Europe Launches FORTIFY to Support Secure Secondary Use of Health Data

FORTIFY

Prime Highlights

  • FORTIFY will develop legal, governance, and technical safeguards to enable secure secondary use of health data across Europe while protecting intellectual property and trade secrets.
  • The project will test its solutions in real healthcare settings and deliver a unified data-sharing framework for Health Data Access Bodies and data holders.

Key Facts

  • FORTIFY is funded by the Innovative Health Initiative (IHI) and supported by the European Union’s Horizon Europe research and innovation programme.
  • The project launched in April 2026 and will run for 36 months, bringing together 34 public and private sector partners from across Europe.

Background

The FORTIFY project has officially launched to help Europe expand the use of health data for research while protecting intellectual property, trade secrets, and other commercially sensitive information.

Funded through the Innovative Health Initiative (IHI) and aligned with the European Health Data Space (EHDS), the project brings together 34 partners from industry, academia, healthcare, policymaking, and patient organisations. The consortium will create and test technical, legal, and governance solutions that facilitate safe and effective health data sharing over the course of the following three years.

The initiative addresses concerns among hospitals, research institutions, and companies that sharing health data could expose valuable intellectual property or sensitive business information. These concerns have slowed the wider adoption of data-sharing frameworks across Europe.

Project leaders said FORTIFY aims to prove that organisations can share health data for research without sacrificing innovation or losing control of valuable assets. The project will create legal guidance, governance frameworks, and model contracts to help data holders understand how to protect sensitive information throughout the data-sharing process.

In addition, FORTIFY will develop technological solutions that enable organisations to track usage of shared data, such as watermarking technology. The program will offer guidance regarding the use of synthetic, anonymised, and transformed datasets in order to minimise risk without compromising their scientific value.

These technologies will be piloted in real-world health settings, such as clinical trials, medical imaging, biobanks, genomics, artificial intelligence models, real-world evidence studies, and device-generated data.

At the end of the program, FORTIFY plans to deliver a unified framework for Health Data Access Bodies and data holders across Europe. The project also intends to share training resources and policy recommendations to support secure, transparent, and consistent health data access while strengthening public trust and pushing medical innovation.

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