CYMEDSEC : Enhanced cybersecurity for networked medical devices through optimisation of guidelines, standards, risk management and security by design

CYMEDSEC has been designed with an optimum consortium
of regulatory, cybersecurity, technology, evaluation, and clinical EU experts to address exactly this challenge. It provides close feedback
loops between new technological paradigms and recommendation of regulatory approaches, fostering regulatory science fresh thinking.
It will deliver novel security-by-design solutions for the oversight of ‘Internet of Medical Things’ (IoMT) devices, including connected in
vitro diagnostics. IoMT ‘fleet’ cybersecurity oversight systems will be developed. Use cases explored include remote patient monitoring
and critical care scenarios, for which the project will develop novel and highly secure gateway middleware. Our technological and
methodological advancement will go hand-in-hand with detailed review of regulations and guidelines, the formal creation of a new
IoMT cybersecurity standard, and evidence collection from representative case studies. These objectives are holistically interlinked, with
learnings form each work area feeding into development and proposals in other areas.