<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">tal</journal-id><journal-title-group><journal-title xml:lang="ru">Теоретическая и прикладная юриспруденция</journal-title><trans-title-group xml:lang="en"><trans-title>Theoretical and Applied Law</trans-title></trans-title-group></journal-title-group><issn pub-type="epub">3034-2813</issn><publisher><publisher-name>СЗИУ РАНХиГС</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.22394/3034-2813-2024-3-96-106</article-id><article-id custom-type="edn" pub-id-type="custom">RYDIZZ</article-id><article-id custom-type="elpub" pub-id-type="custom">tal-445</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ARTICLES</subject></subj-group></article-categories><title-group><article-title>Регулирование и защита персональных медицинских данных в эпоху ИИ: международный опыт</article-title><trans-title-group xml:lang="en"><trans-title>Regulation and protection of personal health data in the AI era: international experience</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0004-6440-3404</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Галкина</surname><given-names>Н. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Galkina</surname><given-names>N. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Галкина Наталия Михайловна - заместитель директора Института исследований национального и сравнительного права факультета права.</p><p>Москва</p></bio><bio xml:lang="en"><p>Nataliia M. Galkina - Deputy Director at the Institute of National and Comparative Legal Studies, LL.M, National Research University Higher School of Economics.</p><p>Moscow</p></bio><email xlink:type="simple">ngalkina@hse.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0003-4059-865X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кузнецова</surname><given-names>Д. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Kuznetsova</surname><given-names>D. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Кузнецова Дарья Владимировна, ведущий эксперт института исследований национального и сравнительного права факультета права.</p><p>Москва</p></bio><bio xml:lang="en"><p>Daria V. Kuznetsova - Lead Expert at the Institute of National and Comparative Legal Studies, LL.M, National Research University Higher School of Economics.</p><p>Moscow</p></bio><email xlink:type="simple">dvkuznetsova@hse.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Национальный исследовательский университет «Высшая школа экономики»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>National Research University Higher School of Economics</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>08</day><month>10</month><year>2024</year></pub-date><volume>0</volume><issue>3</issue><fpage>96</fpage><lpage>106</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Галкина Н.М., Кузнецова Д.В., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Галкина Н.М., Кузнецова Д.В.</copyright-holder><copyright-holder xml:lang="en">Galkina N.M., Kuznetsova D.V.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.taljournal.ru/jour/article/view/445">https://www.taljournal.ru/jour/article/view/445</self-uri><abstract><p>Искусственный интеллект активно захватывает сферу за сферой, в том числе особые успехи и достижения можно видеть в сфере медицины и медицинских технологий. Однако внедрение искусственного интеллекта ставит целый ряд вопросов как практического, так и этического характера. Управление персональными данными становится ключевым вопросом при разработке искусственного интеллекта в медицине, поскольку эффективность таких систем напрямую зависит от доступа к обширным медицинским данным пациентов. Самым удобным решением для их использования является предварительная анонимизация. Однако при анонимизации существует риск повторной идентификации, а также возможна утрата потенциала информативности данных. В рамках настоящей статьи на примере США, ЕС и Сингапура рассматривается опыт в сфере правового регулирования обращения с медицинскими персональными данными при использовании систем искусственного интеллекта в медицине. Каждая из стран пытается найти баланс между защитой конфиденциальности персональных данных и развитием инноваций. На основе проведенного анализа можно сделать вывод, что фокус на развитие искусственного интеллекта требует определенных допущений в области защиты персональных данных, в то время как высокий жесткий стандарт защиты персональных данных может оказывать сдерживающее действие.