na-mic national alliance for medical image computing software licensing, treating patients, and...

NA-MICNational Alliance for Medical Image Computing http://na-mic.org

Software Licensing, Treating Patients, and NA-MIC

Steve Pieper, PhD

“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

National Alliance for Medical Image Computing http://na-mic.org

GoalsOpen Source for ClinicalLicense TypesNA-MIC Policy


Developer Goals

• Why Medical Algorithms?– To Help Patients!


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


NIH NCBC Goals

• http://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…


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


How to Get to the Patients?

?


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


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


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


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


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


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


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


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


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


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


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…


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


Summary

Industry

GPL

NA-MIC Kit

ResearchOnly

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