المؤلفون: Shiau-Ru Yang, Jen-Tzung Chien, Chen-Yi Lee

المصدر: IEEE Open Journal of Engineering in Medicine and Biology, Vol 6, Pp 147-151 (2025)

مصطلحات موضوعية: Software as a medical device (SaMD), AI/ML, computer-aided detection (CADe), computer-aided diagnosis (CADx), computer-aided triage (CADt), Computer applications to medicine. Medical informatics, R858-859.7, Medical technology, R855-855.5

وصف الملف: electronic resource

Relation: https://ieeexplore.ieee.org/document/10729844/; https://doaj.org/toc/2644-1276

URL الوصول: https://doaj.org/article/acbd70ac7a224ec6a08fc9ce0bbe555d

المؤلفون: Oloruntoba, Ayooluwatomiwa, Ingvar, Åsa, Sashindranath, Maithili, Anthony, Ojochonu, Abbott, Lisa, Guitera, Pascale, Caccetta, Tony, Janda, Monika, Soyer, H. Peter, Mar, Victoria

المصدر: Australasian Journal of Dermatology. 65(5):409-422

مصطلحات موضوعية: artificial intellgience, melanoma, mobile applications, skin cancer, Software as a Medical Device, Medicin och hälsovetenskap, Hälsovetenskap, Medicinsk etik, Medical and Health Sciences, Health Sciences, Medical Ethics

URL الوصول: https://lup.lub.lu.se/record/db6811c8-0854-41c1-a1be-7752ba8b410f
http://dx.doi.org/10.1111/ajd.14269

المؤلفون: John P. Docherty, Brett M. Colbert

المصدر: Frontiers in Psychiatry, Vol 15 (2024)

مصطلحات موضوعية: psychotherapy, digital therapeutics, software as a medical device, review, prescription digital therapeutic (PDT), Psychiatry, RC435-571

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fpsyt.2024.1477543/full; https://doaj.org/toc/1664-0640

URL الوصول: https://doaj.org/article/51a2e5dce6884be0b8e76099a561e19d

المؤلفون: Michele Ferrante, Layla E. Esposito, Luke E. Stoeckel

المصدر: Frontiers in Psychiatry, Vol 15 (2024)

مصطلحات موضوعية: prescription digital therapeutics (PDT), software as a medical device (SaMD), digital mental health assessment and interventions, aging adults, youth & adolescence, digital psychiatry, Psychiatry, RC435-571

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fpsyt.2024.1433438/full; https://doaj.org/toc/1664-0640

URL الوصول: https://doaj.org/article/ba0219308c7b4e4f9df423657bf6d7f9

المؤلفون: Persson, Inger, Macura, Andreas, Becedas, David, Sjövall, Fredrik

المصدر: Journal of critical care. 80

مصطلحات موضوعية: Prediction, Early detection, Machine learning, Software as a medical device, Intensive care unit

وصف الملف: electronic

URL الوصول: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-524458
https://doi.org/10.1016/j.jcrc.2023.154400
https://uu.diva-portal.org/smash/get/diva2:1842588/FULLTEXT01.pdf

المؤلفون: Phoebe Li, Robin Williams, Stephen Gilbert, Stuart Anderson

المصدر: Law, Technology and Humans, Vol 5, Iss 2, Pp 94-113 (2023)

مصطلحات موضوعية: artificial intelligence (ai), artificial intelligence-enabled medical device (aiemd), regulation, software as a medical device (samd), autonomous systems, Law in general. Comparative and uniform law. Jurisprudence, K1-7720

وصف الملف: electronic resource

Relation: https://lthj.qut.edu.au/article/view/3073; https://doaj.org/toc/2652-4074

URL الوصول: https://doaj.org/article/08bb7b22a7a54b97975a97ef58bbeb2e

المؤلفون: Taher, Rayan, Hall, Charlotte L, Bergin, Aislinn D Gomez, Gupta, Neha, Heaysman, Clare, Jacobsen, Pamela, Kabir, Thomas, Kalnad, Nayan, Keppens, Jeroen, Hsu, Che-Wei, McGuire, Philip, Peters, Emmanuelle, Shergill, Sukhi, Stahl, Daniel, Stock, Ben Wensley, Yiend, J.

