Uni Systems is one of the most reliable European Information and Communication Technology companies that delivers a wide range of products and services, helping its customers adapt and excel in a rapidly changing and challenging business environment. For more than half a century, Uni Systems remains a strategic partner to financial institutions, public organizations, telecom operators, enterprises and institutions in the European region. It has a proven track record of successful large scale, complex and critical ICT projects in more than 26 countries through its business entities in Athens, Brussels, Bucharest, Luxembourg, Milan and Barcelona.

The company invests in innovation and breakthrough technologies with an established Research and Innovation (RDI) Unit. The RDI Unit keeps the Group abreast of the technological development with participation in significant research activities. Under this mission and objectives, one main and very important RDI activity is to make innovative ideas a reality through Horizon projects. One of the Horizon projects that address the necessity of digital transformation on the medical industry is the ENTRUST Project. Uni Systems will lead WP1 activities and will be responsible for the project coordination as well as for the Quality, Risk and Innovation Management of the project. Also, Uni Systems will actively contribute to the Technical Requirements and the Reference Architecture of the project (WP2), to the Security and Trust Attestation Models for Runtime Verification as well as to the SW and Trust Controls Update for Remote CMDs (WP4). Regarding WP5 activities, Uni Systems will actively participate in the Blockchain Design and Services Specification, with the Enforcement of Distributed Trust Framework and Smart Contracts for the Lifecycle Management of Medical Devices as well as with the CMD Evidence Monitoring Collection. Additionally, Uni Systems will be involved in WP6 with the Integration Design and Testing Plan as well as with the Use Cases Management, Deployments and Validation. Finally, regarding the activities in WP7, we will contribute to the Open-Source Roadmap for CMD Trust Reference Implementation as well as to the Exploitation & Business and Sustainability Planning.

Eindhoven University of Technology (TU/e) is a young university, founded in 1956 by industry, local government and academia. TU/e belongs to the top 1% in global rankings for co-publishing and cooperating with the industry. The university is firmly rooted in Brainport region Eindhoven, one of the smartest regions in the world, with a powerful presence of high-tech companies such as ASML, Philips, NXP and DAF PACCAR. In the context of ENTRUST, TU/e is represented by its Software Engineering and Technology group (SET) part of the Mathematics and Computer Science department. The primary mission of SET is to develop methods and tools for time- and cost-efficient development and maintenance of complex software systems. It focuses on theory, methods and tools for maintaining consistency between models and code and contributes to methodologies such as model-driven software development involving formal models, domain-specific modeling and generic tooling.

TU/e will contribute to the development of the Trust Management Framework by addressing needs at both design and runtime phases. It brings expertise in the design of domain-specific property languages for device attributes that need to be verified, during runtime, as evidence of their level of trustworthiness. It will participate in the development of runtime verification and monitoring techniques to support the device attestation, threat identification, and verification of newly deployed device software updates. TU/e takes the lead of WP3 (Trust Modeling, Risk Assessment and Security-by-Design Toolbox) and participates in tasks WP4.2-4 on trust attestation models for runtime verification and auditing.

SINTEF is the fourth largest independent research organisation in Europe, with 2100 employees of which about 46% of the researchers hold a doctorate degree. The research group on Trustworthy Green IoT Software, which participates in the project, is part of the Sustainable Communication Technologies department within the Digital division. Through applied research in Software Engineering, the group creates new tools and methodologies for software development and operation of intelligent and trustworthy systems spanning across the IoT, edge, and cloud continuum with a particular focus on sustainability. In EnTrust, SINTEF will utilise the prominent Digital Twin paradigm to i) simulate possible attacks on CMDs and thus protect against them by taking preventive actions, and ii) implement scalable software management across the managed fleet of heterogeneous CMDs.

University of Surrey (UoS) is a public research university based in Guildford, Surrey, England. UoS was established in 1966, it has over 15000 students and 2300+ placements. UoS was ranked 305th in the QS 2023, and 18th in the complete university guide 2023.

