Wednesday, November 19, 2008

Harmonized Standards for the Genome and Family History

As one of the first humans to have my genome sequenced, I'm passionate about the standards used to record genomic and family history data. The initial national effort just completed the public comment phase and is not yet approved by the HITSP panel, but we hope to gain panel approval in December and present this work to the AHIC Successor on January 8, 2009 for acceptance by Secretary Leavitt before he leaves office. Here's a summary of the work thus far

IS08 Personalized Healthcare is the overall interoperability specification for exchanging genomic information and family history. It references several other HITSP components:

C32 HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component is the lifetime medical record summary.

C80 Clinical Document and Message Terminology Component includes the vocabularies used to precisely describe the genome and family history.

C83 CDA and CCD Content Modules Component is a detailed overview of family history pedigrees and genetic test results in the lifetime medical record.

C90 Clinical Genomic Decision Support Component is used to communicate genetic and family history information from healthcare IT applications to clinical decision support systems which provide an assessment of risks of diseases.

During our discussion of genomic and family history data, we focused on privacy, since keeping this information confidential per the wishes of the patient is paramount.

Concerns we discussed include:

a) Based on Provider’s different needs, would there have to be an “all or nothing” option for the family member’s access authorization?
b) Who makes the decision about which information is relevant?
c) If the family member is not capable of authorization or has passed away, is legal representation required?
d) What guidance does a Provider use to evaluate the access authorization?

We selected two HITSP Privacy and Security Components to meet these needs.

TP20 HITSP Access Control Transaction Package
ensures only authorized people can view the data.

TP30 HITSP Manage Consent Directives Transaction Package provides an electronic record of patient privacy preferences and consents.

I look forward to engaging my own family in the use of these standards. My parents have agreed to share our histories and genomes as an example to accelerate adoption of these standards. More to come soon!

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