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Bill > HR2396
US HR2396
US HR2396SOFTWARE Act Sensible Oversight for Technology which Advances Regulatory Efficiency Act
summary
Introduced
05/18/2015
05/18/2015
In Committee
05/22/2015
05/22/2015
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
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.
AI Summary
This bill, known as the SOFTWARE Act, amends the Federal Food, Drug, and Cosmetic Act to define and regulate "health software," which generally refers to software used for administrative, operational, workflow, recordkeeping, data management (without active patient monitoring or device control), health education, or providing general health information or patient-specific recommendations. Importantly, health software is largely exempted from regulation by the Food and Drug Administration (FDA), unless it provides patient-specific recommendations and poses a significant risk to patient safety. The bill also clarifies that an "accessory" to a medical device, which is a product intended to support or augment a parent device, will be classified independently from the parent device. Furthermore, the FDA is required to review its existing regulations and guidance concerning health software and may establish a new regulatory framework for it, potentially including classification, development, validation, review, manufacturing, quality systems, labeling, and postmarketing requirements. The bill also clarifies that certain health software is excluded from the definition of a "device" under the Act, unless it's determined to be a safety risk.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Referred to the Subcommittee on Health. (on 05/22/2015)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/house-bill/2396/all-info | 05/19/2015 |
| BillText | https://www.congress.gov/114/bills/hr2396/BILLS-114hr2396ih.pdf | 07/07/2016 |
| Bill | https://www.congress.gov/114/bills/hr2396/BILLS-114hr2396ih.pdf.pdf | 07/07/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114hr2396ih/pdf/BILLS-114hr2396ih.pdf | 05/28/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114hr2396ih/pdf/BILLS-114hr2396ih.pdf.pdf | 05/28/2015 |
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