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

GHI Analysis — Tue, 15 Aug 2017 15:27:53 +0000

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.

LatAm’s Middle Class Pursues Private Healthcare

GHI Analysis — Fri, 11 Aug 2017 18:42:36 +0000

The recent recession in Latin America saw the region’s nominal GDP slide in dollar terms from US$ 5.6 billion in 2014 to an estimated US$ 4.2 billion by year end 2016, putting additional financial strain on already underfunded public health programs.

While countries throughout the region have made efforts to expand healthcare coverage to include a greater percentage of their population, public health spending in Latin America averages only 3.7% of GDP versus an OECD average of 8.3%. The result is often a tradeoff between the accessibility and the depth and quality of care.

The range of public services and their utilization are typically limited to more catastrophic health needs. An in-hospital doctor consultation may require a full day in line, or be limited to only 10 minutes.

The 100 million Latin Americans who ascended to the middle class over the past decade generate larger disposable incomes and are increasingly dissatisfied with such care – they are willing to pay an out-of-pocket premium in order to achieve faster or higher quality care. The fiscal budget crunches resulting from the 2015-16 recession are only expected to further private expenditures as private care rises to fill in the gaps left by the public system.

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

LatAm’s Middle Class Pursues Private Healthcare