UoS takes two roles in this project. The first role is to take the lead in WP4, titled “runtime attestation mechanisms and continues certification for post-market CMD surveillance”. Within this WP4, UoS is taking the lead in task 4.2, titled “security and trust attestation models for runtime verification”. Specifically, our task is to implement a remote trust attestation to cover all phases of a CMD system’s executions. The second role is to take the lead in task 5.3, the main task is to develop a trust-aware authentication and authorization system for medical devices.

University of Murcia (UMU) is a public University located in the south of Spain, which has more than 31.931 students, with a teaching and research staff of about 2,684 spread over 5 university campuses, with 21 Faculties and 5 Affiliated Centres. UMU offers top-quality degrees and innovative research (55 Bachelor’s Degrees, 71 Master’s Degrees and 35 Ph.D. Programmes).

UMU has designed and implemented trust-based access control systems, secure data sharing mechanisms, as well as privacy-preserving identity management solutions for distributed systems, in scenarios such as IoT. Besides, UMU will work on ENTRUST on the dynamic certification of CMD devices based on the definition of security profile and their enforcement within the lifecycle of the CMD. Also, UMU is active in standardization activities with contributions to IETF, ETSI and IEEE.

The University of Piraeus Research Center (UPRC) facilitates the research activities of university members in different programmes and initiatives. In this context, the Department of Digital Systems (through UPRC) has been actively involved and coordinated a significant number of: (i) EU-funded R&D projects, (ii) National projects funded by the Greek Ministry of Development and the General Secretariat of Research and Technology, and (iii) Projects developed in collaboration with enterprises (both international and national).

UPRC has a range of responsibilities in the context of ENTRUST, helping in the design and implementation of various components. One crucial responsibility is to contribute to the design of a reference architecture that can provide a framework for the project's various components. Another responsibility is to identify trusted components for nodes and to identify gaps in runtime verification mechanisms to ensure the project's security. The UPRC will also need to provide input into the development of the blockchain architecture, including the design of smart contracts, and authentication and authorisation via Verifiable Credentials. They will also need to assist in stream monitoring and tracing at runtime attestation using eBPF, as well as AI-based analysis. Additionally, the UPRC will need to contribute to dissemination and communication activities, such as presenting research findings and participating in outreach programs, and standardization efforts to ensure the project's results are widely adopted. Overall, the UPRC's role is essential in ensuring the successful implementation of the project's various components and achieving its objectives.

SIEMENS is a global powerhouse in the electric and electronic industry, a world leader in complex infrastructure solutions and an active provider of technologies.

Siemens expose in the area of digital industry a unique automation portfolio, ranging from integrated drives and smart controllers to innovative PLM software.

As a front-runner for Industry 4.0, Siemens aims for increased productivity, efficiency, speed and quality.

Siemens is the leader of European patent applications; more than a quarter of them are in digitalization. Looking at large, innovation at Siemens is happening in close contact with customer needs and interaction. This way the innovation is done following a pragmatic pattern, seeking for the benefit of all stakeholders.

Within the ENTRUST project, Siemens will lead the activities related to the verification and validation of the software that will be implemented and executed on the connected medical devices as well as the threat modeling to identify possible vulnerabilities and ways of attack. Siemens will be actively involved in the analysis of the requirements for the reference scenarios and the definition of a plan to exploit the artifacts and technological results of the project.

Polaris Medical SA the company, known also as Medicover Hospital Cluj after rebranding and take over by Medicover Group in 2022, is one of the largest privately based hospital in Transylvania. It is a surgical-based hospital with integrated medical services such as Surgery, Medical examinations, Oncology and Rehabilitation,

Build on a surface of over 11000 sqm and 5 floors, the hospital has a capacity of 190 beds and includes 6 Operating Theaters, Intensive Care Unit department, radiology and state-of-the-art technology such as DaVinci Robotic surgery.

The main surgery domains are Orthopedics, Urology, General Surgery, or Bariatric surgery while rehabilitation can address patients with neurology, or orthopedics needs, where technologies as LOKOMAT, or ARMEO Spring can facilitate the rehab process.

