SOFTWARE Act

Summary

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.

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Timeline

1. 18 May 2015

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 18 May 2015

   Introduced

   Introduced in House

   Source: IntroReferral

3. 18 May 2015

   Introduced

   Introduced in House

   Source: IntroReferral

4. 22 May 2015

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 18 May 2015 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 18 May 2015

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 18 May 2015

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 18 May 2015

  Open at official source

Sponsors

• Marsha Blackburn · R · Sponsor
• GENE GREEN · D · Sponsor
• · hsif00 · Standing

Related records

• related to → 21st Century Cures Act