Evidence map›Paper›PMID 32352926›Full record

SynthesisJMIR mHealth and uHealth2020

Need for the Development of a Specific Regulatory Framework for Evaluation of Mobile Health Apps in Peru: Systematic Search on App Stores and Content Analysis.

Leonardo Rojas Mezarina, Javier Silva-Valencia, Stefan Escobar-Agreda, Daniel Hector Espinoza Herrera, Miguel S Egoavil, Mirko Maceda Kuljich, Fiorella Inga-Berrospi, Sergio Ronceros

Abstract readSystematic Review
In one paragraph

Synthesis in JMIR mHealth and uHealth, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Leonardo Rojas Mezarina *Unidad de Telesalud, School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0003-0293-7107
Javier Silva-Valencia *Unidad de Telesalud, School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0002-5982-2821
Stefan Escobar-Agreda *Unidad de Telesalud, School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0002-8355-4310
Daniel Hector Espinoza Herrera *Unidad de Telesalud, School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0002-2484-983X
Miguel S Egoavil *Unidad de Telesalud, School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0002-9065-2576
Mirko Maceda Kuljich *School of Medicine, Universidad San Martin de Porres, Lima, Peru.ORCID 0000-0002-5056-4969
Fiorella Inga-BerrospiUniversidad Continental, Lima, Peru.ORCID 0000-0002-9778-1557
Sergio Ronceros *Deanery of the School of Medicine, Universidad Nacional Mayor de San Marcos, Lima, Peru.ORCID 0000-0003-2117-2357

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn Peru, there is an increase in the creation of mobile health (mHealth) apps; however, this situation could present problems related to the quality of information these apps share, data security and privacy, usability, and effectiveness, as there is no specific local regulation about their creation and use.

objectiveThe objective of this study was to review mHealth apps created, uploaded, or used in Peru, and perform an analysis of the national regulatory framework that could be applied to evaluate whether there is a need to develop and implement a specific regulation to these apps.

methodsA total of 3 reviews were performed. First, we reviewed information about Peruvian mHealth apps created up to May 2019 from scientific publications, news, government communications, and virtual stores, and evaluated their purpose, creator, and the available evidence of their usability and effectiveness. The second review was carried out by taking a sample of the 10 most commonly used mHealth apps in Peru (regardless of the country of creation), to evaluate the information they collect and classify them according to the possible risks that they could present in terms of security and privacy. In addition, we evaluated whether they refer to or endorse the information they provided. Finally, in the third review, we searched for Peruvian standards related to electronic health (eHealth) that involve information technology that can be applied to regulate these apps.

resultsA total of 66 apps meeting our inclusion criteria were identified; of these, 47% (n=31) belonged to government agencies and 47% (n=31) were designed for administrative purposes (private and government agencies). There was no evidence about the usability or effectiveness of any of these apps. Concerning the 10 most commonly used mHealth apps in Peru, about the half of them gathered user information that could be leaked, changed, or lost, thus posing a great harm to their users or to their related patients. In addition, 6/10 (60%) of these apps did not mention the source of the information they provided. Among the Peruvian norms, the Law on the Protection of Personal Data, Law on Medical Devices, and administrative directives on standards and criteria for health information systems have some regulations that could be applied to these apps; however, these do not fully cover all aspects concerning the evaluation of security and privacy of data, quality of provided information, and evidence of an app's usability and effectiveness.

conclusionsBecause many Peruvian mHealth apps have issues related to security and privacy of data, quality of information provided, and lack of available evidence of their usability and effectiveness, there is an urgent need to develop a regulatory framework based on existing medical device and health information system norms in order to promote the evaluation and regulation of all the aforesaid aspects, including the creation of a national repository for these apps that describes all these characteristics.

Indexed as

Mobile ApplicationsTelemedicineComputer SecurityHumansPeruPrivacymHealthmhealth appsPeru, eHealthregulatory framework

Identifiers

PMID32352926
PMCPMC7382017

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.