FDA’s Draft Medical Device Cybersecurity Guidelines Lack Teeth, Say Experts | Sécurité de l'information de santé et plus... | Scoop.it

The FDA's draft of cybersecurity guidelines for medical devices does not go far enough in its recommendations for a framework for protecting devices from future attacks, a new report says.


The report, from the Institute for Critical Infrastructure Technology (ICIT), says the FDA is failing to offer options for "regulatory enforcement" that would assure security standards and measures are adopted in the manufacturing of medical devices.


"In practically all matters of cybersecurity within the health sector, the FDA seems to be in a constant state of offering subtle suggestions where regulatory enforcement is needed," the ICIT report said....

Via Pharma Guy, Philippe Marchal, Lionel Reichardt / le Pharmageek