Abstract
Open collaborative platforms to share open source hardware project designs are a growing paradigm. In the healthcare sector, platforms – such as Careables.org, Patient Innovation, Makers Making Change – are becoming a popular means to share knowledge and create healthcare solutions. Users of these platforms, however, might be unaware of the legal requirements and possible consequences of non-compliance. This paper is addressed to designers and makers involved in co-design and co-creation of open source hardware healthcare solutions. It aims at mapping, using plain language, the common legal challenges for developing Open Source Hardware in healthcare – stemming from laws on privacy and data protection, intellectual property, liability, and medical devices. Publisher’s Note: A correction article relating to this paper has been published and can be found at https://openhardware.metajnl.com/articles/10.5334/joh.37/.
Highlights
Problem statement and purpose of the paper The advent of healthcare open collaborative platforms has given individuals the possibility to share knowledge to design, create and reproduce Open Source Hardware (OSHW)1 projects worldwide
Collaborative innovation3 and digital social innovation4 are phenomena that have rapidly diffused around the world: multiple stakeholders progressively engage in sharing open innovation and create new projects, technologies and solutions through open collaborative platforms (Biasin & Kamenjašević 2020)
The grey areas concerning the applicability of laws and regulations in the OSHW field may result in uncertainty for the stakeholders involved
Summary
Problem statement and purpose of the paper The advent of healthcare open collaborative platforms has given individuals the possibility to share knowledge to design, create and reproduce Open Source Hardware (OSHW) projects worldwide. Those involved in the design and creation of OSHW healthcare projects – such as makers and designers, often lack an outline of possible legal challenges that could arise during the development of these projects. The purpose of this paper is to map the common legal challenges of OSHW healthcare projects.
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