HORIZON-HLTH-2022-IND-13-01

Proposals are expected to address some or all of the following:

• Systematic review of current standards/guidelines/best practices applied to cybersecurity of connected medical devices, with the final objective to identify and specify gaps and requirements based on evidence.
• Propose risk benefit analysis schemes for cybersecurity of connected medical devices, taking into account several novel technological developments ( 5G networks, big data, artificial intelligence, cloud computing, augmented reality, blockchain) and interconnection architectures.
• Explore, develop and validate novel methodologies and toolboxes for ensuring cybersecurity of connected medical devices by design.
• Identify representative case studies, evaluate the applicability of existing guidance MDCG 2019-16 (guidance on cybersecurity for medical devices[3]) and make recommendations to (better) address specificities of the connected medical device, including software, of different risk classes.
• Assessment of the applicability (and revision) of current guidance, the MDCG 2019-16 (guidance on cybersecurity for medical devices), to connected medical device, including software.

 Health Care

 Development and Cooperation

 Biotechnology

 Digital Agenda for Europe

 Innovation & Research

 Horizon Europe

 Research

 Clinical trials

 Artificial Intelligence