Jove
Visualize
Contact Us

Related Experiment Videos

Healthcare software assurance.

Jason G Cooper1, Keith A Pauley

  • 1Mid-Atlantic Technology, Research, and Innovation Center, South Charleston, WV, USA.

AMIA ... Annual Symposium Proceedings. AMIA Symposium
|January 24, 2007
PubMed
Summary
This summary is machine-generated.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Data mining for correlations between diet and Crohn's disease activity.

AMIA ... Annual Symposium proceedings. AMIA Symposiumยท2007
See all related articles
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Software assurance ensures safe and reliable healthcare software. Current Food and Drug Administration (FDA) regulations need updates to cover complex systems like Hospital Information Systems (HIS).

Area of Science:

  • Biomedical Engineering
  • Software Engineering
  • Regulatory Science

Background:

  • Software assurance is crucial for developing safe, reliable, and complete software, especially in life-critical healthcare applications.
  • Current Food and Drug Administration (FDA) regulations and guidance do not fully encompass all aspects of comprehensive software assurance.
  • Increasing complexity of healthcare systems, such as Hospital Information Systems (HIS), necessitates updated oversight processes.

Purpose of the Study:

  • To introduce the importance of complete software assurance in healthcare.
  • To discuss current FDA regulatory requirements and guidance related to software.
  • To highlight the necessity for enhancing FDA oversight for complex healthcare software systems.

Main Methods:

Related Experiment Videos

  • Literature review of existing software assurance principles.
  • Analysis of current FDA regulatory documentation and guidance.
  • Identification of gaps in current regulations concerning advanced healthcare software.

    • Main Results:

    • Software assurance activities are vital throughout the entire software lifecycle.
    • Existing FDA frameworks may not adequately address the nuances of modern, complex healthcare software.
    • There is a clear need for improved FDA processes to ensure the safety and reliability of sophisticated healthcare systems.

    Conclusions:

    • Complete software assurance is paramount for healthcare software integrity.
    • FDA regulations require augmentation to meet the challenges posed by advanced healthcare IT systems.
    • Enhanced FDA oversight is essential for patient safety and the reliable functioning of medical software.