No country or group of countries has yet established regulatory legislation on mobile apps aimed at the healthcare market as existing regulations do not cover them. To help fill this legal void, the Food and Drug Administration (FDA) has published a guide with recommendations for developers, distributors and entities that build these mHealth tools to bear in mind.
The objective of the organization is to apply its regulatory authority to support the choice of software designed for mobile devices. However, the document does not establish legal obligations or regulations, simply suggesting the aspects to which the industry should pay special attention before developing or commercializing these technologies.
In fact, the publication places an emphasis on apps designed to function as medical devices, which could expose the patient to certain risks. To meet this definition, the app must fulfill several functions:
• Help users to manage their condition or disease – suggesting strategies for care and even predetermining a medication schedule.
• Provide tools to organize or monitor data about users’ state of health.
• Provide accessible information about related treatments and diseases.
• Document or communicate potential medical conditions.
• Allow users to interact with electronic health record systems.
• Transfer, store, translate or send data from an external medical device.
• Make automatic routine calculations about medical practice.
For organizations or companies that are developing an application to perform any of these tasks, the FDA recommends:
• Registering the entity and product with the administration.
• In the case of developers using new technologies, work with the FDA before launching the product on the market.
• Present the application to the FDA before making it available for sale so that it is properly classified.
• Establish the requirements necessary to use the application.
• Voluntarily correct errors before they are formally requested by the FDA and report them to the administration.
According to the document, the FDA commits to closely monitoring the performance of mobile applications and determining whether these technologies improve healthcare – reducing the possibility of medical errors and protecting patients – or whether they may be harmful in some clinical scenarios.
