US Congress House Bill 2396 (Prior Session Legislation)

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Spectrum: Bipartisan Bill
Status: Introduced on May 18 2015 - 25% progression, died in committee
Action: 2015-05-22 - Referred to the Subcommittee on Health.
Pending: House Subcommittee on Health Committee
Text: Latest bill text (Introduced) [PDF]

SOFTWARE Act Sensible Oversight for Technology which Advances Regulatory Efficiency Act This bill amends the Federal Food, Drug, and Cosmetic Act to define health software as software that does not acquire, process, or analyze data from an in vitro diagnostic device or signal acquisition system, is not an accessory or part of a medical device, is not used to prevent disease in the transfusion of blood and blood components, and is for: administrative or operational support or the processing and maintenance of financial records; use in clinical, laboratory, or administrative workflow and recordkeeping; managing data but not for active patient monitoring or controlling the functions of a connected medical device; organizing and presenting information for health or wellness education or maintaining a healthy lifestyle; or analyzing information to provide general health information or patient-specific recommendations. The FDA must classify an accessory of a medical device independently from the medical device with which it is used. Health software is exempted from regulation by the FDA (including as a medical device), except for software that provides patient-specific recommendations and poses a significant risk to patient safety. The FDA must review existing regulations and guidance regarding the regulation of health software.

SOFTWARE Act Sensible Oversight for Technology which Advances Regulatory Efficiency Act

Sen. Marsha Blackburn [R-TN]

Rep. Gene Green [D-TX]

Date	Chamber	Action
2015-05-22	House	Referred to the Subcommittee on Health.
2015-05-18	House	Referred to the House Committee on Energy and Commerce.
2015-05-18	House	Introduced in House

HB6 (Related) 2015-07-13 - Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Type	Source
Summary	https://www.congress.gov/bill/114th-congress/house-bill/2396/all-info
Text	https://www.congress.gov/114/bills/hr2396/BILLS-114hr2396ih.pdf