Sarah Figueira, Clinical Trials Manager
For the highly-regulated medical device and pharmaceutical industries, the path to mitigating cybersecurity risks is strewn with challenges, given that threats and vulnerabilities are ever-present and cannot be completely eradicated. Medical devices now often find themselves tethered to the internet and hospital networks, harnessing patient data and providing innovative features to enhance healthcare and empower healthcare providers. Yet, these novel features also magnify potential cybersecurity risks. Like any computer system, medical devices can fall prey to security breaches, consequently affecting their safety and efficacy.
As companies stride toward digital transformation, they increasingly prioritize the secure transmission and storage of information. Safeguarding patient data and maintaining trial confidentiality amid remote environments have attracted attention from regulatory bodies such as the FDA, which has recently issued new guidance on cybersecurity. Non-compliance penalties linked to patient confidentiality and data integrity can pose a grave threat to clinical trial sponsors and their partners, attracting hefty fines that reach into millions from the U.S. Department of Health and Human Services (HHS).
The healthcare landscape is intricate, and a collaborative effort is essential from manufacturers, hospitals, and facilities alike to manage cybersecurity threats effectively. In this digital age, the importance of maintaining patient and trial confidentiality and ensuring data security has heightened significantly. There is no room for error when it comes to security, as the costs for sponsors could be astronomical. If you'd like to discover more about how RQMIS is committed to preserving the integrity of your clinical trials, contact us today.
