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

Ante B V Pettersson; Rosa Maria Ballardini; Marc Mimler; Phoebe Li; Mika Salmi; Timo Minssen; Ian Gibson; Antti Mäkitie

doi:10.3389/fbioe.2023.1102780

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

Front Bioeng Biotechnol. 2023 Feb 27:11:1102780. doi: 10.3389/fbioe.2023.1102780. eCollection 2023.

Authors

Ante B V Pettersson^{1

2

3}, Rosa Maria Ballardini⁴, Marc Mimler⁵, Phoebe Li⁶, Mika Salmi⁷, Timo Minssen⁸, Ian Gibson⁹, Antti Mäkitie^{1

10}

Affiliations

¹ Department of Otorhinolaryngology-Head and Neck Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
² Department of Vascular Surgery, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
³ Department of Surgery, South Karelia Central Hospital, Lappeenranta, Finland.
⁴ Faculty of Law, University of Lapland, Rovaniemi, Finland.
⁵ The City Law School City, University of London, London, United Kingdom.
⁶ Sussex Law School, University of Sussex, Brighton, United Kingdom.
⁷ Department of Mechanical Engineering, Aalto University, Espoo, Finland.
⁸ Center for Advanced Studies in Biomedical Innovation Law (CeBIL), Faculty of Law, University of Copenhagen, Copenhagen, Denmark.
⁹ Department of Design, Production and Management, University of Twente, Enschede, Netherlands.
¹⁰ Research Program in Systems Oncology, Faculty of Medicine, University of Helsinki, Helsinki, Finland.

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. 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.

Keywords: 3D printing; additive manufacturing; legal issues; legislation; medical; medicine; regulation.

Publication types

Review

Grants and funding

AP is supported by grants from the Viipuri Tuberculosis Foundation, the South-Karelia Medical Association, the Emil Aaltonen Foundation and the Finnish Medical Foundation. PL is supported by the UKRI Strategic Priorities Fund to the UKRI Research Node on Trustworthy Autonomous Systems Governance and Regulation (EP/V026607/1, 2020–2024) and the Leverhulme Trust ‘Biomodifying technologies: governing converging research in the life sciences’ (grant number 68387). MS is supported by the Academy of Finland (grant numbers 325509 and 352438). RB has received funding from the project “Shaping, Fixing, and Making Markets via IPR: Regulating Sustainable Innovation Ecosystems (SHARE)”, funded by the Academy of Finland (decision number 332819). TM’s research for this contribution was supported by a Novo Nordisk Foundation for a scientifically independent Collaborative Research Programme in Biomedical Innovation Law (grant agreement number NNF17SA0027784).