Space Hellas S.A. is a leading System Integrator, Value-Added Solution and Service Provider in the areas of ICT and Security for the enterprise, government and defence sectors, based in Athens (Greece). The personnel of the R&D Department has broad experience in the field of various domains including cybersecurity, software development and integration through its participation in numerous EU, ESA and National collaborative R&D activities (currently participating in and/or coordinating more than 20 projects) as well as in national large-scale system integration projects. By participating in European and National R&D projects, as well as internal projects, the company adopts and develops cutting-edge technologies, products and services, while at the same time expanding its partner network. In close collaboration with the Innovation and Business Development units, the company continuously seeks opportunities for commercial exploitation of the products and the services which are developed. In addition, the know-how and expertise gained are directly applied to large-scale commercial projects.

Within ENTRUST project, Space Hellas S.A. team from the R&D Department leads WP6 which performs the Integration and Validation of the Trust Management Framework and coordinates the integration and testing activities of the project. Space Hellas S.A. team also contributes to technical requirements, analysis and outreach activities of ENTRUST project.

UBITECH is a leading, highly innovative software house, systems integrator and technology provider, established to provide leading-edge intelligent technical solutions and consulting services to businesses, organizations and governments in order to allow efficient and effective secure access and communication with various heterogeneous information resources and services, anytime and anywhere. Technology innovation constitutes the lifeblood of UBITECH. We are continuously seeking and validating new, emerging technologies, developing new ideas, concepts and solutions, and improving existing software applications and products for vertical markets or for addressing specific end-users' needs. UBITECH R&D team – that spans across all group’s companies, collaborating and exchanging experiences and technological know-how, reinforcing the group’s research capacity – is engaged in developing, integrating, deploying, piloting, demonstrating, and evaluating innovative technologies, utilities, features and processes, transferring technological know-how to end-user organizations and adapting breakthrough solutions to end-users' demands. The UBITECH R&D team participates in large, multidisciplinary consortiums in complex and highly innovative projects, including experts from universities, research institutes and industry across the enlarged Europe, which partner to provide research, technology integration and skilled project management. UBITECH R&D team members can demonstrate strong involvement in EC and National co-funded research programs, through the design, development and implementation of research and technological development instruments.

Within ENTRUST, UBITECH undertakes the overall scientific and technical coordination and implements the Continuous Risk Assessment and Risk Benefit Analysis mechanism that applies on both the design and runtime phases of the medical devises’ lifecycle. Moreover, UBITECH develops the mechanism for the enforcement of the Distributed Trust framework and the Smart Contracts for Lifecycle Management of Medical Devices.

QUBITECH is a private capital company founded in 2021 in Athens Greece and constitutes a collaboration of Quantum photonics researchers with over 20 years of combined research experience in the development design and implementation of experimental quantum technologies and UBITECH, which has an established track record and expertise in informatics and cybersecurity. QUBITECH is invested in the development of state-of-the-art quantum photonics systems in the fields of Quantum Communications and Cryptography, Quantum Software and Quantum Simulators. The company offers a wide range of expertise and skills from the design and modelling of semiconductor heterostructures and the simulation of optical properties of waveguide circuits to expertise with advanced spectroscopic and interferometric techniques and quantum correlation measurements. Our scientific background is in the fields of solid-state quantum physics, photonics, optoelectronics, and non-linear optics. Within the framework of the European project ENTRUST, the company is involved in the design and implementation of a novel physical unclonable function middleware to explore PUF’s functionality as a novel root of trust, which will be used as the baseline for guaranteeing the HW and SW security design properties of Medical Devices and provide the necessary cryptographic enablers.

