US Congress Senate Bill 1101 (Prior Session Legislation)

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Sponsorship: Bipartisan Bill
Status: Introduced on April 27 2015 - 25% progression, died in chamber
Action: 2016-04-04 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
Text: Latest bill text (Introduced) [PDF]

MEDTECH Act Medical Electronic Data Technology Enhancement for Consumers' Health 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.

MEDTECH Act Medical Electronic Data Technology Enhancement for Consumers' Health Act

Sen. Michael Bennet [D-CO]

Sen. Orrin Hatch [R-UT]

Date	Chamber	Action
2016-04-04	Senate	Placed on Senate Legislative Calendar under General Orders. Calendar No. 409.
2016-04-04	Senate	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.
2016-03-09	Senate	Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
2015-04-27	Senate	Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/senate-bill/1101/all-info
Text	https://www.congress.gov/114/bills/s1101/BILLS-114s1101is.pdf
Text	https://www.congress.gov/114/bills/s1101/BILLS-114s1101rs.pdf