Academic Journal

Legal issues and underexplored data protection in medical 3D printing: A scoping review

التفاصيل البيبلوغرافية
العنوان: Legal issues and underexplored data protection in medical 3D printing: A scoping review
المؤلفون: ABV Pettersson, RM Ballardini, M Mimler, P Li, M Salmi, T Minssen, Ian Gibson, A Mäkitie
سنة النشر: 2023
مصطلحات موضوعية: Other biological sciences not elsewhere classified, Medical biotechnology not elsewhere classified, Biomedical engineering not elsewhere classified, 3D printing, additive manufacturing, legal issues, legislation, medical, medicine, regulation
الوصف: 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.
نوع الوثيقة: article in journal/newspaper
اللغة: unknown
Relation: http://hdl.handle.net/10779/DRO/DU:22493257.v1; https://figshare.com/articles/journal_contribution/Legal_issues_and_underexplored_data_protection_in_medical_3D_printing_A_scoping_review/22493257
الاتاحة: http://hdl.handle.net/10779/DRO/DU:22493257.v1
https://figshare.com/articles/journal_contribution/Legal_issues_and_underexplored_data_protection_in_medical_3D_printing_A_scoping_review/22493257
Rights: All Rights Reserved
رقم الانضمام: edsbas.7CCE1F59
قاعدة البيانات: BASE