COLUMBUS, Ohio (Dec. 3, 2014)—Hacking is in the news every day—retailers, banks, governments, hospitals and many others have been victims. The threat extends to all connected devices and networked medical devices are no exception. Now, Battelle has a service to help.
The worry about data protection and safety may be even greater for medical device manufacturers than others. Because the U.S. Food and Drug Administration mandates safe and effective operation for medical devices, there is a need to know how that applies when it comes to cybersecurity. New processes must happen soon to mitigate the safety, security, and business risks that come with connected medical devices.
Battelle’s DeviceSecure™ is a suite of services for medical device cybersecurity, combining expertise in cybersecurity, medical device design, hardware and software development, and user experience for a complete solution to challenges in cybersecurity for medical devices.
Battelle offers software, hardware and embedded systems solutions in addition to identifying potential security vulnerabilities. Few companies can do both, and even fewer can do this under an ISO 13485 compliant quality system. This comprehensive security risk management plan addresses three critical aspects of cybersecurity: Secure design, vulnerability assessment and intellectual property protection, anti-tampering and anti-counterfeiting.
In order to adequately protect themselves from risk and liability, manufacturers will need to develop their own best practices for risk assessment and mitigation. Battelle can help. “Most medical device manufacturers have done an excellent job of developing protocols to identify and mitigate safety risks, such as electrical components that present a shock risk or poorly designed controls that could lead to an accidental overdose,” said Battelle Senior Research Scientist Scott Sheaf. “But companies must recognize the difference between safety and security within their existing risk management processes, and keep both kinds of exposure in mind. As more medical devices are connected to hospital networks, to the Internet, and to each other, we introduce new risks to patient safety and privacy.”
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.
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