Extending the V3 Framework: Accommodating for scalability and inclusion during implementation of sensor-based digital health technologies

Organizations are taking digital clinical measures and products to scale, raising new needs about the suitability of digital health technologies (DHTs) among larger audiences. To address these challenges, DiMe has announced a new Extending the Verification, Analytical Validation, and Clinical Validation Framework (V3+) project.

DiMe’s existing V3 Framework is the guide for evaluating whether sensor-based DHTs are fit-for-purpose, meaning that the technical, scientific, and clinical performance of the product is suitable for a defined purpose and context. The goal of the new V3+ project is to build on this success by adding new evidence-based components that ensure that DHTs meet the needs of all users through the application of best practices in usability, human factors, and human-centered design.

Together, we can help ensure that digital clinical measures investments, tools, and generated data are scalable in a rapidly evolving space.

Meet the needs of all users by applying best practices in usability, human factors, and human-centered design

The scenario: A researcher develops a proposal to use a digital sensor ring to capture physical activity among study participants with rheumatoid arthritis.

The issue: Many study participants are unable to wear the ring due to inflammation and swelling in their hands.

The scenario: An adhesive patch used for continuous heart rate monitoring is thought to only need replacement once a week.

The issue: Some patients suffering from multiple sclerosis (MS) have an unexpectedly high occurrence of missing data because user testing didn’t account for hydrotherapy sessions regularly undertaken by individuals with MS.

The scenario: A remote monitoring feature for a digital therapy product allows the device to collect data locally and upload it to a secure cloud-based platform daily.

The issue: Users living in rural areas find that the device quickly reaches local data storage capacity and no longer begins a therapy session until the user drives to an area with reliable cellular network.

Resources developed during this project will help ensure that DHTs meet the necessary industry and regulatory standards for usability, while drawing on the principles of diversity, equity, and inclusion with respect to research participants and patients.

Meet the needs of all users by applying best practices in usability, human factors, and human-centered design

The scenario: A researcher develops a proposal to use a digital sensor ring to capture physical activity among study participants with rheumatoid arthritis.

The issue: Many study participants are unable to wear the ring due to inflammation and swelling in their hands.

The scenario: An adhesive patch used for continuous heart rate monitoring is thought to only need replacement once a week.

The issue: Some patients suffering from multiple sclerosis (MS) have an unexpectedly high occurrence of missing data because user testing didn’t account for hydrotherapy sessions regularly undertaken by individuals with MS.

The scenario: A remote monitoring feature for a digital therapy product allows the device to collect data locally and upload it to a secure cloud-based platform daily.

The issue: Users living in rural areas find that the device quickly reaches local data storage capacity and no longer begins a therapy session until the user drives to an area with reliable cellular network.

Resources developed during this project will help ensure that DHTs meet the necessary industry and regulatory standards for usability, while drawing on the principles of diversity, equity, and inclusion with respect to research participants and patients.

Project Partners

We are proud to be working on this project alongside the following leaders from academia, consumer goods, pharmaceutical and life science companies, technology, biomedical research, and more.

Our project in the news

How leaders across the industry are using the V3 Framework

Since its publication in 2020, DiMe’s V3 Framework has emerged as the go-to international resource for evaluating whether sensor-based DHTs are fit-for-purpose.

Today, it maintains successful momentum; it has been accessed over 30,000 times, used by over 130 teams – including NIH, FDA, and EMA – and cited over 100 times in scientific literature. By developing resources to address usability, human factors, and human-centered design, we expect even further adoption over the coming years.

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