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通用数据保护条例下的3D口腔内扫描与诊断石膏模型——法律保护

3D intraoral scan and diagnostic plaster model under General Data Protection Regulation - Legal protection.

作者信息

Jedlińska Luiza, Jedliński Maciej

机构信息

Doctoral School of University of Szczecin, Faculty of Law and Administration, University of Szczecin, Szczecin, Poland.

Department of Interdisciplinary Dentistry, Faculty of Medicine and Dentistry, Pomeranian Medical University in Szczecin, Szczecin, Poland.

出版信息

J Forensic Leg Med. 2023 Apr;95:102503. doi: 10.1016/j.jflm.2023.102503. Epub 2023 Mar 4.

DOI:10.1016/j.jflm.2023.102503
PMID:36893620
Abstract

No legal subsumption of dental impressions, plaster models and intraoral scanning has been attempted yet. It should be examined to what extent the General Data Protection Regulation (GDPR) applies to them. The aim of this study is to legally classify 3D intraoral scans and plaster models prepared on the basis of alginate impressions within the context of personal data safety and determination of legal protection applicable to their use. The authors set the deliberations concerning legal protection of plaster models and 3D intraoral scans in the light of recently published articles regarding palatal rugae pattern stability, thus enabling accurate personal identification regardless of age or dental treatment. The deliberations concerning legal protection will be based on the analysis of the international legal acts, in particular GDPR. The intraoral scan constitutes biometric data, because it is information about a natural person - a patient is identifiable on the basis of elements defining physical identity. The plaster model itself does not constitute personal data. However, both of them constitutes medical documentation. The biometric data must be processed in a manner compliant with the GDPR provisions. The GDPR shapes only aims which should be attained. When creating a data safety system, ISO or NIST standards may help to ensure the proper level of protection against possible liability resulting from breaches in the scope of personal data processing.

摘要

目前尚未尝试对牙印模、石膏模型和口内扫描进行法律归类。应当研究《通用数据保护条例》(GDPR)在多大程度上适用于它们。本研究的目的是在个人数据安全以及确定适用于其使用的法律保护的背景下,对基于藻酸盐印模制备的三维口内扫描和石膏模型进行法律分类。作者根据最近发表的关于腭皱襞图案稳定性的文章,对石膏模型和三维口内扫描的法律保护进行了审议,从而能够在不考虑年龄或牙科治疗的情况下进行准确的个人识别。关于法律保护的审议将基于对国际法律行为,特别是GDPR的分析。口内扫描构成生物识别数据,因为它是关于自然人的信息——患者可根据定义身体特征的要素进行识别。石膏模型本身不构成个人数据。然而,它们两者都构成医疗文档。生物识别数据必须以符合GDPR规定的方式进行处理。GDPR仅规定了应实现的目标。在创建数据安全系统时,ISO或NIST标准可能有助于确保达到适当的保护水平,以防范因个人数据处理范围内的违规行为而可能产生的责任。

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