TABLE 3.

The regulation of electronic informed consent in the United States and the European Union.

	US	EU
Presentation of study-related information	HIPAA	CTR/GDPR
	21 CFR part 50
	45 CFR part 45
Electronic signatures	21 CFR part 11	eIDAS Regulation

CFR, Code of Federal Regulations; CTR, Clinical Trials Regulation; eIC, electronic informed consent; eIDAS, electronic identification and trust services; EU, European Union; GDPR, General Data Protection Regulation; HIPAA, Health Insurance Portability and Accountability Act of 1996; US, United States.