Issues of data subjects’ privacy and data security represent a crucial challenge in the biomedical sector more than in other industries. The current IT landscape in this field shows a myriad of isolated, locally hosted patient data repositories, managed by clinical centres and other organisations, which are subject to frequent and massive data breaches. Patients are disenfranchised in this process, and are not able to have a clear understanding of who uses their personal information and for what purposes. This makes it the ideal field to build and test new models of privacy and data protection, and the technologies that encode them. MyHealthMyData (MHMD) aims at changing the existing scenario by introducing a distributed, peer-to-peer architecture, based on Blockchain and Personal Data Accounts. This approach will determine new mechanisms of trust and of direct, value-based relationships between people, hospitals, research centres and businesses, in what will be the first open biomedical information network centred on the connection between organisations and the individual. The system will develop a comprehensive methodology to guide the implementation of data and identity protection systems, specifically defining approaches and tools to profile and classify sensitive data based on their informational and economic value, to assess the most suitable and robust de-identification and encryption technologies needed to secure different types of information, to allow advanced analytics, and to evaluate the overall reliability of a generic multi modular architecture. MHMD will also analyse users’ behavioural patterns alongside ethical and cultural orientations, to identify hidden dynamics in the interactions between humans and complex information services, to improve the design of data-driven platforms and to foster the development of a true information marketplace, in which individuals will be able to exercise full control on their personal data and leverage their value.

Screening for early detection of a disease is required to reveal groups of individuals from the general population in whom the likelihood of the disease is increased and who could benefit from further medical evaluation. The ideal screening test is high-accuracy, low-cost, non-invasive, easily repeatable, effortlessly operated by a lay-person and has minimal impact on the person’s daily activities.. In the SNIFFPHONE project, we aim to tackle these requirements by integrating heterogeneous micro- and nano-technologies into autonomous smart system that can be attached to a mobile phone and analyze disease markers from exhaled breath. In this approach, an interaction between breath sample and a miniaturized array of highly sensitive nanomaterial-based chemical sensors is recorded, stored and pre-processed by integrated miniature on-chip microfluidics and electronics, and then the relevant electrical signals are transferred wirelessly via the mobile phone’s internet to an external server. Statistical pattern recognition methods are then applied on the received data and a clinical report including the screening results is sent back to the designated receiver (e.g., specialist, family doctor) in case of positive result is revealed. SNIFFPHONE represents a new concept addressing major societal challenges in health and well-being of the general population, while taking into account constituent ethical and security aspects. The SNIFFPHONE end-product will integrate functionalities that are relevant to the health screening applications with decreased size (x30-40), decreased costs (x150), increased predictive and cognitive functions and full autonomy with energy management as well as with operation/use management. Besides the R&D and clinical units, the SNIFFPHONE project will involve four European SMEs and one big industrial company, thus establishing European competitive ecosystems for the design and commercialization of innovative miniaturized smart systems.

The PEROXIS project will develop a new X-ray imaging system with higher sensitivity and spatial resolution compared to conventional ones, which will support diagnosis during intervention and treatments of various diseases. The emerging semiconducting perovskite materials, largely used for photovoltaic applications, are a good candidate since they have the potential to globally address the following ambitious objectives: -Advancing X-ray based imaging systems for advanced diagnostics and treatments of two major diseases: cardiovascular disease (CVD) and stroke -Improving the efficiency and spatial resolution of flat panel X-ray detectors -Groundbreaking perovskite-based direct conversion X-ray imaging detectors for large-area compatibility -Validating the improved image quality of cone beam computed tomography (CBCT) in stroke detection PEROXIS is a multidisciplinary project engaging 7 EU partners from 4 countries (France, Germany, Spain and the Netherlands) covering the academic, RTO and industrial (3 major medical equipment manufacturers) worlds. An implementation plan is presented in the form of 8 work packages, 6 of which are technical in nature. Synergy in communication and dissemination by the several partners and stakeholders (external advisory board mainly composed of physicians who provide letters of intent) will permit to maximize the PEROXIS project impact. Both solutions to overcome the fundamental technological barriers as well as appropriate deliverables, tasks, milestones and risks in order to complete the project objectives in due time are presented. The medical sector will be highly impacted by the PEROXIS project outcome: future applications of an improved PEROXIS imaging system will not be limited to stroke and CVD only, but may be extended to various other clinical domains in which the performance of diagnostic driven therapy systems is limited by current flat panel X-ray detector technology.

The central PANCAIM concept is to successfully exploit available genomic and clinical data to improve personalized medicine of pancreatic cancer. PANCAIM’s concept is unique as it integrates the whole spectrum of genomics with radiomics and pathomics, the three future pillars of personalized medicine. The integration of these three modalities is very challenging in the clinic, but also with AI. PANCAIM uses an explainable, data-efficient, two-staged AI approach. AI biomarkers transform the unimodal data domains into interpretable likelihoods of intermediate disease features. A second AI layer merges the biomarkers and responds with an integrated assessment of prognosis, prediction and monitoring of therapy response, to assist in clinical decision making. PANCAIM builds on four key concepts of AI in Healthcare: data providers, clinical expertise, AI developers, and MedTech companies to connect to data and bring AI to healthcare. Data quantity and quality is the main factor for successful AI. Partners provide eleven Pan European repositories of almost 6000 patients that are open to ongoing accrual. SME Collective Minds builds the GDPR data platform that hosts the data and provides a trustable connection to healthcare for even more and sustainable data. SME TheHyve builds tooling to connect to more genomic repositories (EOSC Health). Six Pan European academic centers provide clinical expertise across all modalities and help realize a curated, high quality annotated data set. Partners also include expert AI healthcare researchers across all clinical modalities with a proven track record. Finally, Siemens Healthineers provides their AI expertise and tooling to bring AI into healthcare for clinical validation and swift clinical integration in 3000 health care institutes.

The objective of the HELoS CSA is to support the Health.E Lighthouse Initiative Advisory Service (LIASE) in its ambition to accelerate innovation in medical devices (“Moore for Medical”). Health.E will accelerate the innovation in medical devices and systems by stimulating the development of open technology platforms and standards , thereby moving away from the inflexible and costly point solutions that presently dominate electronic medical device manufacturing. Open technology platforms, supported by roadmaps, will generate the production volumes needed for sustained technology development, resulting in new and better solutions in the healthcare domain. Health.E will: • Translate the needs of medtech and pharma into ECS opportunities; • Build on the ECS Strategic Research Agenda and identify the gaps; • Stimulate initiatives: towards open technology platforms and standards for medical devices; to anticipate the requirements for regulatory, Notified Bodies, clinical trials and market access; to better apply to the current care practices, necessary conditions for market access. • Connect to European initiatives and relevant communities including PPPs such as ECSEL, IMI, Eureka, and relevant industry associations In the HELoS CSA, three main components are identified that need to be connected in order to address the complex issue of innovation in the medical industry: • Connecting existing networks: ECSEL projects, (inter)national and regional projects and initiatives; • Addressing and connecting scientific/technical issues and non-technical aspects e.g. legal, regulatory, standardization, ethical, economic (cross-cutting issues); • Extending the network of stakeholders and markets across Europe (spreading excellence, facilitating international collaboration, new applications); • The dissemination of the results of this initiative to the stakeholders and the general public.