Distinguishing features in the assessment of mHealth apps

Rosanna Tarricone, Francesco Petracca*, Oriana Ciani, Maria Cucciniello

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review


Introduction: The unparalleled surge in digital health adoption during the COVID-19 pandemic has emphasized the potential of mHealth apps. However, the quality of available evidence is generally low, and regulatory frameworks have focused on apps with medical purposes only, overlooking apps with significant interactions with patients that may require stronger oversight. 

Areas covered: To support this expanded evidence generation process, we identified the reasons that distinguish mHealth apps compared to medical devices at large and that should differentially feature their assessment. mHealth apps are characterized by the iterative nature of the corresponding interventions, frequent user interactions with a non-linear relationship between technology usage, engagement and outcomes, significant organizational implications, as well as challenges associated with genericization, their broad diagnostic potential, and price setting. 

Expert Opinion: The renewed reliance experienced during the pandemic and the unprecedented injection of resources through recovery instruments can further boost the development of apps. Only robust evidence of the benefits of mHealth apps will persuade health-care professionals and beneficiaries to systematically deploy them. Regulatory bodies will need to question their current approaches by adopting comprehensive evaluation processes that adequately consider the specific features of mHealth apps.

Original languageEnglish
Pages (from-to)521-526
Number of pages6
JournalExpert Review of Pharmacoeconomics and Outcomes Research
Issue number4
Early online date4 Mar 2021
Publication statusPublished - 4 Jul 2021


  • assessment
  • HTA
  • mHealth
  • mobile apps
  • regulation


Dive into the research topics of 'Distinguishing features in the assessment of mHealth apps'. Together they form a unique fingerprint.

Cite this