#EU Safety Regulations

[constructionsafetynetwork]

Comparative Study of Global Construction Safety Norms

This article delves into a comparative study of global construction safety norms, highlighting how various countries approach construction safety. We will explore different regulatory frameworks, safety standards, and best practices implemented worldwide, emphasizing their impact on the construction industry. United States: OSHA Standards In the United States, the Occupational Safety and Health…

[postmodernmulticoloredcloak]

I’ve fucking stapled my finger.

If you’re having a bad day, think that at least you didn’t fucking staple your finger.

[ijustwant2ride]

Motorcycle News Noise Regulations in the EU and Radar Love

EU is changing rules on motorcycle news and Honda wants to reflect radar.

What you need to know: EU tightens motorcycle noise regulations. They are not changing the regulation (UN-ECE Regulation R41.05), for new motorcycles, but on how the regulation is tested. Currently regulation requires motorcycles on the road (without the engine running) at 31MPH (50kph) would have to be the same volume as the same bike travelling at 31MPH with the engine running.   Starting in…

[trendynewsnow]

MEPs Delay Reforms to EU Medical Device Regulations

MEPs Reassess EU Medical Device Law Reforms On Wednesday, Members of the European Parliament (MEPs) took a significant step back from their previous stance regarding the reform of the European Union’s medical device regulations. In a non-binding resolution, they eliminated any specific timeline for when these reforms should occur and instead called for changes deemed necessary only after a…

[freyrnigeria]

The General Product Safety Regulation (GPSR) is a regulation from the European Union that aims to safeguard consumers by establishing a standardized framework to guarantee consumers' health and safety throughout the EU.

[ai-innova7ions]

Is AI Regulation Keeping Up? The Urgent Need Explained!

AI regulation is evolving rapidly, with governments and regulatory bodies imposing stricter controls on AI development and deployment. The EU's AI Act aims to ban certain uses of AI, impose obligations on developers of high-risk AI systems, and require transparency from companies using generative AI. This trend reflects mounting concerns over ethics, safety, and the societal impact of artificial intelligence. As we delve into these critical issues, we'll explore the urgent need for robust frameworks to manage this technology's rapid advancement effectively. Stay tuned for an in-depth analysis!

#AIRegulation

#EUAIACT

Video Automatically Generated by Faceless.Video

[michellesanches]

Latest AI Regulatory Developments:

As artificial intelligence (AI) continues to transform industries, governments worldwide are responding with evolving regulatory frameworks. These regulatory advancements are shaping how businesses integrate and leverage AI technologies. Understanding these changes and preparing for them is crucial to remain compliant and competitive. Recent Developments in AI Regulation: United Kingdom: The…

[agreenroad]

Call for Ban of Apple iPhone 12 That Failed the Radiation Safety Test. 30 Groups Call on EU Regulators

Call for Ban of Apple iPhone 12 That Failed the Radiation Safety Test. 30 Groups Call on EU Regulators

[mostlysignssomeportents]

Academic economists get big payouts when they help monopolists beat antitrust

After 40 years of rampant corporate crime, there's a new sheriff in town: Jonathan Kanter was appointed by Biden to run the DOJ Antitrust Divisoon, and he's overseen 170 "significant antitrust actions" in the past 2.5 years, culminating in a court case where Google was ruled to be an illegal monopolist:

https://pluralistic.net/2024/08/07/revealed-preferences/#extinguish-v-improve

Kanter's work is both extraordinary and par for the course. As Kanter said in a recent keynote for the Fordham Law Competition Law Institute’s 51st Annual Conference on International Antitrust Law and Policy, we're witnessing an epochal, global resurgence of antitrust:

https://www.justice.gov/opa/speech/assistant-attorney-general-jonathan-kanter-delivers-remarks-fordham-competition-law-0

Kanter's incredible enforcement track record isn't just part of a national trend – his colleagues in the FTC, CFPB and other agencies have also been pursuing an antitrust agenda not seen in generations – but also a worldwide trend. Antitrust enforcers in Canada, the UK, the EU, South Korea, Australia, Japan and even China are all taking aim at smashing corporate monopolies. Not only are they racking up impressive victories against these giant corporations, they're stealing the companies' swagger. After all, the point of enforcement isn't just to punish wrongdoing, but also to deter wrongdoing by others.

