Introduction: Children represent a large and vulnerable patient group. However, the evidence-base for most paediatric diagnostic and therapeutic procedures remains limited or is often inferred from adults. There is urgency to improve paediatric health care provision based on real-world evidence generation. The digital transformation is a unique opportunity to shape a data-driven, agile, learning health care system and deliver more efficient and personalized care to children and their families. The goal of SwissPedHealth is to build a sustainable and scalable infrastructure to make routine clinical data from paediatric hospitals in Switzerland interoperable, standardized, quality-controlled, and ready for observational research, quality assurance, trials, and health-policy creation. This paper describes the design, aims, and current achievements of SwissPedHealth. Methods and analysis: SwissPedHealth started in September 2022 as one of four National Data Streams co-funded by the Swiss Personalized Health Network (SPHN) and the Personalized Health and Related Technologies (PHRT). SwissPedHealth develops modular governance and regulatory strategies, and harnesses SPHN automatization procedures, in collaboration with clinical data warehouses, the Data Coordination Center, Biomedical Information Technology Network, and other SPHN institutions and funded projects. The SwissPedHealth consortium is led by a multi-site, multi-disciplinary Steering Committee incorporating patient and family representatives. The data stream contains work packages focusing on: 1) governance and implementation of standardized data collection, 2) nested projects to test the feasibility of the data stream, 3) a lighthouse project that enriches the data stream by integrating multi-omics data, aiming to improve diagnoses of rare diseases, and 4) engagement with families through patient and public involvement activities and bioethics interviews. Ethics and dissemination: The health database regulation of SwissPedHealth was approved by the ethics committee (AO_2022-00018). Research findings will be disseminated through national and international conferences, publications in peer-reviewed journals and in lay language via online media and podcasts.  

The authors have declared no competing interest.

This project was supported through the grant NDS-2021-911 (SwissPedHealth) from the Swiss Personalized Health Network (SPHN) and the Strategic Focal Area Personalized Health and Related Technologies (PHRT) of the ETH Domain (Swiss Federal Institutes of Technology).

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The ethics committee Northwest and Central Switzerland (EKNZ, AO_2022-00018) gave ethical approval for the health database regulation of SwissPedHealth. Separate ethics approvals and waivers for each nested research or quality improvement project conducted were obtained: SwissPedGrowth (Ethical committee [EC] Bern, b2023-00022); SwissPedCancer (EC Bern, Req-2023-01081); SwissPedLung (EC Bern, under review), SwissPedAntibio (EKNZ, Req-2023-01501), the lighthouse project (EC Zurich, 2022-00351), and the related bioethics interview project (EC Federal Institute of Technology Zurich, 2023-N-253).

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Research outcomes will be made publicly available according to the FAIR principles and in line with policies and regulations of the partner institutions and guided by Swiss Personalized Health Network (SPHN) and Personalized Health and Related Technologies (PHRT) principles.

https://www.swisspedhealth.ch/