It already has

The AI Act does not apply to the UK.

Stumbled across the game of the year! www.pcgamer.com/games/roguel....

I'm not sure the data is shaky - it's just not publicly available.

I've done dozens of FDA submissions, and they do ask for a hell of a lot of data to support a successful review. It's up to the companies to decide to publish it or not - most of them choose not. We need more transparency.

Let's hope it's not a new nuclear era

Apparently, its very easy.

So sad to see

I'll leave you with one final question to ponder -

Do you know what unregulated growth is called in biological terms, and what it does to ecosystems?

It's called cancer, and it kills everything.

With the next US government threatening even more deregulation, where does this leave organisations like the FDA, who have always done their best to balance innovation with safety?

Or do we want to uphold the values and principles of independent scientific scrutiny and Hippocratic common good, even if it means getting to the end point a little slower?

Who is going to take a stand and ensure we can meet basic scientific and good practice standards?

We, collectively as a scientific community, need to ask ourselves some questions

- do we really want to push innovation faster and harder than regulation can keep up?
- is the prize worth it?
- do we continue risk patient safety with a technology with so many unknown risks?

The ground swell, market pressures and immense funding behind generative AI has created a wave of blatant non-compliance so great that I don't think the FDA can even hold it back. They've lost control of the narrative. They are no longer feared by vendors.

This isn't limited to smaller companies who may claim naivety - big tech companies (the big ones you've heard of) are doing it too. Everyone is all-in on clinical generative AI, and no-one has regulatory authorisation.

I even saw several vendor booths with an FDA logo printed on them, but on deeper inspection and checking the FDA databases, they have no such market authorisation. A blatant lie to potential customers, waving a fake flag of compliance.

From companies selling access to foundational models for generalised reporting, to report summarisation, to EHR insights, to copilots - all of them touting a medical purpose, but with absolutely no regulatory oversight.