One more reason to hate copyright law: clinical tests

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One more reason to hate copyright law: clinical tests

Post by Formless »

In case you ever thought copyright whoring only effects entertainment media:
The Laboratorium wrote:How Copyright Is Like Cognitive Impairment

December 29, 2011 at 10:45 PM

Sometime in your life, it’s likely that a doctor will ask you some silly questions. What day of the week is it? How do you spell “WORLD” backwards? Can you identify a pencil? Remember the word “ball?” Draw a pair of intersecting pentagons?

These questions are part of the MMSE (the “Mini Mental State Exam”) and they’re designed to assess, quickly, whether you’re thinking clearly. Millions of doctors use it. Indeed, it’s hard to get out of medical school without the MMSE becoming second nature. It’s so widely used, I’ve even heard stories of patients trying to memorize the answers to fool their doctors. (Which raises an interesting philosophical question, when you think about it.)

The MMSE was published in 1975, as an appendix to an article by three doctors: Marshall and Susan Folstein, and Paul McHugh. In the 1980s, Johns Hopkins and other hospitals did extensive testing to verify that the MMSE gave consistent scores, that it helped distinguish patients with different levels of cognitive impairment, and that it helped distinguish changes in mental status over time.

The Sweet 16 is another cognitive impairment test. Its creators did a study to validate that Sweet 16 and MMSE scores correlated strongly, and that the Sweet 16 could be as effective when used in a clinical setting.

And now for the bad news.

The Sweet 16 is no longer available for download. As detailed in an essay by John C. Newman and Robin Feldman in today’s New England Journal of Medicine, PAR, the copyright owner of the MMSE, apparently requested that the Sweet 16 be removed from the Internet.

What’s going on is that the Folsteins and McHugh licensed their copyright in the MMSE to PAR, which has been been enforcing copyright claims so that it can make money selling copies. So, for example, PAR sells 50 MMSE test forms for $66, or $1.32 each. The Sweet 16 was designed to be a replacement for the MMSE, but available open-access, so that anyone could use it freely and for free. It appears that the owners of the MMSE didn’t like competition. Newman and Feldman (or perhaps their editors at NEJM) were too polite to say it, but I’m not: any copyright claim here is legally weak and morally indefensible.

In the first place, copyright is not available for any “procedure” or “process.” Administering the MMSE is carrying out a process. It cannot be copyrighted, any more than a new drug could be. That’s what patents are for, not copyright. As the Supreme Court said in Baker v. Selden:

Take the case of medicines. Certain mixtures are found to be of great value in the healing art. If the discoverer writes and publishes a book on the subject (as regular physicians generally do), he gains no exclusive right to the manufacture and sale of the medicine; he gives that to the public.

The same goes for the administration of the MMSE. Its creators “gave that to the public.”

What about the forms? You might object that PAR isn’t trying to stop doctors from using the MMSE, only to stop others from selling the forms that go with it. Well, it turns out the Supreme Court rejected that argument, too. In Baker v. Selden, the defendant was selling a book of blank forms to be used with the plaintiff’s accounting system. The Court held that this, too, was permissible. Yes, the Court said, the plaintiff could copyright his book explaining the system of accounting, but that copyright would not extend to the forms themselves:

And where the art it teaches cannot be used without employing the methods and diagrams used to illustrate the book, or such as are similar to them, such methods and diagrams are to be considered as necessary incidents to the art, and given therewith to the public; not given for the purpose of publication in other works explanatory of the art, but for the purpose of practical application. …

And, of course, in using the art, the ruled lines and headings of accounts must necessarily be used as incident to it.

The same goes for blank MMSE forms. Those are “necessary incidents” to administering the MMSE, at least if you want to write down the answers in a standardized way. Indeed, to the extent that the forms are designed to total up a patient’s score, a Copyright Office regulation says flatly that they’re uncopyrightable:

Blank forms, such as time cards, graph paper, account books, diaries, bank checks, scorecards, address books, report forms, order forms and the like, which are designed for recording information and do not in themselves convey information;

How about the portions of the forms that tell doctors and nurses what questions to ask? Here, the scope of any copyright is sharply limited by the fact that the MMSE is designed to do something, i.e., to measure cognitive status. Just as copyright isn’t available for those parts of a computer program that are “dictated by external factors,” those parts of the MMSE that are specifically useful in assessing cognitive status aren’t copyrightable. Only the unforced parts — which numbers to count backwards, which words to memorize — are potentially copyrightable. These might contain some expressive choices, but not very many. Whatever copyright there is in the MMSE, if any, is thin indeed.