Until recently, companies hurled themselves into illegal schemes (mergers, predatory pricing, tying, refusals to deal, etc) without fear or hesitation. Now, many of these habitual offenders are breaking the habit, giving up before they've even tried. Take Wiz, a startup that turned down Google's record-shattering $23b buyout offer, understanding that the attempt would draw more antitrust scrutiny than it was worth:

https://finance.yahoo.com/news/wiz-turns-down-23-billion-022926296.html

As welcome as this antitrust renaissance is, it prompts an important question: why didn't we enforce antitrust law for the 40 years between Reagan and Biden?

That's what Kanter addresses the majority of his remarks to. The short answer is: crooked academic economists took bribes from monopolists and would-be monopolists to falsify their research on the impacts of monopolists, and made millions (literally – one guy made over $100m at this) testifying that monopolies were good and efficient.

After all, governments aren't just there to enforce rules – they have to make the rules first, and do to that, they need to understand how the world works, so they can understand how to fix the places where it's broken. That's where experts come in, filling regulators' dockets and juries' ears with truthful, factual testimony about their research. Experts can still be wrong, of course, but when the system works well, they're only wrong by accident.

The system doesn't work well. Back in the 1950s, the tobacco industry was threatened by the growing scientific consensus that smoking caused cancer. Industry scientists confirmed this finding. In response, the industry paid statisticians, doctors and scientists to produce deceptive research reports and testimony about the tobacco/cancer link.

The point of this work wasn't necessarily to convince people that tobacco was safe – rather, it was to create the sense that the safety of tobacco was a fundamentally unanswerable question. "Experts disagree," and you're not qualified to figure out who's right and who's wrong, so just stop trying to figure it out and light up.

In other words, Big Tobacco's cancer denial playbook wasn't so much an attack on "the truth" as it was an attack on epistemology – the system by which we figure out what is true and what isn't. The tactic was devastatingly effective. Not only did it allow the tobacco giants to kill millions of people with impunity, it allowed them to reap billions of dollars by doing so.

Since then, epistemology has been under sustained assault. By the 1970s, Big Oil knew that its products would render the Earth unfit for human habitation, and they hired the same companies that had abetted Big Tobacco's mass murder to provide cover for their own slow-motion, planetary scale killing spree.

Time and again, big business has used assaults on epistemology to provide cover for unthinkable crimes. This has given rise to today's epistemological crisis, in which we don't merely disagree about what is true, but (far more importantly) disagree about how the truth can be known:

https://pluralistic.net/2024/03/25/black-boxes/#when-you-know-you-know

Ask a conspiratorialist why they believe in Qanon or Hatians in Springfield eating pets, and you'll get an extremely vibes-based answer – fundamentally, they believe it because it feels true. As the old saying goes, you can't reason someone out of a belief they didn't reason their way into.

This assault on reason itself is at the core of Kanter's critique. He starts off by listing three cases in which academic economists allowed themselves to be corrupted by the monopolies they studied:

George Mason University tricked an international antitrust enforcer into attending a training seminar that they believed to be affiliated with the US government. It was actually sponsored by the very companies that enforcer was scrutnizing, and featured a parade of "experts" who asserted that these companies were great, actually.

An academic from GMU – which receives substantial tech industry funding – signed an amicus brief opposing an enforcement action against their funders. The academic also presented a defense of these funders to the OECD, all while posing as a neutral academic and not disclosing their funding sources.

