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ENsuring Secure and Safe CMD Design with Zero TRUST Principlescore

ENTRUST · Horizon Europe grant · 2023-01-01–2025-12-31

EC contribution

€5,633,088

Total cost

€5,633,090

Beneficiaries

21
About the data

Source: CORDIS (official EU open data), Horizon Europe. Framework HORIZON · call HORIZON-HLTH-2022-IND-13 · scheme HORIZON-RIA · topic HORIZON-HLTH-2022-IND-13-01. CORDIS record →

Objective

Aligned with the guidelines of the Cybersecurity Act and the existing guidance on cybersecurity for medical devices, ENTRUST envisions a Trust Management Architecture intended to dynamically and holistically manage the lifecycle of connected medical devices, strengthening trust and privacy in the entire medical ecosystem. Even from the proposal stage, ENTRUST has identified gaps and necessary revisions of the current guidance (e.g., absence of post-market conformity and certification, real-time surveillance and corrective mechanisms – see 1.2.2). Towards that ENTRUST will leverage a series of breakthrough solutions to enhance assurance without limiting the applicability of connected medical devices by enclosing to them cybersecurity features. The project will introduce a novel remote attestation mechanism to ensure the device’s correct operation at runtime regardless of its computational power; will be efficient enough to run in also resource-constrained real-time systems such as the medical devices. This will be accompanied by dynamic trust assessment models capable of identifying the Required Level of Trustworthiness (RTL) per device and function (service) that will then be verified through a new breed of efficient, attestation mechanisms (to be deployed and executed during runtime). This will also enable us to be aligned with the existing standards on defining appropriate Protection profiles per device (especially considering the heterogeneous types of medical devices provided by different vendors with different requirements) including Targets of Validation Properties to be attested during runtime. The motivation behind ENTRUST is to ensure end-to-end trust management of medical devices including formally verified trust models, risk assessment process, secure lifecycle procedures, security policies, technical recommendations, and the first-ever real-time Conformity Certificates to safeguard connected medical devices.

Beneficiaries (21)

OrganisationCountryRoleEC contributionSME
UNISYSTEMS LUXEMBOURG SARL LU coordinator €400,625
GIOUMPITEK MELETI SCHEDIASMOS YLOPOIISI KAI POLISI ERGON PLIROFORIKIS ETAIREIA PERIORISMENIS EFTHYNIS EL participant €713,123 Yes
SINTEF AS NO participant €489,625
TELLU AS NO participant €419,375 Yes
SUITE5 DATA INTELLIGENCE SOLUTIONS LIMITED CY participant €410,000 Yes
TECHNISCHE UNIVERSITEIT EINDHOVEN NL participant €374,840
SPACE HELLAS ANONYMI ETAIREIA SYSTIMATA KAI YPIRESIES TILEPIKOINONIONPLIROFORIKIS ASFALEIAS - IDIOTIKI EPICHEIRISI PAROCHIS YPERISION ASFA EL participant €348,750
FUTURE NEEDS MANAGEMENT CONSULTING LTD CY participant €342,500 Yes
UNIVERSIDAD DE MURCIA ES participant €335,000
SIEMENS SRL RO participant €307,625
UNIVERSITY OF PIRAEUS RESEARCH CENTER EL participant €300,625
RED ALERT LABS FR participant €267,500 Yes
KARDINERO MEDIKAL SISTEMLER SANAYI VE TICARET ANONIM SIRKETI TR participant €218,125 Yes
PARTICLE SUMMARY PT participant €217,000 Yes
SENTIO LABS MONOPROSOPI IKE EL participant €201,625 Yes
POLARIS MEDICAL SA RO participant €170,000
UNIDADE LOCAL DE SAUDE DO ALENTEJO CENTRAL EPE PT participant €116,750
UNI SYSTEMS SYSTIMATA PLIROFORIKIS MONOPROSOPI ANONYMI EMPORIKI ETAIRIA EL thirdParty €0
QUBITECH IDIOTIKI KEFALAIOUCHIKI ETAIREIA EL thirdParty €0 Yes
MANDAT INTERNATIONAL ALIAS FONDATION POUR LA COOPERATION INTERNATIONALE CH associatedPartner
UNIVERSITY OF SURREY UK associatedPartner

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