Hundreds of analytical validation studies are being published across a broad spectrum of measures, disease types, and technology types. This is essential to advancing the use of DHTs for clinical decision-making in clinical research, patient care, and individual health promotion.

One hundred and twelve of the 1,200 studies were excluded from inclusion in the systematic review because they failed to report a reference standard or the reference standard was inadequate. Of the 303 studies that made it through the systematic review, only 208 are considered high-quality studies and were included in our new Analytical Validation Library.

Only 9% of the studies included reported race and/or ethnicity. This is absolutely unacceptable if we want to ensure that these new tools work equally well for everyone and improve – not worsen – racial disparities in health and health care.  

DiMe’s V3 Framework has become the common evidentiary standard for evaluating DHTs across the field. This is great for innovation, innovators, clinical decision-makers (researchers and clinicians), and patients themselves who have a common standard to build to and benchmark against.  

1. Forthcoming regulatory guidance should codify V3 not just as the defacto industry standard but as the regulatory gold standard for DHT evaluation.