The 21st Century Cures Act recently cleared a hurdle in the US (approval by the House Energy and Commerce committee) to go onto the next step, a vote in the House of Representatives. Quite frankly, having read various versions of the bill, and having seen its evolution, I have to wonder who should really be doing this job. Various people have commented, and the reaction is decidedly mixed in industry.
I'm going to focus on one simple point in the proposed legislation. Current language for the Charter Organization suggests engagement with ANSI accredited standards organizations. I think that is broken. Other language in the same draft is better: "nationally or internationally recognized standard development organization". That phrase is much more appropriate to the work in standards that has already been occurring.
There are many international players who should be engaged, such as HL7, DICOM, IHE International, IEEE, and the US TAG to ISO TC 215. Some of these are ISO Liaisons rather than ANSI accredited (HL7 is both). Neither IHTSDO (home of SNOMED CT) nor Regenstrief (home of LOINC) are ANSI accredited, but certainly should be engaged.
While I think HL7 should play a role in standards development for the US, it is an international organization. I don't want to see the damage too much US influence would do to its standing among international affiliates (this damage is already occurring as a result of Meaningful Use). If there was an HL7 US affiliate (as there should be), that would certainly be a group to be engaged with. We also need players like IHE USA, as well as other "local" standards bodies like X12N, WEDI and NCPDP. I call them local because they are little used outside of the US market, with almost no chance of international adoption (as far as healthcare goes).
Are we to go back to another model like HITSP? I think not. I hope not. I'd really like to see this be a sustainable organization, rather than something funded by government contract, only to die when the money runs out (as the $10M appropriation would). I've suggested other models in the past. Canada tried to bring everything under one roof and succeeded for a while, and other countries have national bodies that bring together or coordinate at least some parts of standards development.
I'm going to focus on one simple point in the proposed legislation. Current language for the Charter Organization suggests engagement with ANSI accredited standards organizations. I think that is broken. Other language in the same draft is better: "nationally or internationally recognized standard development organization". That phrase is much more appropriate to the work in standards that has already been occurring.
There are many international players who should be engaged, such as HL7, DICOM, IHE International, IEEE, and the US TAG to ISO TC 215. Some of these are ISO Liaisons rather than ANSI accredited (HL7 is both). Neither IHTSDO (home of SNOMED CT) nor Regenstrief (home of LOINC) are ANSI accredited, but certainly should be engaged.
While I think HL7 should play a role in standards development for the US, it is an international organization. I don't want to see the damage too much US influence would do to its standing among international affiliates (this damage is already occurring as a result of Meaningful Use). If there was an HL7 US affiliate (as there should be), that would certainly be a group to be engaged with. We also need players like IHE USA, as well as other "local" standards bodies like X12N, WEDI and NCPDP. I call them local because they are little used outside of the US market, with almost no chance of international adoption (as far as healthcare goes).
Are we to go back to another model like HITSP? I think not. I hope not. I'd really like to see this be a sustainable organization, rather than something funded by government contract, only to die when the money runs out (as the $10M appropriation would). I've suggested other models in the past. Canada tried to bring everything under one roof and succeeded for a while, and other countries have national bodies that bring together or coordinate at least some parts of standards development.
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