Dr Hugh Harvey
@drhughharvey.hardian.health
Managing Director @ Hardian Health
Software and AI as a Medical Device
@hardianhealth.com
www.hardianhealth.com
Software and AI as a Medical Device
@hardianhealth.com
www.hardianhealth.com
When is a medical device not a medical device?
Great paper in NPJ Digital Medicine.
The answer is never - but how do we regulate to ensure safe and effective use of general purpose systems?
www.nature.com/articles/s41...
Great paper in NPJ Digital Medicine.
The answer is never - but how do we regulate to ensure safe and effective use of general purpose systems?
www.nature.com/articles/s41...
March 10, 2025 at 9:32 PM
When is a medical device not a medical device?
Great paper in NPJ Digital Medicine.
The answer is never - but how do we regulate to ensure safe and effective use of general purpose systems?
www.nature.com/articles/s41...
Great paper in NPJ Digital Medicine.
The answer is never - but how do we regulate to ensure safe and effective use of general purpose systems?
www.nature.com/articles/s41...
Now hiring - Clinical Associate
As a Clinical Associate (a junior/mid-level role), you will play a key part in guiding the product strategy, clinical evaluations, and regulatory submissions for our clients developing Software and AI medical devices.
www.hardianhealth.com/careers-list...
As a Clinical Associate (a junior/mid-level role), you will play a key part in guiding the product strategy, clinical evaluations, and regulatory submissions for our clients developing Software and AI medical devices.
www.hardianhealth.com/careers-list...
February 10, 2025 at 2:00 PM
Now hiring - Clinical Associate
As a Clinical Associate (a junior/mid-level role), you will play a key part in guiding the product strategy, clinical evaluations, and regulatory submissions for our clients developing Software and AI medical devices.
www.hardianhealth.com/careers-list...
As a Clinical Associate (a junior/mid-level role), you will play a key part in guiding the product strategy, clinical evaluations, and regulatory submissions for our clients developing Software and AI medical devices.
www.hardianhealth.com/careers-list...
Reposted by Dr Hugh Harvey
Did you catch our MD @drhughharvey.hardian.health on the Future Medicines AI podcast?
He shares his expert insights into the challenges and opportunities in #healthcare #AI and explains what it takes to successfully bring AI #medicaldevices to market.
Listen here ➡️ www.fmai-hub.com/videos/navig...
He shares his expert insights into the challenges and opportunities in #healthcare #AI and explains what it takes to successfully bring AI #medicaldevices to market.
Listen here ➡️ www.fmai-hub.com/videos/navig...
January 21, 2025 at 9:18 AM
Did you catch our MD @drhughharvey.hardian.health on the Future Medicines AI podcast?
He shares his expert insights into the challenges and opportunities in #healthcare #AI and explains what it takes to successfully bring AI #medicaldevices to market.
Listen here ➡️ www.fmai-hub.com/videos/navig...
He shares his expert insights into the challenges and opportunities in #healthcare #AI and explains what it takes to successfully bring AI #medicaldevices to market.
Listen here ➡️ www.fmai-hub.com/videos/navig...
Reposted by Dr Hugh Harvey
📋 Ready to elevate your QMS game?
Part 2 of our QMS blog shares the practicalities of implementing & managing a QMS effectively.
Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process⬇️ www.hardianhealth.com/insights/imp...
Part 2 of our QMS blog shares the practicalities of implementing & managing a QMS effectively.
Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process⬇️ www.hardianhealth.com/insights/imp...
January 9, 2025 at 9:25 AM
📋 Ready to elevate your QMS game?
Part 2 of our QMS blog shares the practicalities of implementing & managing a QMS effectively.
Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process⬇️ www.hardianhealth.com/insights/imp...
Part 2 of our QMS blog shares the practicalities of implementing & managing a QMS effectively.
Whether you’re just starting out or optimising your existing system, this is your go-to guide for navigating the process⬇️ www.hardianhealth.com/insights/imp...
Merry QMSmas one and all 🎄
December 23, 2024 at 10:58 AM
Merry QMSmas one and all 🎄
Absolute class from Gukesh, the new world chess champion.
Not only the youngest player ever to achieve the title, but also a total sportsman. Calm, collected, humble - he even stays behind to clear the board like a total pro.
www.youtube.com/watch?v=sbPe...
Not only the youngest player ever to achieve the title, but also a total sportsman. Calm, collected, humble - he even stays behind to clear the board like a total pro.
www.youtube.com/watch?v=sbPe...
