Regulatory Open Forum

 View Only

  • 1.  General Data Protection Regulation GDPR

    Posted 04-Jul-2018 04:54

    Hello colleagues

     

    Recently the EU came up with the General Data Protection Regulation GDPR.

    This is similar to the FDA cybersecurity requirements.

    Has anybody responded to this requirements?

     

    Thank you,

     

    Yoram Levy, Qsite

    Israel

     

    Yoram

    Qsite Logo

    Qsite

    Tel (972)4 638 8837 Fax (972)4 638-0510

    Cell (972)52 279 2871

     



  • 2.  RE: General Data Protection Regulation GDPR

    Posted 05-Jul-2018 05:11
    GDPR is related to personal privacy is not the same as cybersecurity, at least from a medical product perspective. It has to do with how an entity uses personal data that is collected for whatever purpose. Its biggest impact is on clinical research and changes in the informed consent process and how data is managed by a sponsor. But, it impacts any entity that does business in the EC an collects any information on a person.

    In the US, there are several laws that serve to protect personal data, such as HIPAA, but none so far-reaching and restrictive as GDPR.

    ------------------------------
    Glen Park
    Jersey City NJ
    United States
    ------------------------------

    Original Message


  • 3.  RE: General Data Protection Regulation GDPR

    Posted 05-Jul-2018 11:25
    Yoram,

        I agree with Glen's comment, and would say that GDPR is mainly about privacy rights, and that includes cybersecurity obligations on those who wish to use data from EU citizens outside of the EU.  If you are in Israel, one thing you should know is that, prior to GDPR, Israel was one of around 12 countries that had been determined by the EU to have "adequate protection," meaning that the EU felt Israel's data privacy laws were enough to protect EU citizens data transferred to Israel.    See Adequacy of the protection of personal data in non-EU countries 

    Roger

    ------------------------------
    Roger Cepeda, JD, MBA, RAC
    MedTech Law LLC
    roger@medtech.law
    Mobile: 847-421-8361
    ------------------------------

    Original Message


  • 4.  RE: General Data Protection Regulation GDPR

    Posted 11-Jul-2018 15:34
    Cybersecurity and  Privacy are somewhat related as Cybersecurity breach may lead to a privacy risk, they may even share  risks in your RMF.
    Eventually Cybersecurity is associated with safety risk and GDPR/Privacy is a legal compliance risk.
    Anyway, the GDPR came into force in May, so yes, we have completed our gap analysis. 





    ------------------------------
    Adi Michaeli
    RA Specialist
    Burnaby BC
    Canada
    ------------------------------

    Original Message


Related Content