Funded by Horizon Europe, the three-year FORTIFY project brings together more than 60 researchers, technologists and policy experts to develop new approaches to health data sharing across countries and regulatory frameworks.
FORTIFY stands for Framework for Optimized Regulation, Trade Secrets, and Intellectual Property in a Federated European Health Data Space. The project is being conducted as part of the European Health Data Space (EHDS), which aims to establish a common framework for the use and exchange of electronic health data across the EU to foster greater interoperability and innovation.
Among the leading researchers is Khaled El Emam, a University of Ottawa expert in synthetic data and privacy-enhancing technologies.
“The more data you have, the more likely you are to detect patterns that lead to new discoveries,” he says.
But in practice, accessing and sharing that data across countries and regulatory frameworks remains one of the biggest barriers to accelerating discovery.
Challenges balancing access, innovation, privacy, and IP
In health care, many of the datasets used for research are designated “secondary use,” information originally collected during patient care or clinical trials and later reused in aggregate to answer new questions. While this data can unlock new discoveries, accessing it is rarely straightforward.
Rules governing who can access health data and how and under what conditions it can be used vary widely across countries and regulatory frameworks. In Canada, health data is regulated at the provincial level and frameworks differ across the county. In the European Union, countries apply the General Data Protection Regulation, often alongside additional national rules.
Navigating this patchwork can slow or limit access to data, reducing opportunities for research and innovation.
At the same time, the stakes are high for industry. Clinical trial data are costly to generate, yet the insights they contain can lead to new commercial applications, including new uses for existing drugs. As a result, companies may restrict access or limit how data are shared to protect valuable intellectual property.
“Solving real world problems is always multidisciplinary. Working together allows us to develop approaches that can work across different countries and real-world health systems.”
Khaled El Emam
— Professor, School of Epidemiology and Public Health
“The signals, the insights, are always in the data,” says El Emam. “It’s just a question of who gets to them first.”
To address these constraints, researchers and data holders often rely on other methodologies such as synthetic data, AI-generated data that reproduces patterns from real data or anonymized data that removes identifying information, or on negotiating access on a case-by-case basis. But too much alteration can distort results, while too little can increase the risk of exposing sensitive information or valuable intellectual property.
At the same time, the growing use of artificial intelligence in health care is increasing demand for larger and more detailed data sets. Without clearer and more consistent approaches to data sharing, this tension between access, privacy and protection is likely to intensify. This growing pressure is exactly what projects like FORTIFY aim to address.
A coordinated approach to health data sharing
Rather than relying on fragmented, case by case solutions, FORTIFY focuses on developing concrete methods and tools that can be applied consistently across countries and regulatory frameworks.
Working with academic institutions, industry partners and policy experts, the project brings together technical and legal expertise to address both how data is shared and how it is protected. El Emam and his team will contribute to the project’s technology work, developing tools and code that can be applied directly to health data while preserving privacy and protecting intellectual property.
This includes privacy-enhancing technologies, synthetic data and watermarking techniques that can help track the origin of data and detect when it has been modified.
In some cases, these approaches are designed to allow analysis to take place in secure environments, without data needing to be transferred or exposed. The objective is to move beyond fragmented, case by case approaches toward more consistent and reliable ways of sharing health data at scale.
“The vision is for data sharing to be simple and straightforward,” El Emam says. “The hope is that there will be consistency.”
Unlocking new possibilities for research and innovation
FORTIFY could significantly improve how health data is accessed and used for research across countries. By enabling more consistent and scalable access to data, the project could allow researchers to work with larger and richer datasets, helping them identify patterns, test new ideas and accelerate discovery.
For regulators and public health authorities, improved access to data could support more effective monitoring and decision making. For industry, clearer rules and stronger protections may increase confidence in sharing clinical trial data, while reducing the risk of exposing valuable intellectual property.
By making it easier to access and use data responsibly, the project could help shorten the path from research to real world applications, including new treatments, medical devices and improved patient outcomes.
Contributing expertise to global research efforts
For the University of Ottawa, participation in FORTIFY reflects a long-standing focus on privacy-enhancing technologies and the responsible use of data in health care. El Emam and his team bring more than two decades of experience in developing methods to share sensitive data while protecting individual privacy.
Working alongside international partners, the team is helping design solutions that operate across countries and regulatory frameworks, with the potential to influence how health data is shared well beyond the scope of the project.
“Solving real world problems is always multidisciplinary,” El Emam says. “Working together allows us to develop approaches that can work across different countries and real-world health systems.”