Findings
There is a need for appropriate training and infrastructure support to address challenges in implementing digital health technologies.
User acceptance is hindered by discomfort with technology among some participants.
Physicians face time constraints and question the utility of digital health technologies over current practices.
Concerns about data confidentiality among participants need to be addressed.
The complexity of digital health technology affects patient acceptance.

Recommendations
Provide appropriate training to staff and patients.
Ensure availability of appropriate infrastructure support.
Conduct pilot studies before scaling up to larger trials.
Address data confidentiality concerns.
Select devices with FDA clearance to minimize regulatory hurdles.

Regulatory Considerations
The FDA’s Digital Health program provides regulatory advice for digital health technology applications.
Choosing devices with FDA 501(k) clearance can minimize regulatory hurdles.