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Digital Health › New Guidance › Artificial Intelligence

Sheppard Mullin Richter & Hampton LLP

FDA Releases Long-Anticipated Guidance on Predetermined Change Control Plans for Devices That Utilize AI/ML Software

Sheppard Mullin Richter & Hampton LLP on

FDA’s primary challenge in regulating AI-enabled device software functions (“AI-DSF”) has been that the self-modifying nature of these functions simply does not fit within the Agency’s long-standing framework for medical...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Society of Corporate Compliance and Ethics... on

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Health Care Compliance Association (HCCA) on

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Jones Day

Patenting Digital Health Innovations Incorporating AI in View of USPTO's Recent Subject Matter Eligibility Guidance

Jones Day on

Patent procurement activity is increasing to protect embedded artificial intelligence ("AI") technologies in a variety of digital healthcare solutions. The United States Patent and Trademark Office ("USPTO") has issued the...more

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