Unless the law has changed in the last 10 years or so, the FDA's ability to regulate a medical device is based on "marketing" that device. They claim that they have the right to regulate based on use, but that's not what the letter of the law says. When pressed, they refuse to answer (or so I've been told by a frequent member of this list who really would like to know the consequences of making free imaging software available.) It appears that intimidation may help them uphold what they feel is their mandate.
----- Original Message ----- From: "Cameron Schlehuber" <[EMAIL PROTECTED]> To: <hardhats-members@lists.sourceforge.net> Sent: Thursday, August 11, 2005 12:11 PM Subject: RE: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use Re: [Hardhats-members] Re: TIU Interface for Document Scanning >I think "purpose" is being confused with "price". Whether something that is > FDA regulated is paid for, free or even given to someone to use along with a > cash incentive, it's the PURPOSE TO WHICH IT IS PUT OR LLKELY TO BE PUT that > is going to determine whether the item is regulated or not. Of course there > are some things that by law cannot be sold, traded or even given away. But > things that are in the public domain or open source can be freely copied. > If you just create a medical device from a public drawing or description, > you've broken no law. But the minute you even begin to use it on a human, > you may fall under FDA regulation. And even drugs that used to be only > given to animals are now off the market due to the potential of running > afoul of the FDA since said drugs are likely to be diverted to human use. > > Using a camera to take a picture for a passport is unlikely to ever > successfully get the FDA involved (though it wouldn't surprise me if the FDA > tried!) And I would expect that even using a more sophisticated imaging > device could be used for the same purpose (identity) but could be regulated > by the FDA when used for a clinical purpose. Use of common digital camera > pictures of wounds, etc, that require no special resolution may or may not > become regulated. I expect that will come into clearer focus over time. > > -----Original Message----- > From: [EMAIL PROTECTED] > [mailto:[EMAIL PROTECTED] On Behalf Of Joseph > Dal Molin > Sent: Thursday, August 11, 2005 9:45 AM > To: hardhats-members@lists.sourceforge.net > Subject: [Hardhats-members] Re: VistA Imaging FDA and NonCommercial Use Re: > [Hardhats-members] Re: TIU Interface for Document Scanning > > Actually this has nothing to do with open source .... it is how it is > distributed ie. sold vs. given away. > > One of the best medical imaging systems in the market actually started > out as a freebie....the name escapes me now.... not sure what the FDA > history of that solution is but it spread far and wide and then became > commercial and would have had to get FDA approval at that point. > > J > > Greg Woodhouse wrote: >> That's interesting. Frankly, I find it a bit disconcerting to think >> that medical applications might be unregulated just because they are >> open source. >> >> --- Joseph Dal Molin <[EMAIL PROTECTED]> wrote: >> >> >>>There was a recent post on the OSIRIX list that asked the question >>>why >>>is OSIRIX not subject to FDA regs. The answer apparently is "if you >>>sell >>>it installed" it is FDA regulated .... if you give it away it is not. >>>I >>>have asked the people responsible for OSIRIX (BTW it is an open >>>source >>>medical image viewer) to give me a more detailed answer which I will >>>share with this list when I receive it. >>> >>> >>>Joseph >>> >>>Kevin Toppenberg wrote: >>> >>>>I understand the need to protect one's business investments. But >>> >>>it >>> >>>>was my understanding that the entire VI package was FOIA -- its >>> >>>just >>> >>>>that one would need to be careful not to cross the FDA in >>>>implementations. >>>> >>>>So the "import API" should be open source, and the "VI background >>>>processor" should be open source too, I suspect. >>>> >>>>What we need are people who understand the system and can explain >>> >>>it >>> >>>>-- or at least better than the usual documentation. >>>> >>>>I suspect that there is money in the area on this subject and that >>> >>>is >>> >>>>why there is a tendency towards secrecy. >>>> >>>>Kevin >>>> >>>> >>>>On 8/11/05, smcphelan <[EMAIL PROTECTED]> wrote: >>>> >>>> >>>>>We all know how protective the VistA Imaging people are. I cannot >>> >>>share >>> >>>>>anything I obtained because of the IA. Maybe legally I can. But I >>> >>>cannot >>> >>>>>jeopardize our relationship with Silver Springs. So we take the >>> >>>most >>> >>>>>conservative approach. The import API was released as a patch to >>> >>>the MAG >>> >>>>>package. If it is out on FOIA you have it. But it is designed to >>> >>>work >>> >>>>>with >>>>>the VI Background Processor. >>>>> >>>>>----- Original Message ----- >>>>>From: "Kevin Toppenberg" <[EMAIL PROTECTED]> >>>>>To: <hardhats-members@lists.sourceforge.net> >>>>>Sent: Thursday, August 11, 2005 9:36 AM >>>>>Subject: [Hardhats-members] Re: