Technology and artificial intelligence are changing how sponsors and clinical research organizations (CROs) conduct their trials. Through their use, researchers can collect exponentially more data and analyze it more quickly and at deeper levels. However, for all of the benefits that Big Data and AI present, there are also risks. Digital threats exist in the form of hackers looking to corrupt data and steal patient information. Cybersecurity therefore needs to be top priority.
There is always room to improve your security systems. Follow these tips to make sure your patient data is protected.
By the time your data sets are ready for analysis, they have traveled through multiple web connections. As trials grow more decentralized and are increasingly outsourced, it is harder to map out each step in the data collection and submission process. However, someone on your team needs to be responsible for data path management.
“When you think about the entire, end-to-end data flow through the many clinical trial partners, you have to consider the Internet of Things (IoT) and data that is flowing from a lot of different devices,” says Doug Shaw, principal consultant at Halloran Consulting Group. “In decentralized trials, data may flow from WiFi as well as virtual private networks (VPNs), so trial sponsors also need data encryption.”
Identifying the flow of data can help sponsors and CROs find sources of risk, from public WiFi connections to unsecured data transfers.
Clinical trial vendors and suppliers are essential to completing your research. They are tremendous assets to help you work with patients effectively. Still, they can also be a liability. You need to make sure you are on the same page as your suppliers throughout the data collection and sharing processes.
“Urgently expand your understanding of third-party risk to consider second-and third-tier suppliers,” says Abel Archundia, managing director of Global Life Sciences and Industrials at cyber risk management company ISTARI. “Hold these global organisations accountable to improvement and highlight coaching and supplier-development opportunities.”
When everyone is working to improve the security of clinical trial data, both researchers and vendors can stop hackers from compromising your system.
An internet connection isn’t the only source of weakness for data sharing. Devices themselves can fall victim to malware or expose patient information if they are lost or stolen. When patients report symptoms on their smartphones or use take-home devices from clinical teams, their medical information is at risk.
“Increased use of mobile devices (e.g., smartphones, tablets, etc.) and wireless medical devices can create significant data security challenges for pharmaceutical companies,” explains Astrix Technology Group. “Companies should take steps to develop secure authentication for mobile devices, along with the ability to track and secure mobile devices remotely by locking or wiping out information.”
By using these digital security tools, any device that is compromised can quickly be wiped or locked to prevent additional data breaches.
As more information is collected and shared, it becomes harder for teams to track who has access to different documents or data sets. Maintaining control of your data and what can be done to it can help you prevent leaks, theft or abuse.
“Healthcare organizations can use data controls to block specific actions involving sensitive data, such as web uploads, unauthorized email sends, copying to external drives, or printing,” says Nate Lord, account manager at data protection platform Digital Guardian. “Data discovery and classification play an important supporting role in this process by ensuring that sensitive data can be identified and tagged to receive the proper level of protection.”
Data management goes beyond organization and analysis. It also means protecting the data and limiting who can access it.
It’s not enough to rely on HIPAA guidelines to protect your patients and their data. Hackers are constantly looking for ways to work around these restrictions and outsmart them.
“HIPAA compliance is not enough to combat all cybersecurity risks,” Incredible Health staff writes. “Many healthcare providers spend their time trying to meet HIPAA standards. At the same time, those protocols might not protect providers from immediate and severe threats.”
Your team needs to be proactive against new threats, not simply reacting to regulations issued by governing bodies.
Good security of clinical trial data is necessary throughout the entire process. This means it’s not just the IT department that needs to focus on protecting patient data. Every vendor, nurse, analyst, and patient can take steps to protect the integrity of the trial and its data. This is the only way to ensure the information stays safe.
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