Exploring Stakeholder Requirements to Enable the Research and Development of Artificial Intelligence Algorithms in a Hospital-Based Generic Infrastructure: Protocol for a Multistep Mixed Methods Study

BACKGROUND: In recent years, research and developments in advancing artificial intelligence (AI) in health care and medicine have increased. High expectations surround the use of AI technologies, such as improvements for diagnosis and increases in the quality of care with reductions in health care costs. The successful development and testing of new AI algorithms require large amounts of high-quality data. Academic hospitals could provide the data needed for AI development, but granting legal, controlled, and regulated access to these data for developers and researchers is difficult. Therefore, the German Federal Ministry of Health supports the Protected Artificial Intelligence Innovation Environment for Patient-Oriented Digital Health Solutions for Developing, Testing, and Evidence-Based Evaluation of Clinical Value (pAItient) project, aiming to install the AI Innovation Environment at the Heidelberg University Hospital in Germany. The AI Innovation Environment was designed as a proof-of-concept extension of the already existing Medical Data Integration Center. It will establish a process to support every step of developing and testing AI-based technologies. OBJECTIVE: The first part of the pAItient project, as presented in this research protocol, aims to explore stakeholders’ requirements for developing AI in partnership with an academic hospital and granting AI experts access to anonymized personal health data. METHODS: We planned a multistep mixed methods approach. In the first step, researchers and employees from stakeholder organizations were invited to participate in semistructured interviews. In the following step, questionnaires were developed based on the participants’ answers and distributed among the stakeholders’ organizations to quantify qualitative findings and discover important aspects that were not mentioned by the interviewees. The questionnaires will be analyzed descriptively. In addition, patients and physicians were interviewed as well. No survey questionnaires were developed for this second group of participants. The study was approved by the Ethics Committee of the Heidelberg University Hospital (approval number: S-241/2021). RESULTS: Data collection concluded in summer 2022. Data analysis is planned to start in fall 2022. We plan to publish the results in winter 2022 to 2023. CONCLUSIONS: The results of our study will help in shaping the AI Innovation Environment at our academic hospital according to stakeholder requirements. With this approach, in turn, we aim to shape an AI environment that is effective and is deemed acceptable by all parties. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/42208