Influence of the ISO 7101-2023 standard on the medical system
Abstract
The ISO 7101-2023 standard is a new regulatory document adopted globally to improve quality, safety, and efficiency in healthcare systems. This article analyzes the changes that will occur as a result of the implementation of ISO 7101-2023 in the field of medicine, in particular, the integration of digital technologies (AI, telemedicine), patient data management systems, safety and quality control criteria. The integration of ISO 7101:2023 with previously widely used international standards, such as ISO 9001, ISO 13485 and others, and its role in controlling system control in integrated health and safety control are undergoing in-depth analysis. In this process, special attention is paid to ensuring legal and regulatory requirements in clinical practice, the stability and provision of patient needs, as well as the provision of modern innovative technologies and quality management.
In addition, the article provides for the updating of new software in the updated healthcare system of the ISO 71011: ISO 22023 standard, updates, disease control, ensuring the openness of clinical processes, ensuring safety, disease recovery, health improvement. As the author, based on this standard, healthcare problems arise, for which existing and future problems are also analyzed. The article substantiates that the ISO 7101:2023 standard is a new stage in supporting quality management, correction, and innovative development of the medical system.
References
[2] Digital transformation in healthcare – architectures of present and future information technologies. Clin Chem Lab Med 2019; 57(3): 328–335. https://doi.org/10.1515/cclm-2018-0658 Received June 23, 2018; accepted November 28, 2018; previously published online December 11, 2018
[3] Improving healthcare quality by unifying the American electronic medical report system: time for change. Roopa Kumari & Subhash Chander. The Egyptian Heart Journal volume 76, Article number: 32 (2024)
[4] Digital transformation of healthcare during the COVID-19 pandemic: Patients’ teleconsultation acceptance and trusting beliefs. Patricia Baudier Galina Kondrateva b, Chantal Ammi, Victor Chang , Francesco Schiavone. Texnologiya 120-jild ,2023 yil fevral, 102547 https://doi.org/10.1016/j.technovation.2022.102547
[5] Ethical and regulatory challenges of AI technologies in healthcare: A narrative review. Ciro Mennella, Umberto Maniscalco ∗, Giuseppe De Pietro, Massimo Esposito. Heliyon. journal homepage: www.cell.com/heliyon.
[6] Transforming Healthcare with AI: Promises, Pitfalls, and Pathways Forward. Authors Shuaib A. Journals » International Journal of General Medicine. 1 May 2024 Volume 2024:17 Pages 1765—1771. DOI https://doi.org/10.2147/IJGM.S449598.
[7] Artificial intelligence in healthcare. Kun-Hsing Yu , Andrew L. Beam1 and Isaac S. Kohane. Nature Biomedical Engineering | VOL 2 | OCTOBER 2018 | 719–731 | www.nature.com/natbiomedeng. doi.org/10.1038/s41551-018-0305-z
[8] Global Regulatory Frameworks for the Use of Artificial Intelligence (AI) in the Healthcare Services Sector. Kavitha Palaniappan *, Elaine Yan Ting Lin and Silke Vogel. Healthcare 2024, 12, 562. https://doi.org/10.3390/healthcare12050562.
[9] Abujaber, Ahmad A, и Abdulqadir J Nashwan. 2024. «Ethical framework for artificial intelligence in healthcare research: A path to integrity». World Journal of Methodology 14(3). doi:10.5662/wjm.v14.i3.94071. https://www.wjgnet.com/2222-0682/full/v14/i3/94071.htm