</p></abstract><trans-abstract xml:lang="en"><p>Artificial intelligence is actively taking over sphere after sphere and particular successes and achievements can be seen in the medical sector and medical technology. However, the introduction of AI raises a number of practical and ethical issues. One of the main ones is the issue of handling personal data, as access to a large number of patients’ health data plays a key role in the development and use of AI in medicine. The most convenient solution for their use is to anonymise them beforehand. However, with anonymisation, there is a risk of re-identification and the potential for loss of data informativeness may be lost. In the framework of this article the experience in the sphere of legal regulation of personal health data handling when using artificial intelligence systems in medicine is considered in the example of the USA, EU and Singapore. Each country is endeavoring to strike a balance between the protection of personal data privacy and the advancement of technological innovations. The analysis suggests that the emphasis on artificial intelligence development necessitates specific premises in the domain of personal data protection. Conversely, stringent standards for the protection of personal data could potentially exert a restrictive influence.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>искусственный интеллект</kwd><kwd>ИИ</kwd><kwd>медицинские данные</kwd><kwd>большие данные</kwd><kwd>конфиденциальность персональных данных</kwd></kwd-group><kwd-group xml:lang="en"><kwd>artificial intelligence</kwd><kwd>AI</kwd><kwd>health data</kwd><kwd>Big Data</kwd><kwd>privacy data protection</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Алексеева М. Г. Искусственный интеллект в медицине / М. Г. Алексеева, А. И. Зубов, М. Ю. Новиков // Международный научно-исследовательский журнал. 2022. № 7-2 (121). С. 10–13. DOI: 10.23670/IRJ.2022.121.7.038. EDN: JMMMDF</mixed-citation><mixed-citation xml:lang="en">Alekseeva, M. G., Zubov, A. I., Novikov, M. Yu. (2022) Artificial Intelligence in Medicine. International Research Journal. No. 7-2 (121). Pp. 10–13. DOI: 10.23670/IRJ.2022.121.7.038</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Ли Я. Нормативно-правовое регулирование генеративного искусственного интеллекта в Великобритании, США, Европейском союзе и Китае // Право. Журнал Высшей школы экономики. 2023. № 3. С. 245–267. DOI: 10.17323/2072-8166.2023.3.245.267. EDN: YITZOA</mixed-citation><mixed-citation xml:lang="en">Li, Ya. (2023) Specifics of Regulatory and Legal Regulation of Generative Artificial Intelligence in the UK, USA, EU and China. Law. Journal of the Higher School of Economics. Vol. 16, no. 3. Pp. 245–267 (In Russ.). DOI: 10.17323/2072-8166.2023.3.245.267</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Чурилов А. Ю. Принципы Общего регламента Европейского союза о защите персональных данных (GDPR): проблемы и перспективы имплементации // Вестник Омской юридической академии. 2019. Т. 16, № 1. С. 29–35. DOI: 10.19073/2306-1340-2019-16-1-29-35. EDN: ZAYHTV</mixed-citation><mixed-citation xml:lang="en">Churilov, A. Yu. (2019) Principles of the EU general regulations for the protection of personal data (GDPR): problems and perspectives for implementation. Siberian Legal Review. Vol. 16, No. 1. Pp. 29–35. DOI: 10.19073/2306-1340-2019-16-1-29-35</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Bak M., Madai V. I., Fritzsche M.-C., Mayrhofer M. T., McLennan S. (2022) You Can’t Have AI Both Ways: Balancing Health Data Privacy and Access Fairly. Frontiers in Genetics. DOI: 10.3389/fgene.2022.929453</mixed-citation><mixed-citation xml:lang="en">Bak, M., Madai, V. I., Fritzsche, M.