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Managing the Risks Associated with AI-Enabled Health Technologies: Strategies for Addressing Our #1 Hazard
Overview
AI holds great promise in healthcare, aiding clinical decision-making by identifying patterns and offering predictions that can increase the efficiency and precision of medical diagnoses, treatments, and services. It has shown significant potential in medical imaging, diagnostics, and predictive analytics, all contributing to better patient outcomes.
Such benefits are not guaranteed, however. The potential for preventable harm exists if, for example, biases are present in the data used to train the AI model, if the model is not well matched to the target patient population, or if the model’s performance is not evaluated and then monitored over time. Further, AI solutions can yield disappointing results if organizations have unrealistic expectations, fail to define goals, provide insufficient governance and oversight, or don’t adequately prepare their data for use by the AI application.
The potential for harm and inappropriate care decisions prompted ECRI to place “Risks with AI-Enabled Health Technologies” at the top of its list of Health Technology Hazards for 2025. During this webcast, ECRI’s panel of experts will discuss the risks and provide insights on how to mitigate them.
Learning Objectives
In this lab webcast, we’ll discuss:
- The potential benefits of AI in healthcare, along with the challenges that can lead to patient harm or the ineffective application of AI technologies.
- Strategies for mitigating risks, including guidance for establishing an oversight program, conducting a needs assessment, evaluating AI functionality, and monitoring performance over time.
Register to view the recording
Moderator
Rob Schluth
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Principal Project Officer I, Device Safety, ECRI
Rob Schluth is a project leader focusing on content development and program management for ECRI's Device Safety group. During his 30 years at ECRI, Rob has contributed to hundreds of the organization's device evaluations, problem reports, and guidance articles spanning a wide range of health technologies. Rob currently manages special initiatives for the device evaluation & safety team and leads the development of the organization's annual Top 10 Health Technology Hazards report.
Panelists
Francisco Rodriguez-Campos
Principal Project Officer I, Device Safety, ECRI
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Francisco Rodriguez-Campos, Ph.D., is responsible for evaluating medical imaging technologies such as CT and breast tomosynthesis for ECRI’s Device Evaluations group. Before joining ECRI, Francisco was a neuroscientist and instructor at the University of Pennsylvania where he performed image-guided (CT and MRI) surgeries to place chronic implants in old-world macaques and taught in the biomedical engineering program about medical devices. He has served as project manager for a Medical Technology assessment project for the El Salvador Social Security Administration, consultant to PAHO/WHO in the deployment of medical technology-related projects in El Salvador and Nicaragua, director of the clinical engineering graduate program at Universidad Don Bosco and professor of medical imaging in the biomedical engineering undergraduate program.
Scott Lucas, PhD, PE
Vice President, Device Safety, ECRI
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Dr. Lucas has over twenty years of experience in engineering safety in the healthcare, automotive, maritime, and defense industries. He has served as a principal consultant on hundreds of engagements with hospital executives, clinical providers, medical device manufacturers, defense and plaintiff attorneys, accreditors, and regulators, testified in court and before the U.S. FDA on various medical device hazards and investigations, and has authored hundreds of technical reports and academic publications.
At ECRI, Dr. Lucas is the head of medical device safety activities, including device evaluations, preventive consulting services, accident and forensic investigation, and problem reporting services. Also at ECRI, he has served as the Principal and Director of Accident and Forensic Investigation.
Jillian Hillman, PhD
Senior Engineering Manager, Innovation, Device Safety, ECRI
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Jillian Tengood Hillman, PhD manages evaluation and technology assessment of innovation and emerging technology in the Device Safety group at ECRI, bringing hospitals closer to the forefront of medicine in a safe manner. Jillian is particularly interested in postmarket analysis of products, focusing on improving the safety, quality, and cost-effectiveness of care across all healthcare settings worldwide. Her work focuses on assessing the impact of medical devices and technologies, ensuring they meet the highest standards for patient safety and clinical effectiveness. Additionally, Jillian oversees the Functional Equivalents content at ECRI, helping facilities navigate complex decisions about product selection, balancing safety, function, and budgetary considerations.
Jim Martucci
Strategy Consultant, ECRI
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Jim is a Strategy Consultant for ECRI, with 40+ years of medical device experience, including leading Technology Roadmap, landscape, and assessment processes. The process addresses scouting and trending and demonstration execution of early-stage product feasibility. Extensive experience leading complex hardware and software product development programs in heavily regulated pharmaceutical and medical device environments, using systems engineering, risk management and safety assurance case methodologies. Jim is an Inventor on 40+ issued patents and recipient of multiple leadership awards while at Baxter. Jim has also been a judge for Medtech Innovator, NUvention Medical at Northwestern University, mHUB and the Coulter Foundation program at the University of Michigan.
Christie Bergerson, Ph.D.
Device Safety Analyst, ECRI
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Dr. Christie Bergerson is a consultant in the medical device space, currently working exclusively with ECRI on many topics, including AI-enabled medical devices. Prior to partnering with ECRI, Dr. Bergerson worked as a consultant at Exponent and a Systems Engineer for Abbott Laboratories R&D Diagnostics Division. Throughout her various roles, Dr. Bergerson has gained expertise in the fields of in vitro diagnostics, orthopedics and software development, with artificial intelligence being one factor tying the three niches together. Dr. Bergerson has published extensively on these topics and enjoys guest lecturing at various institutions including Johns Hopkins University and Texas A&M University. Please check out her LinkedIn profile for more information.