Validation and verification framework and data integration of biosensors and diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division.

Gruson, Damien;Cobbaert, Christa;Dabla, Pradeep Kumar;Stankovic, Sanja;Gouget, Bernard;et.al.
(2024) Clinical Chemistry and Laboratory Medicine : Associated with FESCC and IFCC — Vol. 62, n° 10, p. 1904-1917 (2024)

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  • Gruson, DamienUCLouvain
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  • Cobbaert, Christa
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  • Dabla, Pradeep Kumar
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  • Stankovic, Sanja
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  • Gouget, Bernardorcid-logo
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Abstract
Advances in technology have transformed healthcare and laboratory medicine. Biosensors have emerged as a promising technology in healthcare, providing a way to monitor human physiological parameters in a continuous, real-time, and non-intrusive manner and offering value and benefits in a wide range of applications. This position statement aims to present the current situation around biosensors, their perspectives and importantly the need to set the framework for their validation and safe use. The development of a qualification framework for biosensors should be conceptually adopted and extended to cover digitally measured biomarkers from biosensors for advancing healthcare and achieving more individualized patient management and better patient outcome.
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Gruson, D., Cobbaert, C., Dabla, P. K., Stankovic, S., Homsak, E., Kotani, K., Samir Assaad, R., Nichols, J. H., & Gouget, B. (2024). Validation and verification framework and data integration of biosensors and diagnostic devices: a position statement of the IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MBHLM) and the IFCC Scientific Division. Clinical Chemistry and Laboratory Medicine : Associated with FESCC and IFCC, 62(10), 1904-1917. https://doi.org/10.1515/cclm-2023-1455 (Original work published 2024)