• Joining forces

    On January 1st 2019 the Horizon2020 Coordinating and Support Action “EU-STANDS4PM - A European standardization framework for data integration and data-driven in silico models for personalised medicine” launched activities.

  • From data to knowledge

    The EU-STANDSPM project seeks to assess and evaluate national standardization strategies for interoperable health data integration as well as data-driven in silico modelling approaches for personalised medicine with the aim to bundle European standardization efforts.

  • Strategies for data integration

    During the last decade many community based standards have been developed to describe biocomplexity of diseases. This led to high degree of fragmentation and many specialised standards that are very often not compatible. 

  • Standards for in silico models for personalised medicine

    Despite the ever progressing technological advances in producing data, the exploitation of Big Data information to generate new knowledge for medical benefits is lacking behind its full potential.

  • Legal, ethics & data governance

    EU-STANDS4PM will address key barriers relating to data access, dissemination as well as governance and provide comprehensive legal and ethical guidance for in silico modelling in personalised medicine.


A European standardization framework for data integration and data-driven in silico models

for personalised medicine

EU-STANDS4PM is a Coordinating and Support Action funded under the Horizon2020 framework programme of the European Commission. Core of the project is a pan-European expert forum and network that combines extensive experience from its sixteen partners, including H2020 collaborative research projects, normative and regulatory agencies, large European infrastructures, Industry as well as ethical and legal expertise from eight European countries.

During the next three years EU-STANDS4PM will initiate an EU-wide mapping process to assess and evaluate strategies for data-driven in silico modelling approaches. A central goal is to develop harmonised transnational standards, recommendations and guidelines that allow a broad application of predictive in silico methodologies in personalised medicine across Europe.

Background and Aims


Programme: European Commission H2020 Work Programme 2018-2020Health, demographic change and wellbeing

Call: Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework (SC1-HCO-02-2018)

Project titel: Data integration and data-driven in-silico models for enabling personalised medicine - a European standardization framework (EU-STANDS4PM)

Type of Action: Coordination and support action

Budget: 2.0 Million Euro

Project duration: 3 years (01/2019 - 12/2021)

Consortium: 16 partners, 8 countries

Coordinator: Forschungszentrum JülichGmbH, Project Management Juelich

EU-STANDS4PM is an open network and seeks input from all relevant stakeholders that have an interest in advancing predictive in silico methodologies in personalised medicine through broadly applicable standards for data integration and harmonisation. Our goal is to sustain the competitiveness of the European Research Area and to ensure a leading role for the European personalised medicine community of stakeholders in the transition from current reactive medical practice to a data-driven and predictive medicine of the future.

The EU-STANDS4PM consortium has the overarching aim to bundle transnational standardization guidelines for in silico methodologies in transnational and clinical research to:

  • harmonise health and disease data integration strategies to further strengthen data-driven in silico modelling approaches for personalised medicine in Europe.
  • facilitate a sustained use of Life Science data in clinical and health research.
  • advise regulatory authorities on a broad adaptation of harmonised health data and standards in research, and industry.
  • enable FAIR principles (Findable, Accessible, Interoperable and Reproducible) (Wilkinson et al., 2016) as well as legal and ethical requirements for the above tasks.
  • accelerate growth of the European data-driven economy.


Big data in health

Although Big Data already drives fundamental medical/scientific applications and the associated socioeconomic potential forward, a large-scale future exploitation of Big Data in research and health care represents a major challenge.

Data integration

Currently there are no widely accepted, overarching strategies or concepts to harmonise the integration of heterogeneous health/disease data and data-driven in silico approaches that interpret Big Data to enable personalised medicine.


While the technological basis for the generation of data and their storage is relatively trivial from an IT perspective, the analysis of data, however, relies on the sharing and integration of data and this relies on standards.

Harmonisation needs

A wide adoption of standards, best practices and data harmonization strategies is key to ensure future benefits for in silico approaches in personalized medicine. 


Marc Kirschner, Coordinator
+49 2461 61-6863

EU-STANDS4PM harmonized Data Access Agreement part of ERA-PerMed call guidelines

In the 2022 joint transnational call of ERA-PerMed "PREVENTION IN PERSONALISED MEDICINE" the EU-SATNDS4PM hDAA is referenced in the guidelines for applicants. This is a reslt of the collaboration between EU-STANDS4PM and ERA-PerMed in an effort to improve data sharing, dissemination and governance for European collaborative research projects.
ERA-PerMed call

Publication on research ethics and protection of personal data

The EU-SATNDS4PM atricle "Controversies between regulations of research ethics and protection of personal data: informed consent at a cross‑road" has been pblished recently. PubMed-ID: 34787769

EU-STANDS4PM ISO Technical Specification

n October 2021 the ISO Technical Specification draft "Biotechnology — Recommendations and requirements for predictive computational models in personalized medicine research — Part 1: Guidelines for constructing, verifying and validating models" has been approved as new work item proposal by the Technical Committee ISO/TC 276 Biotechnology.

New harmonized Data Access Agreement

EU-STANDS4PM rolled out a standardized Data Access Agreement that is fully compatible with the EU General Data Protection Regulation. This new harmonized Data Access Agreement for Controlled Access Data (hDAA) aims at a better harmonization of data across collaborative research projects and improves data governance and flexibility.
The EU-STANDS4PM hDAA is deposited as a standard template at the  European Genome Phenome Archive (EGA).

Towards standardization guidelines for in silico approaches in personalized medicine

EU-STANDS4PM manuscript published in the Journal of Integrative Bioinformatics

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