Fig. 1

Diagnostics of infectious diseases. (A) traditional methods of diagnostics of infectious diseases are performed in a clinical microbiology laboratory mainly by direct identification of the infection agent or the specific immune response to it. Testing methods generally involve isolation of the pathogen in culture, its identification through electron microscopy and histopathology, by molecular methods, and the detection of a specific immune response to it. (B) Metagenomics, unlike traditional genomics which focuses on the genetic material of a single organism, uses high-throughput sequencing and computational analyses to study the microbiome to identify and discover several microbes in the microbial community, their relative frequency in the community, and gene expressions associated with antimicrobial resistance. Immunomics uses next-generation sequencing and computational analyses to profile immune repertoires, collections of B- and T-cell receptors, by analyzing gene expression in response to infections, to understand how the immune system reacts and adapts to pathogens and differentiates between various strains of pathogens based on how they interact with the immune system. Information on V(D)J germline usage is also used to characterize immunity and infection and indicate relative frequencies of immune clones that are indicative of infection. Artificial intelligence advances these types of insights to detect and predict complex patterns and interactions in the host-microbe ecosystem, and ultimately classify infections based on a pathogen-imprinted personal immunity. (C) Software engineering to develop scientific insights into commercially available medical software should be conducted in organizations within the framework of quality management systems (QMS). QMS are essential for ensuring that processes, documentation, and overall quality standards are consistently maintained in an organization. Documentation provides a structured approach to record standard operation procedures, policies, and results, ensuring alignment with requirements, clarity and traceability. Management involves processes and human resources to ensure they align with regulatory requirements based on organizational goals. Audits are systematic reviews to verify compliance with established standards and identify areas for improvement. Audits drive continuous improvements and feedback mechanisms, fostering ongoing refinement of processes to achieve higher quality and efficiency. Alignment to regulatory requirements is achieved through adherence to international standards and local guidelines through certification for QMS, software lifecycle development, risk management, and other standards. Upon development, qualification and classification of the medical software by the manufacturer, the organization applies to regulatory authorities (e.g., FDA in USA, notified body in EU, and swissmedic in Switzerland) for authorization to commercialize the product by demonstrating the safety and efficacy of the medical device software. The software medical device can then enter clinical routine for diagnostics and the citizen market for prevention. Reimbursement policies for softwaremedical devices are still under development in most countries. (icons were modified from licensed images to FHNW/Enkelejda Miho - stock.adobe.com. Image application of im2unity © aiNET. Network image modified from Miho et al. [5]