The EU AI Act’s Impacts on Digital Health
The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This...
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| Format: | Article |
| Language: | English |
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De Gruyter
2024-12-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2024-2046 |
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| _version_ | 1846096861332504576 |
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| author | Djeffal Christian Mehl Philipp Müller Verena |
| author_facet | Djeffal Christian Mehl Philipp Müller Verena |
| author_sort | Djeffal Christian |
| collection | DOAJ |
| description | The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time. |
| format | Article |
| id | doaj-art-479d87f4f4c24ec695cd9652980e6fa1 |
| institution | Kabale University |
| issn | 2364-5504 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj-art-479d87f4f4c24ec695cd9652980e6fa12025-01-02T05:56:33ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042024-12-0110419119510.1515/cdbme-2024-2046The EU AI Act’s Impacts on Digital HealthDjeffal Christian0Mehl Philipp1Müller Verena2Technical University of Munich, Arcisstr. 21, 80333,Munich, GermanyTechnical University of Munich,Munich, GermanyTechnical University of Munich,Munich, GermanyThe European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time.https://doi.org/10.1515/cdbme-2024-2046eu artificial intelligence actregulationinnovationdigital healthhealthcare innovationregulatory challenges |
| spellingShingle | Djeffal Christian Mehl Philipp Müller Verena The EU AI Act’s Impacts on Digital Health Current Directions in Biomedical Engineering eu artificial intelligence act regulation innovation digital health healthcare innovation regulatory challenges |
| title | The EU AI Act’s Impacts on Digital Health |
| title_full | The EU AI Act’s Impacts on Digital Health |
| title_fullStr | The EU AI Act’s Impacts on Digital Health |
| title_full_unstemmed | The EU AI Act’s Impacts on Digital Health |
| title_short | The EU AI Act’s Impacts on Digital Health |
| title_sort | eu ai act s impacts on digital health |
| topic | eu artificial intelligence act regulation innovation digital health healthcare innovation regulatory challenges |
| url | https://doi.org/10.1515/cdbme-2024-2046 |
| work_keys_str_mv | AT djeffalchristian theeuaiactsimpactsondigitalhealth AT mehlphilipp theeuaiactsimpactsondigitalhealth AT mullerverena theeuaiactsimpactsondigitalhealth AT djeffalchristian euaiactsimpactsondigitalhealth AT mehlphilipp euaiactsimpactsondigitalhealth AT mullerverena euaiactsimpactsondigitalhealth |