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

Ante B. Pettersson, Rosa Maria Ballardini, Marc Mimler, Phoebe Li, Mika Salmi, Timo Minssen, Ian Gibson, Antti Mäkitie*

*Corresponding author for this work

Research output: Contribution to journalReview Articlepeer-review

2 Citations (Scopus)
87 Downloads (Pure)

Abstract

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. Conclusions: 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.
Original languageEnglish
Article number1102780
Number of pages8
JournalFrontiers in Bioengineering and Biotechnology
Volume11
DOIs
Publication statusPublished - 2023
MoE publication typeA2 Review article, Literature review, Systematic review

Keywords

  • additive manufacturing
  • 3D printing
  • legal issues
  • legislation
  • regulation
  • medical
  • medicine

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