University of Oulu

Agyei, E.E.Y.F., Pohjolainen, S., Oinas-Kukkonen, H. (2022). Impact of Medical Device Regulation on Developing Health Behavior Change Support Systems. In: Baghaei, N., Vassileva, J., Ali, R., Oyibo, K. (eds) Persuasive Technology. PERSUASIVE 2022. Lecture Notes in Computer Science, vol 13213. Springer, Cham.

Impact of medical device regulation on developing health behavior change support systems

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Author: Agyei, Eunice Eno Yaa Frimponmaa1; Pohjolainen, Sami1; Oinas-Kukkonen, Harri1
Organizations: 1University of Oulu, OASIS, Pentti Kaiteran katu 1, 90570, Oulu, Finland
Format: article
Version: accepted version
Access: embargoed
Persistent link:
Language: English
Published: Springer Nature, 2022
Publish Date: 2023-03-21


The enforcement of the Medical Devices Regulation (MDR) began in the European Union (EU) in May 2021. Under MDR, software and information systems may be considered as medical devices. Behaviour Change Support Systems (BCSS) are information and communication technologies aimed at helping their users to achieve behaviour change targets. Designers, developers, and researchers of health BCSS (hBCSS) need to understand the impact of this new regulation on the development of such systems as the regulation influences both design and development in a variety of ways. Furthermore, myriads of health BCSS have been developed previously in the medical, fitness, and wellbeing domains, and a substantial number of them may require qualification, classification, or reclassification as medical devices under the new regulation. However, the regulation process is complex and requires knowledge and expertise which many manufacturers do not have in-house. Depending on the context and classification, the costs may suddenly ramp up and become too much for smaller developers, and thus they should be carefully assessed. In this paper, we discuss the regulation from the point of view of hBCSS developers. We look at the regulatory process and highlight key issues for developers of hBCSS. Particular attention is given to the classification and design requirements most likely to pose immediate challenges to developers. In addition, we discuss the costs associated with MDR which are difficult to estimate without previous experience.

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Series: Lecture notes in computer science
ISSN: 0302-9743
ISSN-E: 1611-3349
ISSN-L: 0302-9743
ISBN: 978-3-030-98438-0
ISBN Print: 978-3-030-98437-3
Volume: 13213
Pages: 1 - 15
DOI: 10.1007/978-3-030-98438-0_1
Host publication: Persuasive Technology. 17th International Conference, PERSUASIVE 2022, Virtual Event, March 29–31, 2022, Proceedings
Host publication editor: Baghaei, Nilufar
Vassileva, Julita
Ali, Raian
Oyibo, Kiemute
Conference: International Conference on Persuasive Technology
Type of Publication: A4 Article in conference proceedings
Field of Science: 113 Computer and information sciences
Copyright information: © 2022 Springer Nature Switzerland AG. This is a post-peer-review, pre-copyedit version of an article published in Lecture Notes in Computer Science, vol 13213. The final authenticated version is available online at