Recommendations on compiling test datasets for evaluating artificial intelligence solutions in pathology.

Artificial intelligence (AI) solutions that automatically extract information from digital histology images have shown great promise for improving pathological diagnosis. Prior to routine use, it is important to evaluate their predictive performance and obtain regulatory approval. This assessment requires appropriate test datasets. However, compiling such datasets is challenging and specific recommendations are missing. A committee of various stakeholders, including commercial AI developers, pathologists, and researchers, discussed key aspects and conducted extensive literature reviews on test datasets in pathology. Here, we summarize the results and derive general recommendations on compiling test datasets. We address several questions: Which and how many images are needed? How to deal with low-prevalence subsets? How can potential bias be detected? How should datasets be reported? What are the regulatory requirements in different countries? The recommendations are intended to help AI developers demonstrate the utility of their products and to help pathologists and regulatory agencies verify reported performance measures. Further research is needed to formulate criteria for sufficiently representative test datasets so that AI solutions can operate with less user intervention and better support diagnostic workflows in the future.

EMPAIA App Interface: An open and vendor-neutral interface for AI applications in pathology.

BACKGROUND AND OBJECTIVE: Artificial intelligence (AI) apps hold great potential to make pathological diagnoses more accurate and time efficient. Widespread use of AI in pathology is hampered by interface incompatibilities between pathology software. We studied the existing interfaces in order to develop the EMPAIA App Interface, an open standard for the integration of pathology AI apps. METHODS: The EMPAIA App Interface relies on widely-used web communication protocols and containerization. It consists of three parts: A standardized format to describe the semantics of an app, a mechanism to deploy and execute apps in computing environments, and a web API through which apps can exchange data with a host application. RESULTS: Five commercial AI app manufacturers successfully adapted their products to the EMPAIA App Interface and helped improve it with their feedback. Open source tools facilitate the adoption of the interface by providing reusable data access and scheduling functionality and enabling automatic validation of app compliance. CONCLUSIONS: Existing AI apps and pathology software can be adapted to the EMPAIA App Interface with little effort. It is a viable alternative to the proprietary interfaces of current software. If enough vendors join in, the EMPAIA App Interface can help to advance the use of AI in pathology.