COVID19 & Open-Source Hardware: Legal Recommendations for Makers

Hi All

I thought this might be of interest to some:

Has anyone found other useful posts or paper on this topic?

Jenny

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Hi Jenny, there is this paper by Jiri Svorc and Andrew Katz. We also have a special section in the FAQ of CERN OHL v2 for people fighting COVID-19.
Cheers,
Javier

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Thanks a lot for sharing.

A quick look at the documents pointed above indicates different levels of liability to those making/building/selling/using the medical devices. However, there is an urge to clarify the liability of those simply contributing to public repositories in good faith. For reference, the legal department of a large university in Brazil advised the project leaders to hold the release of the firmware of an open source ventilator citing liability concerns (details here - in Portuguese).

The project has “open” on the title, has a call for volunteers, has a crowdfunding campaign, has a public repository released under CERN OHL. Unfortunately, following the legal advice, they may be closing the project source code, or a good part of it.

The advice claims that, even if the university is not manufacturing or distributing ventilators, and even with due warning notices on the project documentation, the developers can be held liable for misuses of the project by third parties. This correspond to an even stricter liability of volunteers/developers than those described for producers of the devices as in Section 4.2.1 of this document. While I cannot tell if Brazilian laws are stricter than the European counterparts, there is also a chance that the legal team of the university did not give due attention to this issue. They may not realize that the dissemination of this technology can save a lot of lives, thus ended up taking the path of least effort.

With big players already leaving the field citing liability, it is clear that further clarifications are central to the future present of open source healthcare.

Rafael

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Hi Rafael and everyone
I’ve observed similar worrying behavior by a group at the German university in Marburg: https://www.uni-marburg.de/de/fb13/halbleiterphotonik/the-breathing-project/the-breathing-project-1
For several weeks, they were quite active in showing pictures, talking on radio/TV and posting progress reports. But there were hardly providing any further details since they were convinced it would be illegal to publish anything that hasn’t gone through medical device certification. They referred to discussions with the university’s legal team if I remember well.
At least withing EU regulations this fear is unfounded since blueprints for a device are not the same as the physical device itself and thus not governed by compliance rules like the European directive for medical devices.

I believe what we are seeing is largely an effect of many teams and individuals actually trying to publish for the very first time hardware and software sources in an open way. This conclusion is based on observing some suboptimal licensing choices (CC etc. without disclaimers) or none at all.
My favorite COVID-19 example so far is the 3D printed Charlotte valve story:


They’ve decided to quickly patent it in order “to prevent any speculation on the price of the component”. :roll_eyes: But of course they want everyone to use the design freely!

In the case of these university decisions, it seems many are either not aware or do not trust in the validity of standard warranty/liability disclaimers being part of the common open source and hardware licenses.

Here’s hoping that this will be an opportunity to make the public more aware of open licenses. We could maybe support this by issuing or prominently highlighting some existing open licensing overview and guidelines? It seems so obvious that it has been maybe done already… I haven’t checked.
“How to license open tools for pandemic-coping”? :wink:
Cheers, Oliver

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Hi @oli.keller, @Javier, @jcm80, all,

today I talked with the coordinators of Milano Ventilatore Meccanico (http://mvm.care). They are withdrawing the CERN OHL from the project and will not release the design following advice from the CERN Legal and Knowlege Transfer departments, citing liability concerns. I also understood that CERN did not allow the High Energy Ventilator (https://hev.web.cern.ch/) to be released as Open Source Hardware.

On one hand, there is a legitimate concern that non-certified equipment might hurt or even kill people. On the other, halting knowledge sharing can have the same effect, though, in a passive way.

It is hard to believe that a researcher, who is applying open science practices as part of her evaluation of different designs of mechanical ventilators, can be held liable if someone builds something based on the lab experiment and decides to use it on people before getting the proper certifications.

We can think on parallel situations on other fields. For instance, on pharmacology, where recipes for untested/unapproved/non-certified substances can be found in scientific papers.

With some institutions affirming that Open Source and Life-support medical devices are incompatible, perhaps we should hire some lawyers to shed some light here.

Rafael

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We need to work more collaboratively on the recognition and legitimization of what we call the 4th Sector.

Here are some interesting links for you on this topic from Sensorica

https://www.sensorica.co/projects/4th-sector

Thanks Rafael. As you know, the MVM project is not managed by people at CERN, and CERN KT has no say whatsoever in their strategy for maximising the impact of their development. There are other projects in which CERN KT does have a say, like this 3D-printable mask and this face shield design, both licensed under CERN-OHL-P v2. It is true that liability concerns are quite frequent in these projects. You can see that both of the CERN designs come with an extra disclaimer, reflecting these worries, also shared by CERN KT. This may also be the reason why the MVM team decided to not open-source their design, I don’t know.

Regarding the HEV design, I don’t think the decision regarding the strategy for the dissemination of the technology has been taken. At CERN KT, their goal is to maximise positive impact, and open-source is one more tool in their tool set. They also need to take into account a number of factors, and consider any risks involved, before making a proposal, which ultimately will, in this case, be taken into account by management before they decide. I am told it is a matter of a few weeks. I hope they open-source it, of course, but I am sure they will have good reasons if they don’t.

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