We propose the Healthware Translation Framework: a novel automatic pre-emergency governance system via independently certified dynamic licensing that enables a proprietary medical Technical Data Package (TDP) to transition back and forth conditionally between shared status for distributed production, and protected status preserving commercialization pathways. This novel infrastructure allows distributed surge capacity to be activated rapidly during strategic periods without sacrificing commercialization potential. The proposed solution would enable ASPR to activate independently certified pre-negotiated agreements.

OSHWA Team: Our team, the Open Source Hardware Association (OSHWA), brings established expertise in open-source hardware ecosystem development and governance. In 2014, OSHWA established the globally recognized definition of open-source hardware licensing, and has maintained a trademarked certification program that has independently certified more than 3,000 open-hardware project licenses submitted by hardware developers across the world. OSHWA’s certification directory is a trusted repository of open-source hardware projects, licenses, and provenance, and its software API enables third parties and sister organizations to contribute to and read from the certified directory. OSHWA hosts the annual Open Hardware Summit that convenes an international network of more than 70 organizations, including manufacturers, developers, standards bodies, humanitarian aid specialists, and businesses working  around distributed development and production.

The OSHWA team recently completed a $1.5 million NSF-funded project to foster an open source ecosystem around health and medical hardware, i.e.,  Healthware. The project established an expert review panel including members of the International Organization for Standardization (ISO), as well as NGO and industry representatives to vet open-source licensing agreements and associated TDPs. Further, it produced recommended practices for sourcing, contributing to, replicating, and assuring the quality of Open Healthware designs and created educational and community infrastructure supporting the adoption of Open Healthware. Its research included audits and physical replication of existing Open Healthware projects and a distributed case study exemplifying the activation of surge production capabilities in which participants across five continents reproduced an open-source tourniquet using their own manufacturing resources. The OSHWA team has a strong relationship with stakeholders throughout the medical hardware ecosystem and is well positioned to address the central challenges addressed by the proposed DS-MRN.