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Evaluation of dataset needs

TEF-Health Service
Consulting
Pricing/Discount Options: Call #2
Unique Identifier: fecf1a14-4495-445f-a55d-6f1994bb4687

Service Description

OVERVIEW This consulting service helps organizations define the clinical data requirements necessary to successfully develop, validate, or deploy AI solutions in healthcare. Through collaboration with clinical experts and data specialists, customers receive guidance on identifying the most appropriate patient populations, data sources, clinical variables, and dataset characteristics for their specific use case. The service supports the early stages of AI projects by ensuring that data requirements are clearly defined, technically feasible, and aligned with clinical objectives, regulatory expectations, and available healthcare data resources.

HOW CAN THE SERVICE HELP YOU ? Many AI projects struggle because the required clinical data are not properly identified at the outset. This service helps organizations understand what data are needed, whether suitable datasets are available, and how they should be structured to support the intended application. By involving clinical and data experts early in the project, customers can avoid costly redesigns, improve project feasibility, and establish a solid foundation for AI development, validation, and regulatory activities.

HOW WILL THE SERVICE BE DELIVERED ? The service is delivered through a series of consultation sessions involving clinical and data experts. The customer's objectives, intended use case, and technical requirements are reviewed to identify the necessary clinical datasets, patient cohorts, variables, and data quality requirements. The outcome is a set of recommendations describing the data needed for the project, potential data sources, and considerations regarding interoperability, governance, and regulatory compliance.

PROVIDER DESCRIPTION HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS The service includes: • Analysis of the intended AI use case and project objectives. • Identification of the clinical data required to support development or validation activities. • Definition of relevant patient cohorts, clinical variables, and outcome measures. • Assessment of data availability, completeness, and quality requirements. • Recommendations regarding interoperability standards such as OMOP CDM and HL7 FHIR where appropriate. • Guidance on data governance, privacy considerations, and regulatory constraints. • Support in defining data acquisition and preparation strategies.

SERVICE CUSTOMIZATION The service is fully tailored to the customer's project and can be adapted according to: • the intended AI application and clinical domain; • the maturity of the project; • the type of clinical data required; • existing datasets and available data sources; • regulatory, ethical, and organizational constraints. The scope of the assessment is defined jointly with the customer and may range from a high-level feasibility analysis to a detailed specification of dataset requirements for subsequent development and validation activities.

Offerings: Ethics & Regulatory Affairs Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
Provider Logo

Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Organisation Website https://www.humani.be/humani/projets-ia/
Ask about this service
Billing: per hour
Full Price 63–265 EUR
Reduced Price 48–202 EUR
Pricing Detail

This price is based on the less qualified human resource who may perform the service. The final price will be determined in the contract between the service provider and the applicant.​

Operational Details

Service Inputs Project description
Service Outputs Evaluation report, recommendations for improvement, feedback from medical professionals
Service Standards
  • International guidance and norms (Good Clinical Practice (ICH-GCP), ISO14155, etc.), and Belgium national laws and royal decrees (loi du 7 mai 2004 relative aux expérmentation sur les êtres humains, loi du 22 décembre 2020 sur les dispositifs médicaux, AR 18-05-2021 relatif aux investigations cliniques de dispositifs médicaux, etc.)
  • Where applicable: EU regulations (AI Act, EU regulations 2017/745-746 and 2020/561 on medical devices (MDR), General Data Protection Regulation (GDPR), etc)

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