I like that Americans, and particularly New Yorkers, are so self-centered that they don't even bother to specify which city's train lines are on the map (New York is only in the HN title). Of course, a Ukrainian frontend developer will be familiar enough with the city's contours to instantly recognize the shape of Manhattan from the train lines.
When my ex-wife just moved to Germany, she was extremely anxious about waste sorting. She spent an hour sorting trash according to video guides on YouTube. Regardless doing everything perfectly, some German neighbor snitched on her to her landlady. Then some other old neighbor was watching through her windows with binoculars (privacy my ass!). Germany is a terrible country, the sick man of Europe once again
> Those things are all necessary anyway
It's a bold statement. Have you ever actually been working on any compliance yourself? 80% of everything is just senseless bureaucracy. I've worked in a medical startup and we had it all: GDPR, HIPPA, FDA approvals etc. The requirements are completely detached from reality and are usually written for some X-Ray producing firms from 20th century, not an health-tech AI startup. And they're trying to regulate everything, even how your organizational structure should look like, how you should create tickets in Jira (or any other _compliant_ products). Developers had to take useless trainings on how a medical organization should operate, which were essentially the courses of Aesopian language of medical bureaucracy. And legal expenses, boy o boy, the company had to spend twice as much on compliance staff than it did on developers. And what was the result? Rich American competitors with a ton of VC money were getting approvals while our company was struggling with all this idiocy despite having a much more superior product.
I'm specifically criticising the claim that GDPR was among the most burdensome requirements. Very little of GDPR is additional to what you need to do anyway, apart from DSARs (which aren't burdensome: you may charge a fee if someone's abusing the process), appointing a DPO (optional for most organisations), and the third-country restrictions (which are partly necessary, and article 45 reduces the burden). I don't dispute that regulations can be silly and a waste of time (e.g. PCI compliance requiring the removal of effective security measures, as directed by incompetent auditors, because the legal requirement is "passes an audit"), but I do dispute the use of GDPR as an example.
I'll note that of the three regulatory acronyms you gave, two of them (HIPPA and FDA approvals) are American.
> two of them (HIPPA and FDA approvals) are American
I specified all three via comma to highlight that we had quite some history in compliance, in different jurisdictions.
HIPPA covers only medical devices, GDPR covers everything. FDA approval process is convoluted and expensive, especially for new types of devices, but it's still much easier than European MDR.
Also, I mentioned FDA because we didn't even try to get a proper compliance in the EU, because it's impossible for a startup without huge support.
No, the HIPAA Privacy Rule covers only medical information: see https://www.hhs.gov/hipaa/for-professionals/privacy/laws-reg.... Perhaps with your organisation, this was restricted to devices, but within a hospital environment there's a lot more covered by the HIPAA Privacy Rule than just medical devices. NB: the combined text of the applicable HIPAA rules (115 pages) are a lot longer than the entire text of the GDPR (88 pages, including recitals).
> The certificates shall be valid for the period they indicate, which shall not exceed five years. On application by the manufacturer, the validity of the certificate may be extended for further periods, each not exceeding five years, based on a re-assessment in accordance with the applicable conformity assessment procedures.
Other than that, it just seems like "do actual science to determine safety" and "if there's no 'intended medical purpose', also do actual science to demonstrate efficacy". The HMT Medizintechnik GmbH consultation feedback seems to say that a small company providing, say, basic sutures, is required to repeatedly prove the adequacy of those sutures, even though everybody knows that basically any sutures are adequate for those cases where sutures are adequate; but I don't think that's a correct reading of the law. (And this shouldn't affect a new device.) So I'm a bit confused. https://www.medtecheurope.org/wp-content/uploads/2025/03/250... clinical evaluation TOP 3 (on page 18) does not describe a problem with the text of MDR, but as a long-term mitigative measure they suggest:
> Possibly making this clearer in the text revision so Notified Bodies do not feel they must ask for PMCF clinical investigations as a default.
You never claimed that the text of the regulation was the issue; and I think I'm starting to see where the problem lies. While the rules are mostly sensible, they delegate to national bodies empowered to exercise discretion, and these bodies are (reportedly) erring on the side of excessive requirements. Was this the reason you gave up on EU certification without attempting it?
I cannot stand reading these comments left by people clearly detached from reality.
I used to work in a medical AI company myself, over the years we had a few requests for deletion, all from some crazy old German people. Moreover, we couldn't train our models on European data, which is absurd.
Medical data is a domain that requires extremely careful consideration of privacy and implications of what you're collecting. Most engineers work in highly regulated fields, except for software engineers, because they're not engineers.
If you can't handle the heat, get out of the kitchen. The big picture is that medical AI is scary stuff that can ruin countless lives if done even slightly wrong.
Well it's not like I know a hundred lofi songs by heart or subscribe to lofi news but it serves as a nice background when I'm working alone in my apartment.
Yeah, that's pretty much it; lofi is loud enough to drown out intermittent noise in the area, while monotonous and simple enough to allow you to concentrate on whatever you're doing instead of on the music.
I like it, but I use it moreso for when I want to tune out noises in my surroundings with something other than say, "bird noises" or "distance thunderstorm".
Yes exactly, I usually listen to it when studying. With it on 25% volume and noise cancelling headphones it tunes out the world very nicely while avoiding dead silence.
I believe that as always problems like this one may be solved only through erasing privatized monopolies from the market. The civilized way to achieve this is to raise number of competitors on the market. And there's a plenty of available options. E.g. cut subsidies and raise taxes for big pharmaceutical companies, make additional subsidies and cheap loans to small ones, give students extra grants for pharmacology courses at universities (in order to increase number of specialists), abolish or at least change patent laws for drugs, support public pharmaceutical researches funding by government and involved companies with results available to everyone. I guess in modern world one of the primary economic responsibilities of government is providing an environment in which not only large business may start to do high-tech.
