Technology driven medical concepts and products bring certain risks, especially in cybersecurity. With the innovations in the medical device industry, it’s becoming not a question of if, but when these new technologies will come into effect and are the systems that protect them secure.
Connected medical devices, like all other computer systems, are vulnerable to hackers and viruses. Two major concerns of medical device security are privacy and patient safety. Cyber criminals target the lucrative medical device industry to exploit the well-known lack of adequate security measures on many connected devices. Whether due to simple security protection or user error, the active attacks on medical devices are increasing. Patient privacy is at risk when a cyber breach allows hackers to access patient health information from interconnected devices, especially in cloud-based environments, that may be sold to different parties. But even more concerning are the safety risks that patients might face in the event of a nefarious hacker gaining access to an interconnected device. Vulnerabilities could result in unauthorized users manipulating the devices—a potentially fatal flaw for critical patient therapies. The FDA is more involved than ever in assisting manufacturers to combat these acts by providing industry guidance associated with cyber risks. The medical device industry standards also provide frameworks to help define roles, responsibilities, and lifecycle management.
With strong government regulations, guidance, and effective cybersecurity standards, manufacturers will be better positioned to acknowledge and address these vulnerabilities and reduce legal risk should issues arise. In an article for Compliance Today, Guidehouse’s Jennifer Mitchell, Scott Thiel, and Miles Johnson lead you through an understanding of the importance of security safeguards, encryption software, cybersecurity risks, and what lies ahead in 2017.