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A method for the classification of digital health architectures as medical devices ; a digital health research perspective
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Despotou, George, Harrison, Stuart and Arvanitis, Theodoros N. (2022) A method for the classification of digital health architectures as medical devices ; a digital health research perspective. In: Mantas, John and Gallos, Parisis and Zoulias, Emmanouil and Hasman, Arie and Househ, Mowafa S. and Diomidous, Marianna and Liaskos, Joseph and Charalampidou, Martha, (eds.) Advances in Informatics, Management and Technology in Healthcare. Studies in Health Technology and Informatics, 295 . IOS Press, pp. 1-4. ISBN 9781643682907
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Official URL: http://dx.doi.org/10.3233/SHTI220645
Abstract
It is typical for many digital health research projects to develop IT architectures that will implement integrated care services that may also deliver interventions. As part of compliance with the requirements of the regulation, the components that are considered as a medical device will need to be classified to a medical device category. This is often seen as task that may increase the business risk and a major barrier of the project, particularly during the earlier stages when not all information is available. The paper offers a method assisting with classification of such architectures in the context of the Medical Devices Rregulation, offering a structured way to identifying how the initial deliverables of a project can be used to provide assurance to the justification of the classification.
| Item Type: | Book Item | ||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RA Public aspects of medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Engineering > WMG (Formerly the Warwick Manufacturing Group) | ||||||
| Library of Congress Subject Headings (LCSH): | Medical technology -- Standards, Medical technology -- Safety measures, Medical care -- Technological innovations, Medical informatics, Medical instruments and apparatus -- Standards | ||||||
| Series Name: | Studies in Health Technology and Informatics | ||||||
| Journal or Publication Title: | Advances in Informatics, Management and Technology in Healthcare | ||||||
| Publisher: | IOS Press | ||||||
| ISBN: | 9781643682907 | ||||||
| ISSN: | 09269630 | ||||||
| Book Title: | Advances in Informatics, Management and Technology in Healthcare | ||||||
| Editor: | Mantas, John and Gallos, Parisis and Zoulias, Emmanouil and Hasman, Arie and Househ, Mowafa S. and Diomidous, Marianna and Liaskos, Joseph and Charalampidou, Martha | ||||||
| Official Date: | 2022 | ||||||
| Dates: |
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| Volume: | 295 | ||||||
| Page Range: | pp. 1-4 | ||||||
| DOI: | 10.3233/SHTI220645 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 4 July 2022 | ||||||
| Date of first compliant Open Access: | 4 July 2022 |
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