The creators of the Sweet 16 did everything right. They used some orientation questions (“What is the year?”) that are also on the MMSE but which doctors have been asking patients for time immemorial. They used different words for the memorization tasks. They devised a new and different set of numeric questions. Their goal was to develop a test that replicated the MMSE’s clinical usefulness, while not borrowing any creative, non-clinical aspects from it. In that, they succeeded.

But that wasn’t enough for PAR, it appears, and the Sweet 16 had to come down. Nelson and Feldman explain the harm to doctors:

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.

All three of these options are bad for patients. And there is no offsetting benefit. The Sweet 16 is so short and sweet that there is no need to restrict copying of it to make it feasible to make them widely available. Thanks to the Internet, anyone can easily download and print off as many copies as they need. Some medical professionals and hospitals genuinely need bulk-printed forms. But with free competition for them, suppliers would charge something much closer to the actual cost of producing the forms, rather than PAR’s inflated $1.32.

Nor is this a case in which copyright over the MMSE form matters one whit in encouraging the development of new diagnostic tests. Copyright wasn’t important in getting the MMSE created: Marshal Folstein wrote the questions down when his wife Susan, who was working the geriatric ward with him, asked him for a list she should ask her patients. Copyright wasn’t important in getting the MMSE published: the journal didn’t ask for a copyright assignment in the MMSE form. And copyright wasn’t important in getting the MMSE tested: it’s researchers’ job, for which they are paid, to do clinical studies.

PAR sells plenty of other items for which copyright makes sense: its manuals explaining how to administer and score some of its more complex tests are exactly the sort of book over which the Supreme Court allowed a copyright in Baker v. Selden. But not here. PAR does not have, and cannot have, a monopoly over the field of mental-status exams.

And finally comes what should have been first. Claiming a copyright to inhibit the use of the Sweet 16 is unethical. It puts profit above patient safety: it makes it harder to do quick and reliable mental-state exams. Physicians shouldn’t take part in a practice that pointlessly restricts the care patients receive; it contravenes the spirit of their most basic professional obligations. I hope that Doctors Folstein and McHugh will do the right thing: terminate their agreement with PAR, and explicitly release the MMSE into the public domain.

UPDATE: Dorothy Bishop, a professor at Oxford who has developed and published psychological tests, has a fascinating post on the issue. She describes her experiences producing her tests both with and without commercial publishers, and she finds something to like about both routes. Do read.
(links can be found at the site)

TL;DR basically, if you make a clinical tool such as a test for mental functioning (say, for use right after a head injury or what have you), if there is another test out there that is copyrighted that does the same thing its owners can come after you with lawyers. Even though there are only so many ways to test such things.
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Simon_Jester
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Re: One more reason to hate copyright law: clinical tests

Post by Simon_Jester »

This happened in April. Any word on legal proceedings? Aren't you supposed to have to get actual court rulings on things like this if you want to ban something in a binding way?
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Re: One more reason to hate copyright law: clinical tests

Post by someone_else »

Meh, for what I care they can go to hell. This can only be enforced in that crazy place called US, outside they'll just laugh at you and do whatever must be done.

I'd like to see them suing the entire national health care system of Italy for copyright infringement and winning the trial in an italian court (copyright law is enforced by the single nations, there is no superior authority for international copyright infringement). :lol: Now that would be a memorable day.
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Re: One more reason to hate copyright law: clinical tests

Post by S.L.Acker »

Another slow clap moment for the United States.
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Re: One more reason to hate copyright law: clinical tests

Post by Darth Tedious »

As was pointed out in the article, they should have applied for a patent, not a copyright.

The law is not at fault here.
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