Abstract
Artificial intelligence (AI) can have a significant positive impact on health and healthcare. AI can be used to improve the quality, efficiency and equity of health care. However, AI has the potential to have significant negative impacts. Therefore, AI medical applications should be designed and deployed in accordance with established guidelines and legislation. There may be gaps or questions in the current regulatory framework related to the interpretation and application of the existing regulatory framework to healthcare applications that include artificial intelligence solutions. Global standardization maintains a consistent approach and can reduce the burden on stakeholders when it comes to establishing regulatory frameworks, interpreting and complying with regulatory requirements. While AI is far from new, it has only recently become mainstream. This chapter outlines the research of the authors who are members of the Hoc Group on Application of AI Technologies in Health Informatics (ISO AHG2 TC215), which was formed by ISO Technical Committee 215 to define goals and directions for standardization in the field of AI in health care.
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Acknowledgements
The authors would like to thank the leadership of Technical Committee ISO/TC 215 “Health Informatics” and Subcommittee ISO/IEC JTC 1/SC 42 “Artificial Intellegence” of ISO Technical Committee ISO/IEC JTC 1 “Information Technology” for providing the opportunity to bring together such a wonderful international team and do useful and meaningful work.
*Hoc Group on Application of AI Technologies in Health Informatics (AHG2 TC215 ISO)
Paolo Alcini1, Pat Baird2, Peter Williams3, SB Bhattacharyya6, Todd Cooper7, Rich de la Cruz8, Chandan Kumar9, Gora Datta10, Dorotea Alessandra De Marco11, Andreas Franken12, Regina Geierhofer13, Peter G. Goldschmidt14, Ilkka Juuso15, 16, Herman Klimenko4, Antonio Kung17, Frederic Laroche18, Joe Lewelling19, Martin Meyer20, Sergey Morozov21, Anna Orlova22, Telonis Panagiotis23, Thomas Penzel24, Derek Ritz25, Gaur Sander26, Soo-Yong Shin27, Alpo Värri28, Anton Vladzimerskiy4, 21, Georgy Lebedev4, 5 (lebedev@d-health.institute).
Affiliations
1European Medicines Agency, 2Royal Philips, Pleasant Prairie, USA, 3Oracle Corporation, 4I.M. Sechenov First Moscow State Medical University (Sechenov University), 5Federal Research Institute for Health Organization and Informatics, 6Bhattacharyyas Clinical Records Research & Informatics, 7Trusted Solutions Foundry, Inc., San Diego, USA, 8Silver Lake Group, Inc., Minnetonka, USA, 9Indian Standards (BIS), New Delhi, India, 10CAL2CAL Corporation, Irvine, USA, 11Italian Data Protection Authority, 12Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn, Germany, 13Medizinische Universität Graz, Austria, 14World Development Group, Inc., 15Cerenion Ltd., 16Center for Machine Vision and Signal Analysis at the University of Oulu, 17Trialog, Paris, France, 18LCI Consulting Inc, Montreal, Canada, 19Association for the Advancement of Medical Instrumentation, Arlington, USA, 20Siemens Healthineers, 21Research and Practical Center of Medical Radiology, Department of Health Care of Moscow, 22School of Medicine, Tufts University, Boston, USA, 23European Medicines Agency, Amsterdam, The Netherlands, 24Charite University Hospital, Interdisciplinary Center of Sleep Medicine, Berlin, Germany, 25ecGroup Inc, 26Centre for Development of Advanced Computing (C-DAC), India, 27SungKyunKwan University, Seoul, Republic of Korea, 28Tampere University, Faculty of Medicine and Health Technology, Tampere, Finland
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Hoc Group on Application of AI Technologies. (2022). Artificial Intelligence in Healthcare: Directions of Standardization. In: Lim, CP., Chen, YW., Vaidya, A., Mahorkar, C., Jain, L.C. (eds) Handbook of Artificial Intelligence in Healthcare. Intelligent Systems Reference Library, vol 212. Springer, Cham. https://doi.org/10.1007/978-3-030-83620-7_10
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