New content review round for Adverse Reaction

Just to let you all know that I have just uploaded a significantly remodelled Adverse Reaction draft archetype and initiated a review round for it.

It has certainly been some time since the first review round, yet there has been considerable activity elsewhere. The time has come to consolidate this work and seek openEHR community input again.

This latest archetype has been fundamentally reworked based on previous openEHR review comments, research and inclusion of input from HL7, ICH, Intermountain Healthcare CEMs, identification of statutory and reporting requirements and feedback from 5 rounds of NEHTA CKM reviews in Australia - see http://dcm.nehta.org.au/ckm/OKM.html#showarchetype_1013.1.868.

The resulting archetype that we are sending out for review has major changes since our first review round by the openEHR community. In fact, it has effectively been remodelled and the changes are so significant that any implementers who have utilised the previous draft model should regard this draft model as a new version. Because of the major restructure of the model, we have also taken the opportunity to revise the archetype ID as well - now OBSERVATION.adverse_reaction - to better reflect the intent of the model and be consistent with updated editorial naming policies.

Overview of changes:

  • Significant enhancement of Concept Description, Purpose, Use, Misuse, Keywords and References.

  • ‘Agent’ is now referred to ‘Substance/Agent’ throughout

  • Addition of Absolute Contraindication; Future Use; Overall Comment; Slots for Additional Reaction Detail, Additional Exposure Detail and Reporting Details; Exposure description; Earliest Exposure; Clinical Management Description; Multimedia; & Reaction Comment

  • Addition of Protocol containing Reaction Reported?, Link to supportive clinical information, Link to Adverse Reaction Report

  • Modification of "Probability of Causation’ to 'Certainty’

  • Inclusion of Translation - Arabic (Syrian) and German (Standard) where data elements/descriptions are consistent with original translations.

  • Inclusion of NEHTA reviewers as contributors

We welcome anyone who would like to participate in the review to do so by registering in CKM and ‘adopting’ the archetype. Please don’t email me directly, but adopt the archetype within CKM. Instructions for Adopting archetypes are here: http://www.openehr.org/wiki/display/healthmod/Adopt+an+archetype

Kind Regards

Heather

Dr Heather Leslie
MBBS FRACGP FACHI
Director of Clinical Modelling
Ocean Informatics
Phone (Aust) +61 (0)418 966 670
Skype - heatherleslie
Twitter - @omowizard

Great work.

What I don't understand is why this is published in the Nehta CKM which also owns the copyright of this archetype (with no license attached to it). My understanding is that the work derived from the openehr community will be published under a CC license. How do we deal with this situation?

Cheers,

Stef

Hi Stef,

I think this is a very important issue in the long-term but my view of
the current position is that this an openEHR copyrighted and
CC-licensed archetype, based on a NEHTA archetype, which itself was
based on an earlier openEHR archetype.

My understanding is that like most governmental bodies, NEHTA were
obliged to copyright and license their archetypes to fit govt. policy,
that their legal departments are struggling to find an appropriate
mechanism to work in a broader community but that there is no desire
to lock-out the use or adaptation of any of their archetypes by the
wider community.

This is going to be a recurring situation with many countries who are
prepared to be 'not evil' in terms of sharing assets but also have to
comply with internal legislation or policy. e.g Although the UK govt
has recently changed its policy on open licensing, it remains UK
specific and, in theory may cause us issues. It will be interesting to
see how CIMI might approach this problem too.

I agree it needs clarification ( over time) but I think we should feel
comfortable that we are not gong to be transported to Oz to answer for
copyright theft.

Ian

Dr Ian McNicoll
office +44 (0)1536 414 994
fax +44 (0)1536 516317
mobile +44 (0)775 209 7859
skype ianmcnicoll
ian.mcnicoll@oceaninformatics.com

Clinical Modelling Consultant, Ocean Informatics, UK
Director/Clinical Knowledge Editor openEHR Foundation www.openehr.org/knowledge
Honorary Senior Research Associate, CHIME, UCL
SCIMP Working Group, NHS Scotland
BCS Primary Health Care www.phcsg.org

For what it's worth, the situation is exactly the same in the UK with
Crown British copyright being required on all public artefacts, but a
very liberal licence - usually Apache 2 or one of the CC licenses, as
far as I understand.

- thomas

OK, but for now it (the NEHTA AT) states ‘© National E-Health Transition Authority’ which IMO means that all the content is proprietary to NEHTA and ‘our’ contributions probably as well…

Don’t want to stir the CC discussion up again but we need to be careful here.

Cheers,

Stef

Hi Stef,

I think your concern is valid. I have expressed similar worries in the
past but I honestly believe that, at least in this case, the issue is
one of legal treacle rather than ill intent. In fact, I suspect that
the original openEHR archetype was based on a older piece of
Australian work, modified by the English US copyright, then of course
taken up again in Australia.

Ian

Dr Ian McNicoll
office +44 (0)1536 414 994
fax +44 (0)1536 516317
mobile +44 (0)775 209 7859
skype ianmcnicoll
ian.mcnicoll@oceaninformatics.com

Clinical Modelling Consultant, Ocean Informatics, UK
Director/Clinical Knowledge Editor openEHR Foundation www.openehr.org/knowledge
Honorary Senior Research Associate, CHIME, UCL
SCIMP Working Group, NHS Scotland
BCS Primary Health Care www.phcsg.org

OK, lets continue to make more great archetypes.

Cheers,

Stef

NEHTA is not a government body. It is not governed by any specific Acts of State or Australian Governments. It is incorporated under Australian Corporations Law and is not 'obliged' to copyright and license Archetypes in the way that government departments and agencies might be. NEHTA may well wish to do so, but I would be surprised if much deliberation has gone into the process hithertofore.

I'm not an expert in copyright law, and so I struggle to understand what a copyright claim on an archetype might mean.

I too agree that clarification, both of any copyright claims and licensing rights/restrictions should be established. I agree that it is an international issue, but the clarification process may struggle with the vagaries of a multitude of individual states' laws.

As for transportation to Oz, I would caution that some of we Australians have long memories. :wink:

eric browne

the important thing is to find out what the licence is, not what the copyright is. If there is no licence, I agree, this should be checked, because Nehta is a publicly funded body, and should not be creating anything proprietary.

  • thomas