Follow Sarah, a researcher aiming to identify new biomarkers of lung cancer, and the six essential steps that would enable her to retrieve patient data from across the country. Discover in this context the concrete role of the BioMedIT secure infrastructure and the Data Coordination Centre of the SPHN, both piloted by the SIB Personalized Health Informatics Group.

The situation so far

Analyses of health-related data can lead to essential discoveries, such as the identification of new biomarkers of diseases, new immunotherapy treatments or the improvement of treatment efficacy and outcomes. However, to be meaningful, such analyses require a critical amount of quality data.

Today, researchers working in this field in Switzerland have to cope with important limitations: no federated query system of suitable data, a lack of harmonized legal and ethical frameworks related to data transfer and use, and the paucity of secure computing resources across the country. Often, this results in having no access to personal sensitive data.

Propelled by the SPHN and thanks to the combined efforts of many stakeholders, including hospitals, ethics committees, experts from institutions across the country and of SIB on the infrastructure side, researchers will soon be able to access and analyze the wealth of data of consenting patients from across Switzerland’s healthcare institutions. Here is how.

Six steps to gain a secure access to nationwide clinical data

Trace the steps of Sarah, a Swiss Researcher aiming to identify new biomarkers of lung cancer by leveraging knowledge from patient data (see infographics).

Step 1 - The data query: in order to build her research project, Sarah channels a data query via the Data Coordination Centre (DCC), thereby acting as a ‘facilitator’ (see box). She learns that three Swiss hospitals have patient data relevant to her project.

Step 2 - Obtaining ethical clearance: Sarah submits her project proposal, detailing the type and proposed usage of patient data, to an ethics committee, and obtains ethical approval.

Step 3 - Signing a Data Transfer and Use Agreement (DTUA): Sarah requests the according data from the hospitals and signs a DTUA with the hospitals to formalize the data use rights and possible Intellectual Property derived from the research.

Step 4 - Registering and access rights: Sarah registers the project and members of the research team with the DCC and obtains access rights.

Step 5 - Ready-to-use encrypted data: The hospitals encrypt and copy the relevant, de-identified and consented data from their lung cancer patients to a BioMedIT node. BioMedIT is a project entrusted to SIB by the SERI, aiming at building a network of secure IT infrastructure facilities.

Step 6 - Access and analysis: Sarah can now access the protected data stored in the nodes, run her analysis and proceed with her research project.

End of the project: Finally, once the project is completed, data is either to be securely archived or deleted.

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The different bricks making up this new nationwide process are currently being laid: key policies and guidelines are already available, such as the SPHN Information Security Policy and the Ethical framework for responsible data processing in personalized health research; the SPHN National Steering Board is expected to review this month the proposed DTUA template; all three BioMedIT nodes should be on line by the end of 2019; moreover, a federated query system that can be searched to know from which Swiss hospital relevant information on patients can be found should be up and running by the end of 2020.