Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order
<p dir="ltr">This paper examines the Saudi Food and Drug Authority’s (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical D...
Saved in:
| Main Author: | |
|---|---|
| Published: |
2024
|
| Subjects: | |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1864513510779650048 |
|---|---|
| author | Barry Solaiman (19160614) |
| author_facet | Barry Solaiman (19160614) |
| author_role | author |
| dc.creator.none.fl_str_mv | Barry Solaiman (19160614) |
| dc.date.none.fl_str_mv | 2024-06-21T12:00:00Z |
| dc.identifier.none.fl_str_mv | 10.1007/s41649-024-00285-6 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/journal_contribution/Regulating_AI-Based_Medical_Devices_in_Saudi_Arabia_New_Legal_Paradigms_in_an_Evolving_Global_Legal_Order/26316883 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Health sciences Health services and systems Information and computing sciences Artificial intelligence Machine learning Law and legal studies Law in context Philosophy and religious studies Applied ethics Artificial intelligence (AI) Saudi Arabia Medical devices Data Health Law |
| dc.title.none.fl_str_mv | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| dc.type.none.fl_str_mv | Text Journal contribution info:eu-repo/semantics/publishedVersion text contribution to journal |
| description | <p dir="ltr">This paper examines the Saudi Food and Drug Authority’s (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical Device Marketing Authorization. The regulation of AI in health is at an early stage worldwide. Therefore, it is critical to examine the scope and nature of the MDS-G010, its influences, and its future directions. It is argued that the guidance is a patchwork of existing international best practices concerning AI regulation, incorporates adapted forms of non-AI-based guidelines, and builds on existing legal requirements in the SFDA’s existing regulatory architecture. There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS-G010 is complex. There are binding ‘components’ within the guidance, but the incorporation of non-binding international best practices which are subordinate to national law results in a lack of clarity about how penalties for non-compliance will operate.</p><h2>Other Information</h2><p dir="ltr">Published in: Asian Bioethics Review<br>License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1007/s41649-024-00285-6" target="_blank">https://dx.doi.org/10.1007/s41649-024-00285-6</a></p> |
| eu_rights_str_mv | openAccess |
| id | Manara2_7021ca6f140b17a74dce9997c8ed5656 |
| identifier_str_mv | 10.1007/s41649-024-00285-6 |
| network_acronym_str | Manara2 |
| network_name_str | Manara2 |
| oai_identifier_str | oai:figshare.com:article/26316883 |
| publishDate | 2024 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal OrderBarry Solaiman (19160614)Health sciencesHealth services and systemsInformation and computing sciencesArtificial intelligenceMachine learningLaw and legal studiesLaw in contextPhilosophy and religious studiesApplied ethicsArtificial intelligence (AI)Saudi ArabiaMedical devicesDataHealthLaw<p dir="ltr">This paper examines the Saudi Food and Drug Authority’s (SFDA) Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices (the MDS-G010). The SFDA has pioneered binding requirements designed for manufacturers to obtain Medical Device Marketing Authorization. The regulation of AI in health is at an early stage worldwide. Therefore, it is critical to examine the scope and nature of the MDS-G010, its influences, and its future directions. It is argued that the guidance is a patchwork of existing international best practices concerning AI regulation, incorporates adapted forms of non-AI-based guidelines, and builds on existing legal requirements in the SFDA’s existing regulatory architecture. There is particular congruence with the approaches of the US Food and Drug Administration (FDA) and the International Medical Device Regulators Forum (IMDRF), but the SFDA goes beyond those approaches to incorporate other best practices into its guidance. Additionally, the binding nature of the MDS-G010 is complex. There are binding ‘components’ within the guidance, but the incorporation of non-binding international best practices which are subordinate to national law results in a lack of clarity about how penalties for non-compliance will operate.</p><h2>Other Information</h2><p dir="ltr">Published in: Asian Bioethics Review<br>License: <a href="https://creativecommons.org/licenses/by/4.0" target="_blank">https://creativecommons.org/licenses/by/4.0</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1007/s41649-024-00285-6" target="_blank">https://dx.doi.org/10.1007/s41649-024-00285-6</a></p>2024-06-21T12:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1007/s41649-024-00285-6https://figshare.com/articles/journal_contribution/Regulating_AI-Based_Medical_Devices_in_Saudi_Arabia_New_Legal_Paradigms_in_an_Evolving_Global_Legal_Order/26316883CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/263168832024-06-21T12:00:00Z |
| spellingShingle | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order Barry Solaiman (19160614) Health sciences Health services and systems Information and computing sciences Artificial intelligence Machine learning Law and legal studies Law in context Philosophy and religious studies Applied ethics Artificial intelligence (AI) Saudi Arabia Medical devices Data Health Law |
| status_str | publishedVersion |
| title | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| title_full | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| title_fullStr | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| title_full_unstemmed | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| title_short | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| title_sort | Regulating AI-Based Medical Devices in Saudi Arabia: New Legal Paradigms in an Evolving Global Legal Order |
| topic | Health sciences Health services and systems Information and computing sciences Artificial intelligence Machine learning Law and legal studies Law in context Philosophy and religious studies Applied ethics Artificial intelligence (AI) Saudi Arabia Medical devices Data Health Law |