Emotional and shocking ending to World Chess Championship 2024
YouTube video by Daily Dose of Chess Clips
www.youtube.com
December 13, 2024 at 9:36 PM
Absolute class from Gukesh, the new world chess champion.
Not only the youngest player ever to achieve the title, but also a total sportsman. Calm, collected, humble - he even stays behind to clear the board like a total pro.
www.youtube.com/watch?v=sbPe...
Not only the youngest player ever to achieve the title, but also a total sportsman. Calm, collected, humble - he even stays behind to clear the board like a total pro.
www.youtube.com/watch?v=sbPe...
Regulations do not stifle innovation.
Spread the word.
Full interview: www.fmai-hub.com/videos/navig...
Spread the word.
Full interview: www.fmai-hub.com/videos/navig...
December 13, 2024 at 9:21 AM
Regulations do not stifle innovation.
Spread the word.
Full interview: www.fmai-hub.com/videos/navig...
Spread the word.
Full interview: www.fmai-hub.com/videos/navig...
Reposted by Dr Hugh Harvey
Excellent podcast on #AI #regulation in #radiology! Great thoughts and insights shared by @asset25.bsky.social, @drhughharvey.hardian.health!!
Hosted by @sublunar.bsky.social and @auntminnie.bsky.social.
m.soundcloud.com/auntminnie-c...
Hosted by @sublunar.bsky.social and @auntminnie.bsky.social.
m.soundcloud.com/auntminnie-c...
Regulating medical AI - Episode 10 Keeping Up With The Radiologists
Stream Regulating medical AI - Episode 10 Keeping Up With The Radiologists by AuntMinnie.com on desktop and mobile. Play over 320 million tracks for free on SoundCloud.
m.soundcloud.com
December 10, 2024 at 6:36 PM
Excellent podcast on #AI #regulation in #radiology! Great thoughts and insights shared by @asset25.bsky.social, @drhughharvey.hardian.health!!
Hosted by @sublunar.bsky.social and @auntminnie.bsky.social.
m.soundcloud.com/auntminnie-c...
Hosted by @sublunar.bsky.social and @auntminnie.bsky.social.
m.soundcloud.com/auntminnie-c...
See you all there #RSNA24
Regulatory Landscape of AI in the US and Beyond | W1-CIN18
Wednesday, Dec 4
8:00 AM - 9:00 AM CST
reg.meeting.rsna.org/flow/rsna/rs...
Regulatory Landscape of AI in the US and Beyond | W1-CIN18
Wednesday, Dec 4
8:00 AM - 9:00 AM CST
reg.meeting.rsna.org/flow/rsna/rs...
RSNA 2024 Meeting CentralRSNA 2024 110th Scientific Assembly and Annual MeetingCheck us out on FacebookCheck us out on InstagramCheck us out on XCheck us out on LinkedInCheck us out on YouTube
reg.meeting.rsna.org
December 3, 2024 at 1:23 PM
See you all there #RSNA24
Regulatory Landscape of AI in the US and Beyond | W1-CIN18
Wednesday, Dec 4
8:00 AM - 9:00 AM CST
reg.meeting.rsna.org/flow/rsna/rs...
Regulatory Landscape of AI in the US and Beyond | W1-CIN18
Wednesday, Dec 4
8:00 AM - 9:00 AM CST
reg.meeting.rsna.org/flow/rsna/rs...
The FDA has lost control of clinical AI.
It pains me to say so, it really does, but this is the feeling I got walking around the AI showcase here in Chicago at #RSNA24.
Booth after booth, row after row, unregulated AI products and claims were everywhere....
It pains me to say so, it really does, but this is the feeling I got walking around the AI showcase here in Chicago at #RSNA24.
Booth after booth, row after row, unregulated AI products and claims were everywhere....
December 2, 2024 at 11:12 PM
The FDA has lost control of clinical AI.
It pains me to say so, it really does, but this is the feeling I got walking around the AI showcase here in Chicago at #RSNA24.
Booth after booth, row after row, unregulated AI products and claims were everywhere....
It pains me to say so, it really does, but this is the feeling I got walking around the AI showcase here in Chicago at #RSNA24.
Booth after booth, row after row, unregulated AI products and claims were everywhere....
Here's to all the #RSNA24 Europeans wide awake at 5am in Chicago waiting for the sun to rise.