Future Needs Management Consulting Ltd is an interdisciplinary socio-technical research and technology development SME. The staff of Future Needs has a long record of successful project management and coordination as well as design and development of digital services, policy evaluation, business development and science communication. Future Needs specialises in shaping the development of technology to best suit the needs of practitioners/end-users. As a team, we bring the latest technology trends and aspects of creativity, (youth) entrepreneurship and start-up mentality to projects we are involved in. We help our clients elicit user requirements for the development of new products and services, we develop R&D roadmaps aiming at product and service commercialisation, and we ensure security standards compliance for services and products we work on before they hit the market. We help our clients from the public and not-for-profit sectors to carry out Impact Assessments and policy evaluation studies, while ensuring secure, ethical and privacy-considerate processes and following the “better regulation guidelines” of the European Commission. Finally, we leverage our relationship with a variety of stakeholders ranging from technical specialists and key industry players to policy-makers and citizen groups when offering dissemination and community-building services. Information technology & telecommunications, education, migration, healthcare, transport, regional development, culture and finance.

Future Needs leads the Dissemination, Communication, Exploitation and Impact Creation work package, where it will create an Open-Source Roadmap. Furthermore, Future Needs leads the tasks for Data Management, Legal and Ethical Compliance of the project and the task Shaping the Ethical & Legal Dimension of Trust Management in Next-Generation of smart connected medical devices in which will conduct an ethical analysis.

Tellu AS (TELLU) develops welfare technology that digitalizes the health sector, and it is a leading provider of Connected Health and digital Care services in Norway. Tellu is a software company possessing significant competence both in technology and the health domain. This is the foundation from which we develop software products to provide services that support the tasks and challenges healthcare workers face at work, making everyday life easier for employees in home care, institutions, hospitals and nursing homes. Tellu provides an eHealth platform and the TelluCare product family enabled by the TelluCare eHealth platform. Tellu services include remote supervision for elderly care and Remote Patient Monitoring to follow up patients with diseases that require frequent following up of health personnel, such as Diabetes, COPD, and Covid-19. Tellu’s main markets are currently the eHealth and home care market in Norway. Tellu also has services deployed in other markets including Sweden and the Netherlands. Tellu has experienced significant growth since 2017, going from 5 employees in 2017 to more than 50 employees end of 2021. The ambition is to continue the growth including significantly growing the international business.

The TelluCare eHelath platform needs to cope with the complete management and trustworthy execution and processing of data and services across the IoT, edge and cloud space. The main role of Tellu in Entrust is a Use Case provider. This includes implementing the Remote Patient Monitoring use case and performing testing and validation of Entrust concepts and technologies. Tellu's main effort will consequently be in WP 6 Integration and Validation of Trust Management Framework, where Tellu is also leading task 6.3 “Use Cases Management, Deployments and Validation. Tellu will also contribute to identifying requirements coming from relevant industrial applications, take part in defining the ENTRUST Framework architecture, and work on the definition of the trusted component as part of WP2. Moreover, Tellu will contribute to the Threat Modelling and the digital twins for dynamic trust assessment in WP3. In addition, Tellu will contribute to exploitation and dissemination activities, in particular seeking exploitation opportunities of the Entrust technologies.

Tellu has significant experience in R&D projects and has participated in numerous national and international R&D projects. Tellu is currently involved in 5 EU projects within the fields of eHealth and ICT.

Red Alert Labs is a leading IoT security lab and cybersecurity consulting agency with a mission to provide innovative, intelligent, and adaptable approaches to connected environments. With a focus on IoT security, Red Alert Labs aims to help organizations trust IoT devices throughout their entire life-cycle.

The company's team members are experts in the field of IoT security and are active contributors to several European and International organizations, including ENISA, CEN-CENELEC, ISO, ACN, ECSO, EUROSMART, CARS CONNECTIVITY CONSORTIUM, and FIDO Alliance. They are involved in different working groups for the development of requirements and standards used in IoT security applicable to the medical domain.

Red Alert Labs' involvement in the project includes reviewing, conducting gap analyses, and classifying current standards, guidelines, and certification processes applicable to cybersecurity of medical devices. We will also validate the project's approach to new type certificates of conformity, which complies with the standards and current regulations and does not expose any sensitive information with regards to GDPR and other medical regulations. Additionally, Red Alert Labs will assess the applicability of current guidance, such as MDCG 2019-16, and other normative frameworks. Finally, RAL will develop a standardization strategy to contribute to ongoing or initiate new standardization activities based on the outcomes of the project.

