Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All of this “big data” also have high value, not only for clinical trials, but also for further analysis and R&D to improve products.
But the process, regulation, and sensitivity of health care data itself is a serious concern. And that’s where the General Data Protection Regulation (GDPR) comes into play. Collection and processing of data is regulated by both the GDPR and, indirectly, by local public health regulations. To use the data and fully extract its potential value, it’s critically important to ensure that data collection, processing, and security is in compliance with the GDPR and local regulations.