BIGAN: Aragón Region Health Data Hub

BIGAN (Aragón) — what it is and how it links to Biobank samples

BIGAN is the Government of Aragón’s secure health‑data platform, operated by the Aragon Health Sciences Institute (IACS), that integrates routinely collected clinical information (primary care, hospital, emergency, pharmacy, imaging/labs and more) into an anonymized environment for analysis and decision‑making in care, management, training and research. It’s formally created and governed by ORDER SAN/1355/2018, which sets its legal, technical and governance framework.

Data coverage & protections

BIGAN consolidates region‑wide electronic health records and administrative data and is catalogued at the European level as a regional real‑world data source whose scope includes biobank among its domains. Data are captured, anonymized, safeguarded, and analyzed by IACS; users never see any direct identifiers.

Access for research (secondary use)

Researchers access data through BIGAN Investigación (BIGAN Research). Projects that use BIGAN data for research purposes must obtain prior approval by CEICA (Aragón’s Research Ethics Committee); only then does BIGAN grant governed access to the required anonymized datasets.

Linkage with the Biobank of the Aragón Health System (BSSA)

The Biobank Aragón (BSSA) is a transversal infrastructure that collects, preserves and provides biological samples together with associated clinical data from Aragón’s health network, making disease‑oriented and population collections available to qualified investigators. Examples include tumor tissue, longitudinal blood samples and disease‑specific cohorts (e.g., dyslipidemias, adipose tissue metabolism).

How linkage works (governed, privacy‑preserving):

1. Cohort definition in BIGAN
   The investigator defines a cohort using anonymized clinical variables (diagnoses, encounters, treatments, lab values, etc.) within BIGAN’s research environment.

2. Ethics & approvals
   The study protocol—including any plan to request biospecimens—is reviewed by CEICA. BIGAN only releases research datasets after CEICA approval; biospecimen use follows the biobank regulatory framework (e.g., Spain’s RD 1716/2011) and BSSA procedures.

3. Biobank query & match
   Under approved protocols, BSSA checks whether pseudonymized donors corresponding to the BIGAN cohort have available biospecimens (e.g., FFPE blocks, serum, PBMCs) and processes the request according to consent, availability and scientific merit.

4. Data‑sample integration for analysis
   The investigator receives:

   • Anonymized BIGAN dataset(s) for the defined cohort; and

   • The requested biospecimens (with associated metadata) from BSSA, released under biobank SOPs and CEICA authorization—enabling multi‑omics, biomarker validation or translational RWD/RWS studies.

The EMA/HMA catalogue explicitly lists BIGAN as containing regional health data “including biobank”, confirming its design for interoperability between the data lake and biobank metadata in vetted research workflows.