

AI in Healthcare Devices and the Challenge of Data Privacy - with Dr. Ankur Sharma at Bayer
Jun 24, 2025
Dr. Ankur Sharma, Head of Medical Affairs for Medical Devices and Digital Radiology at Bayer, dives into the intricate world of AI in healthcare. He highlights the significant hurdles like data privacy and regulatory uncertainty that healthcare institutions face in adopting AI tools. The discussion also covers the vital distinction between regulated predictive models and unregulated generative tools, and how AI can connect clinical research with real-world patient care. Sharma emphasizes the need for new reimbursement strategies to facilitate the growth of digital health innovations.
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Key Challenges of Healthcare AI
- AI tools in healthcare face challenges including data privacy, regulatory hurdles, and integration with clinical workflows.
- Fragmented clinical systems and multiple stakeholders complicate AI deployment in patient care pathways.
Patient Education and Governance Advice
- Educate patients clearly about AI use and data implications before deployment.
- Establish governance boards for AI data safety tailored institutionally due to lack of universal guidelines.
Regulatory Landscape of Healthcare AI
- Predictive AI models in healthcare are regulated as medical devices; generative AI models remain largely unregulated.
- Regulatory frameworks like the FDA and EU AI Act are evolving but currently lack clarity for generative AI in clinical use.