As healthcare services become increasingly interconnected, we can expect that medical devices may become targets for attack by cybercriminals. Stolen data presents an obvious threat to individual privacy, which alone is enough to cause concern. The medical device and healthcare industries need a proactive plan to combat cyberattacks that could compromise wireless devices' accuracy, safety and security.
While the need has been on the industry’s radar for years, regulatory action moves slowly compared to the development of new decryption schemes. Put simply, establishing cybersecurity standards for medical devices is remarkably complicated. Besides the usual IT challenges, medical devices are tightly regulated. Regardless, wireless protocols and standards are urgently needed to protect medical devices from data infringement and nefarious invaders.
The benefits of wireless medical device technology become more evident every day. From accurate and timely reporting to time savings and cost mitigation, both patients and care providers have much to gain from these latest advances. Proven Process will help ensure your medical device innovation employs the latest in wireless security technology to perform as intended from inception to commercial deployment.
Proven Process's approach to manufacturing medical devices has always been built on a foundation of high standards for performance and quality assurance. These principles guide our work in product design, production and processes and in applying the ISO 14971:2007 risk management system. Our development partners trust us to ensure that their devices will exceed requirements and meet evolving standards designed to protect patients and their data.
In fact, Proven Process utilizes several levels of processes that eliminate the threat of a security breach affecting a newly developed medical device. Potential threat modeling is a traceability matrix that has the ability to identify all potential security issues with a device under development. This allows for the selection of clearly defined requirements with regard to design inputs that can help mitigate security issues.
The next step is to develop a software architecture that incorporates remediation activities to eliminate separate security risks or even compound security risks. FDA guidance suggests that these activities be incorporated during development of devices subject to Internet security vulnerabilities.
Finally, Proven Process utilizes penetration testing, which is designed to probe software security at different levels. Testing the device at all stages of development to prove that the mitigation efforts are working is essential to reducing the risk of a cyberattack on a medical device, and Proven Process is committed to enforcing protocols that ensure your next device development project is protected from outside threats.