Earnest Engineer

The NICE framework from a RACI point of view The NICE framework ( NIST SP 800-181 rev. 1) established a standard approach for describing cybersecurity work, in order to help stakeholders share a common language and ideally improve how to identify, recruit, develop and retain talent. It breaks down cybersecurity work role categories into: Oversight and Governance; Design and Development; Implementation and Operation; Protection and Defense; Investigation.  Which is very cybersecurity-centric and not related to common tools for project management within companies. Especially smaller enterprises that do not have dedicated people to mange and coordinate cybersecurity needs. A  RACI chart  is   a project management tool used to define and clarify roles and responsibilities within a project team.   It stands for Responsible, Accountable, Consulted, and Informed, and visually represents who is responsible for what, who is accountable for the outcome, who needs to be c...

From the  EU  MDCG 2019-16 Guidance on Cybersecurity for medical devices, December 2019 , this is the guidance on foreseeable risks.  Medical device manufacturers should ensure that a medical device is designed and manufactured in a way that ensures that the risks associated with reasonably foreseeable environmental conditions are removed or minimised. This may include the infield monitoring of the software’s vulnerabilities and the possibility to perform a device update (outside the context of a field safety corrective action) through, for example delivering patches to ensure the continued security of the device. During the risk management process, the manufacturer should foresee or evaluate the potential exploitation of those vulnerabilities that may be a result of reasonably foreseeable misuse. This, however, may depend on the specific situation. For example, using an unsecured memory-stick to enter data into a medical IT system can be considered “reasonably foreseeabl...