Collaboration Agreements with Swiss University Hospitals

The Infrastructure Implementation Projects (funded through collaboration agreements) aim at developing the core infrastructure which is required to make health-related data FAIR* at the national level. Building interoperable clinical data management systems in research-based health institutions is a prerequisite for the success of the initiative.

At the beginning of 2018, SPHN and the five university hospitals (UH) signed collaboration agreements (CAs) to establish interoperable clinical data management systems for research. Each institution was supported with CHF 3 million over a period of three years, provided specific milestones common to all UH had been reached. The CAs laid the foundation for the close cooperation between SPHN and the hospitals within the frame of the initiative.

The conclusion of the first funding period and review of the initiative at the end of 2020 showed that the hospitals had made great progress in setting up internal data management systems. Local differences in the handling of technical, ethical and legal requirements however still impair accessibility and usability of clinical routine data for research purposes. For the second funding phase 2021-2024, SPHN will therefore focus on shared benefits and on establishing a facilitating legal and regulatory framework between SPHN and UH, based on the concept of a network of trusted partners. Interoperability and sustainability of the infrastructure will be key goals of the new CAs.

In order to seamlessly continue the successful work on developing internal, interoperable clinical data management systems (clinical data warehouse, CDW), SPHN and the UH have now renewed the agreements until 2024. In addition to the work on the CDWs, the CA shall support the hospitals with reaching commonly agreed interoperability targets and with exchanging data for research projects, in compliance with legal and regulatory requirements and best practices. A dedicated SPHN-unimedsuisse working group as well as the HIT-STAG have been paramount for the conceptual elaboration and the pragmatic implementation of the new agreements. The later are now formulated in a more concrete and binding way, with annual milestones, joint monitoring and regular updating of the objectives.

*The FAIR principles require that data are Findable, Accessible, Interoperable, and Reusable. Sensitive health data cannot be openly accessible to third parties, but taking regulatory requirements into account, the data should be FAIR – also with reproducibility and sustainability in mind. The main goal of the FAIR principles is the optimal preparation of research data for reuse by humans and machines.

Examples from the Roadmap and Deliverables for the Collaboration Agreement

The roadmap specifies jointly agreed deliverables that will annually be updated and mutually approved.

Year 1 (01.07.2021 – 30.06.2022)

Data exchange framework

  1. UH designates a single-point-of-contact for all data requests by SPHN-funded projects
  2. UH formally answers requests for signing of a DTUA (according to SPHN template) to the single-point-of-contact within 30 working days (ideally, including signing of DTUAs and MTAs). For denied request, the reasons for rejecting the request will be provided in writing.
  3. UH commits to support the use and further development of the SPHN Data Transfer and Use Agreement (DTUA).

Data provision (milestones to be fulfilled during year 1):

  1. UH provides a quote for data extraction and data delivery according to the SPHN Interoperability Framework to projects and National Data Streams (NDS) applying for SPHN funding and being preselected by SPHN bodies. Quotes shall address howchange requests by projects are handled.
  2. According to projects’ milestones: UH provides extracted data in SPHN-defined format (if available) to SPHN-funded projects at cost agreed in the quote.
  3. According to projects’ milestones: UH transfers data in RDF or other agreed-on formats via BioMedIT to SPHN-funded projects at cost agreed in the quote.

Omics data and biosample interoperability

  1. UH is technically able to provide a minimal set of biosample meta-data according to the Swiss Biobanking Platform (SBP) specifications (https://swissbiobanking.ch/tissue-and-liquid-data-sets/) for patient data under General Consent.
  2. UH is technically able to link sample information to clinical information in the CDW (ID management).
  3. UH delivers a one-time overview/inventory of all generally consented omics data (i.e. genomic, transcriptomic, proteomic, metabolomic) present in the UH departments incl. local pathology departments.

Semantic-based data representation layer

  1. UH designates a person responsible for supporting semantic data representation within UH and in collaboration with SPHN projects as well as DCC.
  2. Within the yearly budget and Roadmap approved by UH and SPHN, the HIT-STAG has the mandate to define implementation of the SPHN Interoperability Framework.
  3. UH formulates a strategy on semantic management of data and building respective capacities.
  4. UH collaborates on the list of suitable domains and sets of information (elaborated by HIT-STAG and DCC) to be represented in a semantic-driven way and encoded to standard terminologies/ontologies (e.g., SNOMED-CT, LOINC), to be submitted for approval in the yearly revision process with UH.

Federated Query System (FQS)

  1. UH loads, at least monthly, consented data following agreed standards into their local instance of the FQS [Clinerion], according to the technical format specifications and quality guidelines from SPHN.
  2. UH provides first level IT support (through the application manager) and takes care of the technical maintenance (e.g., implementation of updates and new releases) for the Federated Query Tool.
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