A4 Vertaisarvioitu artikkeli konferenssijulkaisussa
Clinical Investigation of Health Technologies: A Scoping Review of Evaluation Methods; 
Tekijät: Saukkonen, Axa; Härkönen, Henna; Syrjälä, Jenna; Vanhanen, Minna; Laukka, Elina; Torkki, Paulus; Talman, Kirsi; Yesmean, Monira; Jansson, Miia
Toimittaja: Särestöniemi, Mariella; Singh, Daljeet; Jarva, Erika; Reponen, Jarmo
Konferenssin vakiintunut nimi: Nordic Conference on Digital Health and Wireless Solutions
Kustantaja: Springer Nature Switzerland
Julkaisuvuosi: 2026
Lehti: Communications in Computer and Information Science
Kokoomateoksen nimi: Digital Health and Wireless Solutions : Towards Trustworthy and Person-Centric Digital Health : Second Nordic Conference, NCDHWS 2026, Oulu, Finland, June 16–17, 2026, Proceedings, Part I
Vuosikerta: 3009
Aloitussivu: 151
Lopetussivu: 165
ISBN: 978-3-032-28811-0
eISBN: 978-3-032-28812-7
ISSN: 1865-0929
eISSN: 1865-0937
DOI: https://doi.org/10.1007/978-3-032-28812-7_13
Julkaisun avoimuus kirjaamishetkellä: Avoimesti saatavilla
Julkaisukanavan avoimuus : Kokonaan avoin julkaisukanava
Verkko-osoite: https://doi.org/10.1007/978-3-032-28812-7_13
Rinnakkaistallenteen osoite: https://research.utu.fi/converis/portal/detail/Publication/526922299
Rinnakkaistallenteen lisenssi: CC BY
Rinnakkaistallennetun julkaisun versio: Kustantajan versio
The aim of this scoping review was to synthesize and map recommended evaluation methods for the clinical investigation of health technologies. A database search was conducted in January 2025 in the Scopus, Ovid MEDLINE, and CINAHL databases, and grey literature was searched in the Mednar database. Publications from 2015–2024 were included if they described the clinical investigation of health technologies at various maturity levels, as assessed using the Technology Readiness Level (TRL) framework. Nine studies were included in the review. Recommended evaluation methods varied across different TRLs, with considerable overlap observed between evaluation domains. In addition, these methods exhibited an evolutionary progression, becoming increasingly rigorous and incorporating broader contextual and social considerations as technological maturity advanced. At TRLs 5–6, clinical investigations focused on efficacy; at TRLs 7–8, on effectiveness and clinical validity; and at the highest maturity level, on implementation and clinical utility. Notably, evaluation methods were not recommended by device risk class. The clinical investigations of health technologies remains fragmented, and no consistent approach has been established. The application of the TRL framework provided a novel and structured approach to map evaluation methods according to the stage of maturity. There is a need for harmonized evaluation frameworks that support clinical investigations in line with EU regulations.
Avainsanat:
Clinical Evaluation, Clinical Validation, In Vitro Diagnostic Medical Devices, medical device, Technology Readiness Level
Ladattava julkaisu This is an electronic reprint of the original article. |  |
