The Entrepreneurial Strategy Series

AI in Health Sciences: Regulatory and IP Considerations

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Artificial intelligence is rapidly transforming the health sciences and health care industries—from diagnostics and drug discovery to clinical decision support and digital health tools. Alongside these advances come complex regulatory and intellectual property (IP) challenges that innovators, researchers, and organizations must navigate to bring AI solutions safely and successfully to market.

This podcast explores the evolving regulatory landscape governing AI in health sciences, including oversight of AI-enabled medical technologies, data governance, and risk management considerations. Listeners will also gain insight into key IP issues such as patentability of AI-driven inventions, ownership of data and algorithms, copyright and trade secret protection, and strategies for safeguarding innovation while supporting collaboration and compliance.

Presented by the Entrepreneurial Strategy Series and Gearhart Law.

Recap: Our speakers explored the accelerating adoption of AI tools throughout the sector and the tension they create around traditional concepts of authorship, inventorship, and accountability. While AI promises greater efficiency and improved outcomes, it also raises critical questions about how innovations are protected, disclosed, and governed. Check out the video replay or podcast replay of the event below!

Key Discussion Highlights Included:

  • Patentability challenges for AI-assisted inventions, particularly around novelty, non-obviousness, and disclosure requirements
  • Risks of over-disclosure when explaining AI models in patent filings
  • Strategic use of trade secrets to protect algorithms, training methodologies, and data pipelines

    • From a Healthcare-Specific Perspective, Speakers Emphasized:

    • Liability remains largely human-centered, with developers, providers, and deployers all facing potential exposure
    • Explainability and auditability are becoming essential for both regulatory compliance and effective IP strategy 

      • Practical Guidance for Organizations, Including:

      • Aligning IP strategy early with AI development and regulatory planning
      • Updating contracts to clearly define ownership, risk allocation, and liability
      • Treating data governance as both an IP asset and a compliance imperative.

        • Our Speakers:

        • Sheila M. Mints: Chair, Health Care & Cannabis Law Group, Capehart Scatchard, Attorneys at Law.: https://www.capehart.com/?attorney=sheila-m-mints 
        • Richard Gearhart, Esq.: life sciences intellectual property attorney and the Founding Partner of Gearhart Law: https://gearhartlaw.com/team/richard-gearhart-esq/ 
        • David D. Postolski, Esq: event moderator, is a senior partner at Gearhart Law: https://gearhartlaw.com/team/david-postolski-esq/

          • This podcast is sponsored by Gearhart Law, a full service Intellectual Property firm specializing in Patent, Trademark and Copyright Law domestically and globally. We serve inventors, entrepreneurs, and established businesses. We can help you strategize and build your IP portfolio based on your business needs. Call us for a free consultation at 908-273-0700 or contact us through: https://www.gearhartlaw.com

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          The Entrepreneurial Strategy SeriesBy Gearhart Law