PYA Webinar Recast

PYA, P.C.

Recasts of PYA's Healthcare webinars.

  1. 09/12/2025

    AI-Enabled Medical Devices: New FDA Draft Guidance and Cybersecurity Insights

    The Food and Drug Administration (FDA) has issued draft guidance to establish a comprehensive regulatory framework for artificial intelligence and machine learning (AI/ML) in medical devices. As AI becomes embedded in connected health technologies, the cybersecurity risks associated with such devices are growing exponentially. This webinar explores how the FDA's lifecycle-based approach to AI regulation intersects with cybersecurity for connected medical devices. Principals Barry Mathis and John Cross provided an overview of the FDA's draft guidance on AI/ML-enabled medical devices and discussed how cybersecurity risks in the Internet of Medical Things (IoMT) can be addressed. Attendees gained knowledge through these learning objectives: Learn about AI and its use cases, including use in embedded medical devices Understand the FDA's Total Product Lifecycle approach to regulating AI/ML-enabled medical devices Identify cybersecurity risks unique to IoMT devices Analyze a real-world case study of an AI-enabled insulin pump and its cybersecurity implications Apply compliance strategies, including Secure Product Development Frameworks and Software Bill of Materials, to meet FDA expectations This webinar is part of PYA's twice-monthly Healthcare Regulatory Roundup, a popular series during which PYA experts provide practical insights on the latest industry regulatory developments. PYA is dedicated to helping healthcare organizations understand regulatory requirements and prepare for and respond to cybersecurity threats.

    1h 5m
  2. 08/29/2025

    2026 Inpatient PPS and SNF PPS Final Rules: Key Takeaways and Strategic Implications

    On July 31, the Centers for Medicare & Medicaid Services (CMS) issued both the 2026 Medicare Inpatient Prospective Payment System (PPS) and the Skilled Nursing Facility (SNF) PPS final rules. PYA's Martie Ross and Kathy Reep discussed several key provisions, including: Payment rate increases for inpatient acute facilities, long-term care hospitals, and skilled nursing facilities Revisions to the mandatory Transforming Episode Accountability Model (TEAM) Changes to the wage index and related policies Updates to the Hospital Inpatient Quality Reporting program Changes to the Hospital Readmissions and Hospital-Acquired Conditions Reduction programs, as well as the Hospital Value-Based Purchasing program Revisions to the Promoting Interoperability program Martie and Kathy also addressed key provisions in the 2026 Inpatient Rehabilitation Facility and Inpatient Psychiatric Facility final rules issued by CMS on August 1. 100th Webinar! On August 27, PYA's twice-monthly Healthcare Regulatory Roundup (HCRR) celebrated its 100th webinar in the series. Beginning with the first webinar in 2021, PYA experts have reliably provided practical insights on the latest industry regulatory developments. Thank you for your support of this sentinel series. PYA is dedicated to helping healthcare organizations understand and comply with legislative and regulatory impacts. Contact Martie, Kathy, or any of our experts for assistance.

    1 hr

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Recasts of PYA's Healthcare webinars.

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