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Brexit: what are the consequences for nutraceuticals?

Shock and awe: they did it! A few days after the United Kingdom voted to leave the European Union, many sectors are investigating the consequences thereof for the services and products concerned….
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The final text of the IVDR: first impressions

The IVDR text that the Council, Commission and Parliament reached agreement on is finally public (since 15 June). I’ve had the time to read it now. I am not going to draft…
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Medical devices and the #Brexit

Wow, while I was still working on wrapping my head around the hundreds of pages of final texts of the MDR and IVDR, the Brexit happened. Speaking of surprises – this was…
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Presentations Axon Seminar on the General Data Protection Regulation

Another well-attended seminar we hosted this week. Please find below links to the presentations: Erik Vollebregt, Axon Lawyers – GDPR Impact on Healthcare; Loes Markenstein, Dutch Data Protection Agency – DDPA’s assessment…
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Digitalisering patiëntgegevens uitbesteden?

De Autoriteit Persoonsgegevens heeft recent onderzoek gedaan naar het digitaliseren van patiëntgegevens door ziekenhuizen. Het komt vaak voor dat externe bedrijven worden ingeschakeld voor dergelijke klussen. Dat mag ook, maar omdat het…
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Axon seminar on General Data Protection Regulation

The EU General Data Protection Regulation (GDPR) text has been finalized and the regulation will enter into force soon, setting the legal framework for processing of personal data in the EU for…
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Dwaaldetectie

Onderstaand artikel is op 11 mei 2016 gepubliceerd in de nieuwsbrief van eGPO. ‘Tijdens het juridisch inloopspreekuur in de Zorginnovatiewinkel op 13 april werd aan mij (Sofie van der Meulen, Axon science based…
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Wearables Seminar Presentations

A lot of people turned up at this seminar on wearables and the regulatory, legal and commerical aspects. In case you were not able to make it, please find the presentations below:…
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Vulnerability disclosure: ENISA’s guide and the Dutch approach

Huge numbers of cyber attacks exploit vulnerabilities in computer-based systems and yet vulnerability disclosure is not a straightforward matter, as the discoverer of a vulnerability could face legal risk if they report…
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