Thanks @schutton for your input. I am adding new stuff to this thread. Let’s keep this conversation going, Breathing Game project/network/venture is going through an hyperactive phase and we’re going in a direction that requires brainstorming within IoPA and partnership.
For those of you who are not familiar with Breathing Games, BG, in short, this is an open network and venture that engages in peer production of software and hardware used in medical therapy.
We recently filed a grant proposal. One objective in this proposal is to run the BG game and associated hardware through the Canadian regulatory approval process for medical devices. This process will scrutinize the safety and efficiency of the BG software and hardware, but also the data management, since BG includes a computer game and requires storing the patient’s data and data sharing with a care agent and even with the scientific community at large. The intersection between Sensnrica+BG and IoPA is about the requirements for safety and efficiency of the BG device/hardware.
NOTE: a budget has been included in the proposal for this, I reached out to the administrative core of IoPA to get some feedback and an idea about the budget but I did not get any reply, so I included CAD 20K. If we get the grant, this budget will be spent with any member of IoPA, individual and/or organization who can contribute to the work.
From the proposal: Different collaborative platforms help address regulatory issues of OS hardware (ex. Careables.org, Patient Innovation, Makers Making Change, Ubora). They empower patients and OS contributors to share ideas and co-create solutions, adopting design and documentation principles that meet industry standards, offering a curated catalog of designs, guidelines for fabrication, a curated list of makers, legal help, etc. The platform approach increases the level of standardization, provides trust and can offer a legal blanket for developers and makers. Our project will build on the success of platforms and explore novel ways to make OS medical solutions safe, relying on distributed architectures.
Open Know-How becomes critical in this context. Unlike traditional production, where the designer and the fabricator are the same entity, DIY open source hardware dissociates designers from producers and makes producers unknown in advance. We will prototype new ways to prove provenance of design and of recipe for fabrication (a DIY manual), which is only one half of the solution. So we need to standardize documentation in a way that preserves composability of designs and fabrication methods, and in a machine readable way.
As a note, on the data management side, we just hosted a workshop at the Sensorica lab with OPN, digital privacy and security, where we discussed the architecture of medical/therapeutic devices that provide maximum protection and are compatible with the law. Those who are interested in such things ping me, I’ll include you in the conversation.