Published Versions 1 Vol 2 (1) : 47–55 2019
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The “A” of FAIR - As Open as Possible, as Closed as Necessary
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Abstract & Keywords
Abstract: In order to provide responsible access to health data by reconciling benefits of data sharing with privacy rights and ethical and regulatory requirements, Findable, Accessible, Interoperable and Reusable (FAIR) metadata should be developed. According to the H2020 Program Guidelines on FAIR Data, data should be "as open as possible and as closed as necessary", "open" in order to foster the reusability and to accelerate research, but at the same time they should be "closed" to safeguard the privacy of the subjects. Additional provisions on the protection of natural persons with regard to the processing of personal data have been endorsed by the European General Data Protection Regulation (GDPR), Reg (EU) 2016/679, that came into force in May 2018. This work aims to solve accessibility problems related to the protection of personal data in the digital era and to achieve a responsible access to and responsible use of health data. We strongly suggest associating each data set with FAIR metadata describing both the type of data collected and the In order to provide responsible access to health data by reconciling benefits of data sharing with privacy rights and ethical and regulatory requirements, Findable, Accessible, Interoperable and Reusable (FAIR) metadata should be developed. According to the H2020 Program Guidelines on FAIR Data, data should be "as open as possible and as closed as necessary", "open" in order to foster the reusability and to accelerate research, but at the same time they should be "closed" to safeguard the privacy of the subjects. Additional provisions on the protection of natural persons with regard to the processing of personal data have been endorsed by the European General Data Protection Regulation (GDPR), Reg (EU) 2016/679, that came into force in May 2018. This work aims to solve accessibility problems related to the protection of personal data in the digital era and to achieve a responsible access to and responsible use of health data. We strongly suggest associating each data set with FAIR metadata describing both the type of data collected and the accessibility conditions by considering data protection obligations and ethical and regulatory requirements. Finally, an existing FAIR infrastructure component has been used as an example to explain how FAIR metadatacould facilitate data sharing while ensuring protection of individuals.
Keywords: Accessibility of health data; FAIR metadata; GDPR; Data sharing; ELSI
Acknowledgments
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Article and author information
Annalisa Landi
al@benzifoundation.org
Annalisa Landi, PharmD, II level post-graduate Master in Regulatory Sciences “G.Benzi” atUniversity of Pavia, Researcher at Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus.She is involved in scientific and regulatory activities, in particular related to data protection andconfidentiality, plan and management of patient registries and medicine databases management.ENCePP WG3 member.
0000-0001-9368-6424
Mark Thompson
Mark Thompson is a senior research scientist in the Biosemantics group at the Human Geneticsdepartment of Leiden University Medical Centre. He obtained a PhD in Computer Science fromthe University of Amsterdam in 2012. He has expertise in hardware and software architecture (co-)design, data management, data modeling, FAIR data infrastructure and computational aspects ofknowledge discovery.
0000-0002-7633-1442
Viviana Giannuzzi
Viviana Giannuzzi, PharmD, PhD in pharmacology, post-graduate master in Clinical Research ofMedicines, Senior Researcher at Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus andHead of the Research Department. Her main areas of expertise are: ethics and regulatory, nonclinical and clinical research, clinical studies application, pharmacology, orphan medicines andpaediatric research. She is patient representative at Paediatric Committee, European MedicineAgency (EMA), and member of WP4 Ethics Working Group of EnprEMA.
0000-0002-2534-6783
Fedele Bonifazi
Fedele Bonifazi, Biomedical engineer, II level Master in Health Technology Assessment andManagement, President of Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus. Memberof the HTA working group of the Regional Agency for Health and Social issues AReSS Puglia; expertof the Health Department of the Basilicata Region. At the Benzi Foundation, he is project managerand WP leader in several research projects and Head of the IT & Research Laboratory.
0000-0003-4935-5702
Ignasi Labastida
Ignasi Labastida is currently the work at the Head of the Research Unit at the University ofBarcelona’s Learning and Research Resources Centre (CRAI) where he also leads the Office for theDissemination of Knowledge. He is currently chairing the Board of SPARC Europe and he is amember of the Steering Committee of the Info and Open Access Policy Group at the League ofEuropean Research Universities (LERU). He is the co-author of the LERU Roadmap for ResearchData and the LERU Roadmap on Open Science. He has participated in several research projectsincluding LEARN, a EU H2020 project focused on helping research performing institutions inmanaging their research data.
0000-0001-7030-7030
Luiz Olavo Bonino da Silva Santos
Luiz Olavo Bonino da Silva Santos is the International Technology Coordinator of the GO FAIRInternational Support and Coordination Office, and Associate Professor of the BioSemantics groupat the Leiden University Medical Centre in Leiden, The Netherlands. His background is in ontologydriven conceptual modelling, semantic interoperability, service-oriented computing, requirementsengineering and context-aware computing. In the last five years Luiz has been involved in a numberof activities to realize the FAIR principles, including the development of a number of technologiesand tools to support making, publishing, indexing, searching and annotating FAIR (meta)data.
0000-0002-1164-1351
Marco Roos
Marco Roos is assistant professor and group leader of the Biosemantics group of the LeidenUniversity Medical Centre (Human Genetics Department). The group is known for co-founding andadvocating the FAIR data principles. His research focus is on making state-of-the-art computerscience applicable to enhance biomedical research (e-Science), particularly the application ofcomputational knowledge discovery and linked data techniques to address translational researchchallenges of rare human diseases. At an international level, Marco is focused on the implementationof FAIR principles to create a powerful substrate and worldwide robust infrastructure for knowledgediscovery across distributed rare disease data resources.
0000-0002-8691-772X
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Published: Oct. 17, 2019 (Versions1
References
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