Once hailed as 'the most powerful government agency in the world,' the FDA has become an utterly irresponsible entity when it comes to AI safety, even allowing Babylon Health to operate unchecked.
Thank you for your insights. I have followed Ali Parsa and Babylon Health since 2014 when he was pitching at Royal College of Medicine confabs. There were truck-sized holes in GP At Hand even then as it developed which then led to ditching the UK and opening big time in the US. His new venture Quadrivia is following the same track...and he started it less than a month after the entire Babylon Health business went bankrupt. (I'm still not sure what happened to the US assets.) I've written about it here with more of a focus on the financial backing and setup. https://telecareaware.com/babylon-healths-parsa-founds-new-ai-medical-assistant-venture-quadrivia-one-year-after-babylon-healths-failure/
Donna, this is a fantastic breakdown of Ali Parsa’s latest venture - hands down the best I’ve come across. Thank you for sharing. It really does seem like he’s recycling the same old Babylon concept. It's mind-boggling: the same algorithm, the same engineers, the same incorporation entities. And yes, he’s still bleeding the Swedes dry.
Regarding the fate of Babylon's assets, he burned it all. The company filed for bankruptcy in the U.K. on May 9, 2023, and then in the U.S. three months later, on August 9, 2023. At the very last filing, Babylon's assets stood at £28.4 million, while liabilities were at £305.3 million. Most of that £28.4 million likely went up in smoke through legal fees, with only a small fraction left to cover a tiny sliver of the debts. Just to put it in perspective, Babylon burned through roughly $1.2 billion in equity and $300 million in debt investment in a matter of few years. Completely gone.
On August 31, 2024, Parsa sold GP at Hand - once valued at around £50 million - for a mere £500,000 to eMed. Unsurprisingly, eMed turned GP at Hand into a GLP-pushing business. Classic.
How Parsa has the audacity to return, and how investors continue to throw money at him, is beyond me. Oh, and let’s not forget his previous venture, Circle Health, which he also left rather abruptly, only for it to collapse later. Fun fact: guess who helped him set up Circle Health? None other than Matt Hancock. It’s always good to have friends in high places, isn’t it?
Hi Sergei...thank you for the compliments on the article--considering your investigation and quality/scope of writing, I am greatly appreciative. I report on news in a digest form and with links to original sourcing. But when something 'ticks' I follow a trail to make sense of it And this was one big tick that my friends at the larger pubs didn't sense. (I know the smarter writers are getting their gimlet goggles on though...) ..I didn't expect to go quite as far as I did but you keep turning the cards and the 'ominous parallel' reveals (a term I omitted from the article).
I previously covered Babylon's failure and implosion as it happened so provided readers with an article that would lead back to that sad history which you recapped. The cracked SPAC was all part of it. Even Centene, which was going through its own turmoils, wasn't going to be party to this and delivered a major and near final blow.
Parsa's 'comeback' I assure you will be covered by many. And the hype cycle begins again....
I didn't know about Matt Hancock and Circle Health! No wonder he was on the Babylon Bandwagon as Health Secretary. As a UK private medical provider, it never popped up on my radar until Centene divested itself of its interest in its ongoing monetization of ancillary assets that former CEO Michael Neidorff piled up. (And no wonder that Centene signed agreements with Babylon...)Circle survives with Abu Dhabi money to this day.
Am I the only one who found the Babylon name descriptive of the whole scheme?
The comments from the commissioner are interesting because this has NOT been what I've seen from the agency, with a number of companies going through the approvals process. Perhaps it depends on what team at the FDA you get, but it has been fairly rigorous, and although it's been... bumpy... some of the asks that they seem to now have are quite reasonable for balancing risk and patient benefit. For a while, I was seeing blanket denials for fairly flimsy reasons.
I do agree with the AI scribe thing being somewhat dubious, though the FDA has traditionally stayed out of a lot of these tools in the past, so I'm not really shocked.
I wouldn't be shocked, though so far that hasn't been my current experience of the agency—not to say that they don't have dumb things happening/getting approved, but I'm seeing fairly reasonable actors within it.
James, I see your point. As I mentioned, my experience with the FDA staff during the medical device approval process was actually quite positive. The process itself was long and strenuous, but the staff were consistently helpful and professional.
My concern is different. Putting aside the revolving door issues and other questionable practices, I’m worried about a loophole in the 21st Century Cures Act that basically allows certain AI devices to skip FDA filing if they obtain an independent review instead. (And perhaps that's what the FDA commissioner was referring to.) So what did Ali Parsa do? He found so-called "reviewers" who would only give glowing reports about his product.
And the same goes for AI scribes and other AI-based devices - if there's an option to opt out, of course they’re going to take it. I’ve reviewed the FDA’s list of all 950 AI/ML-Enabled Medical Devices, and I haven’t seen a single scribe or symptom checker. What I did see were plenty of computer vision algorithms, primarily from companies like GE and other big corporations.
What’s even more troubling is that Babylon is conducting over $1 billion worth of business with CMS, the FDA's sister organization, while completely bypassing the FDA. And yet, the FDA hasn’t raised any alarms? It all seems incredibly strange and far from kosher.
