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S 1101 114th Congress Senate Health Computers and information technology Drug safety, medical device, and laboratory regulation Health information and medical records Health technology, devices, supplies

MEDTECH Act

Introduced: April 27, 2015 Introduced by: Bennet, Michael F. Democratic · Colorado See on congress.gov
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 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 4, 2016
Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
Apr 4, 2016
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.
Mar 9, 2016
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Apr 27, 2015
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 27, 2015
Introduced in Senate
 Plain-English summary Congressional Research Service

Medical Electronic Data Technology Enhancement for Consumers’ 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.

What's happening now April 4, 2016

Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.

 Committees of jurisdiction 1