The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research
This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and res...
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| Format: | Article |
| Language: | English |
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Korean Spinal Neurosurgery Society
2025-03-01
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| Series: | Neurospine |
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| Online Access: | http://e-neurospine.org/upload/pdf/ns-2449186-593.pdf |
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| author | Massimo Bottini Seung-Jun Ryu Adrian Elmi Terander Stefanos Voglis Nicolai Maldaner David Bellut Luca Regli Carlo Serra Victor E. Staartjes |
| author_facet | Massimo Bottini Seung-Jun Ryu Adrian Elmi Terander Stefanos Voglis Nicolai Maldaner David Bellut Luca Regli Carlo Serra Victor E. Staartjes |
| author_sort | Massimo Bottini |
| collection | DOAJ |
| description | This paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success. |
| format | Article |
| id | doaj-art-9700d5c3bd8e437b949dbacec7a3ec39 |
| institution | DOAJ |
| issn | 2586-6583 2586-6591 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Korean Spinal Neurosurgery Society |
| record_format | Article |
| series | Neurospine |
| spelling | doaj-art-9700d5c3bd8e437b949dbacec7a3ec392025-08-20T03:06:14ZengKorean Spinal Neurosurgery SocietyNeurospine2586-65832586-65912025-03-0122113414310.14245/ns.2449186.5931678The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence ResearchMassimo Bottini0Seung-Jun Ryu1Adrian Elmi Terander2Stefanos Voglis3Nicolai Maldaner4David Bellut5Luca Regli6Carlo Serra7Victor E. Staartjes8 Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Department of Neurosurgery, Daejeon Eulji University Hospital, Eulji University Medical School, Daejeon, Korea Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, Switzerland Machine Intelligence in Clinical Neuroscience & Microsurgical Neuroanatomy (MICN) Laboratory, Department of Neurosurgery, Clinical Neuroscience Center, University Hospital Zürich, University of Zürich, Zürich, SwitzerlandThis paper analyzes the regulatory frameworks for artificial intelligence/machine learning AI/ML-enabled medical devices in the European Union (EU), the United States (US), and the Republic of Korea, with a focus on applications in spine surgery. The aim is to provide guidance for developers and researchers navigating regulatory pathways. A review of current literature, regulatory documents, and legislative frameworks was conducted. Key differences in regulatory bodies, risk classification, submission requirements, and approval pathways for AI/ML medical devices were examined in the EU, US, and Republic of Korea. The EU AI Act (2024) establishes a risk-based framework, requiring regulatory review based on device risk, with high-risk devices subject to stricter oversight. The US applies a more flexible approach, allowing multiple submission pathways and incorporating a focus on continuous learning. The Republic of Korea emphasizes possibilities of streamlined approval and with growing use of real-world data to support validation. Developers must ensure regulatory alignment early in the development process, focusing on key aspects like dataset quality, transparency, and continuous monitoring. Across all regions, the need for technical documentation, quality management systems, and bias mitigation are essential for approval. Developers are encouraged to adopt adaptable strategies to comply with evolving regulatory standards, ensuring models remain transparent, fair, and reliable. The EU’s comprehensive AI Act enforces stricter oversight, while the US and Korea offer more flexible pathways. Developers of spine surgery AI/ML devices must tailor development strategies to align with regional regulations, emphasizing transparent development, quality assurance, and postmarket monitoring to ensure approval success.http://e-neurospine.org/upload/pdf/ns-2449186-593.pdfartificial intelligencemachine learningmedical devicesspine surgeryregulatory framework |
| spellingShingle | Massimo Bottini Seung-Jun Ryu Adrian Elmi Terander Stefanos Voglis Nicolai Maldaner David Bellut Luca Regli Carlo Serra Victor E. Staartjes The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research Neurospine artificial intelligence machine learning medical devices spine surgery regulatory framework |
| title | The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research |
| title_full | The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research |
| title_fullStr | The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research |
| title_full_unstemmed | The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research |
| title_short | The Ever-Evolving Regulatory Landscape Concerning Development and Clinical Application of Machine Intelligence: Practical Consequences for Spine Artificial Intelligence Research |
| title_sort | ever evolving regulatory landscape concerning development and clinical application of machine intelligence practical consequences for spine artificial intelligence research |
| topic | artificial intelligence machine learning medical devices spine surgery regulatory framework |
| url | http://e-neurospine.org/upload/pdf/ns-2449186-593.pdf |
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