مصطلحات موضوعية: SaMD, Digital mental health, MHRA, Adverse events, Notification of No Objection, Regulatory approval, Digital mental health interventions, Software as a medical device, Safety, Mental Health

Relation: https://repository.canterbury.ac.uk/download/c3d8db19109c7b1b06d66b06fd8535d909296fbd2695ed5e9910d1d452cd342d/1299052/s13063-024-08421-1.pdf; https://doi.org/10.1186/s13063-024-08421-1

الاتاحة: https://repository.canterbury.ac.uk/item/991wz/developing-a-process-for-assessing-the-safety-of-a-digital-mental-health-intervention-and-gaining-regulatory-approval-a-case-study-and-academic-s-guide

المؤلفون: Wójcik-Suffia, Malwina Anna

المصدر: BioLaw Journal - Rivista di BioDiritto; No. 1 (2024); 367-388 ; BioLaw Journal - Rivista di BioDiritto; N. 1 (2024); 367-388 ; 2284-4503 ; 10.15168/2284-4503-20241

مصطلحات موضوعية: M-Health, algorithmic discrimination, intersectional discrimination, software as a medical device, Section 1557 ACA

وصف الملف: application/pdf

Relation: https://teseo.unitn.it/biolaw/article/view/3002/2878; https://teseo.unitn.it/biolaw/article/view/3002

الاتاحة: https://teseo.unitn.it/biolaw/article/view/3002
https://doi.org/10.15168/2284-4503-3002

المؤلفون: Elena Denisova, Eleonora Tiribilli, Alessio Luschi, Piergiorgio Francia, Leonardo Manetti, Leonardo Bocchi, Ernesto Iadanza

المساهمون: Denisova, Elena, Tiribilli, Eleonora, Luschi, Alessio, Francia, Piergiorgio, Manetti, Leonardo, Bocchi, Leonardo, Iadanza, Ernesto

مصطلحات موضوعية: Imaging platform, Medical device, Medical software, Software as a medical device, Usability

وصف الملف: ELETTRONICO

Relation: info:eu-repo/semantics/altIdentifier/wos/WOS:001210789000002; numberofpages:12; journal:HEALTH AND TECHNOLOGY; https://hdl.handle.net/11365/1260126; info:eu-repo/semantics/altIdentifier/scopus/2-s2.0-85191840196; https://link.springer.com/article/10.1007/s12553-024-00859-2

الاتاحة: https://hdl.handle.net/11365/1260126
https://doi.org/10.1007/s12553-024-00859-2
https://link.springer.com/article/10.1007/s12553-024-00859-2

المؤلفون: Persson, Inger, Grunwald, Adam, Morvan, Ludivine, Becedas, David, Arlbrandt, Martin

المصدر: JMIR Formative Research. 7

مصطلحات موضوعية: acute kidney injury, AKI, algorithm, early detection, electronic health records, ICU, intensive care unit, machine learning, nephrology, prediction, software as a medical device

وصف الملف: electronic

URL الوصول: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-520373
https://doi.org/10.2196/45979
https://uu.diva-portal.org/smash/get/diva2:1827243/FULLTEXT01.pdf

المؤلفون: Leonor Cerdá-Alberich, Jimena Solana, Pedro Mallol, Gloria Ribas, Miguel García-Junco, Angel Alberich-Bayarri, Luis Marti-Bonmati

المصدر: Insights into Imaging, Vol 14, Iss 1, Pp 1-9 (2023)

مصطلحات موضوعية: Artificial intelligence, Medical imaging, Checklist, Software as a medical device, Medical physics. Medical radiology. Nuclear medicine, R895-920

وصف الملف: electronic resource

Relation: https://doaj.org/toc/1869-4101

URL الوصول: https://doaj.org/article/0e512d8ec49e41b0a8c4338fa259cd1a

المؤلفون: Anjos, Isaac Tomé dos

مصطلحات موضوعية: Digital twins, Machine learning, Software as a medical device, Biosignals, Affective computing, Simulation

وصف الملف: application/pdf

الاتاحة: http://hdl.handle.net/10773/35145

المؤلفون: Anthony Watson, Richard Chapman, Gigi Shafai, Yuri A. Maricich

المصدر: Frontiers in Digital Health, Vol 5 (2023)