An ex-GMU economist, Joshua Wright, submitted a study defending Qualcomm against the FTC, without disclosing that he'd been paid to do so. Wright has elevated undisclosed conflicts of interest to an art form:

https://www.wsj.com/us-news/law/google-lawyer-secret-weapon-joshua-wright-c98d5a31

Kanter is at pains to point out that these three examples aren't exceptional. The economics profession – whose core tenet is "incentive matter" – has made it standard practice for individual researchers and their academic institutions to take massive sums from giant corporations. Incredibly, they insist that this has nothing to do with their support of monopolies as "efficient."

Academic centers often serve as money-laundries for monopolist funders; researchers can evade disclosure requirements when they publish in journals or testify in court, saying only that they work for some esteemed university, without noting that the university is utterly dependent on money from the companies they're defending.

Now, Kanter is a lawyer, not an academic, and that means that his job is to advocate for positions, and he's at pains to say that he's got nothing but respect for ideological advocacy. What he's objecting to is partisan advocacy dressed up as impartial expertise.

For Kanter, mixing advocacy with expertise doesn't create expert advocacy – it obliterates expertise, as least when it comes to making good policy. This mixing has created a "crisis of expertise…a pervasive breakdown in the distinction between expertise and advocacy in competition policy."

The point of an independent academia, enshrined in the American Association of University Professors' charter, is to "advance knowledge by the unrestricted research and unfettered discussion of impartial investigators." We need an independent academy, because "to be of use to the legislator or the administrator, [an academic] must enjoy their complete confidence in the disinterestedness of [his or her] conclusions."

It's hard to overstate just how much money economists can make by defending monopolies. Writing for The American Prospect, Robert Kuttner gives the rate at $1,000/hour. Monopoly's top defenders make unimaginable sums, like U Chicago's Dennis Carlton, who's brought in over $100m in consulting fees:

https://prospect.org/economy/2024-09-24-economists-as-apologists/

The hidden cost of all of this is epistemological consensus. As Tim Harford writes in his 2021 book The Data Detective, the truth can be known through research and peer-review:

https://pluralistic.net/2021/01/04/how-to-truth/#harford

But when experts deliberately seek to undermine the idea of expertise, they cast laypeople into an epistemological void. We know these questions are important, but we can't trust our corrupted expert institutions. That leaves us with urgent questions – and no answers. That's a terrifying state to be in, and it makes you easy pickings for authoritarian grifters and conspiratorial swindlers.

Seen in this light, Kanter's antitrust work is even more important. In attacking corporate power itself, he is going after the machine that funds this nihilism-inducing corruption machine.

This week, Tor Books published SPILL, a new, free LITTLE BROTHER novella about oil pipelines and indigenous landback!

If you'd like an essay-formatted version of this post to read or share, here's a link to it on pluralistic.net, my surveillance-free, ad-free, tracker-free blog:

https://pluralistic.net/2024/09/25/epistemological-chaos/#incentives-matter

Image: Ron Cogswell (modified) https://en.wikipedia.org/wiki/File:George.Mason.University.Arlington.Campus.jpg

CC BY 2.0 https://creativecommons.org/licenses/by/2.0/

[lyesander]

Not crazy about people writing off the Titan submersible incident as some schadenfreudic buzzstory they can rag on for a handful of internet funny points. I get the frustration, I really do. At least three of the passengers had to shell out $250,000 a ticket for a glorified deep sea Disney ride. The CEO of OceanGate is a capitalist wackjob who has been complaining about and bypassing safety regulations for years, despite multiple warnings, and now the retrieval is taking up time and resources from multiple countries that could have been put to better use. But one of the crew members on board was also the nineteen year old son of another passenger. I doubt his involvement extended much beyond “I’m going on a fun trip with my dad.” Another was an unaffiliated researcher who joined the expedition to collect environmental samples for DNA analysis. Not everyone on board was a high-rolling corporate yuppie. (And even if they were, it’s still a pretty objectively horrific way to die.) Instead of memes, I’d rather see this prompt a discussion on the ethics and potential regulation of scientific tourism.

