Law and digitalization of modern healthcare
- Authors: Romanovskaya O.V.1, Romanovskiy G.B.1
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Affiliations:
- Penza State University
- Issue: Vol 28, No 3 (2024): DIGITALIZATION AND LAW
- Pages: 565-583
- Section: LAW AND DIGITAL TECHNOLOGIES
- URL: https://journals.rudn.ru/law/article/view/40936
- DOI: https://doi.org/10.22363/2313-2337-2024-28-3-565-583
- EDN: https://elibrary.ru/HWMBJC
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Abstract
The article addresses the issues in healthcare delivery and organization of public healthcare in the face of rapid advancements in digital technologies. The purpose of the study is to outline the legal challenges arising during the implementation of concepts such as digital health, e-health, mobile health as well as establishing the legal framework for electronic medical records and telemedicine, and certain types of innovative biomedical activities. The article illustrates the consistent impact of information and communication technologies on the interaction between patients and healthcare providers. It defines the legal framework for telemedicine and its transition to e-health. The study systematizes the particularities of legal regulations concerning both general electronic medical record and those developed by specialized medical organizations. It presents legal challenges related to data compatibility and potential cross-border exchanges. The concept of mobile healthcare is analyzed, with attention given to the risks associated with its development, notably threats to privacy and cybersecurity. The main directions of digital medicine and the challenges faced by modern legal regulations are summarized, including the use of big data, the integration of artificial intelligence, translational bioinformatics, gamification of various stages of medical care, etc. Additionally, the legal challenges arising from the use of big data and introduction of certain digital devices into medical practice are outlined, with special attention given to the brain-computer interface. Comprehensive recommendations for the improvement of healthcare legislation are presented.
About the authors
Olga V. Romanovskaya
Penza State University
Author for correspondence.
Email: pgu-gpd@yandex.ru
ORCID iD: 0000-0002-4563-1725
SPIN-code: 5496-7700
ResearcherId: C-7120-2017
Doctor of Law, Full Professor, Head of the Department of State and Legal Disciplines
40 Krasnaya str., Penza, 440026, Russian FederationGeorgy B. Romanovskiy
Penza State University
Email: vlad93@sura.ru
ORCID iD: 0000-0003-0546-2557
SPIN-code: 2791-8376
ResearcherId: S-7012-2016
Doctor of Law, Full Professor, Head of the Department of Criminal Law
40 Krasnaya str., Penza, 440026, Russian FederationReferences
- Alsahli, S., Hor, S. & Lam, M. (2023) Factors Influencing the Acceptance and Adoption of Mobile Health Apps by Physicians During the COVID-19 Pandemic: Systematic Review. JMIR Mhealth Uhealth. (11), e50419. https://doi.org/10.2196/50419
- Angerer, A., Stahl, J., Krasniqi, E. & Banning, S. (2022) The Management Perspective in Digital Health Literature: Systematic Review. JMIR Mhealth Uhealth. 10(11), e37624. https://doi.org/10.2196/37624
- Bakshi, S.K., Lin, S.R., Ting, D.S.W., Chiang, M.F. & Chodosh, J. (2021) The era of artificial intelligence and virtual reality: transforming surgical education in ophthalmology. British Journal of Ophthalmology. 105(10), 1325-1328. https://doi.org/10.1136/bjophthalmol-2020-316845
- Birrer, А., He, D. & Just, N. (2023) The state is watching you - A cross-national comparison of data retention in Europe. Telecommunications Policy. 47(4), 102542. https://doi.org/10.1016/j.telpol.2023.102542
- Brahams, D. (1995) The medicolegal implications of teleconsulting in the UK. Journal of telemedicine and telecare. 1(4), 196-201. https://doi.org/10.1177/1357633X9500100402
- Burgess, Gluskin & Pinker, (2023) From bedside to portable and wearable: development of a conformable ultrasound patch for deep breast tissue imaging. Molecular Oncology. 17(10), 1947-1949. https://doi.org/10.1002/1878-0261.13531
- Carroll, N., Kennedy, C. & Richardson, I. (2016) Connected Community Healthcare Ecosystem (CCHE) for managing long-term conditions. Gerontechnology. 14(2), 64-77.
