Mar 03

Clinical Data Standards where do I start?

standards (1 of 1)Implementing Clinical data standards or more importantly ensuring that any  software you buy is standards compliant is a difficult but necessary process if you are hoping to be able to share data with a national repository, your local health ecosystem or your patients. For this to happen at a minimum the address details, especially the organization, provider and patient identification elements, need to be standards based so that you can send and receive the information.  There are some great resources available. The one I suggest, as it is the most influential with your EMR vendor will of course be the one developed by the Office of the National Co-ordinator in the USA, which is the biggest EMR market and hence why most major vendors focus on that market and their regulations, incentives and standards.  The 2016 Interoperability Standards Advisory focus  explicitly  on  clinical  health  IT  systems’  interoperability including  electronic  health  information  created  in  the  context of treatment.  It does not include administrative/payment data and transactions which are governed by other areas of the government.

3 key objectives of this document

  • To provide a single, public list of the standards and implementation specifications that can best be used to fulfill specific clinical health information interoperability needs.
  • To reflect  the  results  of  ongoing  dialogue,  debate,  and  consensus  among  industry  stakeholders  when  more  than one standard or implementation specification could be listed as the best available.
  • To document known limitations, preconditions, and dependencies as well as known security patterns among referenced standards  and  implementation  specifications  when  they  are  used  to  fulfill  a  specific  clinical  health IT interoperability need.

3 issues you will need to address if you are implementing any of these standards outside of the United States

  • Not all standards that are listed as free, are free outside the US. The US, like other countries, often buys national memberships for all of their citizens to use the standards (for example SNOMED CT).
  • Suitability of the value sets for your region especially Medications ( RxNorm and NDC) which are US focused and may need to be replaced with a local Drug Dictionary
  • The standards listed will not guarantee interoperability unless your interoperability partner agrees and uses them.

The public comment period for the 2016 Interoperability Standards Advisory (2016 Advisory) has closed effective March 21, 2016 and the work on 2017 will be informed by these comments. My favourite part of the documents is the six informative characteristics to provide for each standard to add context including: Standards Process Maturity; Implementation Maturity; Adoption Level; Federally Required; Cost and Test Tool Availability. I also like the inclusion of “emerging alternative” to a standard or implementation specification when known to show what the future direction may be.  While this is a fantastic first step on your Clinical standards journey, I look forward to when Clinical data models are also included to promote analytics and  help the sharing of knowledge not only the transfer of information.


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