FAQs

OmicSpace is a federated health data space that enables the secure sharing and reuse of health data without requiring data to be transferred outside the originating institutions.

The platform connects clinical and omics data (genomic, molecular, and other biological data) generated by hospitals and research centres, enabling their use for biomedical research and personalised medicine while preserving data sovereignty and ensuring that participating organisations retain full control over their data.

OmicSpace enables the combined use of high-quality clinical and omics data to generate new knowledge and improve healthcare.

It provides controlled access to data for:

• Biomedical and clinical research
• Personalised medicine
• Healthcare quality improvement
• Real-world evidence (RWE) generation

By integrating data from multiple sources under a common framework, OmicSpace accelerates research processes and supports the generation of robust scientific evidence.

OmicSpace is designed as a collaborative ecosystem for:

• Hospitals and healthcare organisations
• Research centres and universities
• Biotechnology startups
• Health technology companies
• Patient associations
• Medical societies
• Other federated data spaces

Its primary users are researchers, clinicians, and organisations driving healthcare innovation, while the ultimate benefits are delivered to patients and healthcare systems.

OmicSpace provides an integrated set of capabilities for health data management and use, including:

• Integration of clinical and omics data from multiple sources
• Data harmonisation through healthcare standards
• Secure federated data exchange between institutions
• Governed and controlled data access
• Secure analytics environments (without data extraction)
• Data catalogue services for dataset discovery

All these capabilities operate within a governance framework that regulates data access, use, and reuse.

The Data Catalogue is a tool that allows users to identify and explore datasets available within OmicSpace.

It includes information about:

• Data type (clinical, genomic, and others)
• Source and coverage
• Key characteristics and level of structuring
• Access conditions

Its purpose is to help researchers assess the feasibility of their studies before requesting access to data. Access to the catalogue is restricted to authorised users.

Participation in OmicSpace is possible in two ways:

• As a data user, by requesting access for research projects
• As a collaborating organisation, by contributing data, technological capabilities, or participating in collaborative projects

Organisations wishing to join OmicSpace must meet a number of technical, ethical, and legal requirements.

If you are interested in joining OmicSpace, please contact us at omicspace@iislafe.es or by telephone at +34 646 275 423.

Data security is a fundamental priority within OmicSpace and is ensured through advanced measures designed to protect citizens’ privacy and comply with applicable regulations, particularly the General Data Protection Regulation (GDPR).

• Protection of Sensitive Data
  Health data, which is considered sensitive information, is protected through advanced techniques such as anonymisation and pseudonymisation, ensuring that individuals cannot be directly identified.
• Privacy and Access Policies
  Strict rules govern who can access data and under which conditions. Only authorised users meeting predefined criteria can access information. In some cases, data may be masked or restricted to further safeguard privacy.
• Privacy-Enhancing Technologies (PETs)
  OmicSpace employs advanced privacy technologies that enable data to be processed securely while ensuring compliance with established access and usage policies.
• Data Sovereignty
  Data owners retain full control over the conditions under which their data can be used. They can define, manage, and enforce these conditions throughout the data lifecycle.
• Authentication and Controlled Access
  The platform uses robust authentication and authorisation mechanisms to ensure that only authorised users can access resources. Encryption and secure communication protocols, including TLS and SSL, are used to protect data exchanges.
• Regulatory Compliance and Security Assessments
  OmicSpace complies with GDPR requirements and performs continuous security testing, privacy assessments, and vulnerability management activities to ensure ongoing data protection.

In addition, OmicSpace complies with Spain’s National Security Framework (ENS) and relevant European frameworks governing the reuse of health data.

Data available through OmicSpace may only be used for legitimate healthcare-related purposes, including:

• Scientific and biomedical research
• Healthcare innovation
• Healthcare quality improvement
• Development, training, and validation of artificial intelligence algorithms and systems aimed at improving public health, healthcare quality, or patient safety

The use of data is not permitted for:

• Commercial advertising purposes
• Marketing activities
• Decisions that could discriminate against or harm individuals
• The development of products or services that may negatively impact individuals, public health, or society
• Illegal activities

All data use is subject to prior authorisation and ongoing monitoring.

OmicSpace adopts internationally recognised healthcare data standards to harmonise information originating from multiple sources and enable its safe and consistent use.

The data space has been designed in accordance with the UNE 0087:2025 standard for data spaces, aiming to ensure both internal interoperability and interoperability with other national and European data spaces.

OmicSpace addresses interoperability across four dimensions:

• Legal interoperability: alignment with applicable regulatory frameworks and legal requirements.
• Organisational interoperability: clear definition of roles, responsibilities, and common operating rules among participants.
• Semantic and syntactic interoperability: adoption of shared standards and vocabularies to ensure consistent interpretation of data.
• Technical interoperability: implementation of technologies and systems that enable secure and efficient information exchange.

This approach enables:

• Preservation of each organisation’s autonomy and control over its data
• Consistent data structures across institutions
• Comparability of information between organisations
• Efficient joint analysis without complex manual processing

Data standardisation is therefore essential for supporting multicentre studies and maximising the reuse of health data in biomedical research.

The use of data within OmicSpace is governed through a robust framework that includes:

• Common rules and policies for data use
• Application of a shared contractual framework
• Continuous legal and ethical compliance oversight
• Monitoring of data access and usage
• Audit and traceability mechanisms

In addition, OmicSpace promotes the dissemination of aggregated study results, ensuring transparency and encouraging the return of knowledge to society.

Yes. Citizens retain their rights over their personal data, including the right to object to the use of their data for research purposes through opt-out mechanisms, in accordance with applicable legislation.

Other rights, including access, rectification, and erasure, are also guaranteed.

OmicSpace has been designed in accordance with the principles promoted by the European Union regarding the secondary use of health data, including:

• Data sovereignty
• Secure cross-border data sharing
• Interoperability
• Data protection
• Ethical governance

The architecture and infrastructure of OmicSpace are aligned with the European Health Data Space (EHDS), which served as a key reference framework during its design and development.

OmicSpace contributes to:

• Accelerating biomedical research
• Supporting the development of personalised therapies
• Facilitating real-world evidence generation
• Enhancing clinical decision-making
• Improving the quality and sustainability of healthcare systems
• Enabling secure and responsible health data collaboration across institutions and countries