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FDA says sharing device manuals with ISOs does not create cybersecurity concerns

September 01, 2021
HTM Parts And Service
By Robert J. Kerwin

A little-known rulemaking proceeding is underway at the U.S. Copyright Office which, depending upon the outcome, may have profoundly favorable implications for the use by servicers of electronic medical device equipment manuals.

Every three years under the Digital Millennium Copyright Act (“DMCA”), the Librarian of Congress, upon receipt of the recommendation of the Register of Copyrights, is permitted to exempt, on a temporary basis, certain classes of copyrighted works from the DMCA’s prohibition against the circumvention of "technology protection measures" (TPMs). Known as the "Triennial Rulemaking Proceeding" (yes that’s quite a mouthful), the Register of Copyrights considers whether “persons who are users of a copyrighted work are or are likely to be, in the succeeding 3-year period, adversely affected by the prohibition [on circumvention].”

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During this proceeding, the Register considers petitions for new exemptions along with renewal requests for past exemptions. At this writing, the Register is considering a petition for exemption of "computer programs and data files that are contained in and controlling the functioning of medical devices for repair."

DMCA can be tool to limit competition without new exemption
There is little doubt that the DMCA has been an enormously impactful law over the last 20 years to prevent copyright infringement. Designed, in large part, to protect companies and artists having their work stolen, many feel that certain parts of the law actually have resulted in copyright protection gone horribly wrong. Some have argued that the law has actually hampered competition.

U.S. Senator Thom Tillis has suggested that the DMCA is ill-suited for the needs of most copyright owners and has called for DMCA’s modernization to encourage “the creation of copyrightable works and to protect users and consumers who are making lawful uses of copyrighted goods and software-enabled products, respectively.” While Congress is considering the draft legislation submitted by Tillis, (which includes measures to improve exemptions available to users), the U.S. Copyright Office is continuing with its eighth rulemaking proceeding to consider exemption renewals and new possible exemptions.

New exemption proposed on medical equipment servicing materials
An exemption pertaining to medical devices is now being considered by the Register of Copyrights for possible recommendation to the Librarian of Congress. The exemption, requested by Transtate Equipment Company, would allow access to computer programs and data files that are contained in and control the functioning of medical devices for the purpose of diagnosis, maintenance, or repair of devices. Note: service manuals are frequently on the device. This exemption is accordingly appropriate for servicing activities (diagnosis, repair and maintenance) to comply with manufacturer and government specifications.
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Tim Martin

Like the article

September 03, 2021 11:03

Good article.

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Wayne Webster

It's abut time

September 07, 2021 02:32

Glad to see that regulatory bodies can step away from the many claims made by manufacturers and address the issues straight on. We don't know where it will all end but, there seems to be a possibility for a rational outcome.

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Peter Pohli

Still a missing link remains.

October 05, 2021 10:39

The Triennial Rulemaking Proceeding appear to be a hopeful step in the right direction, but I continue to be baffled by the silence in the laboratory instrument service arena.
There is clear headway being made in the right-to-repair movement of consumer, automotive, and agricultural products, spearheaded by the efforts of repair.org and other similar organizations. In the medical instrument field, IAMERS is doing a similar good work for the benefit of patients, consumers, and ISOs. Caught in the void between the two, is the laboratory service industry.
While laboratory instrument service and repair stretches its reach a little into both the other categories, there are many manufacturers who feel they are exempt from either of these two categories and blatantly snub their noses at ISOs, right to repair legislation, and anything else that doesn't maximize their bottom line, no matter how unethical it may be. For example, one manufacturer of cryostats used to sell their service manual for about $4000 per manual per model. (Already outrageous.) When my company finally decided we needed to buy one, we were told that "the FDA no longer allows the sale of the service manual." (A bald-faced lie, at best.) Many other companies don't even try to hide behind a lie and will simply tell you that they only allow their in-house technicians to service their instruments.
My search continues for an organization who actively represents this gap. It would seem that government agencies should embrace supporting ISOs for laboratory instrument servicing, since so many of them are also victims of this abuse by scrupulous manufacturers. Everything from colleges and universities to OSHA and environmental testing labs all end up overpaying for service when OEMs refuse to support ISOs. If anyone is aware of such an organization, I would love to know about it!

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