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Titles Actions Overview All Actions Cosponsors Committees Related Bills Subjects Latest Summary All Summaries

Titles (3)

Short Titles

Short Titles - House of Representatives

Short Titles as Introduced

Sensible Oversight for Technology which Advances Regulatory Efficiency Act

Official Titles

Official Titles - House of Representatives

Official Title as Introduced

To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of health software, and for other purposes.

Actions Overview (1)

Date Actions Overview
05/18/2015Introduced in House

All Actions (3)

Date All Actions
05/22/2015Referred to the Subcommittee on Health.
Action By: Committee on Energy and Commerce
05/18/2015Referred to the House Committee on Energy and Commerce.
Action By: House of Representatives
05/18/2015Introduced in House
Action By: House of Representatives

Cosponsors (1)

* = Original cosponsor
CosponsorDate Cosponsored
Rep. Green, Gene [D-TX-29]* 05/18/2015

Committees (1)

Committees, subcommittees and links to reports associated with this bill are listed here, as well as the nature and date of committee activity and Congressional report number.

Committee / Subcommittee Date Activity Related Documents
House Energy and Commerce05/18/2015 Referred to
House Energy and Commerce Subcommittee on Health05/22/2015 Referred to

A related bill may be a companion measure, an identical bill, a procedurally-related measure, or one with text similarities. Bill relationships are identified by the House, the Senate, or CRS, and refer only to same-congress measures.

Latest Summary (1)

There is one summary for H.R.2396. View summaries

Shown Here:
Introduced in House (05/18/2015)

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.