Tim Hudson Quoted on Cybersecurity Risks Relating to Medical Devices

Tim Hudson was quoted in an article published by The Cybersecurity Law Report  (subscription required) discussing cyber risks associated with connected medical devices and the legal considerations companies should consider. Tim suggested medical device companies consider two questions when developing a connected medical device: “(1) What are my potential vulnerabilities? and (2) Am I prepared for a cybersecurity attack on a networked medical device?” Tim noted that manufacturers should conduct a “risk-benefit analysis to determine whether they should move forward. With medical devices, there’s a unique and additional critical component of patient safety, which under all circumstances must be paramount.” Tim also discussed various federal regulations applicable to manufacturers, including prior guidance documents issued by the FDA relating to cybersecurity and medical devices.