And you thought HIPPA was tough

Apparently, pharma companies, CROs, and universities will have new EU privacy rules to contend with in about eight months. Great. The EU’s General Data Protection Regulation (GDPR) applies to all types of data, but it will have a special impact on clinical trials. According to Debra Diener, an attorney and Certified Information Privacy Professional. “Sensitive data now includes, under this regulation, genetic data, biometric data, that is a broader set of data than is covered by HIPAA.” InsightCity has to ask, if you’re a US-based pharma company or CRO, why conduct trials in Europe, why risk it? That said, the informed consent process definitely needs an overhaul. The GDPR indicates the IC must be unambiguous, with affirmative action by the individual. Hard to argue with that. So, sharpen your regulatory pencils and get ready.

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