Regulatory Focus™ > News Articles > Copyright Claim Threatens Medical Diagnostic Test

Copyright Claim Threatens Medical Diagnostic Test

Posted 04 January 2012 | By

A long-standing and popular diagnostic test used by physicians to screen patients for cognitive ailments is being subjected to copyright claims that threaten to restrict the use of the test and others like it.

Writing in the New England Journal of Medicine (NEJM), John C. Newman, PhD and Robin Feldman, JD describe the saga of the Mini-Mental State Examination (MMSE).  First published in 1975, the 30-question test grew in to a ubiquitous presence thanks to lax copyright enforcement by its three creators.

Then, in 2000, an exclusive license was granted to Psychological Assessment Resources (PAR), who in turn began to enforce the copyright and charge for the test.  In response, Tamara Fong developed a similar diagnostic test known as the "Sweet 16" that tested for the same conditions and used a similar line of questioning.

In March of 2011, PAR filed a copyright dispute with Fong, leading to the takedown of the Sweet 16 test.

The NEJM authors see this case as having a chilling effect on the development of further clinical tools.

"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."

The authors propose the development of tools under the "copyleft" blueprint of open-source technology, "[encouraging] innovation and access while protecting author's rights" in order to preserve diagnostic tests for future generations.



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