Regulatory Stress: Life Sciences Market Under the GDPR Regime

27 Mar 2018
by Nitish Mittal, Ritika Dhingra, Shrotima Wadhwa

The European Union General Data Protection Regulation (GDPR) will come into effect on May 25, 2018, superseding the existing 1995 EU Data Protection Directive (DPD). The new law, which will be passed into regulation in all the EU member states by the deadline, expands the rights of individuals to control how their personal information is collected and processed.

The GDPR regulations are expected to affect all industries but the impact on the life sciences vertical is likely to be relatively greater, owing to the large volume of complex sensitive data that is currently processed by relatively less mature IT systems. Each stakeholder in the life sciences ecosystem, comprising pharmaceutical firms, medical device manufacturers, CROs, and their complementary technology partners, faces its own set of impediments in complying with GDPR, and hence, can be expected to focus on its own unique and distinctive priorities in the run up to the GDPR deadline.

To understand the impact GDPR will have on the life sciences ecosystem, Everest Group looked at some basic questions such as:

  • Why GDPR is extremely relevant to the life sciences industry?
  • What impact will GDPR have on the life sciences ecosystem as a whole?
  • How each stakeholder in the ecosystem is likely to react to these new guidelines?
  • What are some of the steps already taken by organizations in a bid to become GDPR compliant?

Membership(s)

Healthcare & Life Sciences IT Services (ITS)

 

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