Practical healthcare increasingly faces the issues of transparency, objectivity and accountability of the artificial intelligence algorithms, prejudiced results offered by the artificial intelligence which depend on the degree of limitation of the data sets used for computer learning, on possible mistakes, respect for the patients’ rights, ethical standards.
medical products, artificial intelligence, software, quality and security of medical activities
1. Topol E.J. High-performance medicine: the convergence of human and artificial intelligence // Nature Medicine. – 2019; 25(1):44–56. https://doi.org/10.1038/s41591-018-0300-7
2. Zamglavy Minzdrava soobschil o zaklyuchenii s bol'shinstvom regionov soglasheniy o vnedrenii II v meduchrezhdeniyah. 15.03.2023 // Onlayn-izdanie d-russia.ru. – [Elektronnyy resurs] – URL:https://d-russia.ru/zamglavy-minzdrava-soobshhil-o-zakljuchenii-s-bolshinstvomregionov- soglashenij-o-vnedrenii-ii-v-meduchrezhdenijah.html
3. Price W.N., Gerke S., Cohen I.G. Potential liability for physicians using artificial intelligence // JAMA. – 2019; 322(18): 1765–1766. https://doi.org/10.1001/jama.2019.15064
4. Wynants L., Van Calster B., Collins G.S., Riley R.D., Heinze G., Schuit E. et al. Prediction models for diagnosis and prognosis of COVID-19: systematic review and critical appraisal BMJ 2020; (369):m1328. https://doi.org/10.1136/bmj.m1328
5. Wong A., Otles E., Donnelly J.P., Krumm A., McCullough J., DeTroyer-Cooley O., Pestrue J., Phillips M., Konye J., Penoza C., Ghous M., Singh K. External Validation of a Widely Implemented Proprietary Sepsis Prediction Model in Hospitalized Patients // JAMA Intern Med. – 2021 Aug 1; 181(8):1065–1070. https://doi.org/10.1001/jamainternmed.2021.2626
6. Ethics and governance of artificial intelligence for health: WHO guidance. Geneva: World Health Organization. – 2021. – Licence: CC BY-NC-SA 3.0 IGO.
7. Generating evidence for artificial intelligence-based medical devices: a framework for training, validation and evaluation. Geneva: World Health Organization. – 2021. – Licence: CC BY-NC-SA 3.0 IGO.
8. Informacionnye pis'ma o medicinskih izdeliyah. Elektronnye servisy. –[Elektronnyy resurs] – URL: https://roszdravnadzor.gov.ru/services/unreg 6 Prikaz Minzdrava Rossii ot 12 noyabrya 2021 g. № 1051n «Ob utverzhdenii Poryadka dachi informirovannogo dobrovol'nogo soglasiya na medicinskoe vmeshatel'stvo i otkaza ot medicinskogo vmeshatel'stva, formy informirovannogo dobrovol'nogo soglasiya na medicinskoe vmeshatel'stvo i formy otkaza ot medicinskogo vmeshatel'stva». 7 Federal'nyy zakon ot 24 aprelya 2020 g. № 123-FZ «O provedenii eksperimenta po ustanovleniyu special'nogo regulirovaniya v celyah sozdaniya neobhodimyh usloviy dlya razrabotki i vnedreniya tehnologiy iskusstvennogo intellekta v sub'ekte Rossiyskoy Federacii – gorode federal'nogo znacheniya Moskve i vnesenii izmeneniy v stat'i 6 i 10 Federal'nogo zakona «O personal'nyh dannyh». 8 Federal'nyy zakon ot 31 iyulya 2020 g. № 258-FZ «Ob eksperimental'nyh pravovyh rezhimah v sfere cifrovyh innovaciy v Rossiyskoy Federacii».
