JD Supra

FDA Clinical Decision Support Software Guidance Refresh : Clearer Rules, Broader Innovation

On January 6, 2026, the FDA issued a Guidance for Industry and Food and Drug Administration Staff regarding Clinical Decision Support (CDS) ...
BMJ

Development and validation of clinical vignettes to inform an educational intervention for physiotherapists to detect serious pathologies: a mixed-methods study

Objectives To develop and validate educational clinical vignettes (CVs) based on real-life patients with serious pathology from the disciplines of oncology, internal medicine and orthopaedics that are ...
Frontiers

Clinical validation of non-contact vital signs in an emergency department setting

Objectives: To evaluate the accuracy of heart rate and respiratory rate acquired by commercially-available device cameras and software. Methods: One-hundred and eleven subjects were enrolled at an ...
Frontiers

Clinical validation and utility of targeted nanopore sequencing for rapid pathogen diagnosis and precision therapy in lung cancer patients with pulmonary infections

Background: Pulmonary infections are common in patients with lung cancer (LC), complicating diagnosis and treatment. This study explored the diagnostic performance and clinical utility of targeted ...
Journal of Medical Internet Research

Methods for Analytical Validation of Novel Digital Clinical Measures: Implementation Feasibility Evaluation Using Real-World Datasets

By utilizing a standardized methodology for evaluating novel digital measures, sDHT developers, biostatisticians and clinical researchers will be able to navigate the complex validation landscape more ...