The need for a system view to regulate artificial intelligence/machine learning-based software as medical device
Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creat...
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Nature Portfolio
2020-04-01
|
| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-020-0262-2 |
| _version_ | 1797427348064174080 |
|---|---|
| author | Sara Gerke Boris Babic Theodoros Evgeniou I. Glenn Cohen |
| author_facet | Sara Gerke Boris Babic Theodoros Evgeniou I. Glenn Cohen |
| author_sort | Sara Gerke |
| collection | DOAJ |
| description | Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition. |
| first_indexed | 2024-03-09T08:42:54Z |
| format | Article |
| id | doaj.art-71fe73e8f86343b4ab6486b9125a611b |
| institution | Directory Open Access Journal |
| issn | 2398-6352 |
| language | English |
| last_indexed | 2024-03-09T08:42:54Z |
| publishDate | 2020-04-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj.art-71fe73e8f86343b4ab6486b9125a611b2023-12-02T16:20:10ZengNature Portfolionpj Digital Medicine2398-63522020-04-01311410.1038/s41746-020-0262-2The need for a system view to regulate artificial intelligence/machine learning-based software as medical deviceSara Gerke0Boris Babic1Theodoros Evgeniou2I. Glenn Cohen3Project on Precision Medicine, Artificial Intelligence, and the Law; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard UniversityINSEAD, 1 Ayer Rajah AveINSEADHarvard Law School; Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard UniversityAbstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug Administration (FDA), for example, has recently proposed a discussion paper to address some of these issues. But it misses an important point: we argue that regulators like the FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition.https://doi.org/10.1038/s41746-020-0262-2 |
| spellingShingle | Sara Gerke Boris Babic Theodoros Evgeniou I. Glenn Cohen The need for a system view to regulate artificial intelligence/machine learning-based software as medical device npj Digital Medicine |
| title | The need for a system view to regulate artificial intelligence/machine learning-based software as medical device |
| title_full | The need for a system view to regulate artificial intelligence/machine learning-based software as medical device |
| title_fullStr | The need for a system view to regulate artificial intelligence/machine learning-based software as medical device |
| title_full_unstemmed | The need for a system view to regulate artificial intelligence/machine learning-based software as medical device |
| title_short | The need for a system view to regulate artificial intelligence/machine learning-based software as medical device |
| title_sort | need for a system view to regulate artificial intelligence machine learning based software as medical device |
| url | https://doi.org/10.1038/s41746-020-0262-2 |
| work_keys_str_mv | AT saragerke theneedforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT borisbabic theneedforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT theodorosevgeniou theneedforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT iglenncohen theneedforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT saragerke needforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT borisbabic needforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT theodorosevgeniou needforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice AT iglenncohen needforasystemviewtoregulateartificialintelligencemachinelearningbasedsoftwareasmedicaldevice |