The Institute of Electrical and Electronics Engineers Standards Association (IEEE) is developing new interoperability standards for medical devices, 3D printers and other eHealth devices. IEEE P3333.2.5, Draft Standard for Bio-CAD File Format for Medical 3D Printing is intended to develop standard methods for the printing of 3D-printed prosthetics and medical devices. IEEE proposes to define the Bio-CAD format for 3D printing based on sectional scan image data containing surface and volumetric information, and its proposed standards are intended to address medical 3D printing services such as anatomic and pathologic models and medical-instrument printing. IEEE also unveiled the Biometrics Open Protocol Standard (BOPS), which is a new eHealth cybersecurity standard designed to protect biometric data exchange.
Earlier this year, Reed Smith's 3D Printing Task Force published a white paper discussing the spectrum of legal issues raised by 3D printing of medical devices and drugs, from product liability to IP to reimbursement.
This article is presented for informational purposes only and is not intended to constitute legal advice.