The Food and Drug Administration (FDA) has implemented temporary policies for the application of innovations in Digital Health during the pandemic. In an article published in npj Digital of the scientific journal Nature, these actions and their implications for the future were identified.
The tools and services based on Digital Health became more relevant during 2020, in response to the COVID-19 pandemic. Telemedicine applied in the remote monitoring of infected or suspected patients, as well as the collection of information through symptom registration applications, were the main applications of health technologies.
In the article: Promotion of digital health: FDA innovation during COVID-19, published in Nature, shows the progress made by this body, such as the temporary policies that promoted the use of Digital Health during the pandemic. The article analyzes the context of each of these policies and actions carried out by the agency.
In 2017, the FDA created the Digital Health Innovation Action Plan, which paid off in 2020 when the Digital Health Center of Excellence was launched. Previous medical device regulations, created in 1976, only applied to analog medical technologies. Devices using software-based hardware did not have the same regulations. It was not until 2013, when to seek digital transformation in the United States medical services, the FDA issued a policy guide.
As part of the Digital Health Innovation Action Plan, the FDA is also exploring the creation of a software precertification program, which is currently under development for software as a medical device as a pilot.
The advances in Digital Health guided by the FDA for years, had in 2020 an increase not only in its use and adoption but also in its development. “The FDA has sought to expand access to low-risk, clinically appropriate digital health tools during the COVID-19 pandemic by declaring its intent to waive certain regulatory requirements for some devices,” the article explains.
The article mentions that Digital Health will be the cornerstone of this effort, and agency officials hope that emerging evidence will inform regulatory science for several key areas. These key areas were divided into three: (1) experience in the use of Digital Health, (2) research on the adoption of digital health products among the population of different age ranges and (3) the use of digital health tools for clinical research.
