INFORMAZIONI SU QUESTO ARTICOLO

Cita
Scarica la copertina

Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SAMD) Action Plan (2021). U.S. Food & Drug Administration. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SAMD) Action Plan 2021 U.S. Food & Drug Administration https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device Search in Google Scholar

Asare, A. (2021). Vigo digitālo terapiju nākotnē varēs apmaksāt valsts. labsoflatvia.com. https://labsoflatvia.com/aktuali/vigo-pieskirts-manipulacijas-kods [rev. 28.02.2022.]. AsareA. 2021 Vigo digitālo terapiju nākotnē varēs apmaksāt valsts labsoflatvia.com https://labsoflatvia.com/aktuali/vigo-pieskirts-manipulacijas-kods [rev. 28.02.2022.] Search in Google Scholar

Everything You Need for a Medtech Adventure. Ministry of Foreign Affairs of Denmark, Invest in Denmark. https://investindk.com/set-up-a-business/life-sciences/medtech [rev. 19.03.2022.] Everything You Need for a Medtech Adventure Ministry of Foreign Affairs of Denmark, Invest in Denmark https://investindk.com/set-up-a-business/life-sciences/medtech [rev. 19.03.2022.] Search in Google Scholar

Factsheet for manufacturers of medical devices (2018). European Commission. https://ec.europa.eu/docsroom/documents/31201 Factsheet for manufacturers of medical devices 2018 European Commission https://ec.europa.eu/docsroom/documents/31201 Search in Google Scholar

Gerke, S., Stern, A. D., Minssen, T. (2020). Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries. NPJ Digit. Med. 3, 94. https://doi.org/10.1038/s41746-020-0306-7 GerkeS. Stern A. D. Minssen T. 2020 Germany’s digital health reforms in the COVID-19 era: lessons and opportunities for other countries NPJ Digit. Med. 3 94 https://doi.org/10.1038/s41746-020-0306-7 Search in Google Scholar

Greco, C. (2015). The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering. Soc Sci Med. 2015 Dec; 147:150–157. https://doi.org/10.1016/j.socscimed.2015.10.068 GrecoC. 2015 The Poly Implant Prothèse breast prostheses scandal: Embodied risk and social suffering Soc Sci Med 2015 Dec 147 150 157 https://doi.org/10.1016/j.socscimed.2015.10.068 Search in Google Scholar

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD (2020). Medical Device Coordination Group. https://ec.europa.eu/docsroom/documents/40301 Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD 2020 Medical Device Coordination Group https://ec.europa.eu/docsroom/documents/40301 Search in Google Scholar

Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR (2019). European Commission. https://ec.europa.eu/docsroom/documents/37581 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR 2019 European Commission https://ec.europa.eu/docsroom/documents/37581 Search in Google Scholar

Hwang, T. J., Sokolov, E., Franklin, J. M., & Kesselheim, A.S. (2016). Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study. BMJ. 2016 Jun 28; 353: i3323. https://doi.org/10.1136/bmj.i3323 HwangT. J. Sokolov E. Franklin J. M. Kesselheim A.S. 2016 Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study BMJ 2016 Jun 28 353 i3323 https://doi.org/10.1136/bmj.i3323 Search in Google Scholar

IQVIA Institute for human data science (2021). Digital Health Trends 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021 [rev. 09.02.2022.]. IQVIA Institute for human data science 2021 Digital Health Trends 2021. https://www.iqvia.com/insights/the-iqvia-institute/reports/digital-health-trends-2021 [rev. 09.02.2022.] Search in Google Scholar

Latvian State Medicine Agency. (2022). Par informācijas sniegšanu, Nr. 1-27/369. Latvian State Medicine Agency 2022 Par informācijas sniegšanu, Nr. 1-27/369 Search in Google Scholar

Lovell, T. (2022). Report names Europe’s digital health app reimbursement leaders and laggards. mobihealthnews.com. https://www.mobihealthnews.com/news/emea/report-names-europe-s-digital-health-app-reimbursement-leaders-and-laggards [rev. 22.02.2022.]. LovellT. 2022 Report names Europe’s digital health app reimbursement leaders and laggards mobihealthnews.com https://www.mobihealthnews.com/news/emea/report-names-europe-s-digital-health-app-reimbursement-leaders-and-laggards [rev. 22.02.2022.] Search in Google Scholar

