medical devices – Techdirt (original) (raw)

Medical Device Makers Sue Library Of Congress For Allowing People To Fix Their Own Medical Devices

from the so-much-nonsense dept

For many years we’ve discussed the sheer ridiculousness of the “triennial review” process of Section 1201 of the DMCA. If you’re lucky, and don’t spend that much time deep in the weeds of semi-obscure copyright law, Section 1201 of the DMCA is the “anti-circumvention” part of the law, that was initially designed to outlaw breaking digital rights management (DRM) tools. Of course, 1201 was written broadly, saying that basically any attempt to “circumvent a technological measure” (even just talking about ways to circumvent a technological measure) would itself be considered copyright infringement even if the underlying purpose for which you were circumventing the technological measure had nothing whatsoever to do with copyright.

This was a bizarrely structured law for so many reasons, and even the drafters of it at the time realized that this would likely lead to all sorts of perfectly reasonable and normal activity being declared “infringing” of copyrights. Indeed, lots of companies almost immediately moved to take advantage of this in order to block people from using “unauthorized” ink cartridges in printers, or unauthorized garage door openers, among other things.

So, the drafters of the DMCA added in this ridiculously weird safety valve: every three years, people could apply to the Librarian of Congress to “exempt” certain classes of items from the law for a three year period. The process itself is ridiculous. People need to apply for the exemption, then there’s a public comment period, followed by recommendations from the director of the Copyright Office, before the Librarian of Congress comes down from the mountain and blesses certain types of circumvention as non-infringing for the next three years.

No sane system would ever do things this way. A reasonable legislature would realize that if you have to apply for exemptions every three years, perhaps the underlying law itself is problematic. But, no, every three years we go through this ridiculous song and dance. Sometimes it leads to truly wacky outcomes, like the time, a decade ago, when the Librarian of Congress refused to renew the phone unlocking exemption, forcing Congress to grandstand about how they should fix things (something that never actually happened).

Anyway… last year was the latest three year cycle, and it’s gotten to the point that it’s barely even worth reporting on the results, which the Librarian of Congress adopted last fall. One of them was an expansion of an earlier exemption (from six years prior) exempting the circumvention of technological protection measures (TPMs) on medical devices in order to access the data on those devices. For the 2021 round, petitioners sought to expand that exemption somewhat, getting rid of the part of the original exemption that limited it to “wholly or partially implanted” devices, arguing that it should apply to any type of medical device.

The Copyright Office recommended allowing this broader exemption and the Librarian of Congress agreed:

For the reasons detailed in the Register’s Recommendation, the Register concluded that accessing medical data outputs likely qualifies as a fair use and that expanding the exemption to include non-implanted medical devices and non-passive monitoring would not alter the fair use analysis. Additionally, the Register concluded that proponents set forth sufficient evidence that the ‘‘wholly or partially implanted’’ language and the passive monitoring limitation are causing, or are likely to cause, adverse effects on these noninfringing uses. The Register also recommended expanding the exemption to permit circumvention ‘‘by or on behalf of a patient.’’ After consultation with the U.S. Food and Drug Administration, the Register recommended removing the language requiring compliance with other laws, and replacing it with a statement that eligibility for the exemption does not preclude liability from other applicable laws.

Basically, in the midst of a pandemic, where locked down medical devices had represented a real problem, the Copyright Office and the Librarian of Congress reasonably decided that both users of medical devices, and their medical care professionals, ought to be able to circumvent various technological protection measures in order to access their own data.

All of this should be relatively uncontroversial. But… that’s not how any of this works. Earlier this year, some medical device company trade associations decided to sue the Librarian of Congress over this exemption. They’re using the standard administrative law argument that the exemption was “arbitrary and capricious.” The complaint has a lot of overwrought language:

The Exemption is manifestly unlawful. By issuing a rule that enables unregulated, for-profit service providers to piggyback off the creative efforts and intellectual property of medical device manufacturers, it not only thwarts the purpose of the Copyright Act, but also puts patient safety, device integrity, and device cybersecurity at risk. What is more, the process by which the Exemption was adopted was infected with major procedural errors, including a failure to address many of the significant legal concerns raised by plaintiffs and other opponents.

In the course of the rulemaking at issue here, moreover, the Library of Congress was acting as an executive agency and is therefore subject to the strictures of, and judicial review under, the Administrative Procedure Act (APA). Because the Exemption is not in accordance with law and was adopted without observance of required procedures, it should be set aside. Alternatively, if the Library of Congress did not assume the character of an executive agency within the meaning of the APA, the Exemption violates separation-of-power principles twice over. Either way, it should be vacated.