-C., Mayrhofer, M. T., McLennan, S. (2022) You Can’t Have AI Both Ways: Balancing Health Data Privacy and Access Fairly. Frontiers in Genetics. DOI: 10.3389/fgene.2022.929453</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Emam K., Alvarez C. (2014) A critical appraisal of the Article 29 Working Party Opinion 05/2014 on data anonymization techniques. International Data Privacy Law. Vol. 5, no. 1. Pp. 73–87. DOI: 10.1093/idpl/ipu033</mixed-citation><mixed-citation xml:lang="en">Emam, K., Alvarez, C. (2014) A critical appraisal of the Article 29 Working Party Opinion 05/2014 on data anonymization techniques. International Data Privacy Law. Vol. 5, no. 1. Pp. 73–87. DOI: 10.1093/idpl/ipu033</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Matheny M., Israni S. T., Ahmed M., Whicher D. (2022) Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. Washington, DC: National Academy of Medicine, 2022.</mixed-citation><mixed-citation xml:lang="en">Matheny, M., Israni, S. T., Ahmed, M., Whicher, D. (2022) Artificial Intelligence in Health Care: The Hope, the Hype, the Promise, the Peril. Washington, DC: National Academy of Medicine.</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Murdoch B. (2021) Privacy and artificial intelligence: challenges for protecting health information in a new era. BMC Medical Ethics. DOI: https://doi.org/10.1186/s12910-021-00687-3</mixed-citation><mixed-citation xml:lang="en">Murdoch, B. (2021) Privacy and artificial intelligence: challenges for protecting health information in a new era. BMC Medical Ethics. DOI: https://doi.org/10.1186/s12910-021-00687-3</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Price II W. N. (2021) Problematic Interactions between AI and Health Privacy. 2021 Utah L. Rev. U of Michigan Public Law Research Paper No. 21-014. Доступно на SSRN: https://ssrn.com/abstract=3797161 (дата обращения: 12.04.2024).</mixed-citation><mixed-citation xml:lang="en">Price II, W. N. (2021) Problematic Interactions between AI and Health Privacy. 2021 Utah L. Rev. U of Michigan Public Law Research Paper No. 21-014. Доступно на SSRN: https://ssrn.com/abstract=3797161 (дата обращения: 12.04.2024).</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">Price W., Cohen I. (2019) Privacy in the age of medical big data. Nature Medicine. Pp. 37–43. DOI: https://doi.org/10.1038/s41591-018-0272-7</mixed-citation><mixed-citation xml:lang="en">Price, W., Cohen, I. (2019) Privacy in the age of medical big data. Nature Medicine. Pp. 37–43. DOI: https://doi.org/10.1038/s41591-018-0272-7</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Raz M., Nguyen T. C., Loh E. (2023) Artificial Intelligence in Medicine. Springer. DOI: https://doi.org/10.1007/978-981-19-1223-8</mixed-citation><mixed-citation xml:lang="en">Raz, M., Nguyen, T. C., Loh, E. (2023) Artificial Intelligence in Medicine. Springer. DOI: https://doi.org/10.1007/978-981-19-1223-8</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Stam A., Kleiner B. (2020) Data anonymisation: legal, ethical, and strategic considerations. FORS Guide No. 11, Version 1.0. Lausanne: Swiss Centre of Expertise in the Social Sciences FORS, 2020. DOI: 10.24449/FG-2020-00011</mixed-citation><mixed-citation xml:lang="en">Stam, A., Kleiner, B. (2020) Data anonymisation: legal, ethical, and strategic considerations. FORS Guide No. 11, Version 1.0. Lausanne: Swiss Centre of Expertise in the Social Sciences FORS, 2020. DOI: 10.24449/FG-2020-00011</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Walters R., Coghlan M. (2019) Data Protection and Artificial Intelligence Law: Europe Australia Singapore — An Actual or Perceived Dichotomy. American Journal of Science, Engineering and Technology. Vol. 4, No. 4. Pp. 55–65. DOI: 10.11648/j.ajset.20190404.11</mixed-citation><mixed-citation xml:lang="en">Walters, R., Coghlan, M. (2019) Data Protection and Artificial Intelligence Law: Europe Australia Singapore — An Actual or Perceived Dichotomy. American Journal of Science, Engineering and Technology. Vol. 4, No. 4. Pp. 55–65. DOI: 10.11648/j.ajset.20190404.11</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
