A FHIR-Based eConsent App for the Digital Hospital.

Area of Science:

• Health Informatics
• Clinical Research
• Mobile Health (mHealth)

Background:

• Human research is highly regulated, facing changes from eHealth and mHealth advancements.
• Patient data and samples are crucial for research but require robust protection.
• Current consent processes for research data use are often inflexible and outdated.

Purpose of the Study:

• To develop a modernized, flexible, and personalized electronic consent (eConsent) system for human research.
• To integrate eConsent into existing hospital IT infrastructure using established data standards.
• To address the demand for a unified yet adaptable approach to patient consent.

Main Methods:

• Development of an Android application to bring consent forms to mobile devices.
• Integration of the app with hospital IT systems using Health Insurance Portability and Accountability Act (HIPAA) and ResearchStack standards.
• User-testing of the application within a hospital environment.

Main Results:

• The developed Android app successfully functions in a hospital setting for electronic consent.
• User testing confirmed the app's viability for managing patient consent on mobile devices.
• Key obstacles identified for immediate implementation include the lack of electronic identification and legal challenges.

Conclusions:

• The developed eConsent app offers a promising, user-friendly solution for modernizing patient consent in research.
• Integration with hospital IT and adherence to data standards like FHIR are feasible.
• Addressing eIdentification and legal frameworks is critical for widespread adoption of mobile eConsent solutions.