The above also doesn’t change the fact that this is dragging media attention away from more pressing issues, such as the sinking of the Andriana. I guess “THE TITANIC CLAIMS ANOTHER FIVE VICTIMS” is a more colorful headline than “the EU’s xenophobic migration policies have led to the deaths of hundreds of migrants seeking asylum in Italy, and an active cover up is now taking place, headed by Greek authorities.” Seeing all this energy be funneled towards dragging this tiny capsule out of the Atlantic when up to five hundred refugees - mostly women and children - were locked in the hull of a ship and left to suffer the exact same fate, while Coast Guard vessels looked on and did nothing (or even had an active role in the capsize after a botched attempt to tow it, according to some testimonies), illustrates the sway money and race have in what we pay attention to. It’s a gruesome example of inequity in action.

I had compared what happened to the Titan to the Kursk incident, but the Andriana doesn’t have the luxury of being a freak accident. Over 25,000 migrants have disappeared or drowned trying to cross the Mediterranean since 2014, with over 2,000 deaths taking place in 2022 alone. Those are staggering numbers. Protests have broken out across Greece over the past week in the wake of the tragedy, advocating for migration reform.

While these sorts of mass casualty events tend to leave us feeling disheartened and helpless, there are ways to help. Below is a link to SOS Humanity’s donation page. Reputable search and rescue organizations such as SOS Humanity or SOS Mediterranée built their mission statements around helping migrants like the ones on board the Andriana. Donate if you can, spread the word if you can’t.

[trainsinanime]

I just want to throw out a quick reminder to go vote next month. The EU parliament is not sexy and does not appear in the news as much as it should, but it is incredibly important. Many important fields of politics are decided there, like all internet regulation (GDPR for Privacy, DSA and DMA for regulating app stores, as just the two most important examples lately), product safety, energy policy, infrastructure funding and so on. A big example: The EU has outlawed the sale of new internal combustion vehicles from 2035.

Conservatives want to overturn that, and this election will be their chance to do so. The EU parliament is arguably the parliament that has the most influence over climate goals. We are seeing a scary rise tide of far-right politicians all throughout Europe that threaten any further progress and want to undo what has been done already. A strong EU parliament with a strong mandate and the right parties can be crucial.

Also note that the EU parliament does not have government and opposition sides, since the government (the commission) is appointed independently by the member states (which is not okay in my book, but that's a separate issue). It works with coalitions that change from issue to issue. What this means is that even tiny parties absolutely get a chance to participate in the political process. So votes for smaller parties are absolutely not wasted.

It seems boring and irrelevant most of the time, but the EU has a tremendous amount of power, and the EU parliament is how we control it. We should take advantage of that.

[strangebiology]

The Science of Humane Slaughter

I asked an expert on humane livestock slaughter how we decided on certain methods of slaughter as more or less humane than others, from a scientific perspective.

He pointed me to this document (PDF) from the European Food Safety Authority called “WELFARE ASPECTS OF ANIMAL STUNNING AND KILLING METHODS:” Scientific Report of the Scientific Panel for Animal Health and Welfare on a request from the Commission related to welfare aspects of animal stunning and killing methods.

It's long, and old (from 2004) but it's a pretty useful document summarizing a lot of the science of why certain methods of killing may be more or less humane.

You can test a method, for example, by hooking an animal up to an EEG and monitoring its brainwaves after stunning it, or delivering a fatal blow (functionally killing it, but it won't always die instantly following a fatal injury, so you can still monitor it.)

Other ways of monitoring and measuring suffering include recording: how many times does an animal vocalize (moo, grunt etc) after being put in a chute? If it moves, does that matter, or is that a post-mortem or unconscious spasm? Does it immediately collapse, does it blink when you touch its eye (corneal reflex)? Is the animal permanently brain-damaged (which is a good thing when you want it to die fast!) or is it only a little knocked out and immobile, with the potential for recovery if you were to not bleed it out? (Which is bad in that circumstance!) A scientist can test that by testing a stunning method on a group of animals and then seeing if they recover. Those individual animals are likely not happy if they do return to consciousness with a hole in their heads, but such is science.

