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The State of Remote Patient Monitoring for Chronic Disease Management in the United States

The State of Remote Patient Monitoring for Chronic Disease Management in the United States

Medical devices in the United States are regulated under applicable parts of Title 21 of the US Code of Federal Regulations, which categorizes devices into one of three classifications (class I, class II, and class III), where the classification level depends on the specifics of the function of the device and its intended use and operators to assure the safety and efficacy of the device.

Margaret M Paul, Nandita Khera, Praneetha R Elugunti, Kevin C Ruff, Musab S Hommos, Leslie F Thomas, Vivek Nagaraja, Ashley L Garrett, Mari Pantoja-Smith, Nathan L Delafield, Blanca C Lizaola-Mayo, Molly M Kresin, Mahesh Seetharam, Sandhya R Nagarakanti, Manreet Kaur

J Med Internet Res 2025;27:e70422

Feasibility of Collecting and Linking Digital Phenotyping, Clinical, and Genetics Data for Mental Health Research: Pilot Observational Study

Feasibility of Collecting and Linking Digital Phenotyping, Clinical, and Genetics Data for Mental Health Research: Pilot Observational Study

For compensation, participants were either entered into a draw for 10 Aus $100 (US $65) e-gift cards (cohort 1) or received an Aus $50 (US $33) e-gift card (cohort 2). Three unique identifiers were randomly assigned to each participant: one upon receipt of the study invitation; one during screening; and one upon confirmation of eligibility. These identifiers enabled linkage between baseline and digital phenotyping data for participants from AGDS.

Joanne R Beames, Omar Dabash, Michael J Spoelma, Artur Shvetcov, Wu Yi Zheng, Aimy Slade, Jin Han, Leonard Hoon, Joost Funke Kupper, Richard Parker, Brittany Mitchell, Nicholas G Martin, Jill M Newby, Alexis E Whitton, Helen Christensen

JMIR Form Res 2025;9:e71377