NA-MIC National Alliance for Medical Image Computing http

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

“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

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

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

NIH NCBC Goals • http: //grants 1. nih. gov/grants/guide/rfa-files/RFARM-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… 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 National Alliance for Medical Image Computing http: //na-mic. org

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

Goals Open Source for Clinical License Types NA-MIC Policy 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 Rare if they Exist at All 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 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 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 National Alliance for Medical Image Computing http: //na-mic. org

Goals Open Source for Clinical License Types NA-MIC Policy 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 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, Free. Surfer, 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 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, Osiri. X, … • 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 National Alliance for Medical Image Computing http: //na-mic. org

Goals Open Source for Clinical License Types NA-MIC Policy 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 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 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… 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. namic. org/Wiki/index. php/NAMIC_Wiki: Community_Licensing_Institutional_Experience s#BWH National Alliance for Medical Image Computing http: //na-mic. org

Summary Re se On arc ly h NA-MIC Kit GPL National Alliance for Medical Image Computing http: //na-mic. org Industry