Anyway, while the testing might sound gruesome, I thought you'd like to know that slaughter regulations are pretty serious and well-studied. And those regulations seem pretty consistent among everywhere I've seen (EU, Norway specifically, the US.) With some minor differences here and there.

Perhaps we will discover better ways to slaughter meat animals in regard to their welfare, or perhaps we will find one day that our preferred method wasn't as good as we thought! There might also be people doing things in very bad, unintentionally cruel ways because of silly, disproven myths (but, if someone is legally selling meat, any US slaughterhouse is required to have a USDA rep see every death.)

I don't want to imply that every animal death goes perfectly well, or that it's even acceptable, or that the meat industry is perfect or good! But I do want to share that there is scientific precedent for why people kill livestock the ways they do, and you can read the studies in the aforementioned document. There are tons.

PS. If you have any interesting insights on the science of humane slaughter, I'd love to see them! Or, even, just tell me how it's done in your country, the role of the government, etc.

[therobotmonster]

Let's talk about Toys in Cereal

This is a part of several posts of mine that have gotten big, but I figure it's best to address the phenomenon itself in a new post.

If you want to just browse a ton of cool old cereal toys once we're done, go to: www.cratercritters.com. It's a neat site.

Cereal toys are a long-standing American tradition. Some tag-questions asked if they went away because of greed or because of regulations, and that's complicated.

There are food regulations that complicate things. You may have heard that Kinder Eggs are not legal in the US.

This is usually framed as a "fear the stupid American Kids will eat the toy" kind of thing. This is not the case.

The actual regulation that blocks the Kinder Egg is about food safety from bacterial and undisclosed allergen contamination. Inserting a baggie with a toy into that exposes everything in the cereal bag to the outside of the toy package, and that's a no-no in the US market. The rare thing we're more strict about than the EU.

But that doesn't affect cereal toys, because they can get around it by having it in a separate package outside the food bag, between the inner back and the cardboard box. Much easier on the parents to find when you open the box, too.

Kinder has, themselves, addressed the US Kinder Egg problem the same way, with the Kinder Joy.

Splitting the package. into two sections that are individually sealed.

But a big blow to the practice was the end of the Australian R&L Toy Company.

R&L made tons of simple pack-in Premium toys from the 60s through the 80s. They were the primary supplier to Kelloggs, and made everything from simple one-piece figurines to little build-yourself-action-toys.

For instance, these "Wacky Walkers" worked by tying a string to the figure and the weight, then dropping the weight off a table. The figures would hobble forward on their feet, pulled by the weight. Neat-o!

Then there's stuff like these Toolybirds. I'd sell any one of you to the goblin king for a set of these, because I sure can't afford them at $25 apiece or more. I'll probably just make some dinosaur-knockoff version or somesuch to 3d print, eventually.

R&L went out of business in the 80s and its molds were sold to a toy manufacturing company in Mexico that produced their stuff as bag toys for awhile, before everything just faded away.

Meanwhile, the cereal market was forced to contract elsewhere without a devoted company doing essentially just that.

Liscenses came to the rescue. Fun fact, if you wanted toys from most of the Disney Afternoon, your only hope was Kellogg's.

As time went on, you started even getting software in cereal.

Chex gave out a free, PG-version of DOOM for free. Not a couple of demo levels, a whole game, run on the doom engine, with aliens you zap with a spoon.

But as time went on, companies got less and less into the idea of enticing with freebies, and parents started objecting to the marketing of sugar cereals with toy surprises, because given the opportunity, most parents will blame the company for making something the kid wants for their unwillingness to say "No."

The eternal conflict:

Cool thing the kid would enjoy that you might have to put your foot down over because enforcing moderation is a parent's job, verses unobjectionable conformist mush designed to increase your kids' "goodness levels."

I think the banning of cartoon mascots for snacks in certain countries is also ridiculous.

