DarshanTalks Podcast
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!
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We focus on life science issues involving medical affairs, marketing and advertising, and clinical research so that you can learn about the industry, enhance your business and grow your career.
DarshanTalks Podcast
6 Categories of "Bulk Data" That Could Land You in Federal Court.
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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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The DOJ's new bulk data rule and why it matters for anyone sharing safety data across borders, including with China. So in January 2025, the DOJ finalized a rule under executive order. The executive order restricts or prohibits certain covered data transactions when they would give a country of concern. So, what constitutes bulk sensitive personal data? The DOJ defines six categories personal health, personal, financial, precise geolocation, biometric identifiers, human omic genomic data, and covered identifiers.
