Currently submitted to: JMIR mHealth and uHealth
Date Submitted: Oct 23, 2019
Open Peer Review Period: Oct 21, 2019 - Dec 16, 2019
(currently open for review)
Mobile Health Applications in Peru: Why is a regulatory framework necessary?
Mobile applications have assumed a leading role in all the daily activities we carry out, but their application in the field of health remains controversial. Although many benefits are reported, the level of evidence is not enough and an uncontrolled creation has led to serious problems as information quality and violations of data privacy.
To make a review of the mobile health Apps created and uploaded in Peru, and make an analysis of the national regulatory framework that could be applied, placing special emphasis on solving the questions about why regulation is necessary
Three reviews were carried out. First, we review the mHealth applications created and uploaded in Peru in the last 5 years recovered from scientific publications, news, government communications and from the virtual stores. The second review was carried out taking a sample of the most used mHealth applications in the Peruvian territory and evaluating the possible risks in security, privacy, medical evidence and reference of the information provided. Finally, in the third review we search for Peruvian regulatory aspects related to e-health that involve information technology that could be applied.
Search queries up to May 2019 located 66 mHealth applications developed and published in Perú. Of those, most were for administrative purposes or to provide information. 47% belonged to government agencies and some applications created by different agencies had the same or similar functions. Furthermore, no evidence was found on its effectiveness, quality or safety parameters. When we analyzed the 10 most used mHealth applications in Peru (regardless of the country of creation), we found violations of data security and doubts about the quality of the information provided. 60% did not mention the origin of the information they provided or if they had a health staff in their development team. This is important for some crucial calculations, such as fertile days. There is no specific regulatory framework for the development or use of mobile health applications in Perú, however, in recent years the country has regulated various aspects related to electronic health as the Law on the protection of personal data, the Law on medical devices and administrative Directives on standards and criteria on health information systems.
There is a need for regulation of mobile health applications in Peru. Currently, there are regulations that apply to other aspects related to eHealth, but that based on experiences from other countries, could somehow also cover mobile applications. It is necessary to promote research studies on the evaluation and use of applications in Peru, in order to establish benefits and associated risks to start the path towards a specific regulatory framework.
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