FDA Digital Health Center of Excellence
The FDA Digital Health Center of Excellence aims to:
Connect and build partnerships to accelerate digital health advancements.
Share knowledge to increase awareness and understanding, drive synergy, and advance best practices.
Innovate regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.
Read the FDA Digital Health Innovation Action Plan
The Digital Health Innovation Action Plan outlines the FDAs efforts to reimagine the FDA’s approach to ensuring all Americans have timely access to high-quality, safe and effective digital health products. As part of this plan, the FDA committed to several key goals, including increasing the number and expertise of digital health staff at the FDA, launching the digital health software precertification pilot program (“Pre-Cert”) and issuing guidance to modernize our policies.
FDA Commissioner’s Statement: Advancing new digital health policies to encourage innovation, bring efficiency and modernization to regulation
Federal Trade Commission (FTC) Mobile Health Apps Interactive Tool
If you are developing a mobile health app that collects, creates, or shares consumer information, click here to take you to the tool on Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply:
The European Commission on eHealth : Digital health and care
Enhancing the use of digital technology through the creation of a Digital Single Market (DSM) is one of the European Commission's main priorities. Launched in 2015, the DSM aims to open up digital opportunities to people and business, and to bring the EU's single market into the digital age. Health is one of the sectors included in this agenda, given the potential benefits that digital services have to offer citizens and enterprises in this area.