Thing is, any company could bring them back at any time.

The Monster cereals did figurines of their mascots in cosplay in 2021. Of course, they did it as a limited edition bullshit thing where the actual monster cereal mascots were chase figures, but they made them, they could do them at any time if they wanted to.

They could bring the magic back. Nothing is stopping them.

'cept there's no room for joy on the spreadsheet.

Gotta hit you with a little ennui. It's that ambergris stink that makes the perfume truly sweet.

[mariacallous]

The European Union today agreed on the details of the AI Act, a far-reaching set of rules for the people building and using artificial intelligence. It’s a milestone law that, lawmakers hope, will create a blueprint for the rest of the world.

After months of debate about how to regulate companies like OpenAI, lawmakers from the EU’s three branches of government—the Parliament, Council, and Commission—spent more than 36 hours in total thrashing out the new legislation between Wednesday afternoon and Friday evening. Lawmakers were under pressure to strike a deal before the EU parliament election campaign starts in the new year.

“The EU AI Act is a global first,” said European Commission president Ursula von der Leyen on X. “[It is] a unique legal framework for the development of AI you can trust. And for the safety and fundamental rights of people and businesses.”

The law itself is not a world-first; China’s new rules for generative AI went into effect in August. But the EU AI Act is the most sweeping rulebook of its kind for the technology. It includes bans on biometric systems that identify people using sensitive characteristics such as sexual orientation and race, and the indiscriminate scraping of faces from the internet. Lawmakers also agreed that law enforcement should be able to use biometric identification systems in public spaces for certain crimes.

New transparency requirements for all general purpose AI models, like OpenAI's GPT-4, which powers ChatGPT, and stronger rules for “very powerful” models were also included. “The AI Act sets rules for large, powerful AI models, ensuring they do not present systemic risks to the Union,” says Dragos Tudorache, member of the European Parliament and one of two co-rapporteurs leading the negotiations.

Companies that don’t comply with the rules can be fined up to 7 percent of their global turnover. The bans on prohibited AI will take effect in six months, the transparency requirements in 12 months, and the full set of rules in around two years.

Measures designed to make it easier to protect copyright holders from generative AI and require general purpose AI systems to be more transparent about their energy use were also included.

“Europe has positioned itself as a pioneer, understanding the importance of its role as a global standard setter,” said European Commissioner Thierry Breton in a press conference on Friday night.

Over the two years lawmakers have been negotiating the rules agreed today, AI technology and the leading concerns about it have dramatically changed. When the AI Act was conceived in April 2021, policymakers were worried about opaque algorithms deciding who would get a job, be granted refugee status or receive social benefits. By 2022, there were examples that AI was actively harming people. In a Dutch scandal, decisions made by algorithms were linked to families being forcibly separated from their children, while students studying remotely alleged that AI systems discriminated against them based on the color of their skin.

Then, in November 2022, OpenAI released ChatGPT, dramatically shifting the debate. The leap in AI’s flexibility and popularity triggered alarm in some AI experts, who drew hyperbolic comparisons between AI and nuclear weapons.

That discussion manifested in the AI Act negotiations in Brussels in the form of a debate about whether makers of so-called foundation models such as the one behind ChatGPT, like OpenAI and Google, should be considered as the root of potential problems and regulated accordingly—or whether new rules should instead focus on companies using those foundational models to build new AI-powered applications, such as chatbots or image generators.

Representatives of Europe’s generative AI industry expressed caution about regulating foundation models, saying it could hamper innovation among the bloc’s AI startups. “We cannot regulate an engine devoid of usage,” Arthur Mensch, CEO of French AI company Mistral, said last month. “We don’t regulate the C [programming] language because one can use it to develop malware. Instead, we ban malware.” Mistral’s foundation model 7B would be exempt under the rules agreed today because the company is still in the research and development phase, Carme Artigas, Spain's Secretary of State for Digitalization and Artificial Intelligence, said in the press conference.

