Publications

From EU-STANDS4PM

Computational Models for Clinical Applications in Personalized Medicine—Guidelines and Recommendations for Data Integration and Model Validation

Review article providing an overview of computational models for personalized medicine, including data integration and model validation guidelines

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Transparency of machine-learning in healthcare: The GDPR & European health law

Article discussing the question of transparency of machine learning models in healthcare.

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Controversies between regulations of research ethics and protection of personal data: informed consent at a cross-road

Article discussing key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: (a) the data protection regime which follows the application of the European Union General Data Protection Regulation (GDPR), and (b) the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations.

 PubMed-ID: 34787769

ISO Technical Specification

EU-STANDS4PM prepared and submitted 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" that has been approved as new work item by the Technical Committee ISO/TC 276 Biotechnology.

 ISO Technical Specification (abstract)

Harmonization and integration of big data of relevance for personalized medicine into in silico modelling? – Recommendations for technically feasible, and ethico-legal sustainable avenues.

Follow up report that explores solutions to the challenges identified in the first report and outline technically feasible as well as legally and ethically sustainable avenues for harmonization/integration of big data of relevance for personalized medicine into in silico modelling.

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Towards standardization guidelines for in silico approaches in personalized medicine

Article addressing requirements with respect to the development of data and model standards as well as data integration tasks in research and clinic, including ethical and legal aspects.

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New harmonized Data Access Agreement  (hDAA)

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.

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White Paper: Towards in silico approaches for personalised medicine – Recommendations for verifying and validating predictive computational models in EU collaborative research

EU-STANDS4PM white paper featuring recommendations for standardization of data integration as well as recommendations for standardization of model validation within a collaborative research context.

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Legal and ethical review of in silico modelling

The development of in silico models for personalised medicine in the EU requires lawful and ethical data integration. The ultimate use of these models will also require the use of information in these automated systems in a fair and transparent way, which respects patients’ rights.

download legal and ethicla review (full version)

download legal and ethicla review (compact version)

Others

RDA Guidelines

The Research Data Alliance (RDA) released a set of comprehensive recommendations and guidelines for data sharing under the present COVID-19 circumstances.

Two universes – one world: Community standards vs. formal ISO standards in the life sciences

Webinar on “formal” standardization efforts for data in the life sciences that tries to bridge between community standards and ISO standards. Given by EU-STANDS4PM partner HITS (The Heidelberg Institute for Theoretical Studies, speaker: Martin Golebiewski).

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