Software Technologies

Definition

Computer programs or software installed on mobile or other electronic devices.  

Rationale

Software technologies span a wide range of translational benefits and include software that drives medical devices for diagnostics and treatment, desktop or server-installed software to track clinical trials and patient care, and mobile applications for community use intended for education and health management. 

Guidance

Advice from authors on searching for information:

Ratings and number of reviews on search engines and app stores can provide a rough estimate of impact and quality of the software should it appear on these services. Access to self-reported researcher or administrative/in-house data may be required to locate documentation on development and implementation of software technologies and applications.
 
FDA regulation of medical software has become more complex with open-source mobile application development. See information regarding “software as a medical device.” 

Resources & Data

Organizations, repositories, websites, and other sources where you can find more information:

Local

Office of Technology Management at Washington University (OTM)
The OTM offers a Technology Search feature to search for all available Washington University technologies. For more information, consult the office at your institution that manages technology transfer and commercialization.

General

Centers for Disease Control and Prevention (CDC)
Entering “software” in the search field on the CDC homepage yields more than 17,000 results, many of which are links to free downloads. Programs include a wide range of applications, including industry & occupation (I&O) code standardization, collecting cancer registry data, and mosquito surveillance. 

National Institutes of Health Software Resources 
Includes a list of biomedical software for specialized analyses. 

Online Software Search Engines for Clinical Trial Management Software 
Websites such as Capterra (search term: Clinical Trial Management Software) and G2 Crowd (search term: Clinical Trial Management Software) provide searches and user reviews for commercial software. Products can be sorted in a variety of methods including quality of the product.  

U.S. Food & Drug Administration (FDA) 
Entering “software” in the search field on the FDA homepage yields more than 18,000 results. Many are programs approved by the FDA including descriptions. 

Data Limitations

Challenges you may encounter while searching for information:

Search engines for commercial software may be influenced by company sponsorship, though some claim to remove fraudulent reviews. 

Publications

Articles, books, and other publications in translational science using the indicator:

Graham G, Sabina A, Barclay, G. Innovations to improve population health and address chronic disease. Am J Public Health. Dec 2014; 104(12): 2245. doi: 10.2105/AJPH.2014.302335.

IMDRF Software as a Medical Device (SaMD) Working Group. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations. International Medical Device Regulators Forum; 2014 September. 

IMDRF Software as a Medical Device (SaMD) Working Group. Software as a Medical Device (SaMD): Key Definitions. International Medical Device Regulators Forum; 2013 December.

IMDRF Software as a Medical Device (SaMD) Working Group. Software as a Medical Device (SaMD): Clinical Evaluation. International Medical Device Regulators Forum; 2017 June.

IMDRF Software as a Medical Device (SaMD) Working Group. Software as a Medical Device (SaMD): Application of Quality Management System. International Medical Device Regulators Forum; 2015 October.

Victorson D, Banas J, Smith J, et al. eSalud: Designing and implementing culturally competent eHealth research with Latino patient populations. Am J Public Health. Dec 2014; 104(12): 2259. doi: 10.2105/AJPH.2014.302187. 

Case Studies

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