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The DOJ just changed the rules of the game for the Life Sciences industry. As of January 2025, transferring "Bulk Sensitive Personal Data" to countries of concern—specifically China—is no longer just a compliance hurdle; it’s a potential federal violation. In this episode, Darshan Kulkarni breaks down the six categories of data you must protect immediately, from genomic data to precise geolocation. If you are handling safety data across borders, this is your mandatory executive briefing.

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Is your state "sandbox" a playground or a legal minefield? In this episode, Darshan Kulkarni—pharmacist and attorney—dissects the quiet movement of states like Utah allowing AI to manage and renew prescriptions. While the innovation is exciting, the federal government is watching closely.

We break down the three massive risks facing life science companies and healthcare providers today:

1. Clinical Logic Failures: Why a state sandbox can't fix bad AI medicine.
2. The Liability Void: If the AI misses a symptom, who stands in court?
3. The Supremacy Clause: Why state "waivers" don't protect you from the FDA.

If you are navigating the intersection of health-tech and regulation, this is the practical take you need to stay compliant and protected.

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The OIG has officially shifted the goalposts for Direct-to-Consumer (DTC) and Direct-to-Patient (DTP) programs. For years, federal healthcare discounts were a "no-go zone," but a new dual-track strategy is emerging—if you know how to build the firewall. In this episode, Darshan Kulkarni breaks down the three core regulatory pillars required to bypass PBM middlemen without triggering federal anti-kickback statutes. We discuss the "one-year commitment" rule, the "seeding" trap, and why your current marketing strategy might be an unintentional red flag for regulators. If you are in Life Sciences commercialization, the "wait and see" approach is now your biggest liability.

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www.kulkarnilawfirm.com