14 results

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Regulation

Posted on 08.11.2018

The fog of war: crunch time in the regulatory cycle

As I followed the 1,075 km cycling route starting at the Belgium coast and ending in Basel, Switzerland, along the Western Front line of the First World War, I began to consider the plight of soldiers and generals a century ago. For military leaders, it was impossible to have an overview of what was happening […]

By Ronald Boumans Senior Regulatory Consultant at Emergo

Health data can transform our lives – but must be used wisely
Ethics

Posted on 09.07.2018

Health data can transform our lives – but must be used wisely

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage,How to create and maintain an ethical culture,Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and […]

By Oba Adewunmi Legal Counsel at Verily Life Science

GMTCC2018-Twitter-Card2
Ethics

Posted on 26.03.2018

Swifter, Higher, Stronger: Promoting MedTech Ethics on the Global Stage

This blog is part of the GMTCC 2018 blog series. You can follow the conversation under #GMTCC and find more details and at gmtcc.com. Check out related blogs: How to create and maintain an ethical culture, Global Responsibility, Global Ethics and Compliance, Global Principles for MedTech Innovation, Progress and new challenges after 10 years of collaboration, Distributors play key role […]

By Christopher White General Counsel, AdvaMed

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Ethics

Posted on 26.04.2017

Two Major Privacy Challenges Facing Medtech Companies

I recently sat down with Peter Blenkinsop, a Partner at DrinkerBiddle, an expert on data privacy and one of the panelists at our upcoming GMTCC Conference (Amsterdam, May 3-4), to get his take on the biggest privacy law challenges currently facing Medtech companies. Peter pointed to two trends that are changing the Medtech sector and provided insight on how privacy […]

By Christopher White General Counsel, AdvaMed

dataprotection
Access Regulation

Posted on 29.01.2014

“Harmonised” data protection in the EU: a new barrier to patient access to medtech?

In Europe, health data are considered so sensitive that processing them is generally prohibited in the EU, unless that processing follows specific guidelines. For example, the prohibition does not apply when sharing data is essential to providing healthcare, where those data are handled by a Healthcare Professional (HCP) subject under national law and subject to professional secrecy laws. With the rapid growth in diversity of medical technologies though, more and more medtech companies are processing health data on behalf of HCPs. 

By Chantal Vets Senior Legal Director, Medtronic