Chatbots in medicine: certification process and applied use case
Chatbots are computer programs designed to engage in natural language conversations in an easy and understandable way. Their use has been accelerated recently with the advent of large language models. However, their application in medicine and healthcare has been limited due to concerns over data p...
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| Format: | Article |
| Language: | English |
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SMW supporting association (Trägerverein Swiss Medical Weekly SMW)
2024-10-01
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| Series: | Swiss Medical Weekly |
| Online Access: | https://smw.ch/index.php/smw/article/view/3954 |
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| _version_ | 1850180006732365824 |
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| author | Mayssam Nehme Franck Schneider Esther Amruthalingam Elio Schnarrenberger Raphaël Trëmeaud Idris Guessous |
| author_facet | Mayssam Nehme Franck Schneider Esther Amruthalingam Elio Schnarrenberger Raphaël Trëmeaud Idris Guessous |
| author_sort | Mayssam Nehme |
| collection | DOAJ |
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Chatbots are computer programs designed to engage in natural language conversations in an easy and understandable way. Their use has been accelerated recently with the advent of large language models. However, their application in medicine and healthcare has been limited due to concerns over data privacy, ther risk of providing medical diagnoses, and ensuring regulatory and legal compliance. Medicine and healthcare could benefit from chatbots if their scope is carefully defined and if they are used appropriately and monitored long-term.
The confIAnce chatbot, developed at the Geneva University Hospitals and the University of Geneva, is an informational tool aimed at providing simplified information to the general public about primary care and chronic diseases. In this paper, we describe the certification and regulatory aspects applicable to chatbots in healthcare, particularly in primary care medicine. We use the confIAnce chatbot as a case study to explore the definition and classification of a medical device and its application to chatbots, considering the applicable Swiss regulations and the European Union AI Act.
Chatbots can be classified anywhere from non-medical devices (informational tools that do not handle patient data or provide recommendations for treatment or diagnosis) to Class III medical devices (high-risk tools capable of predicting potentially fatal events and enabling a pre-emptive medical intervention). Key considerations in the definition and certification process include defining the chatbot’s scope, ensuring compliance with regulations, maintaining security and safety, and continuously evaluating performance, risks, and utility. A lexicon of relevant terms related to artificial intelligence in healthcare, medical devices, and regulatory frameworks is also presented in this paper.
Chatbots hold potential for both patients and healthcare professionals, provided that their scope of practice is clearly defined, and that they comply with regulatory requirements. This review aims to provide transparency by outlining the steps required for certification and regulatory compliance, making it valuable for healthcare professionals, scientists, developers, and patients.
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| format | Article |
| id | doaj-art-ec6deff1a87e48f0872bd8a2fee8fbaf |
| institution | OA Journals |
| issn | 1424-3997 |
| language | English |
| publishDate | 2024-10-01 |
| publisher | SMW supporting association (Trägerverein Swiss Medical Weekly SMW) |
| record_format | Article |
| series | Swiss Medical Weekly |
| spelling | doaj-art-ec6deff1a87e48f0872bd8a2fee8fbaf2025-08-20T02:18:20ZengSMW supporting association (Trägerverein Swiss Medical Weekly SMW)Swiss Medical Weekly1424-39972024-10-011541010.57187/s.3954Chatbots in medicine: certification process and applied use caseMayssam NehmeFranck Schneider0Esther Amruthalingam1Elio Schnarrenberger2Raphaël Trëmeaud3Idris Guessous4Direction of Communication, Geneva University HospitalsFaculty of Medicine, University of GenevaSäfeli SàrlPromotion Sante SuisseDivision of Primary Care Medicine, Geneva University Hospitals and Faculty of Medicine, University of Geneva Chatbots are computer programs designed to engage in natural language conversations in an easy and understandable way. Their use has been accelerated recently with the advent of large language models. However, their application in medicine and healthcare has been limited due to concerns over data privacy, ther risk of providing medical diagnoses, and ensuring regulatory and legal compliance. Medicine and healthcare could benefit from chatbots if their scope is carefully defined and if they are used appropriately and monitored long-term. The confIAnce chatbot, developed at the Geneva University Hospitals and the University of Geneva, is an informational tool aimed at providing simplified information to the general public about primary care and chronic diseases. In this paper, we describe the certification and regulatory aspects applicable to chatbots in healthcare, particularly in primary care medicine. We use the confIAnce chatbot as a case study to explore the definition and classification of a medical device and its application to chatbots, considering the applicable Swiss regulations and the European Union AI Act. Chatbots can be classified anywhere from non-medical devices (informational tools that do not handle patient data or provide recommendations for treatment or diagnosis) to Class III medical devices (high-risk tools capable of predicting potentially fatal events and enabling a pre-emptive medical intervention). Key considerations in the definition and certification process include defining the chatbot’s scope, ensuring compliance with regulations, maintaining security and safety, and continuously evaluating performance, risks, and utility. A lexicon of relevant terms related to artificial intelligence in healthcare, medical devices, and regulatory frameworks is also presented in this paper. Chatbots hold potential for both patients and healthcare professionals, provided that their scope of practice is clearly defined, and that they comply with regulatory requirements. This review aims to provide transparency by outlining the steps required for certification and regulatory compliance, making it valuable for healthcare professionals, scientists, developers, and patients. https://smw.ch/index.php/smw/article/view/3954 |
| spellingShingle | Mayssam Nehme Franck Schneider Esther Amruthalingam Elio Schnarrenberger Raphaël Trëmeaud Idris Guessous Chatbots in medicine: certification process and applied use case Swiss Medical Weekly |
| title | Chatbots in medicine: certification process and applied use case |
| title_full | Chatbots in medicine: certification process and applied use case |
| title_fullStr | Chatbots in medicine: certification process and applied use case |
| title_full_unstemmed | Chatbots in medicine: certification process and applied use case |
| title_short | Chatbots in medicine: certification process and applied use case |
| title_sort | chatbots in medicine certification process and applied use case |
| url | https://smw.ch/index.php/smw/article/view/3954 |
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