H.R. 2396

Sensible Oversight for Technology which Advances Regulatory Efficiency Act or the SOFTWARE Act

This bill amends the Federal Food, Drug, and Cosmetic Act to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components, and is for:

• administrative or operational support or the processing and maintenance of financial records;
• use in clinical, laboratory, or administrative workflow and recordkeeping;
• managing data but not for active patient monitoring or controlling the functions of a connected medical device;
• organizing and presenting information for health or wellness education or maintaining a healthy lifestyle; or
• analyzing information to provide general health information or patient-specific recommendations.

The FDA must classify an accessory of a medical device independently from the medical device with which it is used.

Health software is exempted from regulation by the FDA (including as a medical device), except for software that provides patient-specific recommendations and poses a significant risk to patient safety.

The FDA must review existing regulations and guidance regarding the regulation of health software.