Webinar

Data Integrity in the Age of AI: Securing Connected Devices

As artificial intelligence becomes increasingly embedded in medical devices and healthcare systems, the concept of data integrity is evolving rapidly. This webinar explores the intersection of cybersecurity, regulatory compliance, and AI-driven decision-making in the context of connected medical device data. Drawing from real-world experience and recent FDA guidance, our experts will discuss the foundational principles of data integrity accuracy, consistency, reliability, and traceability. As well as how they apply to modern healthcare technologies.

We examine the challenges of implementing audit logs, the implications of AI hallucinations, and the regulatory distinctions between clinical support and clinical decision-making. The session also reflects on historical cases that shaped today’s standards, including the Barr Decision and Able Labs scandal, and how lessons from the past inform current best practices.

Watch now for a dynamic conversation between industry veterans as they unpack the ethical, technical, and regulatory dimensions of data integrity in the digital age.

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Learning Objectives

By the end of this webinar, participants will be able to: 

  1. Define the core principles of data integrity and explain their relevance in healthcare and medical device ecosystems. 
  2. Differentiate between clinical support and clinical decision-making in AI applications and understand the regulatory implications of each. 
  3. Identify key challenges in implementing audit logs and maintaining traceability in medical device data systems. 
  4. Recognize the risks associated with AI hallucinations and black-box decision-making in clinical environments. 
  5. Evaluate historical case studies (e.g., Barr Decision, Able Labs) to understand how data integrity standards have evolved. 
  6. Apply a risk-based approach to data protection, focusing on critical data and regulatory compliance (HIPAA, FDA, GDPR). 
  7. Discuss the importance of data pruning and anonymization in reducing exposure and enhancing cybersecurity. 

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    Presenters

    Susan Schniepp

    Susan Schniepp

    RCA Distinguished Fellow

    With more than 40 years of industry experience in quality control and quality assurance, Sue has had responsibilities for complaints, labeling, investigations, compendial affairs, and other quality systems. In addition to RCA, she has held leadership roles at Allergy Laboratories, Inc.; OsoBio Pharmaceuticals, LLC; Searle; Abbott; and Hospira.

    She has served the Parenteral Drug Association (PDA) as a member of the Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of PDA's Regulatory Affairs / Quality Advisory Board. She was also awarded PDA's Distinguished Service Award in 2008.

    Jason Tugman

    Cybersecurity SME

    Jason Tugman is a seasoned cybersecurity expert with a diverse background spanning medical device security, critical infrastructure protection, and cyber risk quantification. Currently serving as the Director of Cybersecurity at Tugman Group, he has led the development of numerous U.S. and international cyber standards. Notably, Jason developed an assessment and metrics aggregation tool for a $300 million Lloyd’s of London cyber insurance line slip for U.S. critical infrastructure, assessing over $3 billion in cyber liability.

    Jason’s contributions include establishing the data compatibility working group for the Department of Energy’s Cybersecurity Capability Maturity Model version 2.0 (C2M2v2) and serving on the founding architecture team for the API 1164 Pipeline Security Standard. His career path is uniquely diverse, transitioning from roles in the circus and The Oprah Winfrey Show to becoming a leading figure in cybersecurity.