S. 1101 · 114th Congress
MEDTECH Act
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
BennetSponsor1 cosponsor · 1 R
0 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Medical Electronic Data Technology Enhancement for Consumers’ Health Act or the MEDTECH Act
What it does: CRS summary · Reported to Senate with amendment(s) · Apr 4, 2016
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: MEDTECH Act
Also known as: Medical Electronic Data Technology Enhancement for Consumers' Health Act
Latest action (Apr 4, 2016): Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
Policy area: Health · Origin: Senate · Introduced: Apr 27, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.