FDA’s digital health initiative revives interest in validating health applications in the region

In June 2017, the FDA announced the launch of a specific program for digital health that seeks to establish a new model for regulation of medical software, including health apps and fitness monitors trackers. The initiative, focused more on the manufacturers than on products, seeks to limit the gray areas surrounding the approval and use of these devices, establishing different criteria for evaluation according to whether they are considered “high” or “low” risk. Through this project, dubbed Digital Health Innovation Plan, “the FDA will help innovators navigate a new and modern regulatory process so that promising, safe and effective digital health developments can advance faster. The plan contemplates the development of new guidelines on technologies that, although they fall within the definition of “medical devices”, present sufficiently low risks so that the FDA does not try to subject them to certain regulatory requirements before they are released to the market. The first step starts this week with the opening of a pre-certification pilot program for digital health products (Pre-Cert for Software Pilot Program). Throughout August, the agency will select up to nine companies (from small start-ups to large companies) that register to participate and have “trajectory in the development, testing and maintenance of software products and that have demonstrated a culture Quality and organizational excellence. Throughout the program, the companies commit, among other actions, to collect real-life data from the use of their products and provide them to the FDA.

In Latin America, the regulatory gap is still pronounced. The challenge for the regulator is how to maintain non-regulatory spaces by fostering creativity, while safeguarding people’s rights. Chile has a development of health apps in its pipeline that are yet to be approved but regulation has proved to be an issue. The size of the industry is smaller and regulation requires a relevant maturity and time. Chile regulators stated that, the new FDA policy needs to be observed before they approve the products. As per the Economic Development of Information Technology, Ministry of Information Technologies and Communications of Colombia (MinTIC), Colombia has no specific regulation for the use of mobile applications in the health sector, however, there are guidelines related to the use of health information for different information systems. The public policies in Mexico regarding the regulation of apps are slow and there is not yet a document or structure that allows a regulated and vigilant framework. It is possible that the new FDA initiative will boost regulatory processes in the region.