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PP064 Registration Of Healthcare Mobile Apps In Brazil

Published online by Cambridge University Press:  12 January 2018

Benefran Bezerra  and
Eduardo Alves
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Abstract

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INTRODUCTION:

The use of applications (app) on mobile phones to health care is a trend. Its applications range from the use as energy calculators, monitoring clinical parameters, as well association with medical devices, personal health records or used to request appointments (1). Thus, it is intended to evaluate the regulatory instruments available in Brazil as to their sufficiency to analyze this new technology.

METHODS:

Assessment of regulatory instruments for mobile app registration by the Brazillian Health Regulatory Agency (Anvisa) (2). The main variables in the form of Class I and II are: Submission type, Postal Code, Electronic Site, Product code, Classification Rule, Class, Indication of Use / Purpose, Principle of Operation, Platform, Target Audience, Type of Environment, Compatibility, Safety Characteristics, Technical Standards used, Product Origin.

RESULTS:

Since 2010, the registration of software in Anvisa has been observed. The evaluation of Class I and II software is performed through the registration analysis to be completed by the requesting company. Class III (high risk) software is registered as a medical device embedded software (2).

Anvisa's analysis of the software still depends directly on the application for registration of the companies. In this way most of the analyzed software are for use by health professionals and health services.

CONCLUSIONS:

There are Brazilian regulations for health products with software registration forecast, however its use as a health service still lacks studies mainly with the trends of new information and communication technologies (3).

The regulation of mobile applications becomes difficult because applications are freely downloaded in virtual stores, their domains are usually in foreign territory and their use is given directly by the user.

Type
Poster Presentations
Information
International Journal of Technology Assessment in Health Care , Volume 33 , Special Issue S1: Conference Theme: Towards an HTA Ecosystem: From Local Needs to Global Opportunities , 2017 , pp. 100 - 101
Copyright
Copyright © Cambridge University Press 2018 

References

REFERENCES:

1. Roehrs, A, da Costa, CA, da Rosa Righi, R, de Oliveira, KF. Personal Health Records: A Systematic Literature Review. J Med Internet Res 2017;19 (1):e13. DOI: 10.2196/jmir.5876.Google Scholar
2. BRASIL. Agência Nacional de Vigilância Sanitária. Resolução RDC n° 185, de 22 de outubro de 2001. Aprova o Regulamento Técnico que consta no anexo desta Resolução, que trata do registro, alteração, revalidação e cancelamento do registro de produtos médicos na Agência Nacional de Vigilância Sanitária – ANVISA. Diário Oficial da República Federativa do Brasil, em 06 de novembro de 2001.Google Scholar
3. Lee, JD, Yoon, TS, Chung, SH, Cha, HS. Service-Oriented Security Framework for Remote Medical Services in the Internet of Things Environment. Healthcare Informatics Research, 2015;21 (4):271–282. http://doi.org/10.4258/hir.2015.21.4.271Google Scholar