H.R. 2396 · 114th Congress
Sensible Oversight for Technology which Advances Regulatory Efficiency Act
Key: what the circles and colors mean
Each circle is a bill. The ring fills as it moves through Congress:
Under the number: the Yea · Nay count of its final (or latest) recorded vote. On a member's page, the small badge is how that member voted: Y Yea / Aye, N Nay / No, P Present, – Not voting.
Gold and violet are only for Yea and Nay; they never mean a party. A member's party is the letter on their photo.
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.
R
BlackburnSponsor1 cosponsor · 1 D
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
Sensible Oversight for Technology which Advances Regulatory Efficiency Act or the SOFTWARE Act
What it does: CRS summary · Introduced in House · May 18, 2015
Sensible Oversight for Technology which Advances Regulatory Efficiency Act or the SOFTWARE 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.Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Sensible Oversight for Technology which Advances Regulatory Efficiency Act
Also known as: SOFTWARE Act
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 18, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.