MEDTECH Act

Bill: 114-s-1101
Sponsor: Sen. Bennet, Michael F. [D-CO]
Introduced: 2015-04-27 in the Senate
Policy area: Health
Subjects: Computers and information technology
Drug safety, medical device, and laboratory regulation
Health information and medical records
Health technology, devices, supplies

Summary:
action_date: 2015-04-27
text: 

Medical Electronic Data Technology Enhancement for Consumers&rsquo; Health Act or the MEDTECH Act

 
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.

action_date: 2016-04-04
text: 

Medical Electronic Data Technology Enhancement for Consumers&rsquo; Health Act or the MEDTECH Act

 
(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.


Legislative actions:
action_date: 2016-04-04
text: Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
action_date: 2016-04-04
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute and an amendment to the title. Without written report.
action_date: 2016-04-04
text: Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute and an amendment to the title. Without written report.
action_date: 2016-03-09
text: Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
action_date: 2015-04-27
text: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
action_date: 2015-04-27
text: Introduced in Senate