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# Most Digital Health Submissions Involve Patient-Reported Data, Not Sensors: FDA
- URL: https://www.fdaweb.com/most-digital-health-submissions-involve-patient-reported-data-not-sensors-fda/
- Published: 2026-10-23T15:47:31.000Z
- Updated: 2026-10-23T15:47:31.000Z
- Author: David McFarland
- Tags: Drugs

An FDA analysis of digital health technology (DHT) use in drug development found that electronic diaries and patient-reported outcomes accounted for the largest share of qualifying regulatory submissions, while sensor-based technologies were concentrated in a relatively small number of therapeutic areas.

The [study](https://doi.org/10.1111/cts.70750?ref=fdaweb.com), published in *Clinical and Translational Science* by CDER researchers, examined submissions received between 3/2023 and 12/2025 that were flagged as involving DHTs for remote clinical data acquisition.

Of 2,318 flagged submissions, only 277 (11.9%) met the agency's criteria for inclusion. Another 892 (38.5%) were duplicates or previously captured submissions, while 1,149 (49.6%) were unrelated to qualifying DHT use or involved ineligible submission types.

Among the 277 confirmed submissions, 237 (86%) involved investigational new drug applications, while 40 (14%) involved NDAs or BLAs.

Electronic diaries and electronic patient-reported outcomes were used exclusively in 161 submissions (58.1%), according to the study findings. General objective sensors, including wearable devices, sensor-enabled mobile technologies and photo or video technologies, appeared in 92 submissions (33.2%), sometimes in combination with patient-reported measures. Continuous glucose monitoring appeared in another 24 submissions (8.7%).

Among submissions involving general objective sensors, the largest concentrations were in neuroscience (34), immunology and inflammation (27), and cardiology, hematology, endocrinology and nephrology (22), the researchers found. Most were associated with Phase 2 development.

The researchers said the findings could help FDA identify where specialized review expertise, policy development and additional regulatory guidance may be needed.

They also highlighted widespread problems with sponsors' completion of DHT reporting fields on Forms FDA 1571 and FDA 356h, introduced in March 2023 as part of commitments under the user fee program (PDUFA VII).

For sponsors, the researchers emphasized the importance of early FDA engagement on endpoint selection, technology validation and whether DHT-derived measures are fit for their intended regulatory purpose.

The authors cautioned that the analysis relied on submissions flagged by sponsors and should not be interpreted as measuring the overall prevalence of DHT use across CDER-regulated drug development programs.