In this episode of the DarshanTalks Podcast, we have a discussion about Digital Health with Bakul Patel, Director, Digital Health Center of Excellence of US FDA department. He has over 28 years of leadership, business development, marketing, product management, assessing long and short-term needs, establishing objectives, improving organizational performance, and resource management. Expertise in medical device regulations, product development processes, software engineering, embedded systems, wireless communication systems, and robotics and control systems. Masters in Electronics Engineering, MBA in International Business. Six Sigma, Black-belt certified. With all the bucket of knowledge of digital health, the conversation started off with FDA going through massive changes currently. He explains his area of work in the digital health technology sphere and leading digital health with no jurisdiction boundaries, as this sector is wide in nature, and he further explains how it's always been fun to work in such an atmosphere. When it comes down to FDA there are portions of that spectrum of digital health as it may be general wellness. According to the expert, digital health is a spectrum, a continuum, a journey for an individual and purview under FDA's jurisdiction. The focus of the conversation was on the department that the expert works and the people who don't know much about can reach out to the department for advice, suggestions, reviews or portions of review depending on the products that come to different parts of the agency. There are some policy challenges, he emphasised on FDA needs to start evolving that their agency have been actively working on with other parts of the agency. Recent guidance on digital health tech in clinical trials was launched by his department and he described all the related information and implications in this podcast.

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Disclaimers:

1. This discussion is merely an oral discussion and should not be relied upon solely on its own to support any conclusion of law or fact.

2. The discussion does not and should not reflect any individual products status as safe, efficacious, adulterated, or misbranded or meeting or not meeting expectations at a local, state, federal, or international agency or organization.

3. The discussion should not be construed to be complete advice that is right for you and may not necessarily represent a specific product.

4. This discussion is provided for general educational purposes and should not be construed as legal advice, regulatory advice, or medical advice.

5. This does not create an attorney-client relationship.

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