Comp2Comp: Open-Source Software with FDA-Cleared Artificial Intelligence Algorithms for Computed Tomography Image Analysis

Artificial intelligence allows automatic extraction of imaging biomarkers from already-acquired radiologic images. This paradigm of opportunistic imaging adds value to medical imaging without additional imaging costs or patient radiation exposure. However, many open-source image analysis solutions lack rigorous validation while commercial solutions lack transparency, leading to unexpected failures when deployed. Here, we report development and validation for two of the first fully open-sourced, FDA-510(k)-cleared deep learning pipelines to mitigate both challenges: Abdominal Aortic Quantification (AAQ) and Bone Mineral Density (BMD) estimation are both offered within the Comp2Comp package for opportunistic analysis of computed tomography scans. AAQ segments the abdominal aorta to assess aneurysm size; BMD segments vertebral bodies to estimate trabecular bone density and osteoporosis risk. AAQ-derived maximal aortic diameters were compared against radiologist ground-truth measurements on 258 patient scans enriched for abdominal aortic aneurysms from four external institutions. BMD binary classifications (low vs. normal bone density) were compared against concurrent DXA scan ground truths obtained on 371 patient scans from four external institutions. AAQ had an overall mean absolute error of 1.57 mm (95% CI 1.38-1.80 mm). BMD had a sensitivity of 81.0% (95% CI 74.0-86.8%) and specificity of 78.4% (95% CI 72.3-83.7%). Comp2Comp AAQ and BMD demonstrated sufficient accuracy for clinical use. Open-sourcing these algorithms improves transparency of typically opaque FDA clearance processes, allows hospitals to test the algorithms before cumbersome clinical pilots, and provides researchers with best-in-class methods.

LLM on FHIR -- Demystifying Health Records

Objective: To enhance health literacy and accessibility of health information for a diverse patient population by developing a patient-centered artificial intelligence (AI) solution using large language models (LLMs) and Fast Healthcare Interoperability Resources (FHIR) application programming interfaces (APIs). Materials and Methods: The research involved developing LLM on FHIR, an open-source mobile application allowing users to interact with their health records using LLMs. The app is built on Stanford's Spezi ecosystem and uses OpenAI's GPT-4. A pilot study was conducted with the SyntheticMass patient dataset and evaluated by medical experts to assess the app's effectiveness in increasing health literacy. The evaluation focused on the accuracy, relevance, and understandability of the LLM's responses to common patient questions. Results: LLM on FHIR demonstrated varying but generally high degrees of accuracy and relevance in providing understandable health information to patients. The app effectively translated medical data into patient-friendly language and was able to adapt its responses to different patient profiles. However, challenges included variability in LLM responses and the need for precise filtering of health data. Discussion and Conclusion: LLMs offer significant potential in improving health literacy and making health records more accessible. LLM on FHIR, as a pioneering application in this field, demonstrates the feasibility and challenges of integrating LLMs into patient care. While promising, the implementation and pilot also highlight risks such as inconsistent responses and the importance of replicable output. Future directions include better resource identification mechanisms and executing LLMs on-device to enhance privacy and reduce costs.