Background Health systems face a time of unprecedented change, with spiraling costs, increasing cultural disparity in access to healthcare and research, and an infrastructure that is decades old. Today, telehealth is a realistic alternative making care and research more accessible and personalised with less burden to better support the most vulnerable and under-served in our society. The ability to test and monitor for illnesses using Patient Centric micro-Sampling (PCmS) is at the centre of this reform. Aim and main objectives This project is designed to build upon existing pilots and knowledge, then collaborate cross-sectorially to co-create and test the logistics, infrastructure and tools required to make PCmS a core healthcare tool and an acceptable alternative to venous blood-draw across Europe. This project aligns with many IHI’s objectives focusing on cross-sectorial collaboration, emphasizing patient and end-user- centric co-design of outputs, harmonised regulatory and data generation approaches enhancing the potential of digital innovations in healthcare, while aiming to reduce the environmental footprint during the project and in final outputs to ensure that the expected long-term impact is a reachable reality that will deliver significant benefit to the community and address unmet public health needs at scale. To achieve our objectives, we bring together a broad group of required expertise, know-how and end-users (i.e., public and patients) to form a public-private-partnership specifically equipped to tackle this challenge. This collaborative approach where the relevant stakeholders such as healthcare professionals, regulatory agencies and patients are involved and integrated to deliver solutions and innovation across healthcare systems and ensure the best chances for success and long-term positive impact from this project. Key deliverables include: 1) An optimized, tested and validated ‘Gold Standard’ infrastructure and workflow for PCmS across Europe as a proven and reliable alternative to venipuncture 2) Harmonised and clear regulatory and HTA pathways, standards and acceptability, measures and cost-benefit models across Europe 3) Documented evidence to draw a citable ‘line in the sand’ for future research to support decisions to integrate PCmS into decentralised trials and care pathways 4) Stakeholder engagement and patient involvement models and research on preferences and acceptability for PCmS 5) Foundation for future: Enable access to the developed PCmS scientific findings, tools and assessment measures for rapid uptake and integration of PCmS approaches into decentralised clinical studies and healthcare Expected impact: - Patient-centric microsampling becomes an accepted alternative to the current standard of care venipuncture and the data gathered can be leveraged in healthcare planning. - Lowered patient burden and lowered barrier to access in situations where blood samples need to be collected, whether as part of diagnosis, care plan, health monitoring etc. - A solution to leverage high amounts of data gathered from increased testing can be explored already in this project so that it can pave the way for future research that can improve health outcomes.

The Pharmaceutical industry is currently producing significant amounts of electronic data through manufacturing lines increasingly automated via pervasive sensors and devices. Manufacturing line data sources are heterogeneous with various embedded systems controlling the different processes involved in the production of medicines. Data Integrity and end-to-end traceability have become a key point to be compliant with the different international regulations and guidelines. As an example, in order to release a medicine batch number, it is necessary to ensure that all the data produced is ALCOA (Attributable, Legible, Contemporaneous, Original and Accurate) compliant. Auditable computerised systems are therefore key on pharma production lines, since the industry is becoming increasingly regulated for product quality and patient health purposes. As systems are continuously generating data in various formats, data must be dynamically analysed to ensure the quality and compliance of the overall process. The main idea of this project is to systematically assess all data produced by computerised production systems in representative pharma environments: (i) design data quality assessment models based on the Data Quality dimensions agreed by the European Institute for Innovation Through Health Data, including rules derived from regulatory documents; and, (ii) identify behaviour patterns of data probability distributions over time and among the manufacturing sources to identify outliers, i.e. data behavioural patterns which can violate ALCOA premises. To this end, there will be a semi-autonomous data quality control decision support system aiding pharma manufacturing companies to reduce the effort of analysing compliance data. Finally, a system prototype demonstration in an operational environment (Technology Readiness Level 7) will be evaluated using industry-grade real pharmaceutical manufacturing data sets and streams coupled with best pharma industry practices.