Robert L. Read
Pierre Lonchampt, Darío Hereñú
This is an attempt to construct a new kind of free-libre open source license aimed specifically at medical devices. The COVID-19 pandemic has demonstrated the need for open, transparent devices which are both suppy-chain resilient and fully tested under normal regulatory regimes. In order to build an system of for-profit and non-profit firms that support such devices to alleviate want now and in the future, we believe a license that encourages a new kind of sharing is required: one that allows re-use of device designs and test documentation by forcing publication at the time of reuse for regulatory clearance.
We are currently using a commentable google doc as our working document.
Based on some work by Sabrina Merlo of OSMS, I wrote this essay proposing a new kind of FDA clearance. This is independent of the license, but it is related as a motivational work, so I’m linking it here. It has been submitted to the Day One Project.
Lawyers or paralegals who work with copyright licensing for open-source medical device designs
- Recruit an additional lawyer to assist
- Recruit a regulatory expert to vet the “covered matter”