BIGMED: A big data medical solution for precision medicine.

The BigMed project was funded by The Research Council of Norway as an ICT lighthouse project to address the barriers to clinical implementation of precision medicine and pave the way for big data analytics. The project was finalised in 2021, the same year as the first changes to Norwegian health law that BigMed contributed to were approved by the Norwegian parliament. The consortium, hosted by Oslo University Hospital, was a cooperation of more than 20 partners from industry, academia, and the clinic. Through the project, BigMed sought to pave the way for Big Data analytics through challenging established truths in the healthcare sector. The 2018 BigMed position paper, Big data management for the precise treatment of three patient groups identified the initial barriers to clinical implementation of precision medicine, and served as a starting point for the project. The framework for addressing implementation barriers encompassed legal issues, organisational and governance issues, ICT infrastructure, as well as the life cycle of secondary use of data through data capture, analysis, and application. In the five years BigMed operated, the multidisciplinary teams developed solutions and methodology to support clinical implementation of Precision medicine based on the needs identified in three clinical areas: rare diseases, sudden cardiac death, and colorectal cancer. The solutions included an architecture and prototype of an in-silico innovation zone within the hospital to facilitate data driven tools to support quality assurance, data sharing and clinical decision support. The project found clinical data is a resource that is seldom reused for clinical decision support. Clinical genomics is an exception to this rule and serves as a good example of how data can be reused to support clinical decisions. This can serve as a model for future development of other areas, to see how data can be used for patient similarity analysis and to speed up knowledge development to the benefit of our patients. Among the results from more than 100 documented deliverables in the project, many of which are implemented and in use by the partner institutions, BigMed contributed to establishing a high speed pipeline for genetic analysis of critically ill new-borns at Oslo University Hospital, reducing time from 8 weeks to 2 days. Knowledge and experience form the project has been disseminated through 2 books, 12 reports, 10 articles, a knowledge compendium website, a podcast series, 18 seminars and a large number of external presentations. The seminars were a meeting place for discussing different subjects in BigMed and to share results form the project. Stakeholders from the whole sector have been involved. Project results and knowledge developed through the project is summarized in the white paper Reflections on the clinical implementation of precision medicine (2021). All results will be available on the website for minimum five years after project termination. In addition to this, BigMed has established two competence networks to continue the cooperation. The project identified a need for a more holistic approach to regulating how data can be reused in a safe and balanced manner. The legal work package is continued through establishing a Nordic network, Nordic Permed Law, to facilitate cooperation and sharing of competence across borders through meetings, seminars and project cooperation. https://www.nordicpermedlaw.org/ In cooperation with all health regions in Norway, BigMed has established a competence network for AI in the Norwegian healthcare service, or Kunstig Intelligens i Norsk helsetjeneste (KIN) that contributes to sharing knowledge and experiences around implementing AI solutions in healthcare. Already by the termination of BigMed, the network has gained an important position as the official meeting point between bureaucracy and practictioners in Norway. https://ehealthresearch.no/kin www.bigmed.no

Som utgangspunkt for å utfordre etablerte sannheter i helsetjenesten og bane vei for etterfølgende initiativer, utviklet BigMed beslutningsstøtteverktøy, infrastruktur og metoder for å fremme kliniske implementering av presisjonsmedisin som førte til endring av praksis ved OUS, blant annet gjennom et tilbud om hurtigsekvensering. Organisatoriske endringer som følge av prosjektet omfatter en ny klinikk for innovasjon og teknologi er opprettet ved OUS, ny studieretning ved UiO og nye innovasjonsavdelinger hos industripartnere. Gjennom rollen som nasjonalt fyrtårnprosjekt har BigMed hatt en uttalt strategi om kunnskapsdeling, åpenhet og nettverksbygging. Jussgruppen organiserte Nordic Permed Law (www.nordicpermedlaw.org/) for å klargjøre lovtolkninger samt å gi opphav til lovendringer (vedtatt i 2021). Fagnettverket Kunstig Intelligens i Norsk helsetjeneste (www.ehealthresearch.no/kin) skal øke kunnskapsdeling på tvers i sektoren. www.bigmed.no

Emerging and novel high throughput technologies, such as genomics, can provide large amounts of relevant data and detailed molecular characterization for each patient. The amount of relevant information is so large that the choice of selecting the right treatment algorithm for the patient is difficult. The aim of BIGMED is to lay the foundation for an ICT platform that addresses the analytic bottlenecks for the implementation of precision medicine to improve patient outcomes. BIGMED will develop novel solutions for (i) bioinformatics genome analysis; (ii) integrated analysis of electronic health record information with genomic data and structured and unstructured background information; and (iii) big data analytics that can extract and analyze relevant information; BIGMED will in this way provide physicians currently facing data overload with much needed assistance in their decision making. The BIGMED consortium comprises an interdisciplinary team of experts in clinical medicine, genomics, bioinformatics, informatics, law and health economy as well as highly qualified industrial partners with cutting edge expertise in relevant fields with a common vision of becoming a world leading enabler of precision medicine. BIGMED is implemented following a carefully defined work plan. The initial development is hosted in a secure lab where sensitive data can be legally accessed, thus bypassing the data access hindrance that often impedes innovative ICT development in healthcare. The project addresses in depth legal, economic and technology barriers for an industrial implementation of BIGMED at large, and pilots an initial deployment within a controlled clinical setting.