FLUTE Cross-border Prostate Cancer Data Standard Guide
0.1.0 - ci-build
Funded by the European Union

FLUTE Cross-border Prostate Cancer Data Standard Guide, published by Flute Project. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/flute/ and changes regularly. See the Directory of published versions

Plain Language Summary goes here
Official URL: http://hl7.eu/fhir/ig/flute/ImplementationGuide/hl7.eu.fhir.flute Version: 0.1.0
Draft as of 2025-11-05 Computable Name: FluteImplementationGuide

The FLUTE project

Overview

The goal of the FLUTE project is to advance and scale up data-driven healthcare by developing novel methods for privacy-preserving cross-border utilization of data hubs. The project performs advanced research to push the performance envelope of secure multi-party computation in Federated Learning, including the associated AI models and secure execution environments.

The technical innovations of the project will be integrated in a privacy-enforcing platform that will provide innovators with a provenly secure environment for federated healthcare AI solution development, testing and deployment, including the integration of real world health data from data hubs and the generation and utilization of synthetic data (categorical, numerical and images).

To maximize the impact, adoption and replicability of the results, the project will contribute to the global HL7 FHIR standard development, and create novel guidelines for GDPR-compliant cross-border Federated Learning in healthcare.

To demonstrate the practical use and impact of the results, the project will integrate the FLUTE platform with health data hubs located in three different countries, use their data to develop a novel federated AI toolset for diagnosis of clinically significant prostate cancer, and perform a multi-national clinical validation study of efficacy of the AI toolset. The toolset will help to improve predictions of aggressive prostate cancer while avoiding unnecessary biopsies, thus improving the welfare of patients and significantly reducing the associated costs.

Objectives

The FLUTE project aims to facilitate the sharing and reuse of health data among clinical centers. This is intended to advance research on rare cancers and improve patient access to high-quality care. A significant challenge is building a tool to overcome interoperability issues while complying with privacy regulations.

Dependencies

Package hl7.fhir.uv.extensions.r4#5.2.0

This IG defines the global extensions - the ones defined for everyone. These extensions are always in scope wherever FHIR is being used (built Mon, Feb 10, 2025 21:45+1100+11:00)

Package hl7.fhir.uv.sdc#3.0.0

The SDC specification provides an infrastructure to standardize the capture and expanded use of patient-level data collected within an EHR.
This includes two components:
* Support more sophisticated questionnaire/form use-cases such as those needed for research, oncology, pathology and other clinical domains.
*Support pre-population and auto-population of EHR data into forms/questionnaires for uses outside direct clinical care (patient safety, adverse event reporting, public health reporting, etc.). (built Tue, Mar 8, 2022 18:32+0000+00:00)

Package hl7.fhir.uv.tools.r4#0.8.0

This IG defines the extensions that the tools use internally. Some of these extensions are content that are being evaluated for elevation into the main spec, and others are tooling concerns (built Tue, Aug 5, 2025 20:09+1000+10:00)

Cross Version Analysis

This is an R4 IG. None of the features it uses are changed in R4B, so it can be used as is with R4B systems. Packages for both R4 (hl7.eu.fhir.flute.r4) and R4B (hl7.eu.fhir.flute.r4b) are available.

Global Profiles

There are no Global profiles defined

IP Statements

This publication includes IP covered under the following statements.

Authors and Contributors

Roles Name Organization Contact
Autore