Then, before the government was able to respond to the lawsuit, the medical device makers moved for summary judgment. A big part of their argument is that because this exemption might will allow third party companies to service medical devices (at a cheaper rate than the manufacturers themselves) that it serves a purpose unrelated to copyright and thus is not allowed as an exemption:

But the exemption is for a manifestly infringing use. It was granted at the behest—and solely for the commercial benefit—of two so-called independent service operators, or ISOs, which are unregulated third-party service providers who freeride on the creative labors of device manufacturers. And the Librarian readily admitted the true reason for her decision: Allowing ISO circumvention would reduce the cost of machine servicing contracts and thus serve a separate executive-branch policy. But the DMCA does not grant the Librarian free-ranging policymaking authority untethered to copyright law. In approving the exemption, moreover, the Library failed to address numerous substantial comments that called into question the underlying fair-use analysis. The exemption is thus unlawful many times over: It is contrary to the statutory text, it is arbitrary and capricious, and it was promulgated without observance of procedure required by law

So, to some extent, I find this absolutely hilarious. Because the reason medical device manufacturers lock down these devices with TPMs and then rely on the DMCA to block competitive service providers is also wholly unrelated to copyright law. So, they are actually the ones abusing copyright law to lock out competition — and then when they’re effectively called on it by the Librarian of Congress, they whine that the Librarian of Congress can’t use the triennial review process to exempt their abuse of copyright law, because… it goes beyond the intention of copyright law!

The government has responded, asking for a chance to actually file a motion to dismiss before it has to deal with the summary judgment demand and noting the somewhat bizarre rush by the medical device manufacturers for summary judgment when they waited many months before filing the lawsuit in the first place.

Either way, this really appears to be little more than an extremely cynical move by the device manufacturers. Hopefully the court sees through it, but should it succeed, I imagine we’ll see many other similar lawsuits filed on behalf of other industries where exemptions were granted, potentially taking us back to an even worse world, in which companies can abuse the 1201 anti-circumvention rules to block out all sorts of competition.

Filed Under: carla hayden, competition, copyright, copyright office, dmca 1201, librarian of congress, library of congress, medical devices, triennial review
Companies: advamed, medical imaging technology alliance, mita

Wall Street Journal Editorial Tries To Pretend That Fixing Repair Monopolies Is Bad For Your Health

from the greed-is-not-an-argument dept

Wed, May 5th 2021 05:31am - Karl Bode

So we’ve noted for a long time how efforts to monopolize repair have resulted in a growing, bipartisan interest in right to repair legislation in more than a dozen states. Whether it’s Sony and Microsoft’s efforts to monopolize game console repair, Apple’s tendency to monopolize phone repair (and bully independent repair shops), or John Deere making its tractors a costly nightmare to fix, a sustained backlash has been growing against draconian DRM, rampant abuse of copyright, and other behaviors that make repairing products you own as annoying and expensive as possible.

Granted this anger has extended into the medical arena, where the problem isn’t just a costly hassle, it’s a matter of life and death. This was particularly true during COVID, given many hardware manufacturers made getting access to repair manuals and parts cumbersome and expensive, if not impossible. As such, several states (including Texas) have been pushing both right to repair legislation that generally protects consumers, as well as legislation that takes aim at device manufacturers that make it an expensive headache for hospitals to repair their own equipment in a timely fashion.

Granted as more and more states push such legislation, more and more companies have taken to pushing misleading claims about what this legislation does. Whether it’s Apple’s attempt to claim that such legislation will turn states into “meccas for hackers” (which sounds kind of cool, honestly), or the auto industry’s false claim that such laws will help sexual predators, there’s been no shortage of sleazy efforts to undermine such laws using specious reasoning and unethical claims. And given that legislative efforts keep getting blocked, it has proven pretty effective.

Enter the Wall Street Journal, which this week joined the fun with a nonsensical editorial claiming that medical device right to repair legislation being pushed in Texas is somehow harmful to human health. The piece basically just consists of several paragraphs of author Tom Giovanetti lauding the miraculous innovation of copyright, while claiming the bipartisan right to repair movement is some kind of “leftist” plot. Why would the activist and reform groups operating on a shoestring budget do this? They hate innovation, apparently:

“American innovation is dependent on the protection of intellectual property. It encourages innovation by discouraging theft. But there are those who are philosophically opposed to intellectual property protection. Left-leaning public interest law firms and activist groups led by U.S. PIRG, an association of public-interest law firms, have been trying for years to undermine intellectual-property protection through ?right to repair? campaigns in state legislatures. During this legislative session they are pushing their anti-innovation agenda in the guise of a ?right to repair? advanced medical devices.”

