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DarshanTalks Podcast

Darshan Kulkarni
Artificial Intelligence
Food and Drug Administration
Clinical Research
Anti-Kickback Statute
Department Of Justice
FDA
Office Of Inspector General
Kulkarni Law Firm
Medicare
Executive Order
FSMA
Undeclared Allergens
OIG
Compounded Drugs
Private Membership Association
Personal Health Data
Trumprx
HIPAA
Intellectual Property
Sponsor Protocols

Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni ... more

PublishesDailyEpisodes346Founded7 years ago
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How a "Failed" 4-Minute Molecule Created a Trillion-Dollar Cultural Eclipse

Imagine pitching a drug to a room of venture capitalists that is biologically perfect—except for one tiny flaw: the human body completely destroys it in fo... more

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What happens when an artificial intelligence chatbot generates a fake medical license number and starts giving psychiatric advice?

In this episode of the KF Deep Dive, host Darshan welcomes healthcare regulatory expert and Fox Roth... more

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 NOT LEGAL ADVICE 

For decades, cannabis research in the U.S. was stifled by Schedule I restrictions, requiring high-security vaults, mountains of paperwork, and extremely limited supply chains. With Executive Order 14370, the land... more

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Is your career protected from your company’s mistakes? For decades, a Federal Consent Decree was a corporate headache. Today, it’s a personal professional death sentence. In this episode, Darshan Kulkarni breaks down the seismic shi... more

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The New Yorker Radio Hour
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Recent Guests

Elizabeth Litten
Privacy lawyer focusing on health care regulatory law and privacy
Fox Rothschild
Episode: Unlicensed Medical Advice & The Legal Battle Over Character.AI

Host

Darshan Kulkarni
Host of the KF Deep Dive (interviewer); Host of the podcast; Host of Darshan Talks Podcast (Powered by Kulkarni Law Firm)

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Unlicensed Medical Advice & The Legal Battle Over Character.AI
Q: How important is patient consent when AI handles PHI, and what should be disclosed?
Consent is critical when AI ingests PHI; patients should be informed about data usage, potential data sharing, and the hospital's or clinic's use of AI tools in their care.
Unlicensed Medical Advice & The Legal Battle Over Character.AI
Q: What governance measures should a company implement before releasing an AI tool in healthcare?
Develop a formal AI governance framework, clearly define tool types, establish security/privacy checks, set prohibited and required examination criteria, and ensure proper consent and data handling mechanisms.
Unlicensed Medical Advice & The Legal Battle Over Character.AI
Q: What are the FDA's views on AI that could replace human thought, and how should companies approach regulation?
The FDA looks at AI that could replace human decision-making as requiring thorough review; if the AI is intended to replace thinking, it should be treated like a medical device or decision-support tool with appropriate regulatory oversight.

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Frequently Asked Questions About DarshanTalks Podcast

What is DarshanTalks Podcast about and what kind of topics does it cover?

A clinically focused regulatory podcast that routinely analyzes the intersections of law, policy, and compliance in life sciences, healthcare, and pharma marketing. Across episodes, the show covers AI in medicine, FDA and OIG oversight, clinical research agreements, data governance, and the evolving regulatory landscape for drug and device development. Guests range from regulatory lawyers to industry practitioners, with practical guidance on governance, liability, and enforcement — often paired with real-world case studies and actionable playbooks for risk management and compliant operations. The show tends to emphasize pragmatic strategies for navigating complex regulatory frameworks while spotlighting emerging topics like AI-driven clinic... more

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1. The New Yorker Radio Hour

How many episodes of DarshanTalks Podcast are there?

DarshanTalks Podcast launched 7 years ago and published 346 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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Recent guests on DarshanTalks Podcast include:

1. Elizabeth Litten

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