Good thing that tomorrow there's a breakfast event hosted by Annalise starting at 6:30am in the Great Lakes Room at the Marriot Marquis. See you there!
annaliseairsna24.rsvpify.com
Good thing that tomorrow there's a breakfast event hosted by Annalise starting at 6:30am in the Great Lakes Room at the Marriot Marquis. See you there!
annaliseairsna24.rsvpify.com
December 1, 2024 at 11:34 AM
Here's to all the #RSNA24 Europeans wide awake at 5am in Chicago waiting for the sun to rise.
Good thing that tomorrow there's a breakfast event hosted by Annalise starting at 6:30am in the Great Lakes Room at the Marriot Marquis. See you there!
annaliseairsna24.rsvpify.com
Good thing that tomorrow there's a breakfast event hosted by Annalise starting at 6:30am in the Great Lakes Room at the Marriot Marquis. See you there!
annaliseairsna24.rsvpify.com
Who is responsible for clinical AI bias and discrimination?
You, the user, are.
At least, in America, according to RSNA under federal law ACA Section 1557
www.rsna.org/-/media/file...
You, the user, are.
At least, in America, according to RSNA under federal law ACA Section 1557
www.rsna.org/-/media/file...
November 30, 2024 at 9:23 AM
Who is responsible for clinical AI bias and discrimination?
You, the user, are.
At least, in America, according to RSNA under federal law ACA Section 1557
www.rsna.org/-/media/file...
You, the user, are.
At least, in America, according to RSNA under federal law ACA Section 1557
www.rsna.org/-/media/file...
I'm off to #RSNA2024 in Chicago.
Topics I'm looking forward to:
Large Vision Models - how accurate are they per pathology compared to dedicated DL trained on label data?
LLMs for reporting, catching missed findings, monitoring for downstream follow up
How to fit these into regulatory frameworks
Topics I'm looking forward to:
Large Vision Models - how accurate are they per pathology compared to dedicated DL trained on label data?
LLMs for reporting, catching missed findings, monitoring for downstream follow up
How to fit these into regulatory frameworks
November 29, 2024 at 7:00 PM
I'm off to #RSNA2024 in Chicago.
Topics I'm looking forward to:
Large Vision Models - how accurate are they per pathology compared to dedicated DL trained on label data?
LLMs for reporting, catching missed findings, monitoring for downstream follow up
How to fit these into regulatory frameworks
Topics I'm looking forward to:
Large Vision Models - how accurate are they per pathology compared to dedicated DL trained on label data?
LLMs for reporting, catching missed findings, monitoring for downstream follow up
How to fit these into regulatory frameworks
Repeat after me:
Any software intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease is a medical device, and requires regulatory authorisation.
Why do people still not know this? Let alone, get funding to build it without any regard to the law?
Any software intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease is a medical device, and requires regulatory authorisation.
Why do people still not know this? Let alone, get funding to build it without any regard to the law?
November 26, 2024 at 10:29 AM
Repeat after me:
Any software intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease is a medical device, and requires regulatory authorisation.
Why do people still not know this? Let alone, get funding to build it without any regard to the law?
Any software intended for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease is a medical device, and requires regulatory authorisation.
Why do people still not know this? Let alone, get funding to build it without any regard to the law?
Can 'self-learning' AI get regulatory clearance as a medical device?
Not according to the team of Notified Bodies in the EU.
media.licdn.com/dms/document...
Not according to the team of Notified Bodies in the EU.
media.licdn.com/dms/document...
November 25, 2024 at 1:13 PM
Can 'self-learning' AI get regulatory clearance as a medical device?
Not according to the team of Notified Bodies in the EU.
media.licdn.com/dms/document...
Not according to the team of Notified Bodies in the EU.
media.licdn.com/dms/document...
Medics on Bluesky - you can label your account with up to 4 medical specialities here
bsky.app/profile/meds...
bsky.app/profile/meds...
bsky.app
November 24, 2024 at 8:32 AM
Medics on Bluesky - you can label your account with up to 4 medical specialities here
bsky.app/profile/meds...
bsky.app/profile/meds...
Another hint from the @fda.gov that they are considering regulating ambient scribes.
The FDA also warns manufacturers against using undocumented foundation models, since training data and bias cannot be controlled.
www.fda.gov/media/182871...
The FDA also warns manufacturers against using undocumented foundation models, since training data and bias cannot be controlled.
www.fda.gov/media/182871...
November 23, 2024 at 2:00 PM
Another hint from the @fda.gov that they are considering regulating ambient scribes.