For one thing, USPIRG is neither “left-leaning” nor a law firm (but no matter I guess, huh?). But it’s also amazing how the author just cheerfully floats over the fact that manufacturers enjoy a monopoly on tools, documentation, and replacement parts, and that those monopolies have been putting human lives at risk before, during, and likely after COVID. These restrictions often drive repair technicians to dangerous third-party fixes and firmware because they literally can’t get the help, tools, parts, or documentation they need; so often it’s the repair monopolies and DRM that are putting lives at risk, not the efforts to fix the problem.

Industry pretty consistently tries to claim that opening up access to essential repair tools and documentation somehow always poses some diabolical threat to security, privacy, and safety, when that’s never really been true. That doesn’t really stop Giovanetti, who also trots out the China bogeyman for good measure:

“Forcing disclosure of these advanced medical technologies and opening them up to uncertified technicians may also represent a cybersecurity threat. You may be troubled by the idea that voting machines can be hacked, but what about opening up MRI machines and PET scanners? Patients could be endangered by sabotaged medical devices, but they might also suffer from malfunctions that cause inaccurate test results and thus unidentified medical problems. Such concerns also include direct theft of American innovation by bad actors seeking advanced U.S. technology, such as China.”

Those who work in the industry and realize that draconian DRM, idiotic applications of copyright, and ham-fisted repair monopolies actively harm public health weren’t particularly impressed with the Journal’s latest hot take:

Dearest blocked @WSJ:

You (collectively, and the author who wrote this opinion piece specifically) are an idiot.

Sincerely,
The lead hardware designer and director of regulatory compliance for a FDA-regulated medical device manufacturer.https://t.co/Jt1j8nzLeG

— Michael Graziano (@voretaq7) May 3, 2021

In particular, many of the editorial’s claims about how the FDA works weren’t even remotely close to being true:

Among other things: The FDA STILL DOESN'T REGULATE SERVICE AND REPAIR *UNLESS* IT'S DONE BY A MANUFACTURER. Absent stuff that can nuke you (requires NRC licensing) anyone can service most medical devices.

Why? BECAUSE IT'S OVERWHELMINGLY SAFE: https://t.co/NXCThJy39n

— Michael Graziano (@voretaq7) May 3, 2021

As is the Wall Street Journal’s habit on many subjects, the author tries to dress up greed as some kind of elaborate ethos, and efforts to actually implement reform as some kind of dangerous, diabolical partisan plot. But the “right to repair” movement is growing at an amazing rate because it enjoys broad bipartisan support, from John Deere owners who don’t want to drive a thousand miles and pay a small fortune just to fix the tractors they own, to medical professionals who don’t want patients to die while they navigate some company’s obnoxious repair monopoly bureaucracy just to get a ventilator to work again.

Filed Under: covid, innovation, intellectual property, medical devices, right to repair, tom giovanetti

Live By The Patent, Die By The Patent: Extreme Patent Aggressor Medtronic Loses Patent Lawsuit

from the schadenfreude dept

It’s always slightly amusing to watch extreme patent aggressors get hoisted by their own petard and lose a patent lawsuit. Medical device maker, Medtronic, is somewhat famous for its aggressive pursuit of patent infringement claims against others. In one case, a few years ago, a judge overturned a ruling that Medtronic had actually won and then scolded the company’s lawyers, noting that their “conduct was in disregard for the duty of candor, reflecting an attitude of ‘what can I get away with?'” The judge also noted that they knew “with full awareness that their case was without merit” yet they pressed ahead and “created an illusion of infringement.” And this wasn’t a one off. Just a few weeks later, in a totally different patent lawsuit a completely different judge scolded another set of Medtronic lawyers for doing essentially the same thing.

So it’s difficult to get to worked up in hearing that Medtronic is getting a taste of its own medicine, losing an appeal in a case brought against it by Edwards Lifescience, saying that Medtronic needs to pay $74 million. The appeals court also sent it back to the lower court to see if there needs to be an injunction issued.

Filed Under: medical devices, patents
Companies: edwards lifescience, medtronic

Just Because You Don't Like What People Say About You, Doesn't Mean You Get To Sue For Defamation

from the nuisance dept

We’ve written plenty of times about public interest organization Public Citizen, mainly concerning efforts by its litigation group to protect those who have been sued in bogus lawsuits that would impact the internet’s openness. However, every so often Public Citizen itself gets sued. Late last week, it revealed all of the details of a defamation lawsuit filed against it, concerning its letter to the FDA arguing that a certain product — the LipoTron — was being illegally marketed and promoted.

