Cited by 454Mobile Health and mHealth ApplicationsDigital Mental Health InterventionsHealth, Technology, Consumer Behavior

The DOI matches its Crossref record; 42 of the 42 references it cites were found in a registry or an index; 3 of the 37 sources its claims cite were checked for support.

What is the clinical value of mHealth for patients?

Open access

Abstract

Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mobile apps should be utilized to add value to patient care. We categorize apps according to their functionality (e.g. preventative behavior change, digital self-management of a specific condition, diagnostic) and discuss evidence for effectiveness from published systematic reviews and meta-analyses and the relevance to patient care. We discuss the limitations of the current literature describing clinical outcomes from mHealth apps, what FDA clearance means now (510(k)/de novo FDA clearance) and in the future. We discuss data security and privacy as a major concern for patients when using mHealth apps. Patients are often not involved in the development of mobile health guidelines, and professionals’ views regarding high-quality health apps may not reflect patients’ views. We discuss efforts to develop guidelines for the development of safe and effective mHealth apps in the US and elsewhere and the role of independent app reviews sites in identifying mHealth apps for patient care. There are only a small number of clinical scenarios where published evidence suggests that mHealth apps may improve patient outcomes.

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

This review categorizes mHealth apps by function and assesses the clinical evidence for their value to patients. It concludes that evidence supports use in only a small number of defined clinical scenarios, with major gaps in long-term outcomes, evidence quality, regulation, and data privacy.

Key findings

  • Evidence for clinical benefit is limited to a handful of scenarios. For example, an app screening patient-reported outcomes for lung cancer recurrence improved median survival to 23 months vs 14.8 months with standard imaging follow-up (HR 0.62, 95% CI 0.39–0.995, P = 0.048).
  • Diagnostic symptom-checker apps gave appropriate emergency triage advice in 80% of cases but had only 34% diagnostic accuracy and appropriate non-emergent triage advice in 55%. A separate meta-analysis of apps screening photographs or sensor data reported pooled sensitivity of 82% (95% CI 0.56–0.94) and specificity of 89% (95% CI 0.70–0.97).
  • Behavior-change and digital therapeutic apps show some benefits: a meta-analysis found BMI reduction of 0.43 kg/m² (95% CI −0.74 to −0.13), and an updated meta-analysis of 66 RCTs found improved depression, anxiety, and stress outcomes vs controls, with preliminary evidence showing no difference vs face-to-face therapy.
  • Medication adherence apps are numerous but poorly evidenced: only 4 of 805 included apps had associated published evidence of clinical outcomes. An educational app for knee pain improved actual disease-related knowledge by 52% and perceived knowledge by 22%.

Methods

  • Design: narrative review/perspective that categorizes mHealth apps by functionality and discusses evidence, regulation, and implementation challenges.
  • Data: published systematic reviews, meta-analyses, randomized controlled trials, regulatory documents, and guideline efforts; the authors note a PubMed search for “mHealth” returns more than 30,000 hits.
  • Main analysis: thematic synthesis across four functional categories—diagnostics/clinical decision making, behavior change, digital therapeutics, and disease-related education—plus discussion of FDA clearance, data security/privacy, and app-review/guideline initiatives.

Limitations

  • Stated: most evidence comes from short-term studies, long-term value remains unclear, and variations in language and cultural setting may limit generalizability. The mHealth literature is highly variable, few studies are registered on clinicaltrials.gov, many studied apps are unavailable on app stores, and retrospective analyses risk selection bias, commercial bias, and outdated software versions.
  • Stated: usability and acceptability are often not evaluated, and there is no evidence-based standardized approach for clinicians to counsel patients on mHealth risks such as data privacy.
  • Evident: as a narrative review, it does not report a systematic search strategy, inclusion criteria, or formal risk-of-bias assessment, so its conclusions rely on selected examples and syntheses rather than a comprehensive systematic review.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.1038/s41746-019-0206-x

Cites

42 of 42 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

31 Not checked yet · 6 Own interpretation · 2 Supported · 2 No basis given · 1 Partly supported · 1 Own result · accuracy not yet measured

Verify all 34 references — free account

Show all 28 claims

  • It may state two separate claims as one. 12
  • Probably not a substantial claim. 4
15 of 15
  • The paper relies on this without support.

