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RE: seeks input on Study Data Exchange Standards

From: Mead, Charlie (NIH/NCI) [C] <meadch@mail.nih.gov>
Date: Wed, 15 Aug 2012 12:11:04 -0400
To: "Lin MD, Simon" <LINMD.SIMON@mcrf.mfldclin.edu>, Kerstin Forsberg <kerstin.l.forsberg@gmail.com>, HCLS hcls <public-semweb-lifesci@w3.org>
Message-ID: <4D241B2CAA657641A30147AA5BF6AE782BA5D71F44@NIHMLBX07.nih.gov>
And interoperability with data currently persistent in other technologies.

charlie
________________________________________
From: Lin MD, Simon [LINMD.SIMON@mcrf.mfldclin.edu]
Sent: Wednesday, August 15, 2012 11:11 AM
To: Mead, Charlie (NIH/NCI) [C]; Kerstin Forsberg; HCLS hcls
Subject: RE: seeks input on Study Data Exchange Standards

Great topic! I can imagine a potential white paper from this group.

Besides technology, factors to consider might include: flexibility, implementation cost, return on investments, path to migration etc.

Best regards,

Simon

==================================================
Simon Lin, MD
Director, Biomedical Informatics Research Center
Marshfield Clinic Research Foundation
1000 N Oak Ave, Marshfield, WI 54449
Office 715-221-7299
Lin.Simon@mcrf.mfldclin.edu
www.marshfieldclinic.org/birc

For scheduling assistance, please contact
      Crystal Gumz, Administrative Secretary
      gumz.crystal@mcrf.mfldclin.edu
      715-221-6403


-----Original Message-----
From: Mead, Charlie (NIH/NCI) [C] [mailto:meadch@mail.nih.gov]
Sent: Wednesday, August 15, 2012 1:02 AM
To: Kerstin Forsberg; HCLS hcls
Subject: RE: seeks input on Study Data Exchange Standards

I would say Yes -- particularly since there is now an effort to represent some of newest HL7 standards -- FHIR resource definitions in particular -- using SW approaches...and the BRIDG OWL representation will almost certainly benefit from this effort.

charlie
________________________________________
From: Kerstin Forsberg [kerstin.l.forsberg@gmail.com]
Sent: Wednesday, August 15, 2012 1:57 AM
To: HCLS hcls
Subject: FDA: seeks input on Study Data Exchange Standards

FDA seeks "input from industry, technology vendors, and other members of the public regarding the advantages and disadvantages of current and emerging open, consensus-based standards for the exchange of regulated study data. "

In the annoncement for a meeting 5 November FDA ask for responses, before 5 October, on questions such as "- What are the advantages and disadvantages of HL7 v3 and CDISC ODM?"

And, interestingly, they also ask: "- Are there other open data exchange standards that should be evaluated?"

Is this an opportunity for a semantic web based proposal?

Kind Regards

Kerstin Forsberg

AstraZeneca



https://www.federalregister.gov/articles/2012/08/14/2012-19748/regulatory-new-drug-review-solutions-for-study-data-exchange-standards-notice-of-meeting-request-for

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Received on Wednesday, 15 August 2012 16:12:03 GMT

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