Cognitive screening test off-limits after copyright dispute

Physicians are barred from using an online cognitive screening exam after administrators of a similar test issued a copyright claim over the online test's content.

In December 2011, developers of the Sweet 16 permanently removed the cognitive impairment examination from the Internet, saying it no longer could be distributed. The move stems from a copyright infringement accusation by Psychological Assessment Resources, a corporation that manages the copyright license to another cognitive screening test, the Mini-Mental State Examination.

Doctors no longer can use the Sweet 16 during clinical care, said Rachel J. Whitehouse, a spokeswoman for Hebrew SeniorLife, the medical center where Tamara Fong, MD, practices. Dr. Fong is one of the Sweet 16's creators.

Physicians are concerned that the action could be the start of tighter copyright restrictions on frequently used tests by doctors, or as in the Sweet 16's case, complete revocation of previously available exams. Concerns about copyright lawsuits also could harm innovation from new clinical tests, doctors and legal experts said.

"We use little tools like this every day, all the time," said geriatrician John C. Newman, MD, who wrote an editorial about the topic in the Dec. 29, 2011, issue of The New England Journal of Medicine. "To have one disappear from the Internet is unheard of. My fear is that this episode with the [MMSE] could be the start of a trend of strict enforcement of copyright on tests. If that happens, it will change the way we practice medicine."

Testing for further evaluation

Dr. Fong and others developed the Sweet 16, a set of verbal questions to test for cognitive impairment such as dementia, in 2010. The test helps doctors identify patients who might need further evaluation by a specialist. Test developers provided physicians and others with open access to the Sweet 16, noting that copyright rules restrict the wider-known MMSE.

The MMSE was created in 1975 by Marshal Folstein, MD, and was freely available to doctors until PAR started managing the test's copyright license in 2001, according to doctors and U.S. Copyright Office records. Individual copies of the MMSE now must be purchased from PAR, and reproducing the test in publications or research papers is prohibited without written permission from PAR.

The Sweet 16 was removed from the Internet in the spring without explanation. Then in December 2011, the test's website posted this note: "In response to a demand from Psychological Assessment Resources Inc. (PAR), and without admission of any liability, the Sweet 16 instrument has been removed from the website and is no longer available for dissemination."

PAR said the Sweet 16 copied directly from the MMSE and that use of the test violated the MMSE's copyright.

"It is our belief that the Sweet 16 doesn't just resemble the MMSE, but that it actually is a subset of the MMSE items," according to an email from R. Bob Smith III, PhD, PAR chair and CEO. "The Sweet 16 was developed by analyzing preexisting sets of MMSE item data from two research studies conducted earlier using the MMSE and does not include original content and thus is an infringement of the MMSE registered copyright."

The Sweet 16's creators acknowledged to the U.S. Copyright Office that their test contained content from the MMSE, Smith said.

Dr. Fong said the test was removed from the Internet after a settlement with PAR, but she denied violating MMSE's copyrights. "It remains our position that the Sweet 16 did not infringe on copyright," said Dr. Fong, a neurologist and assistant scientist for the Institute for Aging Research at Harvard Medical School in Boston. "We are disappointed that the Sweet 16 can no longer be disseminated or published and used to improve the standard of care of seniors."

Copyright challenges costly

Most doctors are probably unaware that the majority of medical tests they use are connected to a copyright, said Robin Feldman, a law professor and director of the Law & Bioscience Project at the UC Hastings College of Law in San Francisco.

Though patents cover processes and products, copyright protects the expression of an idea, often written words, she said. Commonly used tests that are copyrighted include the Framingham risk score, which accesses a patient's risk of stroke; the FRAX, a predictor of fractures; and the Katz Activities of Daily Living assessment, which measures a person's functional status. Copyrights expire 70 years after the copyright owner's death or longer in some cases.

How far copyright power extends over an idea, such as a medical test, is not clearly defined in the law, Feldman said.

Despite legitimate defenses against some copyright claims, most medical professionals are hesitant to take on a legal challenge, Feldman said.

"Threats can be very effective," she said. "A doctor or hospital trying to defend a copyright claim is very costly. The wiser course of action may be to pay the fee or to simply not use the test."

Commercial interests should not hinder physicians from using simple tests to help patients, said Ziad Nasreddine, MD, a Canadian neurologist and inventor of the Montreal Cognitive Assessment. The cognitive screening test, created in 1996, is widely used in North America and other countries. Dr. Nasreddine provides free access to the MoCA test for doctors and others, enforcing copyright restrictions only for commercial or industry-funded uses.

"The objective was to keep it accessible to clinicians around the world," he said. "It was not meant to be developed for a commercial purpose, and I have no intention to go that way. Certain things should stay free. We do not always need to receive money and incentives to feel better about our contributions."

Dr. Nasreddine was not aware that the Sweet 16 had been removed from the Internet. James Galvin, MD, a neurology and psychiatry professor at the NYU Langone Medical Center, also was unaware of the change to the Sweet 16's use. Dr. Galvin created the Ad8 dementia screening test and, like Dr. Nasreddine, provides open access to users, except to for-profit entitles.

"The important thing is to find the best way to help doctors help patients. If a company wants to use your test, I don't see a problem with a license fee, but if the goal is to improve the care of patients, I think the test should be available," Dr. Galvin said.

Shift away from free use

However, legal experts say free use of tests appears to be shifting, as more medical test developers see opportunities to profit from their ideas.

"There is a sea change that's occurring as people become aware of the possibility of exercising copyright in this area," Feldman said. "I think because of [the Sweet 16 action], you will see a greater awareness of copyright within the medical field and potentially a broader interpretation of those rights."

For doctors, more restrictions mean weighing which tests or words spoken to patients may be copyright infringements, Dr. Newman said. Publishing, sharing or even using part of a copyrighted test could constitute a copyright violation.

"It would drive up the complexity and cost [of health care] and drive down the quality of care if every clinical tool needs a special license. Somebody has to pay for that, and somebody has to keep track of that," he said.

No doubt, innovation of new clinical tools also would suffer, he said. Wherever there is a new, better test, another test developer could come and assert copyright authority, Dr. Newman said.

"I think it's going to bring to a screeching halt the development of new cognitive tools," he said. "It's reasonable that a threat of legal action is enough of a deterrent for a researcher to stay away from the subject matter."

Smith, of PAR, believes the opposite is true.

"Copyright restrictions protect the rights of authors of existing content from the unauthorized use by others of their content, but do not prevent others from developing new tests using original content," he said. "On the contrary, copyright laws actually encourage the development of new tests by providing authors protection on the significant investment they make in developing their original work."