The need to transition from paper to electronic instructions for use for diabetes devices
Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices. However, challenges remain regarding the implementation of eIF...
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| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Nature Portfolio
2025-06-01
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| Series: | npj Digital Medicine |
| Online Access: | https://doi.org/10.1038/s41746-025-01720-0 |
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| _version_ | 1849334543692070912 |
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| author | Cindy N. Ho Alessandra T. Ayers Lutz Heinemann David C. Klonoff |
| author_facet | Cindy N. Ho Alessandra T. Ayers Lutz Heinemann David C. Klonoff |
| author_sort | Cindy N. Ho |
| collection | DOAJ |
| description | Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices. However, challenges remain regarding the implementation of eIFUs to replace paper IFUs in the era of digital health. Our work examines regulatory, consumer, and environmental factors that influence the transition from paper-based IFUs to eIFUs for wearable diabetes devices. |
| format | Article |
| id | doaj-art-75ea157cc6f34cd688e96231de74915b |
| institution | Kabale University |
| issn | 2398-6352 |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Nature Portfolio |
| record_format | Article |
| series | npj Digital Medicine |
| spelling | doaj-art-75ea157cc6f34cd688e96231de74915b2025-08-20T03:45:32ZengNature Portfolionpj Digital Medicine2398-63522025-06-01811410.1038/s41746-025-01720-0The need to transition from paper to electronic instructions for use for diabetes devicesCindy N. Ho0Alessandra T. Ayers1Lutz Heinemann2David C. Klonoff3Diabetes Technology SocietyDiabetes Technology SocietyScience-Consulting in Diabetes GmbHDiabetes Research Institute, Mills-Peninsula Medical CenterRegulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices. However, challenges remain regarding the implementation of eIFUs to replace paper IFUs in the era of digital health. Our work examines regulatory, consumer, and environmental factors that influence the transition from paper-based IFUs to eIFUs for wearable diabetes devices.https://doi.org/10.1038/s41746-025-01720-0 |
| spellingShingle | Cindy N. Ho Alessandra T. Ayers Lutz Heinemann David C. Klonoff The need to transition from paper to electronic instructions for use for diabetes devices npj Digital Medicine |
| title | The need to transition from paper to electronic instructions for use for diabetes devices |
| title_full | The need to transition from paper to electronic instructions for use for diabetes devices |
| title_fullStr | The need to transition from paper to electronic instructions for use for diabetes devices |
| title_full_unstemmed | The need to transition from paper to electronic instructions for use for diabetes devices |
| title_short | The need to transition from paper to electronic instructions for use for diabetes devices |
| title_sort | need to transition from paper to electronic instructions for use for diabetes devices |
| url | https://doi.org/10.1038/s41746-025-01720-0 |
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