Youch! Anxious if people have not heard of this!
Almost by definition, if a product is a medical device in Europe, the data is health data under the GDPR. You need the right people identified and the right processes in place including special officers or contract services within the EU. Despite being an EU regulation, there are country to country differences as the agencies are different. The fines are potentially crippling for a large company as they are based on percentage of turnover. So talk to an EU lawyer, IT Specialist or RA Consultant that has been dealing in the issue. Happy to provide intros off line, but if you really have not heard of GDPR and hold personal or healthcare data in the EU or on EU citizens you really need to make this your #1 priority now!
Good luck!
Neil
------------------------------
Neil Armstrong FRAPS
CEO
MeddiQuest Limited
Peterborough
United Kingdom
------------------------------
Original Message:
Sent: 18-Jan-2018 18:26
From: Rashmi Pillay
Subject: The EU General Data Protection Regulation (GDPR)
Hi ,
Has anybody heard about this regulation? https://www.eugdpr.org/eugdpr.org.html
How can one comply with this requirement ?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
T + 61 8 7074 8105
E rpillay@ellex.com
W ellex.com
.............................................................................
One Powerful Vision.
Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document.