Red Alert Labs' extensive experience in cybersecurity assessment and certification, security risk analysis methodologies, standards, and best practices makes it an ideal partner for any organization seeking to ensure the security of its IoT medical devices. By working with Red Alert Labs, organizations can benefit from innovative, adaptable, and intelligent approaches to connected environments, ensuring that their IoT devices are secure throughout their entire life cycle.

Suite5 is an Information Technology Solutions and Services SME with the mission to deliver innovative data-driven intelligence solutions through state-of-the-art technologies, required for any organization to be placed at the forefront of competition through greater efficiency. By combining strong technology know-how and a hands-on approach in managing and implementing projects commissioned by the public and the private sector, Suite5 provides research-inspired solutions and practical support for its clients, in areas such as AI, Data Management and Analytics, Semantic Interoperability and Trusted Data Sharing, in order to leverage business and crowd intelligence into their everyday operations.

Within the context of the ENTRUST project, Suite5 will lead the design and development of the policy-compliant blockchain architecture and the AI-based misbehavior detection solutions of the provided ENTRUST system.

Kardinero has been a leading medical device manufacturer, for more than thirty years, with the main expertise in PC-Based ECG and ECG Stress Test Systems with Treadmill. Currently, hundreds of Kardinero devices, which have been sold over the years, are still in use in many hospitals and clinics.

Besides manufacturing, Kardinero puts a significant amount of effort into R&D to bring innovation to the medical field. Kardinero’s ongoing R&D projects include the BLE-Based ECG and multi-parameter acquisition devices, namely the KardinBlu family, and the Connected Medical Device (CMD) Cybersecurity Project, ENTRUST.

Kardinero will contribute to ENTRUST in several ways. Having been designing and manufacturing CE Certified devices for many years, Kardinero is well-experienced in terms of medical device quality requirements and standards. All the medical device and cybersecurity-related standards, regulations, EU guidelines have to be reviewed for the sake of identification of potential gaps and the requirements to be satisfied. The outcomes of this review will be used as a guide for the development of the ENTRUST; formulation of trust models, and threat classification and categorization, considering the core features of specific CMDs, such as mobility, connectivity, performance, etc.

Kardinero will also provide a test bed for the developed system, at Ankara University Hospital, where its previously released devices are already in use. The first use case scenario includes the use of Kardinero’s recently prototyped KardinBlu product family, of which members are hospital-use ECG only and home-use multi-parameter acquisition devices, while they are connected to the hospital network. The second use case scenario will be performed using stationary medical devices, which are also connected to the hospital network, HIS and/or PACS.

Sentio Labs, the Greek branch of Feel Therapeutics Inc., is the company where the entirety of the company’s research and development (R&D) activities are conducted. Feel Therapeutics is a San Francisco-based start-up, which develops Biomarkers and Digital Therapeutics to bring objective data and passive measurement to reinvent the way we diagnose, manage, and care for mental health. The company is backed by top-tier investors (Felicis, Anthemis, SOSV) and partners with large Pharmaceuticals to develop novel digital biomarkers and bring digital health solutions to market as standalone therapeutics (DTx) or alongside medications.

Sentio Labs has designed and implemented the Feel Mental Health Biomarkers Platform, which focuses on the discovery, extraction, and validation of mental health-related biomarkers and metrics for various mental and physical health use cases based on physiological data collected by the Feel Emotion Sensor (FES). The FES is a proprietary wrist-worn device that provides ubiquitous and unobtrusive monitoring of the user’s physiological data (i.e Electrodermal Activity, Heart Rate Variability, and Skin Temperature) to detect changes in the activation of their Autonomic Nervous System (ANS) and extract a series of mental health metrics. These metrics are combined with activity-oriented ones, reflecting the user’s physical and psychomotor activity patterns, and are deployed in various steps of the patient care process: diagnosis, patient management and treatment.

Within the EnTrust Project, Sentio Labs leads the Use Case regarding the compliant protection of wearable devices for Mental Health Monitoring and Integrity of accompanying data. This Use Case will validate ENTRUST’s Trust Assessment Framework in wearables. Sentio Labs also contributes to technical requirements and analysis of the EnTrust Project.

