Development of medical applications based on AI models and register data – regulatory considerations

Jaakko Lähteenmäki; Juha Pajula; Emmi Antikainen

Development of medical applications based on AI models and register data – regulatory considerations

Jaakko Lähteenmäki
, Juha Pajula
, Emmi Antikainen

BA6308 Health data analytics

Research output: Chapter in Book/Report/Conference proceeding › Conference article in proceedings › Scientific › peer-review

Abstract

Artificial intelligence based methods, especially machine learning (ML), are increasingly used in healthcare for automatic medical image analysis and clinical decision support systems. Development and validation of ML models involve processing of large volumes of personal data. We analysed regulatory impacts on ML based application development especially from the perspective of privacy protection and usage of ML models as a basis for software under medical device regulation (MDR). We present best practices for ML application development and personal data usage in a use case of predicting elderly individuals’ future need for healthcare and social welfare services.

Original language	English
Title of host publication	Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022)
Editors	André Henriksen, Elia Gabarron, Vivian Vimarlund
Publisher	Linköping University Electronic Press
Pages	141-146
Number of pages	6
ISBN (Electronic)	978-91-7929-344-4
Publication status	Published - 24 Aug 2022
MoE publication type	A4 Article in a conference publication
Event	18th Scandinavian Conference on Health Informatics, SHI 2022 - Tromsø, Norway Duration: 22 Aug 2022 → 24 Aug 2022 Conference number: 18 https://uit.no/tavla/artikkel/764177/scandinavian_conference_on_health_informatics

Publication series

Series	Linköping Electronic Conference Proceedings
Number	187
ISSN	1650-3686

Conference

Conference	18th Scandinavian Conference on Health Informatics, SHI 2022
Abbreviated title	SHI 2022
Country/Territory	Norway
City	Tromsø
Period	22/08/22 → 24/08/22
Internet address	https://uit.no/tavla/artikkel/764177/scandinavian_conference_on_health_informatics

Keywords

artificial intelligence
machine learning
medical device regulation
MDR
privacy protection

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Lähteenmäki, J., Pajula, J., & Antikainen, E. (2022). Development of medical applications based on AI models and register data – regulatory considerations. In A. Henriksen, E. Gabarron, & V. Vimarlund (Eds.), Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022) (pp. 141-146). Linköping University Electronic Press. https://ecp.ep.liu.se/index.php/shi/issue/view/58/56

Lähteenmäki, Jaakko ; Pajula, Juha ; Antikainen, Emmi. / Development of medical applications based on AI models and register data – regulatory considerations. Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022). editor / André Henriksen ; Elia Gabarron ; Vivian Vimarlund. Linköping University Electronic Press, 2022. pp. 141-146 (Linköping Electronic Conference Proceedings; No. 187).

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abstract = "Artificial intelligence based methods, especially machine learning (ML), are increasingly used in healthcare for automatic medical image analysis and clinical decision support systems. Development and validation of ML models involve processing of large volumes of personal data. We analysed regulatory impacts on ML based application development especially from the perspective of privacy protection and usage of ML models as a basis for software under medical device regulation (MDR). We present best practices for ML application development and personal data usage in a use case of predicting elderly individuals{\textquoteright} future need for healthcare and social welfare services.",

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booktitle = "Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022)",

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note = "18th Scandinavian Conference on Health Informatics, SHI 2022, SHI 2022 ; Conference date: 22-08-2022 Through 24-08-2022",

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Lähteenmäki, J , Pajula, J & Antikainen, E 2022, Development of medical applications based on AI models and register data – regulatory considerations. in A Henriksen, E Gabarron & V Vimarlund (eds), Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022). Linköping University Electronic Press, Linköping Electronic Conference Proceedings, no. 187, pp. 141-146, 18th Scandinavian Conference on Health Informatics, SHI 2022, Tromsø, Norway, 22/08/22. <https://ecp.ep.liu.se/index.php/shi/issue/view/58/56>

Development of medical applications based on AI models and register data – regulatory considerations. / Lähteenmäki, Jaakko ; Pajula, Juha; Antikainen, Emmi.
Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022). ed. / André Henriksen; Elia Gabarron; Vivian Vimarlund. Linköping University Electronic Press, 2022. p. 141-146 (Linköping Electronic Conference Proceedings; No. 187).

Research output: Chapter in Book/Report/Conference proceeding › Conference article in proceedings › Scientific › peer-review

TY - GEN

T1 - Development of medical applications based on AI models and register data – regulatory considerations

AU - Lähteenmäki, Jaakko

AU - Pajula, Juha

AU - Antikainen, Emmi

N1 - Conference code: 18

PY - 2022/8/24

Y1 - 2022/8/24

N2 - Artificial intelligence based methods, especially machine learning (ML), are increasingly used in healthcare for automatic medical image analysis and clinical decision support systems. Development and validation of ML models involve processing of large volumes of personal data. We analysed regulatory impacts on ML based application development especially from the perspective of privacy protection and usage of ML models as a basis for software under medical device regulation (MDR). We present best practices for ML application development and personal data usage in a use case of predicting elderly individuals’ future need for healthcare and social welfare services.

AB - Artificial intelligence based methods, especially machine learning (ML), are increasingly used in healthcare for automatic medical image analysis and clinical decision support systems. Development and validation of ML models involve processing of large volumes of personal data. We analysed regulatory impacts on ML based application development especially from the perspective of privacy protection and usage of ML models as a basis for software under medical device regulation (MDR). We present best practices for ML application development and personal data usage in a use case of predicting elderly individuals’ future need for healthcare and social welfare services.

KW - artificial intelligence

KW - machine learning

KW - medical device regulation

KW - MDR

KW - privacy protection

M3 - Conference article in proceedings

T3 - Linköping Electronic Conference Proceedings

SP - 141

EP - 146

BT - Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022)

A2 - Henriksen, André

A2 - Gabarron, Elia

A2 - Vimarlund, Vivian

PB - Linköping University Electronic Press

T2 - 18th Scandinavian Conference on Health Informatics, SHI 2022

Y2 - 22 August 2022 through 24 August 2022

ER -

Lähteenmäki J , Pajula J, Antikainen E. Development of medical applications based on AI models and register data – regulatory considerations. In Henriksen A, Gabarron E, Vimarlund V, editors, Proceedings of the 18th Scandinavian Conference on Health Informatics (SHI 2022). Linköping University Electronic Press. 2022. p. 141-146. (Linköping Electronic Conference Proceedings; No. 187).

Development of medical applications based on AI models and register data – regulatory considerations

Abstract

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