Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation

Carlos Luis Parra-Calderón; Giulia Finocchiaro; Saif Ul Islam; Stuart Harrison; Gregory Epiphaniou; Carsten Maple; Parisis Gallos

doi:10.3233/SHTI250093

Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation

Carlos Luis Parra-Calderón^*
, Giulia Finocchiaro
, Saif Ul Islam
, Stuart Harrison
, Gregory Epiphaniou
, Carsten Maple
, Parisis Gallos

^*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

1 Scopus citations

Abstract

This paper presents a structured framework to assess the implementation of FAIR (Findable, Accessible, Interoperable, Reusable) principles in health datasets used in regulatory processes for digital health devices. With the FAIR Data Maturity Model from the Research Data Alliance (RDA) and the Pistoia Alliance's FAIR Maturity Matrix as foundational guides, this framework provides a scalable, adaptable approach for evaluating dataset readiness and compliance with regulatory requirements. By focusing on metadata quality, interoperability, and privacy, this study supports regulatory bodies and developers in aligning with FAIR principles, enhancing transparency, and ensuring that data meets the standards necessary for digital health device approval.

Original language	English
Title of host publication	Envisioning the Future of Health Informatics and Digital Health
Editors	John Mantas, Arie Hasman, Emmanouil Zoulias, Konstantinos Karitis, Parisis Gallos, Marianna Diomidous, Spyridon Zogas, Martha Charalampidou
Publisher	IOS Press BV
Pages	270-274
Number of pages	5
ISBN (Electronic)	9781643685908
DOIs	https://doi.org/10.3233/SHTI250093
State	Published - 8 Apr 2025
Externally published	Yes
Event	2024 International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2024 - Virtual, Online Duration: 13 Dec 2024 → 15 Dec 2024

Publication series

Name	Studies in Health Technology and Informatics
Volume	323
ISSN (Print)	0926-9630
ISSN (Electronic)	1879-8365

Conference

Conference	2024 International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2024
City	Virtual, Online
Period	13/12/24 → 15/12/24

Bibliographical note

Publisher Copyright:
© 2025 The Authors.

Keywords

digital health device regulation
digital health devices
FAIR data maturity Matrix
FAIR data maturity model
FAIR principles
health data
interoperability
Pistoia Alliance
privacy
RDA

ASJC Scopus subject areas

Biomedical Engineering
Health Informatics
Health Information Management

Access to Document

10.3233/SHTI250093

Cite this

Parra-Calderón, C. L., Finocchiaro, G., Ul Islam, S., Harrison, S., Epiphaniou, G., Maple, C., & Gallos, P. (2025). Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation. In J. Mantas, A. Hasman, E. Zoulias, K. Karitis, P. Gallos, M. Diomidous, S. Zogas, & M. Charalampidou (Eds.), Envisioning the Future of Health Informatics and Digital Health (pp. 270-274). (Studies in Health Technology and Informatics; Vol. 323). IOS Press BV. https://doi.org/10.3233/SHTI250093

Parra-Calderón, Carlos Luis ; Finocchiaro, Giulia ; Ul Islam, Saif et al. / Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation. Envisioning the Future of Health Informatics and Digital Health. editor / John Mantas ; Arie Hasman ; Emmanouil Zoulias ; Konstantinos Karitis ; Parisis Gallos ; Marianna Diomidous ; Spyridon Zogas ; Martha Charalampidou. IOS Press BV, 2025. pp. 270-274 (Studies in Health Technology and Informatics).

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abstract = "This paper presents a structured framework to assess the implementation of FAIR (Findable, Accessible, Interoperable, Reusable) principles in health datasets used in regulatory processes for digital health devices. With the FAIR Data Maturity Model from the Research Data Alliance (RDA) and the Pistoia Alliance's FAIR Maturity Matrix as foundational guides, this framework provides a scalable, adaptable approach for evaluating dataset readiness and compliance with regulatory requirements. By focusing on metadata quality, interoperability, and privacy, this study supports regulatory bodies and developers in aligning with FAIR principles, enhancing transparency, and ensuring that data meets the standards necessary for digital health device approval.",

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Parra-Calderón, CL, Finocchiaro, G, Ul Islam, S, Harrison, S, Epiphaniou, G, Maple, C & Gallos, P 2025, Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation. in J Mantas, A Hasman, E Zoulias, K Karitis, P Gallos, M Diomidous, S Zogas & M Charalampidou (eds), Envisioning the Future of Health Informatics and Digital Health. Studies in Health Technology and Informatics, vol. 323, IOS Press BV, pp. 270-274, 2024 International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2024, Virtual, Online, 13/12/24. https://doi.org/10.3233/SHTI250093

Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation. / Parra-Calderón, Carlos Luis; Finocchiaro, Giulia; Ul Islam, Saif et al.
Envisioning the Future of Health Informatics and Digital Health. ed. / John Mantas; Arie Hasman; Emmanouil Zoulias; Konstantinos Karitis; Parisis Gallos; Marianna Diomidous; Spyridon Zogas; Martha Charalampidou. IOS Press BV, 2025. p. 270-274 (Studies in Health Technology and Informatics; Vol. 323).

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution › peer-review

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Parra-Calderón CL, Finocchiaro G, Ul Islam S, Harrison S, Epiphaniou G, Maple C et al. Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation. In Mantas J, Hasman A, Zoulias E, Karitis K, Gallos P, Diomidous M, Zogas S, Charalampidou M, editors, Envisioning the Future of Health Informatics and Digital Health. IOS Press BV. 2025. p. 270-274. (Studies in Health Technology and Informatics). doi: 10.3233/SHTI250093

Characterizing a Framework for Assessment of the Use of FAIR Principles for Health Data in Digital Health Devices Regulation

Abstract

Publication series

Conference

Bibliographical note

Keywords

ASJC Scopus subject areas

Access to Document

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Cite this