    There is little clinical guidance on how mHealth apps should be utilized to add value to patient care.

    “Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mHealth apps should be utilized to add value to patient care”
  • The paper relies on this without support.

    Patients are often not involved in the development of mobile health guidelines, and professionals’ views regarding high-quality health apps may not reflect patients’ views.

    “Patients are often not involved in the development of mobile health guidelines, and professionals’ views regarding high-quality health apps may not reflect patients’ views.”
  • The paper relies on this without support.

    Data security and privacy are a major concern for patients when using mHealth apps.

    “We discuss data security and privacy as a major concern for patients when using mHealth apps.”
  • The paper relies on this without support.

    More often than not mHealth developers do not have the resources available to fund large premarket prospective multicenter randomized controlled trials, and regulators currently do not insist on this.

    “More often than not mHealth developers simply do not have the resources available to fund large premarket prospective multicenter randomized controlled trials (equivalent to Phase III studies in the development of a pharmaceutical) and regulators currently do not insist on this.”
  • The paper relies on this without support.

    Many mHealth app developers are under pressure from early stage investors to demonstrate short-term product growth.

    “Furthermore, many mHealth app developers are under pressure from early stage investors to demonstrate short-term product growth.”
  • The paper relies on this without support.

    Preliminary data suggest there is no significant increase in adverse events with short-term use of CBT based digital therapeutics.

    “Preliminary data suggest there is no significant increase in adverse events with short-term use of CBT based digital therapeutics.”
  • The paper relies on this without support.

    Clinicians often lack the necessary training to counsel patients on risks that are unique to mHealth such as data privacy, and there is a lack of guidance on how to integrate digital technologies into established treatment protocols.

    “Clinicians often lack the necessary training to counsel patients on risks that are unique to mHealth such as data privacy, which are very important to patients, and there is a lack of guidance on how to integrate digital technologies into established treatment protocols.”
  • The paper relies on this without support.

    510k clearance requires the manufacturer to demonstrate substantial equivalence to a previously approved medical device but the standards of evidence for clinical effectiveness are variable and different to those that apply to pharmaceuticals.

    “510k clearance requires the manufacturer to demonstrate substantial equivalence to a previously approved medical device but the standards of evidence for clinical effectiveness are variable and different to those that apply to pharmaceuticals.”
  • The paper relies on this without support.

    There is no evidence based standardized approach to counselling patients on mHealth apps.

    “Counselling patients on mHealth apps is challenging and there is no evidence based standardized approach.”
9 of 9

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Citations

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Metadata

Authors
Rowland, S. P., Fitzgerald, J. E., Holme, T., Powell, J., & McGregor, A.
Affiliations
  • Imperial College London (GB)
  • KPMG (United Kingdom) (GB)
  • St Helier Hospital (GB)
  • University of Oxford (GB)
Corresponding author
Rowland, Simon P.
Venue
npj Digital Medicine
Published
2020-01-13
Volume
3
Issue
1
Pages
4-4
ISSN
2398-6352 (ISSN-L)
OpenAlex
W2999080334
Cited by
454
References
42
Citations by year
2026: 34 · 2025: 82 · 2024: 92 · 2023: 94 · 2022: 75 · 2021: 62 · 2020: 13
FWCI
11.63
Type
journal article
Language
en
Open access
Locations
  • npj Digital Medicine (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Spiral (Imperial College London) (submittedVersion, cc-by)
Funders
Care Oxford at Oxford Health NHS Foundation Trust. National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research
Topics
  • Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
  • Social Sciences › Psychology › Applied Psychology › Digital Mental Health Interventions
  • Health Sciences › Health Professions › Health Information Management › Health, Technology, Consumer Behavior
Keywords
mobile health, mobile health apps, clinical value, patient care, behavior change, digital self-management, FDA 510(k) clearance, data security, privacy

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