Brenna Loufek

DPhil in Evidence-Based Health Care

Thesis

Regulatory Frameworks for Evaluation of AI/ML-Enabled Digital Health Technologies in Healthcare Institutions

Research abstract

As healthcare evolves to include more connected and complex digital products that support the treatment, diagnosis, and care management of patients; health systems increasingly need evidence-based tools (e.g., policies, frameworks, etc.) to address the regulatory and ethical challenges of developing and deploying AI-enabled devices. My project will evaluate the healthcare industry’s existing application of regulatory requirements and ethical considerations for medical products containing algorithms incorporating artificial intelligence/machine learning. I will investigate the current barriers and unmet needs among key stakeholders using a qualitative approach, including semi-structure interviews, focus groups, and consensus building. These results will inform the generation of evidence-based tools to guide health systems and policy makers in facilitating compliant and ethical AI product realization. To determine the feasibility, acceptability, and utility of these tools; I will conduct a series of case studies with AI products that are purposively selected to cover a range of technical approaches, disease areas, and patient populations. This research will contribute new knowledge to the field by shaping the way healthcare institutions apply regulatory and ethical best practices for product management and influencing policy development that addresses the unique compliance needs of AI-enabled devices.

Supervisor(s)

John Powell, Jamie Hartmann-Boyce

Biography

Brenna Tilka Loufek works in Regulatory Affairs at Mayo Clinic’s Center for Digital Health, specializing in AI/ML-enabled digital health technologies (DHTs). She serves as a cross-departmental liaison to provide interpretation and application of current regulations and standards. She has facilitated the commercialization of DHTs across various departments, including cardiology, radiology, and pathology. Brenna has a master’s degree in Patient Safety & Healthcare Quality from Johns Hopkins. She is based in the United States (Minnesota).

Research interests

Regulations and Standards for DHTs, AI/ML-Enabled DHTs, Risks and Harms of DHTs, Transparency of AI/ML-enabled DHTs, Explainability of AI/ML-enabled DHTs, Trustworthiness of DHTs among Patients and Providers