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Analytical Validation Library

The Analytical Validation Library is a one-stop-shop for digital health product developers, researchers, clinicians, regulators, payers, and patients to access peer-reviewed manuscripts reporting the performance of best-in-class analytical validation studies as defined by DATAcc by DiMe’s V3 Framework.

Analytical validation is defined as the process by which the performance of an algorithm converting DHT sensor-level data to physiological or behavioral outcomes is assessed against an appropriate reference standard amongst a study sample representative of the complete population of interest.” (Sharma et al., 2023).

Access the Analytical Validation Library to discover ‘what good looks like’ in terms of high-quality analytical validation to implement these best practices when validating measures of digital health products.

The Study​

The DATAcc team performed a systematic review of over 1,200 studies to assess the state of evidence for analytical validation of digital health measurement products. DATAcc’s systemic review benchmarked the state of the science describing analytical validation studies of connected, mobile, sensor-based digital health technologies (DHTs) and assessed the quality of study reporting by applying DiMe’s EVIDENCE Checklist to identified papers.

The Findings

Analytical validation studies are important.

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.

Improvements in study design and reporting are needed.

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.

Inclusivity remains a critical issue.

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.  

Adoption of the V3 framework is increasing.

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.

Read the full manuscript, including all findings and results, and learn more about the methodology used for the Analytical Validation Library.

Similar to DATAcc by DiMe’s Library of Digital Endpoints, the Analytical Validation Library will be maintained over time as the industry’s premier open-access resource benchmarking the state of the analytical validation science for DHTs.