One of the organizations mentioned in the letter took exception to the claims in the letter and discussion on the web, and sent a cease-and-desist arguing that the claims were defamatory. In response, Public Citizen sent back a long letter backing up all of its claims (and also noting that they had never named the principal in the company, Mark Durante, so having him claim defamation personally didn’t make much sense). This is the point where it makes sense to give up, but Durante’s company, Advanced Aesthetic Concepts LP, sued anyway for libel, and asked the court for a temporary restraining order (TRO). When Public Citizen signed up a top local lawyer in Texas, pointed to Texas’ new anti-SLAPP law (which would allow them to seek lawyers’ fees), and told the lawyer that they were prepared to show up in court to contest the TRO, they were told that the case against them would be dropped.

At the very least, this yet again highlights the value of good anti-SLAPP laws in protecting those who are sued. But, once again we’re amazed at how many people seem to think that filing defamation lawsuits in situations like this could possibly bring about a good result. In this case, all it’s serving to do is call significantly more attention to the original claims that Public Citizen made in its original letter to the FDA (and then backed up in the legal filings).

Filed Under: defamation, fda, lipotron, marketing, medical devices, nuisance
Companies: advanced aesthetic concepts, public citizen

FDA's Pharma-First Focus Driving Medical Device Tech Away From The US

from the total-failure dept

Five years ago, we wrote about Andy Kessler’s excellent book, The End of Medicine, a book I still think about frequently. Kessler’s book explores why medical innovation hasn’t followed the same innovation curve as every other technology space, where the technology gets better while the prices get cheaper. There are many reasons described in the book, but one key hurdle? The FDA. And it’s not just the FDA’s process, but the entire concept of the FDA, which is set up to approve or disapprove drugs. That’s it. It’s not designed to help review what will make people healthy. And for that reason, it pretty much ignores medical devices and technology. This was a big problem described in the book, and a few FDA folks in the book suggested the FDA was working on solving that issue. But it’s been five years, and new reports suggest nothing much has changed.

Reason has an article about how the FDA is driving medical device innovation to Europe and elsewhere because it’s still not set up to even think about medical devices. The article focuses on the new X-Prize attempt to create a “tricorder.” It’s a great contest, but then the article points to the news that the FDA won’t certify such things:

The regulatory environment could present problems for any such device. “The Food and Drug Administration has stated that it will not certify tech that makes a diagnosis directly,” said Ross Mitchell, the author of a study published last week that shows that strokes can be diagnosed with the aid of a smart-phone application with the same degree of accuracy as with a hospital computer.

Bartholomew says that because of FDA restrictions, the contest could lead to innovations that might only be used outside the United States.

Indeed, the report points to many other examples of useful new technologies showing up elsewhere, but not in the US due to the FDA. So why is the FDA so bad at actually helping people get healthy? Take a guess. It seems like regulatory capture has taken hold of the FDA in a big bad way. Just recently, we discussed how the FDA has set up a system to limit competition in the medical field to just a few giant pharma companies, and has been actively banning cheaper drug competitors, in order to help big pharma companies jack up the prices on old medicines.

While the FDA is supposed to be keeping us healthy, it looks like its general focus is on keeping the profits of a few pharma firms healthy instead.

Filed Under: fda, innovation, medical devices, patents, pharma

Is It Time For Computer Security Experts To Get Jobs In The Medical Device Arena?

from the dance,-heart-patient,-dance! dept

Last week, one of the stories that got a few headlines and made the rounds concerned the news that some popular heart monitors could be hacked, potentially in a way that would provide powerful shocks to to the heart of someone who had such a device implanted. The reports made it very clear that the likelihood of such a hack was incredibly slim, as it would require a tremendous amount of access. So, this isn’t something to worry about today, but it does suggest one area where it may pay for medical device makers to start thinking a little bit more about security. There was a report, about two years ago, that also warned of something similar, which we played down as a bit of fear-mongering (it had no real details, just suggesting that pacemakers would become a hacking target). It still seems like this is not going to be a huge threat any time in the near future, but that doesn’t mean that those who design medical devices, especially those with connections to the outside world, shouldn’t at least think through the potential security concerns and design these devices with security in mind from the beginning. That seems a lot safer than having to fix all of the installed devices down the road.

Filed Under: computer security, hacking, medical devices