Health Level Seven Reference Implementation Model
How to cite this record FAIRsharing.org: HL7; Health Level Seven Reference Implementation Model; DOI: https://doi.org/10.25504/FAIRsharing.ka5tfc; Last edited: Jan. 8, 2019, 1:40 p.m.; Last accessed: Oct 19 2019 12:21 a.m.
Record updated: Jan. 16, 2017, 11:57 a.m. by The FAIRsharing Team.
Edits to 'https://fairsharing.org/FAIRsharing.ka5tfc' by 'The FAIRsharing Team' at 11:57, 16 Jan 2017 (approved): 'status' has been modified: Before: Ready After: Uncertain
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The Global Unique Device Identification Database (GUDID - pronounced "Good ID") is a database administered by the FDA as part of the UDI system. The GUDID contains device identification information submitted by device companies to the FDA. The GUDID contains ONLY the Device Identifier (DI), which serves as the primary key to obtain information in the database. Production Identifiers (PI) are not submitted to or stored in the GUDID, but GUDID data indicates which PIs are on the device label. Many data elements in the GUDID correspond to information on the medical device label. The figure below shows a fictitious medical device label and identifies the GUDID data elements that appear on the label. Please refer to the FDA UDI website for more information about GUDID data elements.
Medical Data Models
MDM-Portal (Medical Data-Models) is a meta-data registry for creating, analysing, sharing and reusing medical forms, developed by the Institute of Medical Informatics, University of Muenster in Germany. see also http://www.ncbi.nlm.nih.gov/pubmed/26868052 Electronic forms for documentation of patient data are an integral part within the workflow of physicians. A huge amount of data is collected either through routine documentation forms (EHRs) for electronic health records or as case report forms (CRFs) for clinical trials. This raises major scientific challenges for health care, since different health information systems are not necessarily compatible with each other and thus information exchange of structured data is hampered. Software vendors provide a variety of individual documentation forms according to their standard contracts, which function as isolated applications. Furthermore, free availability of those forms is rarely the case. Currently less than 5 % of medical forms are freely accessible. Based on this lack of transparency harmonization of data models in health care is extremely cumbersome, thus work and know-how of completed clinical trials and routine documentation in hospitals are hard to be re-used. The MDM-Portal serves as an infrastructure for academic (non-commercial) medical research to contribute a solution to this problem. It already contains more than 6,000 system-independent forms (CDISC ODM Format, www.cdisc.org, Operational Data Model) with more than 470,000 data-elements. This enables researchers to view, discuss, download and export forms in most common technical formats such as PDF, CSV, Excel, SQL, SPSS, R, etc. A growing user community will lead to a growing database of medical forms. In this matter, we would like to encourage all medical researchers to register and add forms and discuss existing forms.
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