Regulatory Guidance

The expansion of digital health related technologies has grown rapidly - accelerating even more during the COVID-19 pandemic. As digital health continues to hold an important place in modern healthcare, it is critical to ensure the safety and efficacy of digital health-related solutions (from devices, applications, and beyond). Regulation by the US Food and Drug Administration (FDA) is fundamental to achieving this goal and has been evolving.

Below are some resources to understand the FDA and European regulatory frameworks.

FDA
The FDA Digital Health Center of Excellence

The Center connects and builds partnerships to accelerate digital health advancements, facilitates the process of sharing knowledge to increase awareness and understanding, drive synergy, and advance best practices, and innovates regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.


FDA
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. Another helpful guide is available to those looking to understand Software as a Medical Device (SaMD).


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.