1. NA-MIC National Alliance for Medical Image Computing http://na-mic.org Software Licensing, Treating Patients, and NA-MIC Steve Pieper, PhD

2. “Newton said, 'If I have seen further than others, it is because I've stood on the shoulders of giants’. These days we stand on each other's feet!” Richard Hamming, from “You and Your Research” Quoted by Tim Killeen, NCAR

3. National Alliance for Medical Image Computing http://na-mic.org Goals Open Source for Clinical License Types NA-MIC Policy

4. National Alliance for Medical Image Computing http://na-mic.org Developer Goals Why Medical Algorithms? –To Help Patients!

5. National Alliance for Medical Image Computing http://na-mic.org NIH Goals “Simply described, the goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold.” –http://www.nih.gov/about/Faqs.htm#NIH

6. National Alliance for Medical Image Computing http://na-mic.org NIH NCBC Goals http://grants1.nih.gov/grants/guide/rfa-files/RFA- RM-04-003.htmlhttp://grants1.nih.gov/grants/guide/rfa-files/RFA- RM-04-003.html …NIH does have goals for software dissemination… …software should be freely available… …permit the commercialization of enhanced or customized versions… …include the ability of researchers outside the center and its collaborating projects to modify the source code and to share modifications…

7. National Alliance for Medical Image Computing http://na-mic.org FDA Goals Illegal to Distribute Medical Products without Approval –Quality Assurance –Clinical Safety and Efficacy Testing –Person or Organization to Hold Responsible (as a last resort, someone to put in jail…) The Process –Time Consuming and Expensive –Medical Products are Almost Exclusively Distributed by For- Profit Companies –People Get Paid to Take Risk

8. National Alliance for Medical Image Computing http://na-mic.org How to Get to the Patients? ?

9. National Alliance for Medical Image Computing http://na-mic.org Policy Implications NIH –Support Research to Improve Public Health FDA –Require Accountability and Testing of Healthcare Technologies Logical Deduction: –Licensing of NIH Funded Research Must Be Compatible with Commercialization

10. National Alliance for Medical Image Computing http://na-mic.org Goals Open Source for Clinical License Types NA-MIC Policy

11. National Alliance for Medical Image Computing http://na-mic.org Open Source in Medical Products VTK Used in Variety of Radiology, Surgery Planning, Surgical Navigation, and Other Products at GE and Elsewhere ITK On Similar Path if not Already Used in Products Java, Tcl/Tk, Python, Perl, GCC, etc. all Widely used for Medical Product Development GE Scanner Consoles and Other Products use Linux –Other Medical Products Incorporating GPL Software are Rare if they Exist at All

12. National Alliance for Medical Image Computing http://na-mic.org Intellectual Property Basics Copyright –Attaches on Creation –May be Assigned (to employer or licensee) Trademarks –Separate Set of Law Trade Secrets Patents –Temporary Monopolies to Reward Innovation –Obscure Language and Interpretation –Only Court Cases Can Define Meaning

13. National Alliance for Medical Image Computing http://na-mic.org Open Source Licenses Define Terms for Use by Licensee –Broad Leeway for Licensor to Protect/Promote Interests in Exchange for Rights “Reciprocal” –GPL, LGPL “Academic” –BSD, MIT… OSI opensource.org –Self-Appointed Voice of “The Community” Open Source Licensing Software Freedom and Intellectual Property Law –by Lawrence Rosen with a foreword by Lawrence Lessig Links –http://www.rosenlaw.com/oslbook.htm –http://www.opensource.org –http://wiki.na-mic.org/Wiki/index.php/NAMIC_Wiki:Community_Licensing

14. National Alliance for Medical Image Computing http://na-mic.org Critical Issue of Derived Work Legal Definition is Vague “Reasonable People May Differ” –GPL Advocates that Any Linkage Results in Derived Work –Rosen Argues Linkage Can Create Collective Work (Non-Viral) Safe Haven is to Accept GPL at Face Value Until a Court Decides Otherwise Note: GPL Language Defers to Intent of the Author; Linus Torvolds Interprets Kernel Linkage as Non-Derived –Rosen, p. 118

