[Open Design + Hardware] Liability in hacking medical equipment

Sun Nov 10 16:41:13 UTC 2013

Hi Anna and Jesper,

That's more a liability/hacking question more than an open hardware one.
I'd suggest the hackerspaces lists and forums (eg
http://hackerspaces.org/wiki/, http://www.reddit.com/r/hackerspaces/ )  -
although there can be a US bias, and you'll need to check the Denmark
situation specifically.  Checking whether your national hackerspace
community has any friendly lawyers might be worth it too - a quick chat
with someone who understands what you are doing could be really useful. If
you are seeking hackspace-aware lawyers but aren't finding them, asking in
the FOSS/startup space can be a good way to find legal experts who
understand the latest tech, which is a good sign :)

Good luck!  Helping improve and personalise assistive devices is incredibly
useful - and finding the way to do this so the risks are understood and
managed is important.

Laura

On 10 November 2013 15:57, Greg Austic <gbathree at gmail.com> wrote:

> I don't know the answer, but here's some people I would consider asking
> who have lots of experience with maker spaces and/or open hardware - at
> least they could brainstorm more people to ask:
>
> http://www.oshwa.org<http://www.oshwa.org/research/brief-history-of-open-source-hardware-organizations-and-definitions/>- they have some legal resources which are used to help hardware designers
> bring products to market in an open way.
>
> James at Schoolfactory - james at schoolfactory.org.  He interacts with lots
> of makerspaces and does some work on the legal and organizing side of
> things.  He may also know or direct you further (and he's usually pretty
> responsive).
>
> Those folks may even be on this list, I don't know :)  Anyway, I hope that
> helps!
>
> Greg
>
>
>
> On Sun, Nov 10, 2013 at 10:30 AM, anNa seravalli <anna.seravalli at mah.se>wrote:
>
>> hi Greg,
>> thank you for your quick reply. Just to make the issue more clear I'll
>> copy an example Jesper made in relation to bicycles.
>>
>>  John goes to makers-space, receives some advice from the manager, and
>>> based on that advice, John makes some changes to the bicycle's brakes. Then
>>> John is involved in an accident with his bicycle, because it suddenly can't
>>> brake.
>>>
>>> If he hadn't made any changes, John would probably be able to sue the
>>> bicycle manufacturer. Now, the manufacturer would likely claim that the
>>> accident was not because of the original product, but because of the
>>> changes John made. Will John now be able to sue the makers-space?
>>>
>>
>>
>>
>>
>> 2013/11/9 Greg Austic <gbathree at gmail.com>
>>
>>>   This is an interesting question...
>>>
>>>  I don't have a specific answer, but just to clarify... if the products
>>> that you are making are 3D printable and/or manufacturable on-site, can't
>>> you just make the design and let the users themselves actually make the
>>> object (push the button on the 3D printer, for example)?  That way, you are
>>> not selling them anything, you're just providing them a space to create
>>> their own products.
>>>
>>>  Greg
>>>
>>>
>>> On Sat, Nov 9, 2013 at 12:49 PM, anNa seravalli <anna.seravalli at mah.se>wrote:
>>>
>>>>   Hi guys,
>>>>  I am writing you with a question that I got from Jesper a friend that
>>>> is involved in a maker-space in Roskilde, Denmark. It a nutshell is about
>>>> how to deal with liability when organizing workshops where people is
>>>> invited to hack their own assistive technology (please scroll down for a
>>>> more detailed description of the issue).
>>>>
>>>>  Do you have any tips, contacts, experiences that could help with this?
>>>>
>>>>  ciao!
>>>> anNa
>>>>
>>>>
>>>> 2013/11/8 Jesper Holck <jesper.holck at roskilde-festival.dk>
>>>>
>>>>> Hi Anna,
>>>>>
>>>>> As promised, I send a few words describing our concerns about
>>>>> liability.
>>>>>
>>>>> As part of our makerspace in Roskilde, we're planning to also work
>>>>> with assistive technology devices (hjælpemidler, hjälpmedel). In Denmark,
>>>>> and I guess in Sweden also, these are under heavy regulation, and
>>>>> manufacturers must get their products certified. In Denmark, they are
>>>>> classified as medical equipment.
>>>>>
>>>>> You are of course allowed to make small repairs, decorations, and
>>>>> maintenance of assistive devices. But you are not allowed to make
>>>>> constructive changes. Or rather, if you make constructive changes, you
>>>>> should get a new certification of the device.
>>>>>
>>>>> I talked to the Danish "lægemiddelstyrelse" (the Danish governmental
>>>>> office for medicine and medical equipment) and they said, that we as a
>>>>> makerspace may be liable for the changes our users make to their assistive
>>>>> devices.
>>>>>
>>>>>
>>>>> Warm regards,
>>>>> Jesper
>>>>>
>>>>>
>>>>> --
>>>>> Jesper Holck
>>>>> Project Manager
>>>>>  <http://orangeinnovation.dk>
>>>>> www.orangeinnovation.dk
>>>>> www.twitter.com/orange_inno
>>>>> www.orangeinovation.dk/blog
>>>>>
>>>>> Skype: jesper.holck
>>>>> Mobile: +45 29467652
>>>>>
>>>>> Roskilde Office:
>>>>>
>>>>> Havsteensvej 11
>>>>> DK-4000 Roskilde
>>>>> Tel.: +45 4636 6613
>>>>> Fax: +45 4632 1499
>>>>>
>>>>>
>>>>> Cph Office:
>>>>>
>>>>> The Hub, Nørrebrogade 52 B
>>>>> DK-2200 København N
>>>>>
>>>>>
>>>>>
>>>>>
>>>>>
>>>>
>>>>
>>>> --
>>>> >>>>>>>>>>>>>>>>>>>>>>>>
>>>> Anna Seravalli
>>>> PhD Candidate Research Fellow
>>>> MEDEA Collaborative Media Initiative
>>>> Malmö University
>>>>
>>>> +46 72 744 55 24
>>>>
>>>> medea.mah.se
>>>> prototypingalternativefutures.wordpress.com
>>>>
>>>>
>>>>
>>>>
>>>>
>>>> _______________________________________________
>>>> OpenDesign mailing list
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>>>>
>>>
>>>
>>> --
>>> Greg Austic
>>>
>>>  2198 Seminole Dr.
>>> Okemos, MI 48864
>>> (919) 545 1083
>>>
>>>  www.austiclabs.com
>>>
>>
>>
>>
>> --
>> >>>>>>>>>>>>>>>>>>>>>>>>
>> Anna Seravalli
>> PhD Candidate Research Fellow
>> MEDEA Collaborative Media Initiative
>> Malmö University
>>
>> +46 72 744 55 24
>>
>> medea.mah.se
>> prototypingalternativefutures.wordpress.com
>>
>>
>>
>>
>>
>
>
> --
> Greg Austic
>
> 2198 Seminole Dr.
> Okemos, MI 48864
> (919) 545 1083
>
> www.austiclabs.com
>
> _______________________________________________
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-- 

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