Stream: fmg
Topic: Regulations <--> Standards
John Moehrke (Jan 21 2021 at 14:59):
How about this governance wording?:
With regard to relationship between Standards and Regulations, and appropriate mentions of Regulations within Standards; Standards conformance can be required by Regulations (no reference should be made of the regulation in that standard), Standards can have clauses traced back to Regulations , Standards can aspire to be required by Regulations, but Standards should not require Regulations conformance.
Note "should not", as a indication of trend guidance
also, this is very similar to REST guidance on pointers directionality, that thing that comes later points at the thing that existed before.
But the main point is that a declaration in an Standard (implementation guide) of a "shall be compliant with regulation X", is a legal opinion. HL7 is not an organization authorized to make legal opinions. It is a standards organization, authorized to publish standard. It is very appropriate for HL7 Standards to remind their reader of potential legal obligations.
Lloyd McKenzie (Jan 21 2021 at 15:05):
SHALL be compliant with regulation X isn't a legal opinion. It's a statement of expectation. A standard could require adherence to a regulation (in order to be compliant with the standard) even if a legal opinion indicated that adherence wouldn't otherwise be needed. (Side note - Da Vinci doesn't mention the specific regulations when asserting SHALL/SHOULD language)
Last updated: Apr 12 2022 at 19:14 UTC
