Following the news that the FDA, regulators and medical-device-makers are bracing for an expected barrage of hacking attacks even as legal and technical uncertainties leave them in uncharted territory. Mike Ahmadi, Global Director – Critical Systems Security at Synopsys commented below.
Mike Ahmadi, Global Director – Critical Systems Security at Synopsys:
“If the past year in hacking news is any indicator, the medical industry and regulators should indeed be wringing their hands over what is likely on the horizon. Medical devices remain extremely vulnerable by any standard, and device manufacturers are simply neither incentivized to resolve security issues, nor are they legally motivated to do so. The FDA has issued guidelines to help address cybersecurity issues, but device manufacturers are forced to prioritize resources on meeting FDA requirements to bring products to market. The only organizations I, and many others, have witnessed taking meaningful steps towards addressing security and building programs that receive board level attention are ones who have had to address security issues head on. Others simply follow legal guidance, which often fails to meet the mark. I can recall sitting in a room with a major medical device manufacturer and the FDA and the manufacturer security lead told that FDA that if the FDA wants more secure medical devices, they have to make them do it, because his lawyers determine how far they go based on legal risks, which remain quite low for device manufacturers who fail to adequately address security.”