(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to exempt certain software from requirements for medical devices. The exemption applies to:

• administrative software used in health care facilities;
• software for maintaining or encouraging a healthy lifestyle unrelated to medical care;
• electronic patient records that are part of certified health information technology;
• software for transferring, storing, converting, or displaying medical information; and
• software that provides medical recommendations and the basis for those recommendations to health care professionals.

Software remains subject to regulation as a medical device if: (1) the software acquires, processes, analyzes, or interprets medical information; or (2) the Food and Drug Administration (FDA) identifies use of the software as reasonably likely to have serious adverse health consequences.

When assessing a medical device that includes a software function exempted from medical device requirements, the FDA may assess the impact of the software on the functioning of the device.

The Department of Health and Human Services must report on the health risks and benefits associated with exempted software.

The FDA must classify a medical device accessory based on its intended function, not based on the classification of the medical device with which it is used.

This bill amends the Federal Food, Drug, and Cosmetic Act to exclude from regulation by the Food and Drug Administration (FDA) as a medical device:

• administrative, operational, or financial records software used in health care settings;
• software for maintaining or encouraging a healthy lifestyle unrelated to medical treatment;
• electronic patient records, excluding software for interpreting or analyzing medical image data;
• software for clinical laboratory testing, excluding software for interpreting or analyzing test data; and
• software that provides medical recommendations and the basis for those recommendations to health care professionals, excluding software for acquiring, processing, or analyzing medical images or signals.

The FDA may assess a software function excluded from regulation above when determining the safety and effectiveness of a medical device with multiple functions.

The FDA must classify a medical device accessory based on its intended function, not based on the classification of the medical device with which it is used.