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Applying Evidence-Based Medicine Standards to Digital Tools.

David Cooper1

  • 1Therapists in Tech, Seattle, WA, USA.

American Journal of Health Promotion : AJHP
|October 28, 2025
PubMed
Summary

Clinicians should use the same evidence-based medicine standards for digital health interventions as traditional treatments. A significant evidence gap exists between regulated digital therapeutics and unvalidated apps, impacting patient care.

Keywords:
FDA regulatory approvalclinical evaluation frameworksdigital therapeuticsevidence-based practicehealth technology assessmentmobile health applications

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Area of Science:

  • Digital health
  • Evidence-based medicine
  • Health informatics

Background:

  • Digital health interventions are increasingly prevalent in healthcare.
  • Traditional treatments follow established evidence-based medicine (EBM) hierarchies.
  • Digital health tools vary widely in validation and regulatory oversight.

Purpose of the Study:

  • To advocate for uniform EBM standards across all health interventions, regardless of delivery method.
  • To highlight the evidence gap between regulated digital therapeutics and unvalidated commercial applications.
  • To examine implementation barriers for digital health tools in clinical practice.

Main Methods:

  • Review of the evidence-based medicine hierarchy.
  • Analysis of the FDA approval process for digital therapeutics.
  • Case study using substance use disorder treatment to illustrate the evidence gap.
  • Discussion of systemic and practical implementation barriers.

Main Results:

  • A spectrum of digital health tools exists, from general digital health to regulated digital therapeutics.
  • FDA-approved digital therapeutics undergo rigorous trials (Phase III RCTs) comparable to pharmaceuticals.
  • A significant "evidence gap" exists between validated digital therapeutics and unvalidated apps relying on testimonials.
  • Barriers include reimbursement, provider awareness, workflow integration, cost, engagement, and liability.

Conclusions:

  • Consistent EBM standards are crucial for evaluating all health interventions, including digital ones.
  • The distinction between validated digital therapeutics and other digital health tools must be clear to clinicians.
  • Addressing implementation barriers is essential for the effective integration of digital health into patient care.