Case Study: W. L. Gore & Associates achieves swift regulatory approval for medical device studies with Privacy Analytics

W. L. Gore & Associates secures approval in months with Privacy Analytics

W. L. Gore & Associates Inc faced a challenge with Italian data protection authorities, who required proof that future patient data from two medical device studies would be properly anonymized after a 15-year retention period. After over a year of stalled progress, Gore engaged Privacy Analytics to help demonstrate how the anonymization of this not-yet-fully-generated data would be achieved to protect patient privacy and gain the necessary regulatory waiver.

Privacy Analytics implemented a novel solution using synthetic data, creating demographic profiles and modeling future health events to assess re-identification risks. This analysis formed the basis of a report that secured swift regulatory approval from the Italian authority. As a result, the studies resumed, ensuring compliance and allowing life-saving treatments to reach more patients. Privacy Analytics provided the expertise that enabled Gore to overcome this significant hurdle.

W. L. Gore & Associates Inc