HOW CAN WE APPROACH WHOLE HEALTH USING DIGITAL BIOMARKERS AND ENDPOINTS FROM CONSUMER WEARABLES?
Author(s)
Annette Champion, BSc, MBA1, Anita D. Burrell, BA, MA, MBA2, Artem Tarasovic Boltyenkov, MBA, PhD3, Arturo Cabra, BS, MSc4, Brian Seal, MBA, RPh, PhD5, Michael Joseph Cangelosi, MA, MPH6.
1Healthcare Research Insights, Inc, Lake Forest, IL, USA, 2Anita Burrell Consulting LLC, Flemington, NJ, USA, 3Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 4GE HealthCare, Miami, FL, USA, 5Organon Pharmaceuticals, Germantown, MD, USA, 6Boston Scientific, Natick, MA, USA.
1Healthcare Research Insights, Inc, Lake Forest, IL, USA, 2Anita Burrell Consulting LLC, Flemington, NJ, USA, 3Siemens Healthcare Diagnostics Inc., Lexington, SC, USA, 4GE HealthCare, Miami, FL, USA, 5Organon Pharmaceuticals, Germantown, MD, USA, 6Boston Scientific, Natick, MA, USA.
OBJECTIVES: Digital health is transforming healthcare. Sensors in consumer wearables (e.g. smartphones, watches, rings) collect biomarkers that can be used to derive digital endpoints. ISPOR’s Whole Health concept expands the HEOR value definition, encompassing Physical, Behavioral, Socioeconomic, Environmental, and Spiritual dimensions, to capture the full range of costs and outcomes. Our objective is to determine how consumer wearable digital biomarkers and endpoints can support Whole Health; what can they measure, how does this fit with Whole Health, and how can they be used?
METHODS: Targeted literature review and structured exercise to map wearable-derived digital biomarkers and endpoints to Whole Health dimensions.
RESULTS: Wearable devices capture a wide range of biomarkers that provide insight into the user’s health and wellbeing, including physical function (e.g. walking speed, gait), speech and vocal characteristics, eye movements, metabolic levels (e.g. glucose), and physiological function (e.g. heart rate, skin conductivity, temperature) and can be used to develop endpoints that matter to patients. Digital devices enable frequent, longitudinal measurements, improving detection of rare events and supporting earlier diagnosis and treatment.
Alignment was found with Whole Health Physical (e.g. gait abnormalities and voice changes aid in diagnosis of Parkinson’s disease), Behavioral (e.g. physiological measures provide insight into stress levels, anxiety and depression), and Spiritual (e.g. individualized goal attainment, and purpose-driven behavior tracking) dimensions. There is limited coverage of Environmental (i.e. sound exposure) and Socioeconomic (e.g. referral completion) dimensions.
Digital biomarkers can be used by individuals for health and fitness tracking, by physicians to provide personalized medicine, and by researchers to generate digital endpoints to complement traditional outcomes in traditional and decentralized clinical trials that support regulatory filings and inform HTA and payer decisions.
CONCLUSIONS: Digital biomarkers and endpoints from wearable devices can make a meaningful contribution to Whole Health based value assessments by contributing patient-centric, real-world outcomes which should improve patient health.
METHODS: Targeted literature review and structured exercise to map wearable-derived digital biomarkers and endpoints to Whole Health dimensions.
RESULTS: Wearable devices capture a wide range of biomarkers that provide insight into the user’s health and wellbeing, including physical function (e.g. walking speed, gait), speech and vocal characteristics, eye movements, metabolic levels (e.g. glucose), and physiological function (e.g. heart rate, skin conductivity, temperature) and can be used to develop endpoints that matter to patients. Digital devices enable frequent, longitudinal measurements, improving detection of rare events and supporting earlier diagnosis and treatment.
Alignment was found with Whole Health Physical (e.g. gait abnormalities and voice changes aid in diagnosis of Parkinson’s disease), Behavioral (e.g. physiological measures provide insight into stress levels, anxiety and depression), and Spiritual (e.g. individualized goal attainment, and purpose-driven behavior tracking) dimensions. There is limited coverage of Environmental (i.e. sound exposure) and Socioeconomic (e.g. referral completion) dimensions.
Digital biomarkers can be used by individuals for health and fitness tracking, by physicians to provide personalized medicine, and by researchers to generate digital endpoints to complement traditional outcomes in traditional and decentralized clinical trials that support regulatory filings and inform HTA and payer decisions.
CONCLUSIONS: Digital biomarkers and endpoints from wearable devices can make a meaningful contribution to Whole Health based value assessments by contributing patient-centric, real-world outcomes which should improve patient health.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PCR210
Topic
Clinical Outcomes, Medical Technologies, Patient-Centered Research
Disease
No Additional Disease & Conditions/Specialized Treatment Areas