HL7 is an independent, worldwide standards development organization. Which specific framework are you referring to?

I have personally participated in quite a bit of HL7 standards development and I can guarantee you that regulators have only minor influence over the process. HL7 work groups have multiple types of participants including providers, payers, vendors, and regulators.

The older HL7 V2 and V3 standards can take a while to learn. FHIR (which is essentially HL7 V4) is a bit easier to understand. But the health IT domain is inherently complex and can never be made simple.