- Curtis, R.G., Bartel, B., Ferguson, T., Blake, H.T., Northcott, C., Virgara, R. & Maher, C.A. (2021) Improving User Experience of Virtual Health Assistants: Scoping Review. Journal of Medical Internet Research. 23(12), e31737. https://doi.org/10.2196/31737
- Drexler, М., Elsner, С., Gabelmann, V., Gori, Т. & Münzel, Т. (2020) Apple Watch detecting coronary ischaemia during chest pain episodes or an apple a day may keep myocardial infarction away. European Heart Journal. 41(23), 2224. https://doi.org/10.1093/eurheartj/ehaa290
- Driver, R. & Mishra, S. (2023) Organ-On-A-Chip Technology: An In-depth Review of Recent Advancements and Future of Whole Body-on-chip. BioChip Journal. (17), 1-23. https://doi.org/10.1007/s13206-022-00087-8
- Eysenbach, G. (2001) What is e-health? Journal of Medical Internet Research. 3(2), e20. https://doi.org/10.2196/jmir.3.2.e20
- Haidhar Athir Mohd Puat & Nor Azlina Abd Rahman (2020). IoMT: A Review of Pacemaker Vulnerabilities and Security Strategy. Journal of Physics: Conference Series. (1712), 012009. https://doi.org/10.1088/1742-6596/1712/1/012009
- Hurtado, J.H. (2022) Envisioning postmortal futures: six archetypes on future societal approaches to seeking immortality. Mortality, 1-19. https://doi.org/10.1080/13576275.2022.2100250
- Kierkegaard, P. (2011) Electronic health record: Wiring Europe’s healthcare. Computer Law & Security Review. 27(5), 503-515.
- Kim, O.T., Dadaeva, V.A., Telhigova, A.A. & Drapkina, O.M. (2021) Mobile medical applications: opportunities, problems and prospects. Russian Journal of Preventive Medicine. 24(7). 96-102. https://doi.org/10.17116/profmed20212407196 (in Russian).
- Lin, M., Zhang, Z. & Gao, X., et al. (2023) A fully integrated wearable ultrasound system to monitor deep tissues in moving subjects. Nature Biotechnology. (42), 448-457. https://doi.org/10.1038/s41587-023-01800-0
- Margolis, R.E. (1994) Law and policy barriers hamper growth of telemedicine. Healthspan. 11 (10), 14-15.
- Mokhov, A.A. (2010) Electronic medical record as a factor in the development of healthcare and protection of the rights of Russian citizens. Medical Law. (1), 23-26. (in Russian).
- Muthuppalaniappan, M. & Stevenson, K. (2021) Healthcare cyber-attacks and the COVID-19 pandemic: An urgent threat to global health. International Journal for Quality in Health Care. Journal of the International Society for Quality in Health Care. 33(1), mzaa117. https://doi.org/10.1093/intqhc/mzaa117
- Peters, M.A., Jandrić, P. & Hayes, S. (2021) Biodigital Philosophy, Technological Convergence, and Postdigital Knowledge Ecologies. Postdigital Science and Education. 3(2), 370-388. https://doi.org/10.1007/s42438-020-00211-7
- Rad, M.A., Mahmodi, H., Filipe, E.C., Cox, T.R., Kabakova, I. & Tipper, J.L. (2022) Micromechanical characterisation of 3D bioprinted neural cell models using Brillouin microspectroscopy. Bioprinting. (25), e00179. https://doi.org/10.1101/2021.08.17.456575
- Romanovskaya, O.V. & Romanovsky, G.B. (2023) Legal regulation of additive technologies in modern biomedicine. RUDN Journal of Law. 27(1), 21-40. https://doi.org/10.22363/2313-2337-2023-27-1-21-40 (in Russian).
- Sanders, J.H. & Bashshur, R.L. (1995) Challenges to the implementation of telemedicine. Telemedicine Journal. 1(2), 115-123.
- Staunton, C., Slokenberga, S. & Mascalzoni, D. (2019) The GDPR and the research exemption: Considerations on the necessary safeguards for research biobanks. European Journal of Human Genetics. 27(8). 1159-1167.
- Stecher, C., Pfisterer, B., Harden, S.M., Epstein, D., Hirschmann, J.M., Wunsch, K. & Buman, M.P. (2023) Assessing the Pragmatic Nature of Mobile Health Interventions Promoting Physical Activity: Systematic Review and Meta-analysis. JMIR Mhealth Uhealth. (11), e43162. https://doi.org/10.2196/43162
- Van Veen, E.-B. (2018) Observational health research in Europe: understanding the General Data Protection Regulation and underlying debate. European Journal of Cancer. (104), 70-80. https://doi.org/10.1016/j.ejca.2018.09.032
- Wadmann, S., Hartlev, M. & Hoeyer, K. (2023) The life and death of confidentiality: A historical analysis of the flows of patient information. BioSocieties. (18), 282-307. https://doi.org/10.1057/s41292-021-00269-x
- Williams, S. (2018) GDPR - not just an EU regulation? The Lancet Oncology. 19(10), e508. https://doi.org/10.1016/S1470-2045(18)30696-X
- Yang, X., Mu, D., Peng, H., Li, H., Wang, Y., Wang, P., Wang, Y. & Han, S. (2022) Research and Application of Artificial Intelligence Based on Electronic Health Records of Patients with Cancer: Systematic Review. JMIR Medical Informatics. 10(4). e33799. https://doi.org/10.2196/33799