15. National Alliance for Medical Image Computing http://na-mic.org Goals Open Source for Clinical License Types NA-MIC Policy

16. National Alliance for Medical Image Computing http://na-mic.org Non-Clinical Clauses Motivated by Institutional Desire to Limit Liability Example: Slicer 2.x License Not Compatible with OSI Since it Discriminates on Field of Use Not Consistent with NIH Goal of Encouraging Commercialization

17. National Alliance for Medical Image Computing http://na-mic.org Non-Commercial Clauses Motivated by Desire to Promote Research Community –Commercial Users Must Buy License Examples: FSL, FreeSurfer, LONI … Model is Generally Reasonable –Scientists Might Get Rich –Fees may Fund Further Science Issue: Court Ruling that Universities and Scientists are “Commercial” Since they Seek Grants and Other Funding –Madey v. Duke If This is Your Plan: –Please Disclose it Up Front to Users

18. National Alliance for Medical Image Computing http://na-mic.org Reciprocal Licenses Motivated by Desire to Keep Software and Improvements Available to All –Often Stated As “Why shouldn’t they share if they use my code?” Reasonable Approach, but Realize this Software is Likely to Remain Out of the Clinical Routine –Can become a “non-commercial standard” –Examples: AFNI, SPM, OsiriX, … Issue: “Viral” Nature Ill-Defined –Scares off some potential users –FDA requires testing, testing costs $$$, testing requires distribution, distribution invokes GPL, competitors get code… Practically: If Needed in Products, Non-Reciprocal Software Versions Will Be Written –Creates Parallel Versions –Delays Technology Diffusion to Patient Treatment –Perhaps Someday GPL Medical Products, but Not Generally Today

19. National Alliance for Medical Image Computing http://na-mic.org Goals Open Source for Clinical License Types NA-MIC Policy

20. National Alliance for Medical Image Computing http://na-mic.org Analogy NA-MIC, as a Taxpayer Funded Activity is Like a Public Road System –Provides Infrastructure for a Variety of Uses –Driveways can Lead to anything a Coop Grocery Store a Factory a Park a Gated Community

21. National Alliance for Medical Image Computing http://na-mic.org NA-MIC Kit Policies Technology Base for Research and Commercialization –Okay to build GPL or Closed SW on top of NA-MIC Kit –But no GPL or Closed SW in NA-MIC Kit “Reference Standard Distribution” –Avoid Code Forking, Non-Free Code Creeping into Core No “Knowing” Addition of Patented Techniques into NA- MIC Kit Copyright to Substantive Works Remains with Creators –Available under NA-MIC Approved Licenses for Distribution with Kit –Insight Journal is Example of this Process

22. National Alliance for Medical Image Computing http://na-mic.org NA-MIC Approved Licenses BSD-Style Licenses For Core –As Used in VTK, ITK, KWWidgets –Slicer 3.0 License with Clarifications and Disclaimers LGPL + Allowance for Static Linking –Acceptable for Libraries used “as is” –Example: FLTK Methodology Relies on Variety of Open Tools –Cvs, svn, mediawiki, apache, gcc, etc…

23. National Alliance for Medical Image Computing http://na-mic.org Slicer 3.0 Draft License Language Excerpt The Software has been designed for research purposes only and has not been reviewed or approved by the Food and Drug Administration or by any other agency. YOU ACKNOWLEDGE AND AGREE THAT CLINICAL APPLICATIONS ARE NEITHER RECOMMENDED NOR ADVISED. Any commercialization of the Software is at the sole risk of the party or parties engaged in such commercialization. http://wiki.na- mic.org/Wiki/index.php/NAMIC_Wiki:Community_Licensing_Institutional_Experiences #BWH

24. National Alliance for Medical Image Computing http://na-mic.org Summary Industry GPL NA-MIC Kit Research Only