FDA’s Post

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Proper integration of AI across the health care ecosystem will be paramount to achieving its potential while reducing risks and challenges, writes Troy Tazbaz, Director, Digital Health Center of Excellence (DHCoE), Center for Devices and Radiological Health, U.S. Food and Drug Administration, in a new blog post. Read more: https://lnkd.in/esaj8efR

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Claudio D'Antonoli

Digital Health Leadership & AI Compliance Expert | Innovator in Healthcare Quality & Regulatory Compliance

1mo

I agree, we should work to create a unified framework that covers all aspects related to AI, from concept to operation, including security, ethical and social impact. This framework should foster collaboration among key stakeholders, including healthcare professionals, technologists, policymakers and patients, ensuring it is comprehensive and practical. Additionally, it should be adaptable to evolving technologies and continuously updated to address new challenges and opportunities. Keep up the great work!

Jeff Barson

Co-founder, CEO of Storyline (Behavioral A.I.) Co-founder Primordial AI (Algorithms as Drugs) Champion of rogue ingenuity and underdog concepts. Chief Storyteller + Space Cowboy.

3w

The FDA's call for "proper AI integration" in healthcare is well-intentioned but risks stifling the real innovation. Here's why: 1. Consensus-driven approaches lead to mediocrity, not breakthroughs. 2. We need a DARPA-like environment encouraging high-risk, high-reward research, not a system dominated by established players resistant to disruptive change. ARPA-H (Terrible name - couldn't call it HARPA?) is a good first step but only one. 3. Healthcare's complexity demands AI-driven solutions. Human expertise and manual delivery will never meet the need. 4. The notion that "we can't treat everyone" is a self-fulfilling prophecy born from conventional thinking. AI approaches already show promise and proofs in developing broadly effective treatments. We must embrace AI as a paradigm shift, not just a tool. This means the FDA creating regulations that encourage innovation while ensuring safety, and being open to unconventional approaches - and they can be done - that don't put patients at risk but push for transformative care.

DEAR F.D.A I HAVE SOME QUESTIONS FOR YOU: IS HERBALISM NOT A PRIMARY FOCUS OF THE F.D.A? DOES THE F.D.A SUPPORT A PLANT BASED LIFESTYLE? DO YOU BELIEVE MAN MADE MEDICINE IS MORE EFFECTIVE THAN PLANTS & HERBS? WHAT PERCENTAGE OF F.D.A APPROVED PRODUCTS ARE RECALLED PER YEAR? DOES THE F.D.A TAKE ACCOUNTABILITY FOR PRE-APPROVED PRODUCTS THAT WERE RECALLED? DOES THE F.D.A TAKE PREVENTIVE MEASURES TO KEEP FROM HAVING F.D.A PRODUCTS RECALLED?  ARE THERE ANY DEATH RELATED CASES TO RECALLED FOODS? WHAT INFLUENCES F.D.A STANDARDS? DOES THE F.D.A. APPROVE FOODS THAT ARE SIMILAR TO MEDICATION HOW “ THE FOOD HELPS ONE ISSUE BUT MAY HURT ANOTHER?” AND IF SO. WHY? DO YOU APPROVE FOODS BASED ON SATISFACTORY OF CONSUMERS OR DO YOU APPROVE FOODS THAT ARE NON-LIFE THREATNING?

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Rachelle Lemke

Senior Research Specialist at University of Wisconsin Madison

1mo

AI is not tested well enough, it has significant errors. I'd like to see more posts and papers about how much it fails.

Qing Liu, Ph.D., ASA Fellow

Gene and Cell Therapies and Rare Disease Drug Development with Innovative Trial Designs and Analytics/Plant-Based Lifestyle for High Quality of Life/Overland Adventures in National Parks, Deep Forests and High Deserts

4w

It is the disease care ecosystem 🤣🤣🤣

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Mahboob Milan

Milan Mahboob, DGM Quality at Eskayef Pharmaceuticals Limited

1mo

I'll keep this in mind

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Hiram Valencia

Global Head of Information Technology

1mo

Thanks for sharing!

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Rafael Garibay

Global Clinical Trial Operations & Management | Purposeful Site Engagement

1mo

Very informative!

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Useful tips

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