The EU General Data Protection Regulation (GDPR) takes effect on 25 May 2018, bringing new challenges for US companies processing data on EU citizens. In recent years, the pharmaceutical and biotech industries have been hyper-diligent in protecting personal information of subjects involved in clinical research as well as post-marketing activities and all that comes with managing global organizations, products, advertising, and safety reporting. We have redacted, encoded, and safeguarded in what seems every way possible…but now there is more! Companies outside the EU that are targeting EU customers will be required to follow the GDPR, which gives strict guidance on the integrity, use, and procurement of personal data. With this, US companies will be challenged to protect private data on a broader and deeper level.
It is anticipated that small to mid-sized companies are the most vulnerable in terms of GDPR readiness. While regulators tend to understand the challenges of crossing every ‘t’ and dotting every ‘I’ just in time to comply with new regulations and guidance, there is little leeway when it comes to exposure of private/personal data these days. Even social media is feeling the squeeze -and those platforms don’t normally deal with sensitive patient health records.
The key impacts to US companies may expand org charts and shrink the wallet. You may need to hire a Data Protection Officer and your files just got fatter. More documentation will be required-remember, if it’s not documented, it didn’t happen. Informed consent is an R&D cornerstone of our industry; we aim to inform subjects and keep them safe. Now you may need consent that goes beyond R&D.
These items are the tip of the iceberg. Don’t get caught off guard! Join this live webinar to identify how the GDPR will impact your company, and how you can best strategize and execute solutions that will safeguard not only your research subjects and customers but also your employees and company.
At the completion of this session, you will be able to:
- Execute a gap analysis to identify how the GDRP will specifically impact your company
- Identify strategies for closing any gaps you have identified
- Determine how to best document your gap analysis and strategy to demonstrate your due diligence considering that all may not be in place by May 25th