Hugh Harvey Profile picture
Managing Director @HardianHealth SaMD and AIaMD consultancy
Daniel Rubin QILab Profile picture 1 subscribed
Sep 1, 2023 18 tweets 3 min read
Babylon Health collapsed last night.

I used to work there - it was my first industry job in healthtech 7 years ago. I left after 12 months, frustrated, disillusioned and wanting to do healthtech properly.

What went wrong?...

techcrunch.com/2023/08/31/the… The day I started I was on the 'clinical AI' team and was shown the 'ground-breaking AI system'. Turns out it was just a bunch of Excel spreadsheets with some decision trees written by junior doctors. It was a disappointing start.
Jan 4, 2023 9 tweets 3 min read
"Regulations stifle innovation"

A phrase I hear a lot.
And disagree with.

A thread 🧵👇 First - let's find common ground.

We can all agree that 'do no harm' is a generally sensible approach to clinical care.

In reality, most things we do in medicine *can* cause harm.

So, really, it's 'do minimal harm'
Dec 23, 2022 10 tweets 4 min read
This paper is making the rounds, so I thought I'd do a thread.

The headline is "AI can't pass the radiology board exam" so let's explore what that actually means, and if it's even the right benchmark to test.

bmj.com/content/379/bm… First off, it's worth saying that the methodology and the writing of this paper are excellent. It is well structured, clear, understandable, and reports exactly what it set out to report, with an honest discussion and conclusion.

It's a good paper. But...
Nov 15, 2022 13 tweets 3 min read
I see healthtech developers tie themselves in knots over their Intended Use a lot.

10 tips on how to formulate a clear, concise intended use statement that will appease the medical device regulators

🧵 ... Intended Use is the start point for all regulatory documentation. Skip it, and you'll never be able to articulate what your device actually does to your customers.

Tip 1: Be specific using commonly accepted clinical terminology, and be prepared to evidence everything
Jun 26, 2022 13 tweets 3 min read
New from @MHRAdevices on the future of regulations, what UKCA and the transition towards it will look like.

A lot to unpack but here are the highlights for software as a medical device (SAMD)... 🧵

gov.uk/government/con… These are the results of a public consultation.

1) The UK will align with the IMDRF risk classification system (which the EU and the FDA use) - this means no more class I software products self-certifying

Verdict: As expected, utterly sensible. Bye bye loophole.
Feb 23, 2022 16 tweets 5 min read
Crypto is a scam, a ponzi, and the whole market is a fraud.

To prove how easy it is to demonstrate market manipulation I started a paper trading account in December 2020.

I started with $100,000 (fake) US dollars.

Today I have $82 trillion (fake) US dollars

.... Paper trading accounts let you 'buy' and 'sell' crypto assets but with fake money. This lets you test out trading strategies and theories. You can also create trading bots that trade when certain pre-specified conditions arise...

These are my recent automated transactions...