New methods for the effective use of real-world data and/or synthetic data in regulatory decision-making and/or in health technology assessment

Last updated: 16.7.2025
Grant

This Horizon Europe funding program, HORIZON-HLTH-2022-TOOL-11-02, supports the development of innovative methods for using real-world and synthetic data in health regulatory decision-making and health technology assessment (HTA). It aims to optimize data-driven methodologies and foster better assessment of medicinal products and digital health innovations across Europe. The program seeks to enhance the quality and effectiveness of healthcare through advanced data utilization.

Who is Funded

This section summarizes who is generally eligible for funding under this Horizon Europe program. It details the target groups, geographical scope, and the program's overarching objectives, highlighting its focus on advancing health technology and digital solutions through robust data utilization.

What is Funded

This section provides details on eligible project types, thematic areas, and activities. It clarifies the covered sectors and the typical developmental stage of supported projects, emphasizing data-driven innovation in health.

Type and Scope of Funding

This section provides details on the nature of financial support, including the type of funding and available amounts.

Conditions and Requirements

This section outlines critical conditions and requirements for applicants and beneficiaries, including application terms, collaboration rules, budget stipulations, and other important provisions.

Application Procedure

This section guides through the application process, from preparation and submission to how decisions are made and communicated.

This section outlines the foundational legal and official documents that authorize, establish, and govern the funding program.

Similar Programs

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Funding Overview

Funding Status

Funding Status:

Closed

Maximum Amount

Maximum Amount:

7.000.000 €

Allocated Budget

Allocated Budget:

Total Budget: 35.000.000 € (for topic HORIZON-HLTH-2022-TOOL-11-02); Annual Budget: 35.000.000 € (for 2022)

Award Channel

Award Channel:

Framework Programme Call

Region

Region:

European Union, United States of America

Sectors

Sectors:

Healthcare, Medical Technology, Information and Communication Technology, Research and Development

Beneficiaries

Beneficiaries:

Health regulatory bodies, Health Technology Assessment bodies, pharmaceutical industry, medical devices industry

Application Type

Application Type:

Consortium Required

Funding Stages

Funding Stages:

Applied Research, Experimental Development, Product Development, Market Introduction

Funding Provider

Program Level:

European Union

Funding Body:

European Commission

Additional Partners:

European Medicines Agency (EMA), Joint Research Centre (JRC)

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