HHS Report Finds FDA Postmarket Cybersecurity Lacking, FDA Fires Back

FDA and the HHS Office of Inspector General are butting heads over whether the agency is equipped to address postmarket cybersecurity risks to medical devices. A report released by the OIG last month says FDA has a long way to go on addressing such risks, pointing out a lack of written procedures for handling cybersecurity events, for sharing information between stakeholders, and for recalling vulnerable devices, as well as a lack of testing of the agency’s ability to respond to...