Thank you for your insights. I have followed Ali Parsa and Babylon Health since 2014 when he was pitching at Royal College of Medicine confabs. There were truck-sized holes in GP At Hand even then as it developed which then led to ditching the UK and opening big time in the US. His new venture Quadrivia is following the same track...and he started it less than a month after the entire Babylon Health business went bankrupt. (I'm still not sure what happened to the US assets.) I've written about it here with more of a focus on the financial backing and setup. https://telecareaware.com/babylon-healths-parsa-founds-new-ai-medical-assistant-venture-quadrivia-one-year-after-babylon-healths-failure/
Donna, this is a fantastic breakdown of Ali Parsa’s latest venture - hands down the best I’ve come across. Thank you for sharing. It really does seem like he’s recycling the same old Babylon concept. It's mind-boggling: the same algorithm, the same engineers, the same incorporation entities. And yes, he’s still bleeding the Swedes dry.
Regarding the fate of Babylon's assets, he burned it all. The company filed for bankruptcy in the U.K. on May 9, 2023, and then in the U.S. three months later, on August 9, 2023. At the very last filing, Babylon's assets stood at £28.4 million, while liabilities were at £305.3 million. Most of that £28.4 million likely went up in smoke through legal fees, with only a small fraction left to cover a tiny sliver of the debts. Just to put it in perspective, Babylon burned through roughly $1.2 billion in equity and $300 million in debt investment in a matter of few years. Completely gone.
On August 31, 2024, Parsa sold GP at Hand - once valued at around £50 million - for a mere £500,000 to eMed. Unsurprisingly, eMed turned GP at Hand into a GLP-pushing business. Classic.
How Parsa has the audacity to return, and how investors continue to throw money at him, is beyond me. Oh, and let’s not forget his previous venture, Circle Health, which he also left rather abruptly, only for it to collapse later. Fun fact: guess who helped him set up Circle Health? None other than Matt Hancock. It’s always good to have friends in high places, isn’t it?
Hi Sergei...thank you for the compliments on the article--considering your investigation and quality/scope of writing, I am greatly appreciative. I report on news in a digest form and with links to original sourcing. But when something 'ticks' I follow a trail to make sense of it And this was one big tick that my friends at the larger pubs didn't sense. (I know the smarter writers are getting their gimlet goggles on though...) ..I didn't expect to go quite as far as I did but you keep turning the cards and the 'ominous parallel' reveals (a term I omitted from the article).
I previously covered Babylon's failure and implosion as it happened so provided readers with an article that would lead back to that sad history which you recapped. The cracked SPAC was all part of it. Even Centene, which was going through its own turmoils, wasn't going to be party to this and delivered a major and near final blow.
Parsa's 'comeback' I assure you will be covered by many. And the hype cycle begins again....
I didn't know about Matt Hancock and Circle Health! No wonder he was on the Babylon Bandwagon as Health Secretary. As a UK private medical provider, it never popped up on my radar until Centene divested itself of its interest in its ongoing monetization of ancillary assets that former CEO Michael Neidorff piled up. (And no wonder that Centene signed agreements with Babylon...)Circle survives with Abu Dhabi money to this day.
Am I the only one who found the Babylon name descriptive of the whole scheme?
The comments from the commissioner are interesting because this has NOT been what I've seen from the agency, with a number of companies going through the approvals process. Perhaps it depends on what team at the FDA you get, but it has been fairly rigorous, and although it's been... bumpy... some of the asks that they seem to now have are quite reasonable for balancing risk and patient benefit. For a while, I was seeing blanket denials for fairly flimsy reasons.
I do agree with the AI scribe thing being somewhat dubious, though the FDA has traditionally stayed out of a lot of these tools in the past, so I'm not really shocked.
I wouldn't be shocked, though so far that hasn't been my current experience of the agency—not to say that they don't have dumb things happening/getting approved, but I'm seeing fairly reasonable actors within it.
James, I see your point. As I mentioned, my experience with the FDA staff during the medical device approval process was actually quite positive. The process itself was long and strenuous, but the staff were consistently helpful and professional.
My concern is different. Putting aside the revolving door issues and other questionable practices, I’m worried about a loophole in the 21st Century Cures Act that basically allows certain AI devices to skip FDA filing if they obtain an independent review instead. (And perhaps that's what the FDA commissioner was referring to.) So what did Ali Parsa do? He found so-called "reviewers" who would only give glowing reports about his product.
And the same goes for AI scribes and other AI-based devices - if there's an option to opt out, of course they’re going to take it. I’ve reviewed the FDA’s list of all 950 AI/ML-Enabled Medical Devices, and I haven’t seen a single scribe or symptom checker. What I did see were plenty of computer vision algorithms, primarily from companies like GE and other big corporations.
What’s even more troubling is that Babylon is conducting over $1 billion worth of business with CMS, the FDA's sister organization, while completely bypassing the FDA. And yet, the FDA hasn’t raised any alarms? It all seems incredibly strange and far from kosher.