The FDA also warns manufacturers against using undocumented foundation models, since training data and bias cannot be controlled.
www.fda.gov/media/182871...
The FDA also warns manufacturers against using undocumented foundation models, since training data and bias cannot be controlled.
www.fda.gov/media/182871...
Thanks to @radiopaedia-org.bsky.social for hosting this session on AI regulation in radiology.
www.podbean.com/media/share/...
www.podbean.com/media/share/...
November 23, 2024 at 10:35 AM
Thanks to @radiopaedia-org.bsky.social for hosting this session on AI regulation in radiology.
www.podbean.com/media/share/...
www.podbean.com/media/share/...
Want to know the latest international standards for AI medical devices?
I've broken them down into essential base standards, best practice guidance, and cutting edge new standards.
https://www.hardianhealth.com/insights/every-regulatory-ai-medical-device-standard-you-need-to-know
I've broken them down into essential base standards, best practice guidance, and cutting edge new standards.
https://www.hardianhealth.com/insights/every-regulatory-ai-medical-device-standard-you-need-to-know
November 25, 2024 at 4:53 AM
Want to know the latest international standards for AI medical devices?
I've broken them down into essential base standards, best practice guidance, and cutting edge new standards.
https://www.hardianhealth.com/insights/every-regulatory-ai-medical-device-standard-you-need-to-know
I've broken them down into essential base standards, best practice guidance, and cutting edge new standards.
https://www.hardianhealth.com/insights/every-regulatory-ai-medical-device-standard-you-need-to-know
If AI is 'so good at coding and will replace developers' - why are OpenAI still hiring coders?
November 25, 2024 at 4:53 AM
If AI is 'so good at coding and will replace developers' - why are OpenAI still hiring coders?
Tell me again that medical device regulations aren't sexy.
Apple's 6th FDA approval (pending) allows the airpods to be used as hearing aids, and conduct a clinical-grade hearing test.
Apple's 6th FDA approval (pending) allows the airpods to be used as hearing aids, and conduct a clinical-grade hearing test.
November 25, 2024 at 4:53 AM
Tell me again that medical device regulations aren't sexy.
Apple's 6th FDA approval (pending) allows the airpods to be used as hearing aids, and conduct a clinical-grade hearing test.
Apple's 6th FDA approval (pending) allows the airpods to be used as hearing aids, and conduct a clinical-grade hearing test.
I'm not a fan of slick marketing campaigns.
It's better when happy clients do the talking....
A zero non-conformity audit is a rare thing, so well done to the @MycardiumAI team, and thanks for working with @HardianHealth
It's better when happy clients do the talking....
A zero non-conformity audit is a rare thing, so well done to the @MycardiumAI team, and thanks for working with @HardianHealth
November 25, 2024 at 4:53 AM
I'm not a fan of slick marketing campaigns.
It's better when happy clients do the talking....
A zero non-conformity audit is a rare thing, so well done to the @MycardiumAI team, and thanks for working with @HardianHealth
It's better when happy clients do the talking....
A zero non-conformity audit is a rare thing, so well done to the @MycardiumAI team, and thanks for working with @HardianHealth
Interested in the cutting edge of regulatory science for AI medical devices?
Want to better understand NICE EVA, or NHS procurement?
Or just fancy networking with people passionate about healthtech?
Sign up to get the ticket announcement on 1st...
Want to better understand NICE EVA, or NHS procurement?
Or just fancy networking with people passionate about healthtech?
Sign up to get the ticket announcement on 1st...
November 25, 2024 at 5:01 AM
Interested in the cutting edge of regulatory science for AI medical devices?
Want to better understand NICE EVA, or NHS procurement?
Or just fancy networking with people passionate about healthtech?
Sign up to get the ticket announcement on 1st...
Want to better understand NICE EVA, or NHS procurement?
Or just fancy networking with people passionate about healthtech?
Sign up to get the ticket announcement on 1st...
Just your friendly reminder that #GPT4O terms of use prohibit use for medical purposes, and that medical device regulations apply for any intended purposes such as diagnosis, monitoring, treatment, alleviation or prevention of a disease or injury.
Carry on.
Carry on.
November 25, 2024 at 5:01 AM
Just your friendly reminder that #GPT4O terms of use prohibit use for medical purposes, and that medical device regulations apply for any intended purposes such as diagnosis, monitoring, treatment, alleviation or prevention of a disease or injury.
Carry on.
Carry on.