Legal issues and underexplored data protection in medical 3D printing: A scoping review.
Legal issues and underexplored data protection in medical 3D printing: A scoping review.
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DOI：
10.3389/fbioe.2023.1102780
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发表时间：
2023
影响因子：
5.7
通讯作者：
Makitie, Antti
中科院分区：
文献类型：
--
作者：
Pettersson, Ante B. V.;Ballardini, Rosa Maria;Mimler, Marc;Li, Phoebe;Salmi, Mika;Minssen, Timo;Gibson, Ian;Makitie, Antti
导读：3D打印在医学领域很快就有了许多应用。然而，与任何新技术一样，监管环境正在努力跟上步伐。立法不明确或缺乏立法被认为是大规模采用的一个障碍。 研究方法：在PubMed、Web of Science、SCOPUS和Westlaw International中进行了范围审查，以识别涉及医疗3D打印中法律的问题的文章。 结果：在医学/技术数据库中确定了34篇符合纳入标准的文章，在法律的数据库中确定了15篇。大多数文章涉及美国，而欧盟也有突出的代表性。确定了一些常见的未解决的法律的问题，其中包括定制器械和患者匹配器械之间的术语混淆，缺乏针对患者匹配产品的具体立法，以及从责任和知识产权角度来看CAD文件的法律的作用不明确。数据保护仅在两篇论文中提到，似乎是一个未充分探讨的主题。 结论：在这次范围审查中，确定了几篇相关文章和几个常见的未解决的法律的问题，包括医疗3D打印术语统一的需求。这项工作的结果计划为我们今后对这些问题进行更深入的法律的分析提供信息。
Introduction: 3D printing has quickly found many applications in medicine. However, as with any new technology the regulatory landscape is struggling to stay abreast. Unclear legislation or lack of legislation has been suggested as being one hindrance for wide-scale adoption. Methods: A scoping review was performed in PubMed, Web of Science, SCOPUS and Westlaw International to identify articles dealing with legal issues in medical 3D printing. Results: Thirty-four articles fulfilling inclusion criteria were identified in medical/technical databases and fifteen in the legal database. The majority of articles dealt with the USA, while the EU was also prominently represented. Some common unresolved legal issues were identified, among them terminological confusion between custom-made and patient-matched devices, lack of specific legislation for patient-matched products, and the undefined legal role of CAD files both from a liability and from an intellectual property standpoint. Data protection was mentioned only in two papers and seems an underexplored topic. Conclusion: In this scoping review, several relevant articles and several common unresolved legal issues were identified including a need for terminological uniformity in medical 3D printing. The results of this work are planned to inform our own deeper legal analysis of these issues in the future.
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影响因子：
2.9
作者：
FAIRGRIEVE D;FELDSCHREIBER P;HOWELLS G;PILGERSTORFER M QC
通讯作者：
PILGERSTORFER M QC
影响因子：
3.7
作者：
Di Prima, Matthew;Coburn, James;Ricles, Laura
通讯作者：
Ricles, Laura
影响因子：
1.8
作者：
Chae MP;Rozen WM;McMenamin PG;Findlay MW;Spychal RT;Hunter-Smith DJ
通讯作者：
Hunter-Smith DJ
影响因子：
2.7
作者：
Hourd, Paul;Medcalf, Nicholas;Williams, David J.
通讯作者：
Williams, David J.
影响因子：
0.9
作者：
Hatamleh, Muhanad M.;Ong, Juling;Huppa, Chrisopher
通讯作者：
Huppa, Chrisopher