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Summary
Sound Bites
“The biggest challenge is the interpretation of these (LDT) rules.”
“Typically I’m not in favor of what Congress is doing.”
“Trying to understand how we’re going to navigate the space … it’s just been confusing.”
"The FDA is trying to protect us, but they need to navigate these things and engage industry experts."
“(regarding AI) Where does marketing end and reality begin?”
"AI isn't going to say, 'We don't need the doctor, just use AI.'"
“The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.”
“The whole promise of AI is taking massive amounts of data and finding those patterns
Chapters
01:33 Introduction and Background
04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis
07:49 Patient-Centric Solutions in Healthcare and Zealic Health
13:26 Plan B - Moving offices from Ukraine to Poland
20:02 New News!! - The Controversy of LDTs Becoming Medical Devices
27:20 Implications of healthcare and regulations as it applies to AI
30:07 How AI Aids in Diagnosis
New News Story: House committee tells FDA to suspend lab developed test rule
https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/
How to reach us:
Crohn's & Colitis Foundation
https://www.crohnscolitisfoundation.org/
Chuck Piccirillo
https://www.linkedin.com/in/cpiccirillo/
Zealic Health - http://www.zealichealth.com
Dr. Chad Briscoe
https://www.linkedin.com/in/chadbriscoe/
Celerion - https://www.celerion.com/
Gregory Austin
https://www.linkedin.com/in/gregoryaustin1/
ECI - https://eci-rx.com /
Image credits:
https://www.crohnscolitisfoundation.org/
LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657
Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/
Cost, https://www.freepik.com/photos/increasing-costs
Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm
CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/
#BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice
By BioTalk UnzippedSummary
Sound Bites
“The biggest challenge is the interpretation of these (LDT) rules.”
“Typically I’m not in favor of what Congress is doing.”
“Trying to understand how we’re going to navigate the space … it’s just been confusing.”
"The FDA is trying to protect us, but they need to navigate these things and engage industry experts."
“(regarding AI) Where does marketing end and reality begin?”
"AI isn't going to say, 'We don't need the doctor, just use AI.'"
“The people who are out of their jobs won't be the ones using AI. The people who are out of their jobs will be the ones who don't.”
“The whole promise of AI is taking massive amounts of data and finding those patterns
Chapters
01:33 Introduction and Background
04:03 The Crohn’s & Colitis Foundation and Chuck’s struggle with Colitis
07:49 Patient-Centric Solutions in Healthcare and Zealic Health
13:26 Plan B - Moving offices from Ukraine to Poland
20:02 New News!! - The Controversy of LDTs Becoming Medical Devices
27:20 Implications of healthcare and regulations as it applies to AI
30:07 How AI Aids in Diagnosis
New News Story: House committee tells FDA to suspend lab developed test rule
https://www.healthcaredive.com/news/house-committee-fda-suspend-ldt-rule/721362/
How to reach us:
Crohn's & Colitis Foundation
https://www.crohnscolitisfoundation.org/
Chuck Piccirillo
https://www.linkedin.com/in/cpiccirillo/
Zealic Health - http://www.zealichealth.com
Dr. Chad Briscoe
https://www.linkedin.com/in/chadbriscoe/
Celerion - https://www.celerion.com/
Gregory Austin
https://www.linkedin.com/in/gregoryaustin1/
ECI - https://eci-rx.com /
Image credits:
https://www.crohnscolitisfoundation.org/
LDT/FDA, https://x.com/FDADeviceInfo/status/1784965525522493657
Congress, https://worldstrides.com/blog/2013/07/u-s-capitol/
Cost, https://www.freepik.com/photos/increasing-costs
Cancer patient, https://www.freepik.com/free-photo/sick-asian-man-sitting-chair-side-view_33753979.htm
CAD - Computer Aided Detection, https://researchoutreach.org/articles/assessing-performances-computer-aided-diagnosis-breast-cancer/
#BioTalkUnzipped #Podcast #HealthcareInnovation #PatientCare #AIinHealthcare #FDARegulations #Ukraine #LifeSciences #DigitalHealth #AI #pharmaceutical #biotechnology #medicaldevice