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CYMEDSEC

Financiado

Enhanced cybersecurity for networked medical devices through optimisation of gui...

Enhanced cybersecurity for networked medical devices through optimisation of guidelines, standards, risk management and security by design For the EU health industry to be competitive and to sustainably deliver internationally leading care quality, it is important that EU regulation, guidelines and standards enable effective and interoperable digital health innovatio... ver más

31/10/2027

TUD

6M€

Presupuesto del proyecto: 6M€

Líder del proyecto

TECHNISCHE UNIVERSITAET DRESDEN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Ver 12 Participantes

Financiación concedida El organismo HORIZON EUROPE notifico la concesión del proyecto el día 2023-10-10

HORIZON-HLTH-2022-IND-13-01: Enhancing cybersecurity of connecte... ExpectedOutcome:This topic aims at supporting activities that are enabling or contributing to one or...

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

12 Participantes

TUD

1.55M€ | Lider

ICONS

279.88K€ | Participante

AUSTRIAN STANDARDS INTERNATI...

298.48K€ | Participante

UMANA MEDICAL TECHNOLOGIES L...

383.13K€ | Participante

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Duración del proyecto: 48 meses Fecha Inicio: 2023-10-10
Fecha Fin: 2027-10-31

Líder del proyecto

TECHNISCHE UNIVERSITAET DRESDEN No se ha especificado una descripción o un objeto social para esta compañía.

TRL 4-5

Presupuesto del proyecto 6M€

Descripción del proyecto For the EU health industry to be competitive and to sustainably deliver internationally leading care quality, it is important that EU regulation, guidelines and standards enable effective and interoperable digital health innovation and promote a vibrant entrepreneurial EU sector. Safety and competitiveness are not mutually exclusive. To deliver on them requires a pace and intensity of technological innovation that is matched by intensive regulatory innovation. Smarter, adaptive, dynamic, and evidence-based regulatory approaches are needed, based on real world experience in representative use scenarios. 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. Key to this is the in-project development of a cybersecurity benefit-risk toolbox, which will further develop the state of the art, using qualitative and quantitively approaches, and will make these available as easily usable and findable Open-Source resources for manufactures and regulatory bodies.

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