Medical device cybersecurity challenges and solution
Presentation Synopsis:
Address the challenges facing medical device manufacturers in developing secure devices, FDA expectations, standards and best practices and also SelectEvidence® – a cybersecurity risk analysis expert system
Speaker Bio:
Anita is a member of the AAMI Medical Device Security Working Group and also an active member of IEC SC62a JWG7, ISO/TC 215 and EWICS. Anita has authored two medical device cybersecurity international technical reports – IEC/TR 80001-2-8 and IEC/TR 80001-2-9. She represents NSAI as Ireland’s medical device security expert representing Ireland at International medical device standards meetings. Her PhD research focused on the use of security assurance cases in the medical device domain. Anita has led an Enterprise Ireland funded Medical Device Security commercialisation project within the Regulated Software Research Centre (RSRC) in Dundalk Institute of Technology, Ireland and subsequently spun-out Nova Leah from this. Nova Leah specialise in cybersecurity risk analysis solutions for the healthcare domain.