Open Source Hardware and Healthcare Collaborative Platforms: Common Legal Challenges

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.