Overview #
The digitalisation of biobanks refers to the transformation of traditional biobanking infrastructures into integrated digital ecosystems capable of collecting, managing, storing, sharing, and analysing large volumes of biological and health-related data. Beyond the management of biological specimens, digital biobanks incorporate clinical, pathological, genomic, imaging, and other molecular data into interoperable digital platforms that support biomedical research, precision medicine, and the development of data-driven healthcare solutions.
Recent advances in next-generation sequencing (NGS), digital pathology, medical imaging, artificial intelligence (AI), machine learning, and high-throughput omics technologies have generated unprecedented quantities of heterogeneous biomedical data. Digital biobanks serve as critical infrastructures for organising these data, enabling their standardisation, integration, and reuse across institutions and research domains.
Digital biobanks have the potential to facilitate the sharing of curated and standardised clinical, imaging, pathological, and molecular data, fostering the development of predictive computational models and supporting precision medicine. Similarly, the growing adoption of digital pathology and automated data acquisition systems is transforming biobanks into interconnected repositories capable of supporting translational and personalised medicine.
The digitalisation process encompasses multiple components, including digital specimen tracking, laboratory information management systems (LIMS), electronic consent management, digital pathology platforms, cloud computing infrastructures, data integration frameworks, and secure mechanisms for data sharing and governance.
Key ethical, legal and societal issues #
Data protection and privacy #
Digital biobanks process large volumes of sensitive personal data, including genetic, health, imaging, and lifestyle information. Ensuring compliance with data protection principles, including data minimisation, purpose limitation, and security safeguards, is therefore essential.
Informed consent in the digital environment #
Digitalisation raises important questions regarding consent models. Traditional study-specific consent may not adequately address future secondary uses of data, international sharing, AI-driven analyses, or integration with external datasets. Dynamic consent and electronic consent models have emerged as potential solutions, enabling ongoing participant engagement and greater transparency.
Data sharing and international collaboration #
The scientific value of digital biobanks depends on data accessibility and interoperability. However, balancing open science objectives with privacy protection remains challenging. Cross-border data transfers, differing legal frameworks, and governance requirements may complicate international collaboration.
Artificial intelligence and secondary data use #
Digital biobanks increasingly support AI and machine learning applications. While these technologies can accelerate discovery and improve diagnostics, they may also introduce concerns regarding algorithmic bias, transparency, explainability, and accountability. Secondary uses of biobank data should remain consistent with ethical principles and applicable legal requirements.
Data quality, standardisation, and reproducibility #
The integration of data generated by different technologies and institutions requires harmonised standards and metadata frameworks. Insufficient standardisation may reduce scientific validity and limit data reuse.
Equity and digital inclusion #
Digital transformation should not exacerbate existing inequalities in healthcare and research participation. Unequal access to digital technologies, underrepresentation of specific populations, and disparities in data availability may affect the fairness and generalisability of research outcomes.
Governance and public trust #
Public trust remains fundamental to biobank sustainability. Transparent governance structures, clear policies regarding data access and sharing, stakeholder engagement, and accountability mechanisms are necessary to maintain societal confidence in digital biobanking initiatives.
Cybersecurity and data security #
As biobanks become increasingly digitalised, they are exposed to cybersecurity threats such as unauthorised access, ransomware attacks, data breaches, and system failures. Robust technical and organisational measures are required to ensure data integrity, confidentiality, and availability.
Relevant EU legislation #
- Charter of Fundamental Rights of the European Union: it establishes the foundational principles of human dignity, privacy, data protection, integrity of the person, and non-discrimination that underpin the governance of digital biobanks.
- General Data Protection Regulation (GDPR) – Regulation (EU) 2016/679: The GDPR constitutes the primary legal framework governing the processing of personal and genetic data within digital biobanks.
- Data Governance Act – Regulation (EU) 2022/868: The Data Governance Act promotes trustworthy mechanisms for data sharing and reuse, including the responsible use of data for scientific research purposes.
- European Health Data Space (EHDS) Regulation: The EHDS establishes a framework for the secure access, sharing, and secondary use of electronic health data across the European Union, creating significant opportunities for digital biobanks and health research infrastructures.
- Data Act – Regulation (EU) 2023/2854: The Data Act aims to improve access to and use of data generated across sectors, facilitating innovation and data sharing while protecting legitimate interests and fundamental rights.
- Clinical Trials Regulation – Regulation (EU) No 536/2014: Where digital biobanks support clinical research, this regulation establishes requirements regarding participant protection, informed consent, transparency, and data management.
- Artificial Intelligence Act – Regulation (EU) 2024/1689: The AI Act may apply to AI systems developed using biobank-derived data, particularly in healthcare and medical research contexts, introducing requirements relating to transparency, risk management, and human oversight.
BBMRI-ERIC resources #
- BBMRI-ERIC Guidelines and Quality Management Resources: Standardisation
- MIABIS: MINIMUM INFORMATION ABOUT BIOBANK DATA SHARING
External resources #
- International Agency for Research on Cancer (IARC). Technical Publication No. 44: Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research (Section 3: Information Management Systems and Digital Infrastructure), 2017.
- HL7 FHIR (Fast Healthcare Interoperability Resources)
Relevant literature #
- Brancato, V., Esposito, G., Coppola, L. et al. Standardizing digital biobanks: integrating imaging, genomic, and clinical data for precision medicine. J Transl Med 22, 136 (2024). https://doi.org/10.1186/s12967-024-04891-8
- Bukreeva, A.S.; Malsagova, K.A.; Petrovskiy, D.V.; Butkova, T.V.; Nakhod, V.I.; Rudnev, V.R.; Izotov, A.A.; Kaysheva, A.L. Biobank Digitalization: From Data Acquisition to Efficient Use. Biology 2024, 13, 957. https://doi.org/10.3390/biology13120957
- Bonizzi G, Zattoni L, Fusco N. Biobanking in the digital pathology era. Oncol Res. 2022 Aug 31;29(4):229-233. https://doi.org/10.32604/or.2022.024892
- Tozzo, P.; Delicati, A.; Marcante, B.; Caenazzo, L. Digital Biobanking and Big Data as a New Research Tool: A Position Paper. Healthcare 2023, 11, 1825. https://doi.org/10.3390/healthcare11131825
