Please note: I would have posted this question on HealthIT.SE but they are apparently now closed for business, and I believe this site is the next most appropriate place to ask this. I believe this question is on topic because it involves circuit verification and certification.
I'm very interested in the open source OpenBCI device and the bevy of apps and devices I could see it allowing integration with. Their open source license allows derivation (provided attribution), and I think this is going to open up flood gates with respect to commercial devices that build off of its hardware design.
In the commercial domain, I was curious as to what regulations/standards may come into focus for any companies selling OpenBCI and/or hardware componentry built up off of the OpenBCI mainboard. I ask because the biodata being streamed from the OpenBCI is EEG (brain wave) data, EMG data, EKG data, etc… this may very well constitute biomedical data that may be protected by things like HIPAA, etc.
I've heard of IEC 6061 but that is the only biomedical/technical safety standard I'm aware of.
So I ask: if I was building a commercial device that used OpenBCI as its core, and that was streaming EEG/EMG/EKG data from it, what sort of standards (besides IEC 6061) might I have to have the electronics verified/certified to?
Best Answer
There is nothing wrong in using open source software or hardware to design medical devices. But at end of the day provider of these equipment has to comply with regulation in jurisdiction the devices are sold. I have experiences ubuntu (Linux) computers used in US doctors offices.
In general in USA and Europe the devices have to be compliant to government regulations such as FDA - 21 CFR 820 (I have attach references below). IEC 6061 which you have referenced is commonly used in both and USA and Europe. This document contains product performance in with respect to EMC/EMI and others.
One of the major issue with open source software and hardware is compliance to quality requirements. There are many more ...
All in all there are companies starting medical device development work using open source tools but migrate into traditionally accept development process as the product is getting closer to regulatory approval.
References: