Table 2.

Data standards for regulatory submissions of BioMeTs

Standard name	Format	Focus
CDISC	Tabulation data:	Objective: regulatory submission of clinical trial data
	− The Study Data Tabulation Model (SDTM) including (SDTMIG-MD for medical devices collected data)	Note: additional metadata collected from medical devices is required with respect to data collected from BioMeTs (e.g., the location where the device was used) (Badawy et al. [64])
	− Standard Exchange for Nonclinical Data (SEND)	Geographic scope:
	Analysis data:	− Recommended by FDA and Japan PMDA for regulatory submissions
	− Analysis Data Model (ADaM)	− Preferred by China NMPA
		− Endorsed by EMA
Open mHealth	Open Mobile Health	Objective: Mobile health data interoperability standard for patient health generated data