RWE Brings Data Privacy Concerns and Solutions

The use of real world evidence (RWE) has put a spotlight on data privacy and regulatory concerns. Regulatory expert Jackie Mulryne and former European Medicines Agency legal advisor Alexander Roussanov share their thoughts on essential steps for RWE studies, including deidentifying patient data and employing a transparent study design.

“It will be important to demonstrate to the regulatory authorities that robust controls have been put in place, with a clear design and analysis methodology, and that the accuracy and integrity of the data has been maintained.” Read more here.

(Source:  Jackie Mulryne and Alexander Roussanov, The Journal of mHealth, 9/29/21)