The major point of disagreement during the final discussions that ran late into the night twice this week was whether law enforcement should be allowed to use facial recognition or other types of biometrics to identify people either in real time or retrospectively. “Both destroy anonymity in public spaces,” says Daniel Leufer, a senior policy analyst at digital rights group Access Now. Real-time biometric identification can identify a person standing in a train station right now using live security camera feeds, he explains, while “post” or retrospective biometric identification can figure out that the same person also visited the train station, a bank, and a supermarket yesterday, using previously banked images or video.

Leufer said he was disappointed by the “loopholes” for law enforcement that appeared to have been built into the version of the act finalized today.

European regulators’ slow response to the emergence of social media era loomed over discussions. Almost 20 years elapsed between Facebook's launch and the passage of the Digital Services Act—the EU rulebook designed to protect human rights online—taking effect this year. In that time, the bloc was forced to deal with the problems created by US platforms, while being unable to foster their smaller European challengers. “Maybe we could have prevented [the problems] better by earlier regulation,” Brando Benifei, one of two lead negotiators for the European Parliament, told WIRED in July. AI technology is moving fast. But it will still be many years until it’s possible to say whether the AI Act is more successful in containing the downsides of Silicon Valley’s latest export.

[rinielelrandir]

This is related, but slightly off-topic, so bear with me.

Beyond the general horrifying way biotech startups will behave the one thing that comes to mind for me here is just that the entire medical device industry is deeply and fundamentaly fucked up.

I say that as someone who works in pharmaceutical safety assesment and is familiar with (though by no means an expert in) the federal regulations on drug & medical device approvals as part of my job.

Drug/pharmaceutical regulations for approval? The US is actually doing pretty well on this one. We're not as strict as some countries (Japan for example) but we're relatively in-line with the rest of the world overall, or at least enough so that if you meet the requirements for approval in the US you've more than likely done enough for things to get approved elsewhere, especially if you're a big, multinational pharmaceutical corporation. Big pharma sucks, but you can generally trust that the drugs they make are safe & effective, especially if they have approval beyond the States. The regulations are pretty good at their job of protecting the public.

The thing is though, medical device regulations? Not nearly as good, basically thanks to a loophole in the law that is easily exploited by big pharma and biotech startups alike. If your device is an "improvement" on an existing medical device, you don't have to go through a full review, the way a new device or drug would. The process for approval is modified & abbreviated and the amount of safety & efficacy data you have to provide is significantly less because you are essentially saying "this is fundamentally the same device as already on the market, which is safe & effective, but improved slightly to make it more safe & effective". Except, if a device was originally approved 20 or 30 years ago and then modified every 5 to 10 years since that current device on the market? Is fundamentally different from the original approved device.

So those "new & improved" bionic implants that rely on some app? Not only do they not have plans for if the company supporting them fails, they also were more than likely approved based on their similarity to "existing" devices. They are *fundamentally* different. But every 5 to 10 years for the past 30-50 years someone has submitted to the FDA for approval for a "modified" version of whatever device (say, a cochlear implant or a pacemaker) and now the device being pushed on you by doctors & marketing is unrecognizable from the original. But it was approved as if it was simply the original thing with minor modifications. Because each successive design was a minor modification of the design before it so it counted under this rule.

FDA regulations were written in blood (if you're interested I encourage you to look up the history of the FDA's founding because it's fascinating). We have safe foods and medicines *now* because people 100+ years ago died and their loved ones fought for no one else to do the same. Medical devices (in the US at least, I know next to nothing about other countries medical device regulations) do not have the same level of safety and regulation. The regulations governing them are, in comparison, much newer and more easily exploitable.

The rule on approval based on modification of an existing device? Needs to go. For the safety of us all. It does not serve its intended purpose (safer & improved devices reaching market faster, thereby improving public health & fostering innovation). It only serves the interests of corporate greed and allows shit like bionic eyes and other devices that rely on software that will be abandoned in 5 years time to proliferate on the market.