Nate Brown Quoted on Cybersecurity Risks for Medical Devices
The threat of cyber attacks against medical devices is the subject of an article in POLITICO in which Akin Gump health care and life sciences partner Nate Brown is quoted.
The article, “FDA, manufacturers tackle hypothetical cyber threats to medical devices,” discusses a meeting this week with officials from the Food and Drug Administration (FDA) and elsewhere who are looking at ways to build cybersecurity into medical devices such as insulin pumps and X-ray machines. Hacking of the devices or their data could alter safety settings. The FDA, which regulates these devices, has, according to the article, issued guidance on cybersecurity precautions that device makers should take before filing marketing applications.
Brown, who worked on device safety at the FDA and the Senate Committee on Health, Education, Labor & Pensions, said device manufacturers are concerned that adding security controls might interfere with the safety and effectiveness of their devices. “There’s sort of a balancing approach needed,” he added, as the industry “is somewhat concerned about the need for flexibility to strike that right balance.”