Tuesday, 10 January 2017
FDA lays out postmarket medical device cybersecurity recs in final guidance.
As our world becomes more interconnected, so do our medical devices: we are connecting devices such as insulin pumps and glucose meters to apps, some of which also have cloud connectivity, enabling patients to share their health data with caregivers and loved ones. But this increased interconnectivity comes with vulnerability to cybersecurity threats.
The FDA published its final guidance on the postmarket management of cybersecurity in medical devices last week. The recommendations apply to medical devices that use software, including programmable logic and software that is regulated as a medical device, including mobile medical apps. The document follows the agency’s final guidance on premarket cybersecurity for medical devices issued in 2014.