As with security challenges accompanying other new technologies, open collaboration and communication are key to managing and reducing risk. This includes collaboration and communication among regulators, as well as between regulators, industry, and medical and healthcare practitioners. Several recommendations will help foster innovation while minimizing exposure to security risks:
Stress security at the outset, rather than as an afterthought
Improve private-private and public-private collaboration
Move toward evolutionary change of the regulatory approval paradigm for medical devices
Introduce an independent voice for the public
Medical device manufacturers must adopt a “secure-by-design” approach to research and development.
In the past, security has...