TIU Interface for Document Scanning >>>>> >>>>> >>>>>On 8/10/05, smcphelan <[EMAIL PROTECTED]> wrote: >>>>> >>>>> >>>>>>... >>>>> >>>>>We cannot share the import functionality with >>>>> >>>>> >>>>>>anyone as that would be a violation of our IA with VistA Imaging. >>>>> >>>>>I don't understand. If one has an IA with VistA imaging, then one >>> >>>is >>> >>>>>not allowed to share code? >>>>> >>>>>Kevin >>>>> >>>>> >>>>>------------------------------------------------------- >>>>>SF.Net email is Sponsored by the Better Software Conference & EXPO >>>>>September 19-22, 2005 * San Francisco, CA * Development Lifecycle >>> >>>Practices >>> >>>>>Agile & Plan-Driven Development * Managing Projects & Teams * >>> >>>Testing & QA >>> >>>>>Security * Process Improvement & Measurement * >>> >>>http://www.sqe.com/bsce5sf >>> >>>>>_______________________________________________ >>>>>Hardhats-members mailing list >>>>>Hardhats-members@lists.sourceforge.net >>>>>https://lists.sourceforge.net/lists/listinfo/hardhats-members >>>>> >>>>> >>>>> >>>>> >>>>>------------------------------------------------------- >>>>>SF.Net email is Sponsored by the Better Software Conference & EXPO >>>>>September 19-22, 2005 * San Francisco, CA * Development Lifecycle >>> >>>Practices >>> >>>>>Agile & Plan-Driven Development * Managing Projects & Teams * >>> >>>Testing & QA >>> >>>>>Security * Process Improvement & Measurement * >>> >>>http://www.sqe.com/bsce5sf >>> >>>>>_______________________________________________ >>>>>Hardhats-members mailing list >>>>>Hardhats-members@lists.sourceforge.net >>>>>https://lists.sourceforge.net/lists/listinfo/hardhats-members >>>>> >>>> >>>> >>>> >>>>------------------------------------------------------- >>>>SF.Net email is Sponsored by the Better Software Conference & EXPO >>>>September 19-22, 2005 * San Francisco, CA * Development Lifecycle >>> >>>Practices >>> >>>>Agile & Plan-Driven Development * Managing Projects & Teams * >>> >>>Testing & QA >>> >>>>Security * Process Improvement & Measurement * >>> >>>http://www.sqe.com/bsce5sf >>> >>>>_______________________________________________ >>>>Hardhats-members mailing list >>>>Hardhats-members@lists.sourceforge.net >>>>https://lists.sourceforge.net/lists/listinfo/hardhats-members >>>> >>>>. >>>> >>> >>> >>>------------------------------------------------------- >>>SF.Net email is Sponsored by the Better Software Conference & EXPO >>>September 19-22, 2005 * San Francisco, CA * Development Lifecycle >>>Practices >>>Agile & Plan-Driven Development * Managing Projects & Teams * Testing >>>& QA >>>Security * Process Improvement & Measurement * >>>http://www.sqe.com/bsce5sf >>>_______________________________________________ >>>Hardhats-members mailing list >>>Hardhats-members@lists.sourceforge.net >>>https://lists.sourceforge.net/lists/listinfo/hardhats-members >>> >> >> >> >> >> === >> Gregory Woodhouse <[EMAIL PROTECTED]> >> >> "Design quality doesn't ensure success, but design failure can ensure > failure." >> >> --Kent Beck >> >> >> >> >> >> >> >> >> ------------------------------------------------------- >> SF.Net email is Sponsored by the Better Software Conference & EXPO >> September 19-22, 2005 * San Francisco, CA * Development Lifecycle > Practices >> Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA >> Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf >> _______________________________________________ >> Hardhats-members mailing list >> Hardhats-members@lists.sourceforge.net >> https://lists.sourceforge.net/lists/listinfo/hardhats-members >> >> . >> > > > ------------------------------------------------------- > SF.Net email is Sponsored by the Better Software Conference & EXPO > September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices > Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA > Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf > _______________________________________________ > Hardhats-members mailing list > Hardhats-members@lists.sourceforge.net > https://lists.sourceforge.net/lists/listinfo/hardhats-members > > > > ------------------------------------------------------- > SF.Net email is Sponsored by the Better Software Conference & EXPO > September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices > Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA > Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf > _______________________________________________ > Hardhats-members mailing list > Hardhats-members@lists.sourceforge.net > https://lists.sourceforge.net/lists/listinfo/hardhats-members > ------------------------------------------------------- SF.Net email is Sponsored by the Better Software Conference & EXPO September 19-22, 2005 * San Francisco, CA * Development Lifecycle Practices Agile & Plan-Driven Development * Managing Projects & Teams * Testing & QA Security * Process Improvement & Measurement * http://www.sqe.com/bsce5sf _______________________________________________ Hardhats-members mailing list Hardhats-members@lists.sourceforge.net https://lists.sourceforge.net/lists/listinfo/hardhats-members
