. 2020 Dec; 41(Suppl 2):103-110.
doi: 10.1007/s00292-020-00871-z.

[Technical, operational, and regulatory considerations for the adoption of digital and computational pathology]

Markus D Herrmann 1 Jochen K Lennerz 2 
  • PMID: 33263808
  •     21 References


Background: Innovative information technologies open new possibilities for diagnostics and promise to improve patient care. However, the integration of data- and computing-intensive procedures into diagnostic workflows also poses risks and considerable challenges for pathologists.

Objectives: Considering technical, operational, and regulatory aspects, we present a holistic and systematic approach for the adoption of digital and computational pathology.

Material And Methods: We discuss challenges for the implementation of computational diagnostic procedures and analyze regulatory frameworks for risk-based assessment and monitoring of software as an in vitro diagnostic device. Applying regulatory science, we develop an approach to streamline adoption of digital workflows in pathology.

Results: Data- and computing-intensive workflows in digital pathology are complex and underscore the need for computational and regulatory science as a central part of pathological diagnostics. To promote the adoption of computational diagnostics, we have founded an interdisciplinary initiative (the Alliance) that focuses on regulatory research in the field of digital pathology and works closely with a number of expert and interest groups on the precompetitive development of standards for computational workflows.

Discussion: The inclusion of different stakeholder groups and the coordination of technical, operational, and regulatory aspects is necessary to maintain the balance between progress and safety in diagnostics and to make innovations quickly and safely available for patient care.

Keywords: Artificial intelligence; In vitro diagnostics; Machine learning; Quality assurance; Regulatory science.

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