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COVID-19 and Open Source Hardware: Legal aspects for Makers

A guide on how to legitimately design or reproduce open source medical devices and PPE.
How can makers help the Covid-19 response in an informative way? This guide by Elisabetta Biasin and Erik Kamenjašević (Ku Leuven) describes legal and ethical aspects such as intellectual property management issues, tort law and liability aspects, as well as medical devices and personal protective equipment laws. It also recommends ethical principles in promoting and respecting the highest level of safety for healthcare solutions.

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CERTIFICATION & LEGAL

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Covid19Ethical requirementslegal guidelineslegislationmakers

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Ku Leuven

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COVID-19 and Open Source Hardware: Legal aspects for Makers

Aim of the resource

The aim of this resource is to foster awareness for a safe and responsible use of healthcare solutions by providing some background information on possible legal aspects that Makers should be aware of when designing or reproducing a healthcare solution (such as a careable).
This article contains:
1. Context: how and why careables project is providing support against the Covid-19 pandemic;
2. Framework: crucial factors that should be taken into account such as intellectual property law, tort law and liability, medical devices and personal protective equipment laws;
3. Recommendations: ethical and legal cautious approach towards the design and replication of healthcare solutions.
4. Other useful resources: a list of additional essential resources such as European legal sources, standards, regulations and recommendation for designing and printing supports for Covid-19.

How to use it

The resource is meant to makers, designer, researchers, lawyers and anyone interested in the topic of legal implications in design for emergency.

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