مصطلحات موضوعية: digital therapeutics, prescription digital therapeutics, food and drug administration, regulatory reform, FDA, software as a medical device (SaMD), Medicine, Public aspects of medicine, RA1-1270, Electronic computers. Computer science, QA75.5-76.95

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fdgth.2023.1086219/full; https://doaj.org/toc/2673-253X

URL الوصول: https://doaj.org/article/7a92c4671a8b427f9b4143b2975e2ac9

المؤلفون: Welzel, Cindy, Cotte, Fabienne, Wekenborg, Magdalene, Vasey, Baptiste, McCulloch, Peter, Gilbert, Stephen

مصطلحات موضوعية: health technology assessment, human factors, postmarket surveillance, software as a medical device, digital health tools, quality assessment, quality improvement, regulatory framework, user experience, health care, info:eu-repo/classification/ddc/610, ddc:610

Relation: e50158

الاتاحة: https://tud.qucosa.de/id/qucosa%3A94641
https://tud.qucosa.de/api/qucosa%3A94641/attachment/ATT-0/

المؤلفون: Zhang Jiannan, Li Yingying, Zhou Jiahui, Zhu Yelin, Li Lanjuan

المصدر: 中国工程科学, Vol 24, Iss 1, Pp 198-204 (2022)

مصطلحات موضوعية: software as a medical device (SaMD)，artificial intelligence (AI)，supervision science, Engineering (General). Civil engineering (General), TA1-2040

وصف الملف: electronic resource

Relation: http://www.engineering.org.cn/en/10.15302/J-SSCAE-2022.01.021; https://doaj.org/toc/2096-0034

URL الوصول: https://doaj.org/article/61c60df2f57d4d51936aa10d53f7d675

المؤلفون: Li, Phoebe, Williams, Robin, Gilbert, Stephen, Anderson, Stuart

المصدر: Law, Technology and Humans; Vol. 5 No. 2 (2023): Law, Technology and Humans; 94-113 ; 2652-4074

مصطلحات موضوعية: Artificial Intelligence (AI), Artificial Intelligence-enabled Medical Device (AIeMD), regulation, Software as a Medical Device (SaMD), autonomous systems

وصف الملف: application/pdf

Relation: https://lthj.qut.edu.au/article/view/3073/1421; https://lthj.qut.edu.au/article/view/3073

الاتاحة: https://lthj.qut.edu.au/article/view/3073

المؤلفون: Ernst Wellnhofer

المصدر: Frontiers in Cardiovascular Medicine, Vol 9 (2022)

مصطلحات موضوعية: machine learning (ML), regulation, innovation, software as a medical device (SaMD), safety and risk, total product life cycle (TPLC), Diseases of the circulatory (Cardiovascular) system, RC666-701

وصف الملف: electronic resource

Relation: https://www.frontiersin.org/articles/10.3389/fcvm.2022.890809/full; https://doaj.org/toc/2297-055X

URL الوصول: https://doaj.org/article/5297fef0917145739d6882460037f23a

المؤلفون: Hideto YOKOI, 横井 英人

المصدر: レギュラトリーサイエンス学会誌 / Regulatory Science of Medical Products. 2023, 13(3):245

المؤلفون: Shinichi TAKAE, 髙江 慎一

المصدر: レギュラトリーサイエンス学会誌 / Regulatory Science of Medical Products. 2023, 13(3):231

المؤلفون: Persson, Inger, Östling, Andreas, Arlbrandt, Martin, Söderberg, Joakim, Becedas, David

المصدر: JMIR Formative Research. 5(9)

مصطلحات موضوعية: EHR, ICU, algorithm, detection, early detection, electronic health record, intensive care unit, machine learning, prediction, proof of concept, sepsis, software as a medical device., Anaesthesiology and Intensive Care, Anestesiologi och intensivvård, Artificial Intelligence, Artificiell intelligens, Bioinformatik, Bioinformatics, Infectious Diseases, Infektionssjukdomar

وصف الملف: electronic

URL الوصول: https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-454945
https://doi.org/10.2196/28000
https://uu.diva-portal.org/smash/get/diva2:1599660/FULLTEXT01.pdf