PP064 Registration Of Healthcare Mobile Apps In Brazil

Abstract

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.