ArticleJournal of medical Internet research2022
Assessing the Clinical Robustness of Digital Health Startups: Cross-sectional Observational Analysis.
Article in Journal of medical Internet research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.
What it found
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
24 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Mobile phone interventions to improve health outcomes among patients with chronic diseases: an umbrella review and evidence synthesis from 34 meta-analyses.The Lancet. Digital health · 2024Pooled it
- Patient Engagement with Conversational Agents in Health Applications 2016-2022: A Systematic Review and Meta-Analysis.Journal of medical systems · 2024Pooled it
- Healthcare professionals' perspectives on digital biomarkers for monitoring inflammatory arthritis: insights from a qualitative study rooted in design thinking.EULAR rheumatology open · 2026Article
- The United States Leads the Globe in Venture Capital Funding for Orthopaedic Surgery.Arthroscopy, sports medicine, and rehabilitation · 2026Article
- Populations and Health Domains Served by Direct-to-Consumer Digital Health Companies in the United States, 2011-2023: Cross-Sectional Study.JMIR formative research · 2025Article
- Suitable Evaluation Frameworks for Disease-Agnostic Platforms for Remote Patient Monitoring: Scoping Review.Journal of medical Internet research · 2025Article
- The Application of Preventive Medicine in the Future Digital Health Era.Journal of medical Internet research · 2025Review
- Top-funded digital health companies offering lifestyle interventions for dementia prevention: Company overview and evidence analysis.PloS one · 2025Article
- Ethical challenges in contemporary psychiatry: an overview and an appraisal of possible strategies and research needs.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2024Article
- The case for inclusive co-creation in digital health innovation.NPJ digital medicine · 2024Article
- Clinical Simulation in the Regulation of Software as a Medical Device: An eDelphi Study.JMIR formative research · 2024Article
- Key Considerations for Designing Clinical Studies to Evaluate Digital Health Solutions.Journal of medical Internet research · 2024Article
- Digital Mental Health's Unstable Dichotomy-Wellness and Health.JAMA psychiatry · 2024Article
- Clinical Validation of Digital Healthcare Solutions: State of the Art, Challenges and Opportunities.Healthcare (Basel, Switzerland) · 2024Review
- mHealth Apps for the Self-Management of Low Back Pain: Systematic Search in App Stores and Content Analysis.JMIR mHealth and uHealth · 2024Article
- MedTech start-ups: A comprehensive scoping review of current research trends and future directions.PloS one · 2024Article
- The Buzz Surrounding Precision Medicine: The Imperative of Incorporating It into Evidence-Based Medical Practice.Journal of personalized medicine · 2023Article
- Digital Health Programs to Reduce Readmissions in Coronary Artery Disease: A Systematic Review and Meta-Analysis.JACC. Advances · 2023Article
- A Narrow Definition of Clinical Robustness.Journal of medical Internet research · 2023Article
- Assessing the Quality and Impact of eHealth Tools: Systematic Literature Review and Narrative Synthesis.JMIR human factors · 2023Review
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe digital health sector has experienced rapid growth over the past decade. However, health care technology stakeholders lack a comprehensive understanding of clinical robustness and claims across the industry.
objectiveThis analysis aimed to examine the clinical robustness and public claims made by digital health companies.
methodsA cross-sectional observational analysis was conducted using company data from the Rock Health Digital Health Venture Funding Database, the US Food and Drug Administration, and the US National Library of Medicine. Companies were included if they sell products targeting the prevention, diagnosis, or treatment phases of the care continuum. Clinical robustness was defined using regulatory filings and clinical trials completed by each company. Public claims data included clinical, economic, and engagement claims regarding product outcomes made by each company on its website.
resultsA total of 224 digital health companies with an average age of 7.7 years were included in our cohort. Average clinical robustness was 2.5 (1.8 clinical trials and 0.8 regulatory filings) with a median score of 1. Ninety-eight (44%) companies had a clinical robustness score of 0, while 45 (20%) companies had a clinical robustness score of 5 or more. The average number of public claims was 1.3 (0.5 clinical, 0.4 economic, and 0.4 engagement); the median number of claims was 1. No correlation was observed between clinical robustness and number of clinical claims (r
conclusionsMany digital health companies have a low level of clinical robustness and do not make many claims as measured by regulatory filings, clinical trials, and public data shared online. Companies and customers may benefit from investing in greater clinical validation efforts.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.