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EMA Calls for Public Consultation on Clinical Trial Protocol, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

June 2017 The EMA has opened for public consultation a draft guideline for the notification of serious breaches of the Clinical Trial Protocol (Regulation (EU) No 536/2014)...more

EMA Green Lights New EudraVigilance System for Adverse Reactions, Pharmaceutical & Medical Device Update, Vol. IV, Issue III

by Jones Day on

On May 22, 2017, the European Medicines Agency ("EMA") announced the full functionality of the new EudraVigilance system for the collection and monitoring of suspected adverse reactions with medicinal products that are...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

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

The New EU Regulation on Medical Devices Aims at Enhanced Product Safety and Further Harmonization

by McDermott Will & Emery on

On May 5, 2017, the new Regulation on Medical Devices (MDR) and the new Regulation on In Vitro Diagnostics (IVDR) have been published in the European Official Journal. The Regulations will become effective 20 days after...more

Guest Post – Come Together: Is UK Product Liability Law Getting More Like the U.S.?

by Reed Smith on

This guest post – only our second post ever on European issues is brought to you by Reed Smith partners Marilyn Moberg and (in the UK) associate Bond, Kathryn Bond (sorry, couldn’t resist). Our previous (and only) foray into...more

French Companies Must Show Duty of Care for Human and Environmental Rights

by Morgan Lewis on

After the Constitutional Court rendered its recent decision on the law regarding the duty of care of parent companies and ordering companies, the rule has finally entered into force—but is it much ado about nothing?...more

Implications of Brexit for the mining and minerals sectors

by DLA Piper on

The debate surrounding Britain’s proposed exit from the EU (Brexit) has primarily focused upon its potential impact on the British economy, Britain’s international standing and its capacity for self-governance. This article...more

European General Data Protection Regulation to Apply from May 2018

by McDermott Will & Emery on

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

EU Reaches Deal on New Medical Device Regulations

by Knobbe Martens on

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

by Dentons on

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

Tobacco Cases Expose Tension Between Antitrust and Public Health

A recent decision of the European Court of Justice (“ECJ”) regarding the sale of tobacco products highlights a long-standing tension between two sets of laws: antitrust/competition laws, which seek to keep products affordable...more

Data Transmission, Personalized Medicine, and Privacy

by Foley & Lardner LLP on

Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of...more

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

by King & Spalding on

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

The Department of Justice is Committed to Protecting Consumers from “Bad Medicine”

by Arnall Golden Gregory LLP on

Last month, the Acting Associate Attorney General Stuart F. Delery, announced that the Department of Justice (DOJ) would continue to target illegitimate online pharmacies, which pose a threat to drug safety and undermine...more

Enbrel Biosimilar in Europe and US

On November 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion, recommending marketing authorization of Benepali, the first biosimilar of Enbrel...more

Health Care E-Note - October 2015

by Burr & Forman on

For health care professionals who began accepting Meaningful Use incentive money at the outset of availability under the Medicare option in 2011, the year 2015 is an important year. By starting early, eligible health care...more

Data-Harvesting Zombie Hackers, Blood-Thirsty Auditors, and Other Reasons to be Scared on Halloween

This Halloween, the scariest monsters might not be in your closet or under your bed. They may be overseas, orchestrating intrusions into your electronic medical record. Or they may be lurking in your own workforce, carrying...more

Data privacy in the Americas - At a glance

by FordHarrison on

As multinational employers are aware, data privacy laws can vary greatly from jurisdiction to jurisdiction. Ensuring compliance with the different requirements can be challenging, and the penalties for noncompliance can be...more

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

by Foley & Lardner LLP on

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

European Commission Seeking Comments On Draft Text Laying Out The Safety Features To Appear On Pharmaceutical Packaging

by McGuireWoods LLP on

On 12 August 2015, the European Commission published its long awaited discussion draft of the European Union Delegated Act (EUDA) addressing safety features to appear on the outer packaging of medicinal products for human...more

Privacy Tuesday – August 2015: Three Bytes for End of Summer

It’s Privacy Tuesday again – and summer is winding down. Here are three bytes of privacy/security information to start your week...more

Privacy Tuesday - January 2015

Good Tuesday – The East Coast prepares for Apocalypse (Sn)ow. In the meantime, here are three privacy-related tidbits for your day. Privacy Concerns Cause Scale Back of Release of HealthCare.gov Data - We...more

Ensuring Data Protection In The Implementation Of The EFPIA Disclosure Code: Key Challenges And How Pharmaceutical Companies Are...

by Allen & Overy LLP on

The EFPIA Disclosure Code will, from 2016, require pharmaceutical companies to disclose details of payments and transfers of value made to healthcare professionals and healthcare organisations. The Code aims to promote,...more

Realizing the Potential of Telemedicine in China, Part 2: Data Privacy and Security

by Foley & Lardner LLP on

The Chinese market presents a tremendous opportunity for U.S. hospitals and providers, as long as the intricacies of data privacy and security issues are thoroughly understood. This includes Chinese regulations regarding...more

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