Founded in 2019, PARTICLE is a Portuguese SME with a technology drive that provides secure systems and applications for improved situational awareness, leveraging the IoT paradigm and supporting high volumes of data exchange. PARTICLE’s solutions are fit for the Healthcare, Emergency, Security and Defence markets, integrating comprehensive monitoring capabilities, robust communication protocols, secure cloud platforms and Big Data architectures that enable advanced analytics and artificial intelligence, upholding innovative interoperability, security and privacy features.

PARTICLE contributes to the ENTRUST Project by providing the testbed to support the Use Case involving Patient Transport Services. In ambulance transportation, the vehicle is equipped with a large number of connected medical devices that continuously monitor the patient’s vital signs, collecting data that is valuable for providing adequate medical assistance. In addition, the emergency medical technicians (EMTs) collect medically-relevant information on the patient’s condition. Today, this data is only available at the ambulance for the EMTs to monitor the patient’s status and stability during transport. The Use Case will explore the cybersecurity aspects associated with the real-time exchange of the vehicle’s devices data and patient information to the destination hospital, so as to keep the point-of-care medical team apprised of the patient’s status at all times. This information will support the hospital’s medical intervention and early diagnosis and will allow for better planning of the resources required to assist the incoming patient. Specifically, ENTRUST will address the security vulnerabilities associated with connected medical devices and the exchange of medical data between an unsecure space (i.e., public communications network) and the secure hospital IT infrastructure and will integrate different cybersecurity tools to validate how the ENTRUST System delivers superior levels of cyber protection, ensuring secure data exchange from connected medical devices, the safeguard of the hospital’s IT infrastructure and the privacy of patient data.

The Unidade Local de Saúde do Alentejo Central (ULS) is the largest and main hospital unit in Alentejo, offering the greatest differentiation and, in addition to receiving patients from Central Alentejo (152,865 inhabitants), it treats an increasing number of patients from Alto Alentejo, Baixo Alentejo and Litoral Alentejo (345,939 inhabitants), for a total of 498,804 inhabitants (Eurostat estimate, 2019).

ULS is characterized as the place of reference for healthcare in the Alentejo region and one of its baselines is the search for improvement of its infrastructures, and that is where the collaboration with European consortia under Horizon 2020 and Horizon Europe come in. In fact, in recent years the Hospital has placed itself at the forefront of IT development, with continued participation in projects such as SPHINX - A Universal Cybersecurity Toolkit for Healthcare Sector (GA 826183), PharmaLedger - Blockchain Enabled Healthcare (GA 85399) and more recently VALKYRIES - Harmonization and Pre-Standardization of Equipment, Training and Tactical Coordinated procedures for First Aid Vehicles deployment on European multi-victim Disasters (GA 101020676), AI4CYBER (GA 101070450) and DynaBIC (GA 101070455).

In the ENTRUST Project, ULS focuses on Use Case 3 - Digital Assistance Towards Enhancing the Health and Well-being of Patients and Carers – and the Smart Ambulance Scenario, where it is expected to contribute towards testing and validating proposed solutions that can change the way data is safely transmitted to and from the Hospital, guaranteeing data privacy, security, analysis and monitoring in real time during transportation, resulting in better patient care alongside well-suited infrastructure.

Mandat International is a foundation and research center which aims at promoting international cooperation with strong expertise in ICT and Internet of Things technologies, personal data protection, cybersecurity, smart cities, and standardization. Established in Geneva, in the vicinity of the UN and other international organizations, it gathers complementary expertise in international cooperation, international law, data protection regulations, sustainable development and economics.

Within ENTRUST, MI ensures that it is in line with relevant global standards and legislations, and identifies appropriate sections of research that are brought into the standardization and liaison process. MI also supports the project’s pathway towards maximizing impact ensuring proper communication and dissemination. Additionally, they provide support on ensuring legal and ethical compliance and will be active in shaping the ENTRUST reference architecture