Podcast Summary: Becker’s Healthcare Podcast

Guest: Brenna T. Lofek, Director of AI Regulatory and Quality, Center for Digital Health at Mayo Clinic
Host: Scott King
Date: November 22, 2025

Episode Overview

This episode features Brenna T. Lofek from Mayo Clinic, who discusses the evolving landscape of AI in healthcare—specifically, how leading organizations are approaching responsible deployment of AI-driven tools. The conversation explores current use cases, governance strategies, leadership evolution, and essential advice for health IT leaders navigating the fast-changing digital health environment.

Key Discussion Points & Insights

1. Brenna’s Background and Role at Mayo Clinic

• [01:10] Brenna leads AI regulatory and quality strategy, focused on safely translating digital innovation into clinical practice by building infrastructure for responsible AI deployment.
  • She emphasizes her dual experience in both medical device industry and healthcare delivery.
  • Academic background: Master’s in Patient Safety and Healthcare Quality (Johns Hopkins) and current doctoral student focusing on health policy and AI.
  • Quote:
    "My work centers on building the infrastructure that allows AI technologies to be deployed responsibly… balancing innovation with patient safety and ethical responsibility." — Brenna Lofek [01:17]

2. Current AI Use Cases in Healthcare

• Administrative Support vs. Clinical Decision Support

  • [02:57] Two main categories of AI in use:

    • Administrative Support: Tasks like scheduling and internal workflow automation that save time and reduce burdens on clinicians.
    • Clinical Decision Support: Tools aiding in diagnosis, risk detection, and treatment recommendations.

  • Example Use Cases:

    • Automated scheduling and communication tools.
    • Analysis of Electronic Health Records (EHR) for risk detection/recommendations.
    • Image processing (segmentation, calculations), and analysis of physiological signals (e.g., ECGs).
    • Use of Open Evidence tool for differential diagnoses (claimed by Brenna that ~60% of professionals use it).

  • Quote:
    "Administrative support tools... are not directly doing any sort of diagnosis, treatment, cure or mitigation... Whereas clinical decision support software... are assisting healthcare professionals with diagnosis and treatment." — Brenna Lofek [02:57]

  • Quote:
    "We also see more advanced technologies doing really brilliant things where they're analyzing medical images, signals or patterns to do early detection and diagnosis..." — Brenna Lofek [04:46]

3. The Paradigm Shift in Healthcare Technology

• [07:01] Shift from traditional medtech manufacturers to local, clinician-driven innovation within healthcare institutions.
  • Now, clinicians and internal teams at places like Mayo Clinic can directly identify problems and build AI solutions, leveraging collaborative work with data scientists.
  • Impacts: Faster innovation, but more responsibility and ethical challenges for healthcare providers.
  • Quote:
    "AI enabled technologies are in the hands of health care professionals themselves... a massive boom, incredible expansion. But it's also a real shift..." — Brenna Lofek [07:25]

4. Governance as an Enabler (Not a Roadblock) of Innovation

• [09:52] Importance of adaptable, risk-based governance to evaluate and implement AI tools.
  • Differentiates between governance needs for low-risk admin tools vs. high-risk clinical tools.
  • Mayo Clinic’s approach: Risk-based assessment framework, standardized evidence requirements, tiered deployment, and top-down policy under Chief AI Implementation Officer Mickey Tripathy.
  • Fundamental principle: "Innovation must move at the speed of trust."
  • Quote:
    “Your governance within your health care organization should be seen as a mechanism that accelerates and prioritizes innovation. It should not be perceived as a roadblock.” — Brenna Lofek [09:52]
  • Quote:
    “We don't want to apply the same level of rigor... for tools that are being used for admin support... compared with tools that are analyzing medical images...” — Brenna Lofek [10:44]

5. Advice for Healthcare Leaders Navigating New Technology

• [13:00] Organizations should operationalize governance, establish multidisciplinary review teams, ensure data-driven and transparent decision-making, and embed their own risk tolerance into AI adoption.
  • Stress on culture, cross-functional collaboration, and clinician engagement as keys beside technical deployment.
  • The need for outcome measurements post-deployment to ensure tools benefit clinical or operational objectives.
  • Quote:
    “The future belongs to those organizations that effectively operationalize governance... and ensure decisions about AI deployment are data driven, transparent and clinically grounded.” — Brenna Lofek [13:00]
  • Quote:
    “Technology can't transform care unless people trust and understand it. Leaders should prioritize digital literacy, cross functional collaboration and clinician engagement just as much as the technical infrastructure.” — Brenna Lofek [13:27]

6. Leadership Evolution

• [14:54] Brenna reflects on her transition from industry regulatory expert (focused on FDA submission and commercialization) to a healthcare leader navigating more general digital health innovation and implementation.
  • Shift to a broader, more collaborative, clinically-focused approach—translating AI from research to patient-centered practice rather than just seeking regulatory approval.
  • Quote:
    “I have grown from what I would say is a pure formal regulatory expert to being someone who is more of a generalist in translation science... taking a generalist approach that really leans on the clinician's expertise…” — Brenna Lofek [16:23]

Notable Quotes & Moments

• “Innovation must move at the speed of trust and this is the trust with the practice providers, patients and the public.” — Brenna Lofek [11:49]
• “Culture is the true enabler of responsible AI...” — Brenna Lofek [13:41]
• “Every AI or digital tool must serve a clear clinical or operational purpose and we should measure for outcomes that support that...” — Brenna Lofek [13:50]

Key Timestamps

• [01:10] — Brenna’s background and professional focus
• [02:57] — Two categories of AI use in healthcare
• [07:01] — Paradigm shift: Healthcare-driven innovation
• [09:52] — Governance as catalyst for responsible innovation
• [13:00] — Advice on future readiness and responsible AI leadership
• [14:54] — Leadership growth from regulator to translational generalist

Conclusion

Brenna Lofek provides deep insights into the current and future state of AI in healthcare, emphasizing adaptive governance, clinician-led innovation, and the centrality of trust and culture in responsible deployment. Her journey reflects a wider trend: moving from compliance-oriented roles to collaborative, patient-centered leadership—crucial as digital health technologies transform care delivery.