You don't want some gatekeeping on who will be doing surgery on you? You do obviously, and medical malpractice is a good thing if there is a problem.

Why don't you want the software engineer building your pacemaker or your medical CRM (or any other job where your immediate security is engaged) to have the same kind of verification and consequences for their actions?

It's mostly the problem of required regulations, so no we don't want mandatory gatekeeeping on surgeons as this is for example leading to doctor shortages

It's fine to set up voluntary standards and choose surgeons you think live up to those

So we want to enable more people to be able to create for example pacemakers because of things like Linus's law, "Given enough eyeballs, all bugs are shallow". If we exclude "non-professionals" from the process of creating "professional" products, we tend to have less participation in the process of innovation and therefore get less innovation

But there is already mandatory gatekeeping of surgeons? They went to medical school for so many years, and they are liable to malpractice if they don't do their job correctly. Engineering is the same. They sign building plans with their names and may be liable for damages caused by gross negligence.

Why shouldn't any self taught "software engineer" be liable for damages they caused due to negligence? If we had to sign off builds of critical components (like a pacemaker to stay with the analogy), there would be way more pushback against malpractice in the development process. Of course not all software projects require that level of rigor, but for medical stuff and I'm sure a lot of other fields, it should be mandatory to have at least one qualified engineer that is ultimately responsible.

1. 99.999999% of software is not equivalent to "doing surgery" so doesn't need gatekeeping. I work on free, open-source PDF reader SumatraPDF. What kind of authorization should I get and from whom to ship this software to people?

2. pacemakers and other medical devices have to get approval from the government. So that's covered.

medical CRM software is covered by medical privacy laws which does what you say you want (criminalizes "bad" software) but in reality is a giant set of rules, many idiotic, that make health care more expensive for no benefit at all.