Findings
The term “clinically validated” is frequently used in marketing but lacks a clear, standardized meaning, leading to confusion. The rapid development of BioMeTs has outpaced the creation of systematic, evidence-based evaluation frameworks, creating a knowledge gap. Existing validation standards from software, hardware, and clinical development are often applied in silos and are not fully sufficient for modern BioMeTs. Evaluating a BioMeT requires assessing the entire “data supply chain,” from the sensor hardware (verification) and data processing algorithms (analytical validation) to its performance against a meaningful clinical concept (clinical validation).

Recommendations
The digital medicine field should adopt the V3 (Verification, Analytical Validation, Clinical Validation) framework as a foundational evaluation standard for all BioMeTs to ensure they are fit-for-purpose. Technology manufacturers, clinical trial sponsors, and researchers should transparently report their V3 processes and results to overcome “black box” approaches and build a common evidence base. Technology manufacturers are primarily responsible for verification , while the entity developing the algorithm (e.g., manufacturer or sponsor) is responsible for analytical validation. The sponsor or clinical team using the BioMeT for a specific purpose is responsible for clinical validation in that context of use.

Regulatory Considerations
The V3 framework is designed to inform and align with the current regulatory landscape, although the regulatory pathway for a specific BioMeT depends on its intended use and marketing claims, not just its underlying technology. The 21st Century Cures Act and the concept of Software as a Medical Device (SaMD) have created new regulatory paradigms that decouple software from specific hardware. BioMeTs used to support drug development may follow a tool qualification pathway, while those marketed as standalone medical devices are subject to device clearance or approval processes. Stakeholders should engage with regulatory agencies early to determine appropriate validation approaches.