Re: Status of uw-prism packaging for Debian
Hi, I'm tuning in late, but regarding Ira Kalet's question: 3. Finally, there is still the issue of what the US FDA might say about distribution within the US, We have to worry about more than just the US. Almost every country regulates the marketing of medical devices. as software products that do what Prism does are considered medical devices and cannot be distributed without FDA 510K premarket approval, an onerous process to be sure. It does not matter that no money is involved. What do you do about other debian-med packages? Might any of them be considered a medical device? In my opinion: yes, almost certainly. PACS software, for example, is regulated as a medical device and Debian has some DICOM viewers if not full PACS implementations. Ira states that approval by FDA is required even if no money is involved. In my superficial search, I didn't find any reference from the FDA stating this, but it wouldn't surprise me since I did find such a statement [1] from Health Canada: Note that the Regulations apply to Free and Open-Source (FOSS) device software, since the definition of sell in the Food and Drugs Act, includes transactions without compensation. [1] http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_software_im_avis_logicels-eng.php I don't know whether this issue has been considered within Debian before. But I'd like to point out that there is a long history of free/open source PACS and DICOM viewers [2] including the very well known Osirix [3] that can be downloaded for free (download is described as not cleared for clinical use) or purchased as a fully approved medical device. [2] http://www.medfloss.org/taxonomy/term/84 [3] http://www.osirix-viewer.com/ My guess is that the legality of distribution hinges on how the software is represented. For example, [1] defines device as: any article, instrument, apparatus or contrivance, including any component, part or accessory thereof, manufactured, sold or represented for use in a.the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical sate, or its symptoms, in human beings or animals, ... etc. If the software makes no claim about diagnosis or treatment, perhaps it's still OK, as in the Osirix case. Note that I'm not a lawyer so these opinions are worth what you paid for them. I do, however, write medical device software in my professional life that has been cleared by regulatory bodies in US, Europe, Canada, and elsewhere. Regards, -Steve -- To UNSUBSCRIBE, email to debian-legal-requ...@lists.debian.org with a subject of unsubscribe. Trouble? Contact listmas...@lists.debian.org Archive: https://lists.debian.org/3202909.EYXrNivtNs@riemann
Re: GFDL'ed documents with Front Cover text
On Wed, Mar 29, 2006 at 12:55:33AM -0500, Nathanael Nerode wrote: [EMAIL PROTECTED] wrote: If so, I expect it will be more efficient if we can approach the FSF for a blanket license change. No; from what we can tell, RMS is personally blocking even the simplest and most obvious license changes, and nobody with authority in the FSF will go up against him, although a very large number of GNU developers disagree with him. Get the individual developers to relicense/dual-license under the GPL. They ain't willing to do so: they told me to ask FSF :-( -Steve -- To UNSUBSCRIBE, email to [EMAIL PROTECTED] with a subject of unsubscribe. Trouble? Contact [EMAIL PROTECTED]
Re: GFDL'ed documents with Front Cover text
On Sun, Mar 26, 2006 at 01:08:16AM -0800, Steve Langasek wrote: On Sat, Mar 25, 2006 at 02:09:02PM -0500, Steve M. Robbins wrote: This implies that a document with no invariant sections, but with one-sentence front- and back-cover sections does not meet the DFSG? Is that Debian's position? For example, GMP has Front-Cover Text A GNU Manual and Back-Cover Text You have freedom to copy and modify this GNU Manual, like GNU software and no invariant sections. Must I really throw this document out of Debian (BTS 335403)? [...] So yes, the current manual seems to fail the DFSG as confirmed by the latest GR, and can't be distributed in main for etch without a license change. I would hope that this doesn't mean throwing it out of Debian, though; if we fail to secure even such a modest licensing change as to make such cover texts removable, then I would encourage you to consider at least shipping the documentation in non-free. OK; let's concentrate on requesting such a modest licensing change. I have approached the GMP developers both on the GMP list and privately. It turns out that the copyright is assigned to FSF so they have no authority (or so they claim) to change the license. I was advised to contact FSF about it. I'll bet that this is not the only documentation copyrighted by FSF and licensed under the GFDL with only short cover texts standing in the way of Debian's acceptance. If so, I expect it will be more efficient if we can approach the FSF for a blanket license change. I also expect that some readers of debian-legal have a contact or two within the FSF. I imagine that writing directly to someone would be more effective than an email to [EMAIL PROTECTED] Perhaps someone who's been there could offer tips on who and how to approach this? While I don't mind writing the emails to pursue this, I don't really feel I'm best qualified to articulate the nuances of Debian's position on the matter. Perhaps one of the debian-legal readers would prefer to take up the charge? Thanks, -Steve -- To UNSUBSCRIBE, email to [EMAIL PROTECTED] with a subject of unsubscribe. Trouble? Contact [EMAIL PROTECTED]
GFDL'ed documents with Front Cover text
Hi, Frank said: assume a document licensed under GFDL, with no invariant sections (and ...) has a front cover text (like A GNU Manual) and a back cover text [...] What should the developers do in order to make it DFSG-free [...] This implies that a document with no invariant sections, but with one-sentence front- and back-cover sections does not meet the DFSG? Is that Debian's position? For example, GMP has Front-Cover Text A GNU Manual and Back-Cover Text You have freedom to copy and modify this GNU Manual, like GNU software and no invariant sections. Must I really throw this document out of Debian (BTS 335403)? Regards, -Steve -- To UNSUBSCRIBE, email to [EMAIL PROTECTED] with a subject of unsubscribe. Trouble? Contact [EMAIL PROTECTED]
mpeg2enc code in simage
Hi, I'd like to package some software (simage, from http://www.coin3d.org/download/source-code/) which contains the source code for mpeg2enc. Simage per se is in the public domain, but mpeg2enc is rather more encumbered (see below). As I read it, the patent claims disallow this from Debian. Is that true? Can it go into non-free? If this is not allowable, is it enough to build it without the mpeg2enc code enabled or do I need to sanitize the *source* package too? Thanks, -Steve - mpeg2enc copyright /* Copyright (C) 1996, MPEG Software Simulation Group. All Rights Reserved. */ /* * Disclaimer of Warranty * * These software programs are available to the user without any license fee or * royalty on an as is basis. The MPEG Software Simulation Group disclaims * any and all warranties, whether express, implied, or statuary, including any * implied warranties or merchantability or of fitness for a particular * purpose. In no event shall the copyright-holder be liable for any * incidental, punitive, or consequential damages of any kind whatsoever * arising from the use of these programs. * * This disclaimer of warranty extends to the user of these programs and user's * customers, employees, agents, transferees, successors, and assigns. * * The MPEG Software Simulation Group does not represent or warrant that the * programs furnished hereunder are free of infringement of any third-party * patents. * * Commercial implementations of MPEG-1 and MPEG-2 video, including shareware, * are subject to royalty fees to patent holders. Many of these patents are * general enough such that they are unavoidable regardless of implementation * design. * * Please visit MPEGLA at http://www.mpegla.com/ for more information about * licensing. * */
