References
- 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
- Asare, A. (2021). Vigo digitālo terapiju nākotnē varēs apmaksāt valsts. labsoflatvia.com. https://labsoflatvia.com/aktuali/vigo-pieskirts-manipulacijas-kods [rev. 28.02.2022.].
- 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.]
- Factsheet for manufacturers of medical devices (2018). European Commission. https://ec.europa.eu/docsroom/documents/31201
- 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
- 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
- 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 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
- 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
- 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.].
- Latvian State Medicine Agency. (2022). Par informācijas sniegšanu, Nr. 1-27/369.
- 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.].
- 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
- 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
- Nando Information System. European Commission. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.main [rev. 19.03.2022.].
- 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
- 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
- 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
- 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). U.S. Food & Drug Administration. https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd [rev. 09.02.2022.].
- The European Medical Technology Industry in figures. (2021). MedTech Europe. https://www.medtecheurope.org/resource-library/medtech-europes-facts-and-figures-2021/
- 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
- 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.].