Machine Learning-enabled Medical Devices – A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions. The International Medical Device Regulators Forum. https://www.imdrf.org/consultations/machine-learning-enabled-medical-devices-subset-artificial-intelligence-enabled-medical-devices-key-terms-and-definitions Machine Learning-enabled Medical Devices – A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions The International Medical Device Regulators Forum https://www.imdrf.org/consultations/machine-learning-enabled-medical-devices-subset-artificial-intelligence-enabled-medical-devices-key-terms-and-definitions Search in Google Scholar

Muehlematter, U. J., Daniore, P., & Vokinger, K. N. (2021). Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis. The Lancet Digital Health, 2021 Jan 18; 3, i3, E195–E203. https://doi.org/10.1016/S2589-7500(20)30292-2 MuehlematterU. J. Daniore P. Vokinger K. N. 2021 Approval of artificial intelligence and machine learning-based medical devices in the USA and Europe (2015–20): a comparative analysis The Lancet Digital Health 2021 Jan 18 3 i3 E195 E203 https://doi.org/10.1016/S2589-7500(20)30292-2 Search in Google Scholar

Nando Information System. European Commission. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main [rev. 19.03.2022.]. Nando Information System European Commission https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main [rev. 19.03.2022.] Search in Google Scholar

Peter, L., Hájek, L., Maresov, P., Augustynek, M., & Penhaker, M. (2020). Medical Devices: Regulation, Risk Classification, and Open Innovation. Journal of Open Innovation: Technology, Market, and Complexity. 6. 42. https://doi.org/10.3390/joitmc6020042 PeterL. Hájek L. Maresov P. Augustynek M. Penhaker M. 2020 Medical Devices: Regulation, Risk Classification, and Open Innovation Journal of Open Innovation: Technology, Market, and Complexity 6 42 https://doi.org/10.3390/joitmc6020042 Search in Google Scholar

Proposal for a Regulation of The European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts (2021). European Commission. https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206 Proposal for a Regulation of The European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amending Certain Union Legislative Acts 2021 European Commission https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1623335154975&uri=CELEX%3A52021PC0206 Search in Google Scholar

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC Official Journal of the European Union https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745 Search in Google Scholar

Software as a Medical Device (SAMD): Key Definitions. (2013). The International Medical Device Regulators Forum. https://www.imdrf.org/documents/software-medical-device-samd-key-definitions Software as a Medical Device (SAMD): Key Definitions 2013 The International Medical Device Regulators Forum https://www.imdrf.org/documents/software-medical-device-samd-key-definitions Search in Google Scholar

Software as a Medical Device (SAMD). U.S. Food & Drug Administration. https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd [rev. 09.02.2022.]. Software as a Medical Device (SAMD) U.S. Food & Drug Administration https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd [rev. 09.02.2022.] Search in Google Scholar

The European Medical Technology Industry in figures. (2021). MedTech Europe. https://www.medtecheurope.org/resource-library/medtech-europes-facts-and-figures-2021/ The European Medical Technology Industry in figures 2021 MedTech Europe https://www.medtecheurope.org/resource-library/medtech-europes-facts-and-figures-2021/ Search in Google Scholar

Yala, A., Mikhael, P. G., Lehman, C., ..., & Barzilay, R. (2022). Optimizing risk-based breast cancer screening policies with reinforcement learning. Nat Med 28, 136–143. https://doi.org/10.1038/s41591-021-01599-w YalaA. Mikhael P. G. Lehman C. Barzilay R. 2022 Optimizing risk-based breast cancer screening policies with reinforcement learning Nat Med 28 136 143 https://doi.org/10.1038/s41591-021-01599-w Search in Google Scholar

Zewe, A. (2022). Artificial intelligence system rapidly predicts how two proteins will attach. MIT News. https://news.mit.edu/2022/ai-predicts-protein-docking-0201 [rev. 09.02.2022.]. ZeweA. 2022 Artificial intelligence system rapidly predicts how two proteins will attach MIT News https://news.mit.edu/2022/ai-predicts-protein-docking-0201 [rev. 09.02.2022.] Search in Google Scholar