[Infowarrior] - Copyright and Open Access at the Bedside

[Richard Forno]

Copyright and Open Access at the Bedside

John C. Newman, M.D., Ph.D., and Robin Feldman, J.D.

N Engl J Med 2011; 365:2447-2449December 29, 2011

http://www.nejm.org/doi/full/10.1056/NEJMp1110652

For three decades after its publication, in 1975, the Mini–Mental State Examination (MMSE) was widely distributed in textbooks, pocket guides, and Web sites and memorized by countless residents and medical students. The simplicity and ubiquity of this 30-item screening test — covering such functions as arithmetic, memory, language comprehension, visuospatial skills, and orientation — made it the de facto standard for cognitive screening. Yet all that time, it was under copyright protection. In 2000, its authors, Marshal Folstein, Susan Folstein, and Paul McHugh, began taking steps to enforce their rights, first transferring the copyright to MiniMental, a corporation the Folsteins founded, and then in 2001 granting a worldwide exclusive license to Psychological Assessment Resources (PAR) to publish, distribute, and manage all intellectual property rights.1,2 A licensed version of the MMSE can now be purchased from PAR for $1.23 per test. The MMSE form is gradually disappearing from textbooks, Web sites, and clinical tool kits.1

Clinicians' response to this “lockdown” has been muted. A few commentators have expressed concern about continuing to use a now-proprietary tool in training2 or about implications for the developing world,1 echoing debates about patented pharmaceuticals. In our experience, many clinicians are either unaware of the MMSE's copyright restrictions or simply ignore them, despite the risk of copyright infringement.

But then in March 2011, a promising new cognitive screening tool that was to be available through “open access,” the Sweet 16 — a 16-item assessment of thinking, learning, and memory developed by Harvard's Tamara Fong3 — was removed from the Internet at the request of PAR in an apparent copyright dispute.4 The Sweet 16 includes orientation and three-object recall items, similar to the MMSE's, along with a digit-span item. This action, unprecedented for a bedside clinical assessment tool, has sent a chill through the academic community; clearly, clinicians and researchers can no longer live in blissful ignorance of copyright.

Copyright derives from one of the few powers explicitly mentioned in the U.S. Constitution. Any new intellectual work is under copyright protection automatically from the moment it is fixed in a tangible medium of expression — a category now including blog posts, iPhone apps, and cognitive screening tools. Copyright law grants the author (or owner, for copyright can be transferred) exclusive rights to copy the work, distribute it, make works derivative of it, and perform or display it publicly. These rights last for 70 years past the date of the author's death, or up to 120 years from the time of creation if the work was done “for hire.” This duration has been retroactively extended several times, so that works published as early as 1923 may remain under copyright today (and will until at least 2019).

For persons or entities other than the copyright holder to copy or distribute a work, they must have permission from the owner, usually in the form of a license. Copying or distribution without permission is copyright infringement and carries stiff civil or even criminal penalties. There is limited protection under “fair use” law for certain nonprofit uses of limited parts of a work — for example, for teaching or research — but that exception is narrower than it sounds. One need not have intended to infringe someone's copyright to be subject to damages of up to $30,000 per work, and willful infringers pay up to $150,000 — and may, under certain circumstances, be subject to a jail term.

For clinicians, the risk of infringement is real. Photocopying or downloading the MMSE probably constitutes infringement; those who publish the MMSE on a Web site or pocket card could incur more severe penalties for distribution. Even more chilling is the “takedown” of the Sweet 16, apparently under threat of legal action from PAR (although PAR has not commented publicly). Are the creators of any new cognitive test that includes orientation questions or requires a patient to recall three items subject to action by PAR? However disputable the legal niceties, few physicians or institutions would want to have to argue their case in court.

The MMSE case may be a harbinger of more to come. Many clinical tools we take for granted, such as the Katz Index of Independence in Activities of Daily Living, fall into the same “benign neglect” copyright category as the MMSE did before 2000. At any time, they might be pulled back behind a wall of active copyright enforcement by the authors or their heirs.

What can researchers do to ensure that our colleagues can use the tools we develop to improve patient care? One option is to essentially place works in the public domain by declaring free and open rights for all users. The Geriatric Depression Scale, the Patient Health Questionnaire (PHQ-9) depression scale, and the Saint Louis University Mental Status (SLUMS) cognitive assessment tool are all in the public domain. That domain, however offers no mechanism for ensuring that authors are recognized or compensated and no means of guaranteeing that later improvements will be made freely available. The ability to improve a clinical tool is crucial. Even licenses granting wide permission to copy, such as those of the Montreal Cognitive Assessment and the Lawton Instrumental Activities of Daily Living (IADL) scale, while laudable, might still inhibit innovation by permitting legal challenges to improved tools perceived as derivative (as may have been the case with Sweet 16 and the MMSE).

A better solution is to apply the principle of “copyleft” from the open-source technology movement to encourage innovation and access while protecting authors' rights. Copyleft is intellectual jujitsu that uses copyright protection to guarantee the right of anyone to use, modify, copy, and distribute a work, as long as it and any derivatives remain under the same license. The author retains the right to offer the work under a different license simultaneously — for example, giving a company specific license to commercialize the work without copyleft protections. Popular copyleft licenses include the Creative Commons Attribution-ShareAlike license and the GNU Free Documentation License.

Google, Apple, Facebook, and Twitter all use open-source software at the heart of their products, because there is a clear economic benefit to using well-tested, well-validated, continually improved software in the core of complex products. Similarly, there is a clear clinical benefit to using well-tested, well-validated, continually improved clinical tools in complex patient care — as demonstrated by the MMSE's use before 2000. In a sense, copyleft is how academic medicine has always been assumed to work.2 Restrictive licensing of such basic tools wastes resources, prevents standardization, and detracts from efforts to improve patient care.

We suggest that authors of widely used clinical tools provide explicit permissive licensing, ideally with a form of copyleft. Any new tool developed with public funds should be required to use a copyleft or similar license to guarantee the freedom to distribute and improve it, similar to the requirement for open-access publication of research funded by the National Institutes of Health.5 The solution can be as simple as placing a copy of the tool on the authors' Web site, with a statement naming or linking to the license. Clinicians and researchers would be free to use, copy, and improve the tool; improvements would have to offer a similar copyleft license, perpetuating the benefits. Yet authors would maintain ownership and copyright of their tool and could profit by licensing it for a fee to commercial users or publishers who wished to include it in a non-copyleft work.

The restrictions on the MMSE's use present clinicians with difficult choices: increase practice costs and complexity, risk copyright infringement, or sacrifice 30 years of practical experience and validation to adopt new cognitive assessment tools. By embracing the principles of copyleft licensing, we can avoid such setbacks and build a more open future of continually improving patient care.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Division of Geriatrics, San Francisco Veterans Affairs Medical Center, and the University of California San Francisco (J.C.N.); and the Law and Bioscience Project, University of California Hastings College of the Law (R.F.) — all in San Francisco.


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