provincial FDAs to Approve Certain Changes to Medical Device Registration Certificates – June 21,...more

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