In January 2016 the Food and Drugs Administration (FDA) issued draft guidance (the Guidance) to assist medical device manufacturers in managing cyber security risks during the lifecycle of medical devices.
The Guidance primarily apply to “postmarket” and relates to (1) medical devices that contain software (including firmware) or programmable logic, and (2) software that is a held to be a medical device.
The Guidelines state that: “manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health.”
The Guidance is open for comment and response until 21st April. To read the Draft Guidance in full please click here.