Agile and Holistic Medical Software Development: Final report of AHMED project

Jaakko Lähteenmäki; Pasi Ahola; Andrei Baraian; Klaus Förger; Tuomas Granlund; Jani Hopia; Risto Kaikkonen; Tommi Mikkonen; Timo Niemirepo; Juha Pajula; Jari Partanen; Timo Pellinen; Vlad Stirbu; Mika Torhola

Agile and Holistic Medical Software Development: Final report of AHMED project

Jaakko Lähteenmäki (Editor), Pasi Ahola, Andrei Baraian, Klaus Förger, Tuomas Granlund, Jani Hopia, Risto Kaikkonen, Tommi Mikkonen, Timo Niemirepo, Juha Pajula, Jari Partanen, Timo Pellinen, Vlad Stirbu, Mika Torhola

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Abstract

AHMED is a co-innovation project (https://www.regops.fi/) with six companies (Atostek, Bittium, Mylab, Solita, Taipuva Consulting and Terveystalo) and two research organisations (University of Helsinki and VTT). This report provides summarized results of the AHMED project focused on research, development and adoption of solutions for efficient production of data-driven applications for healthcare. The project particularly addressed challenges related to the usage of artificial intelligence, machine learning and personal data in regulated medical software. We present experiences and best practices for transition to the new medical device regulation (MDR), AI/ML compliant RegOps models, tools and toolchains for medical software development, healthcare register data usage for innovative applications and traceability approaches for research and AI/ML model development.

Original language	English
Publisher	VTT Technical Research Centre of Finland
Number of pages	53
Publication status	Published - 13 Feb 2023
MoE publication type	D4 Published development or research report or study

Publication series

Series	VTT Research Report
Number	VTT-R-01079-22

Keywords

medical device regulation
MLOps
DevOps
machine learning
artificial intelligence
medical device software

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VTT-R-01079-22Final published version, 2.24 MB

AHMED: Agile and Holistic MEdical software Development
Ahola, J., Lähteenmäki, J., Niemirepo, T. & Pärkkä, J.
1/07/20 → 30/06/22
Project: Business Finland project

Cite this

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abstract = "AHMED is a co-innovation project (https://www.regops.fi/) with six companies (Atostek, Bittium, Mylab, Solita, Taipuva Consulting and Terveystalo) and two research organisations (University of Helsinki and VTT). This report provides summarized results of the AHMED project focused on research, development and adoption of solutions for efficient production of data-driven applications for healthcare. The project particularly addressed challenges related to the usage of artificial intelligence, machine learning and personal data in regulated medical software. We present experiences and best practices for transition to the new medical device regulation (MDR), AI/ML compliant RegOps models, tools and toolchains for medical software development, healthcare register data usage for innovative applications and traceability approaches for research and AI/ML model development.",

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T1 - Agile and Holistic Medical Software Development

T2 - Final report of AHMED project

AU - Ahola, Pasi

AU - Baraian, Andrei

AU - Förger, Klaus

AU - Granlund, Tuomas

AU - Hopia, Jani

AU - Kaikkonen, Risto

AU - Mikkonen, Tommi

AU - Niemirepo, Timo

AU - Pajula, Juha

AU - Partanen, Jari

AU - Pellinen, Timo

AU - Stirbu, Vlad

AU - Torhola, Mika

A2 - Lähteenmäki, Jaakko

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N2 - AHMED is a co-innovation project (https://www.regops.fi/) with six companies (Atostek, Bittium, Mylab, Solita, Taipuva Consulting and Terveystalo) and two research organisations (University of Helsinki and VTT). This report provides summarized results of the AHMED project focused on research, development and adoption of solutions for efficient production of data-driven applications for healthcare. The project particularly addressed challenges related to the usage of artificial intelligence, machine learning and personal data in regulated medical software. We present experiences and best practices for transition to the new medical device regulation (MDR), AI/ML compliant RegOps models, tools and toolchains for medical software development, healthcare register data usage for innovative applications and traceability approaches for research and AI/ML model development.

AB - AHMED is a co-innovation project (https://www.regops.fi/) with six companies (Atostek, Bittium, Mylab, Solita, Taipuva Consulting and Terveystalo) and two research organisations (University of Helsinki and VTT). This report provides summarized results of the AHMED project focused on research, development and adoption of solutions for efficient production of data-driven applications for healthcare. The project particularly addressed challenges related to the usage of artificial intelligence, machine learning and personal data in regulated medical software. We present experiences and best practices for transition to the new medical device regulation (MDR), AI/ML compliant RegOps models, tools and toolchains for medical software development, healthcare register data usage for innovative applications and traceability approaches for research and AI/ML model development.

KW - medical device regulation

KW - MLOps

KW - DevOps

KW - machine learning

KW - artificial intelligence

KW - medical device software

M3 - Report

T3 - VTT Research Report

BT - Agile and Holistic Medical Software Development

PB - VTT Technical Research Centre of Finland

ER -

Agile and Holistic Medical Software Development: Final report of AHMED project

Abstract

Publication series

Keywords

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AHMED: Agile and Holistic MEdical software Development

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