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.

<< Objectives >>Our aim; To provide digitalization in the field of cardiovascular surgery. In this field, digitalization will be ensured with equal opportunity and innovation in vocational education will be contributed. Quality assurance in vocational training will be improved by ensuring that cardiovascular surgeons document their experiences. At the same time, a standard data set manual will be developed so that scientific comparative analyzes will give more accurate results.<< Implementation >>The project was designed with the emphasis on the development of vocational education, its renewal with digitalization and its transfer with quality assurance. The Digital Gallery will facilitate access to information on new techniques for all cardiovascular surgeons. Log Book will enable surgeons to share their experiences with standard document system that is accessible to all institutions. Manual datasets will enable comparative analyzes to yield healthier results with standardized variables.<< Results >>With the innovations and developments, it provides, the project will reveal digital outputs that every cardiovascular surgeon can easily access and benefit from free of charge. With this project; Resources will be created that facilitate surgeons' access to information, document their experiences, help them refresh their knowledge with catchy visuals before surgery, and provide more accurate results by arranging scientific comparative analyzes with standard data.

In patients undergoing open-heart surgeries, perioperative cardiac monitoring is used to track the functioning of the heart and identify complications. However, myocardial failure and other severe complications can escape detection using current monitoring technologies, given the trade-offs between invasiveness, real time measurements, accessibility and accuracy of data. Given the high-risk profile of these surgeries, failure to timely detect complications leads to increased mortality and morbidity, which in turn results in increased hospitalization costs and lower quality of life for the affected patients. For effective cardiac monitoring, surgeons need real time data, 24h continuous monitoring during and post-surgery, and an accurate biosignal marker that can be trusted for immediate detection and assessment of cardiac events. No current technology enables this with low invasiveness and risk. Cardiaccs (SME) and Osypka (SME) will bring to market a patented solution that involves adding a 3-axis accelerometer to a standard epicardial pace lead, which is routinely used for most cardiac surgical patients, to assess cardiac motion and contractility in real time, both during and after surgery – and up to 7 days. Data from CardiSense will appear on a monitor and an alert function will let surgeons and nurses know as soon as a complication is picked-up on the continuously analysed data. SAMBAfun brings together 2 SMEs with complementary know-how, IPR and value chain positions. Cardiaccs patented the concept, whereas Osypka has 40 years of experience in developing cardiac pace leads. Osypka dominates the German market and has extensive ties to global distributors. Three leading research hospitals (Oslo, Aarhus and Berlin) will demonstrate the latest advances in this device, provide Key Opinion Leader input and contribute with multi-market, highly credible data for regulatory certification and health economic models to support reimbursement applications in all markets.

Coronary Artery Bypass (CAB) surgery is performed annually in >700,000 patients to treat coronary artery disease and prevent myocardial infarction (heart attack). Standard CAB surgery involves a highly invasive open-heart procedure in arrested/non-beating heart, that is associated with long recovery times and severe complications. The surgeons are seeking for less invasive, closed chest CAB procedures on beating heart, but current solutions are technically extremely challenging and thereby only used in €89M and >€192M. Dutch SME AMT Medical has developed the proprietary SAFE-CAB technology to clinical readiness. To substantially accelerate the market entry of the product, the company partners with a leading European cardiac surgery hospital Deutsches Herzzentrum Berlin and a pan-European clinical/regulatory medical device company HEMEX to obtain regulatory approval through final clinical validation . To realize European wide-implementation, the consortium is complemented by a surgery training company LifeTec Group and the oldest professional organisation for cardiac surgeons European Society of CardioVascular and Endovascular Surgery.