ISPOR Special Interest Group Research Published in Value in Health Shows PICOTS-ComTeC Aligns With Global Digital Healthcare Assessment Guidelines
Lawrenceville, NJ, USA—January 20, 2026—Value in Health, the official journal of ISPOR—The Professional Society for Health Economics and Outcomes Research, announced today the publication of a comprehensive international study demonstrating that the PICOTS-ComTeC framework serves as an effective universal standard for defining patient-facing digital health interventions. The report, “Towards a Common Ground for Defining Digital Health Interventions, Mapping Digital Health Frameworks to PICOTS-ComTeC: An ISPOR Special Interest Group Report” was published in the January 2026 issue of Value in Health.
Digital health interventions continue to proliferate, with much of the growth in patient-facing applications; however, their potential has yet to be fully realized in clinical practice. International, regional, and national health organizations are facilitating the integration of digital innovations into healthcare systems, while seeking to minimize risks to patient safety and privacy. "Patient-facing digital health interventions (ie, apps and wearables) should be defined in a comparable, structured manner to facilitate research informing clinical and financial decisions," noted lead author Annette Champion, BS, MBA, Healthcare Research Insights, Inc, Lake Forest, IL, USA, on behalf of the project team. “Despite numerous published guidelines and frameworks for standardizing patient-facing digital health intervention evidence generation, reporting, and assessment, concerns persist about the quality of the definitions and the need for standardized reporting of these interventions.”
The PICOTS-ComTeC (Population, Intervention, Comparator, Outcomes, Timing, Setting, Communication, Technology, Context) framework was developed in 2024 to define patient-facing digital health interventions for health economics and outcomes research.
To determine how the PICOTS-ComTeC framework fits with other established digital health intervention frameworks, an international team representing ISPOR's Digital Health Special Interest Group compared PICOTS-ComTeC against 16 established frameworks, including guidelines from major health technology assessment bodies and international healthcare organizations. The research objective was to determine the degree of overlap, the additional value of PICOTS-ComTeC, and how the frameworks might be used together.
Key findings:
- Diverse Framework Coverage: A total of 16 frameworks were examined, 15 digital health (9 international, and 6 national health technology assessment and payer), and 1 international health economic reporting
- Comprehensive Definition: PICOTS-ComTeC was the only framework to present a comprehensive, systematic framework for defining patient-facing digital health interventions, although several frameworks included classification schemes such as the World Health Organization’s CDISAH
- High Domain Agreement: Across all frameworks, 81% of PICOTS-ComTeC domains matched (range 44% - 100%), and the mean number of domain matches for a framework was 7.3
- Subcategory Coverage: On average, comparator frameworks matched 48% of the 32 PICOTS-ComTeC subcategories (range 16% - 81%) and the mean number of subcategory matches for a framework was 15.4
- Complete Domain Alignment: Five frameworks had all 9 domains present: the World Health Organization’s CDISAH, Belgium's RIZIV, Germany's DiGA, United Kingdom’s NICE, and CONSORT-EHEALTH. No framework had all 32 subcategories present.
- Universal Applicability: The study analyzed frameworks ranging from international classification systems to national health technology assessment guidelines from Germany, France, Belgium, Finland, Australia, and the United Kingdom
"PICOTS-ComTeC contains items not uniformly present in comparator frameworks. Missing PICOTS-ComTeC items can be added to comparator frameworks to more comprehensively define patient-facing digital health interventions.
At the same time, information from comparator frameworks, such as the WHO's CDISAH classification scheme, can be used when completing items in the PICOTS-ComTeC framework.
Following its publication in April 2024, the PICOTS-ComTeC framework was endorsed by the EQUATOR Network, which promotes transparent and accurate reporting of health research worldwide," noted Champion.
In conclusion, the findings of this research suggest that PICOTS-ComTeC represents an appropriate common ground for defining digital health interventions for research, reporting, and assessment purposes, thereby improving patient care by accelerating the adoption of effective patient-facing digital health interventions.
About ISPOR’s Digital Health Special Interest Group
Mission:
To address new opportunities in the healthcare sector emerging from the increasing use of digital technologies, specifically telemedicine and mobile devices, and to evaluate the impact of information and communication technology on health outcomes.
Goals:
- Establish a forum to address the opportunities and challenges emerging in the field of digital health
- Understand the role of health economics and outcomes research (HEOR) in the value assessment of digital health solutions
- Investigate the ways in which the validity and reliability of digital health technologies can be evaluated
- Promote the effective use of digital technologies to improve patient outcomes and efficiency of healthcare systems
Background:
The term "digital health" is extremely broad and can include electronic medical records, electronic health records, telemedicine, mobile health (mHealth), and wireless health, amongst others. Utilization of digital health technologies provides opportunities to increase the quality of care, accuracy of healthcare analytics, and ensure greater safety owing to the patient follow-up. However, digital health represents a field fraught with challenges within the healthcare market. Not only are there numerous and different ways to classify and define “digital health” and related subtopics, but there is also a lack of methodological approaches available to assess the value of digital health solutions. The usefulness along with the quality and reliability of health information gathered via digital health (eg, mobile apps) must be addressed before one can feel confident of the reliability of digital health solutions and subsequent use by patients and researchers for assessing the value of healthcare interventions. Click here to learn more.
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ABOUT ISPOR
ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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ABOUT VALUE IN HEALTH
Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s current impact factor score is 6.0 and its 5-year impact factor score is 5.7. Value in Health is ranked 5th of 124 journals in Health Policy and Services, 12th of 185 journals in Health Care Sciences & Services, and 37th of 617 journals in Economics. Value in Health is a monthly publication that circulates to more than 60,000 readers around the world.
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