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Articles by Bakul
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My Trip to India: 10 Days at the Forefront of the Digital Health Revolution
My Trip to India: 10 Days at the Forefront of the Digital Health Revolution
By Bakul Patel
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FDA Seeking Digital Health Advisor for the Digital Health Team
FDA Seeking Digital Health Advisor for the Digital Health Team
By Bakul Patel
Activity
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India's incredible #digital transformation has been a testament to the potential for #technology to empower and uplift. And with #AI, this impact is…
India's incredible #digital transformation has been a testament to the potential for #technology to empower and uplift. And with #AI, this impact is…
Liked by Bakul Patel
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A novel regulatory approach for Generative AI based clinical applications. Generative AI and discussions around it has been happening in many…
A novel regulatory approach for Generative AI based clinical applications. Generative AI and discussions around it has been happening in many…
Shared by Bakul Patel
Experience & Education
Licenses & Certifications
Publications
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Software as a Medical Device (SaMD): Application of Quality Management System
International Medical Device Regulators Forum
An international document that shares converged thinking of medical device regulators across the world. This document shows how good software quality and engineering practices that are used to control the quality of software products readily align with the general principles of medical device Quality management systems requirements when the patient safety perspective is included.
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Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations
International Medical Device Regulators Forum
An international document that represents a converged thinking and introduces a foundational approach, harmonized vocabulary and general and specific considerations for manufacturers, regulators, and users alike to address the unique challenges associated with the use of software as as Medical device (SaMD).
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Software as a Medical Device: Key Definitions (SaMD)
International Medical Device Regulators Forum
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Mobile medical apps - FDA guidance
Food and drug administration
First foundational US federal policy for mobile apps and software clarifying FDA's regulations for mobile apps that are used for healthcare.
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Being named among HealthTech Magazine's 30 Healthcare IT Influencers is a reflection of our teams collective work. It is thrilling to be a part of…
Being named among HealthTech Magazine's 30 Healthcare IT Influencers is a reflection of our teams collective work. It is thrilling to be a part of…
Liked by Bakul Patel
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Sonal Paul, MD, Joins the George Washington University Cancer Center as a Hematologist-Oncologist Welcome to GW Cancer Center, Dr…
Sonal Paul, MD, Joins the George Washington University Cancer Center as a Hematologist-Oncologist Welcome to GW Cancer Center, Dr…
Liked by Bakul Patel
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Earlier this month I had the privilege to join several health technology thought leaders at the inaugural @Stanford Byers Center for Design’s Health…
Earlier this month I had the privilege to join several health technology thought leaders at the inaugural @Stanford Byers Center for Design’s Health…
Shared by Bakul Patel
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Cool new GPT that's an 'expert' in AI/SaMD regulation: ADHOCON-GPT. Anyone with access to the free tier of CharGPT can access it. Worth playing…
Cool new GPT that's an 'expert' in AI/SaMD regulation: ADHOCON-GPT. Anyone with access to the free tier of CharGPT can access it. Worth playing…
Liked by Bakul Patel
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Some personal reflection & news... Second acts & mid-career pivots/expansions are hard. As the only child to the world’s greatest parents, a single…
Some personal reflection & news... Second acts & mid-career pivots/expansions are hard. As the only child to the world’s greatest parents, a single…
Liked by Bakul Patel
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