Guideline for software life cycle in health informatics.

The long-lasting trend of medical informatics is to adapt novel technologies in the medical context. In particular, incorporating artificial intelligence to support clinical decision-making can significantly improve monitoring, diagnostics, and prognostics for the patient's and medic's sake. However, obstacles hinder a timely technology transfer from research to the clinic. Due to the pressure for novelty in the research context, projects rarely implement quality standards. Here, we propose a guideline for academic software life cycle processes tailored to the needs and capabilities of research organizations. While the complete implementation of a software life cycle according to commercial standards is not feasible in scientific work, we propose a subset of elements that we are convinced will provide a significant benefit while keeping the effort within a feasible range. Ultimately, the emerging quality checks for academic software development can pave the way for an accelerated deployment of academic advances in clinical practice.

Fostering reproducibility, reusability, and technology transfer in health informatics.

Computational methods can transform healthcare. In particular, health informatics with artificial intelligence has shown tremendous potential when applied in various fields of medical research and has opened a new era for precision medicine. The development of reusable biomedical software for research or clinical practice is time-consuming and requires rigorous compliance with quality requirements as defined by international standards. However, research projects rarely implement such measures, hindering smooth technology transfer into the research community or manufacturers as well as reproducibility and reusability. Here, we present a guideline for quality management systems (QMS) for academic organizations incorporating the essential components while confining the requirements to an easily manageable effort. It provides a starting point to implement a QMS tailored to specific needs effortlessly and greatly facilitates technology transfer in a controlled manner, thereby supporting reproducibility and reusability. Ultimately, the emerging standardized workflows can pave the way for an accelerated deployment in clinical practice.