Q. What standards are available to healthcare trading partners and who manages them?
There are two types of data standards primarily used in the healthcare supply chain: those to identify organizations and locations (e.g. hospital, supplier, distributor), functional entities (e.g. purchasing department, nursing station) and physical locations (e.g. warehouse, loading dock, cabinet); and those to identify products at each specific unit of measure.

There are two main standards bodies that operate in the healthcare industry and administer standards for both organization/location and product identification: GS1 Healthcare and the Health Industry Business Communications Council (HIBCC). The GS1 standards include the Global Location Number (GLN) for organization/location identification and the Global Trade Identification Number (GTIN) for product identification. The HIBCC standards include the Health Industry Number (HIN) for organization and location identification and the HIBC-Labeler Identification Code for product identification.

Q. What are the industry standard sunrise dates and are they a regulatory requirement?
Many of the major U.S. group purchasing organizations (GPOs) and some large healthcare systems began using Global Location Numbers (GLNs) in place of proprietary account numbers on December 31, 2010, and have issued statements indicating they will require healthcare trading partners to begin using Global Trade Identification Numbers (GTINs) in place of custom item numbers by December 31, 2012. These are industry-proposed sunrise dates for GLN and GTIN implementation, and are not regulatory mandates.

Q. What is the Global Data Synchronization Network?
The GS1 Global Data Synchronization Network (GDSN) enables data synchronization using GS1 standard identifiers, namely, Global Trade Item Numbers (GTINs). The network comprises two parts: a GDSN-certified data pool and a Global Registry. A healthcare supplier can publish its data in the form of GTINs and associated product attributes to the GDSN through a GDSN-certified data pool so that authorized data subscribers, including providers, distributors, group purchasing organizations (GPOs) and solution providers, can gain access to accurate and timely product information. The Global Registry serves as a central place where parties publishing data and those accessing data through data pools must identify themselves with Global Location Numbers (GLNs), ensuring that only authorized subscribers can access a supplier’s product information via the network.

Q. What is the relationship between global data standards and the UDI?
In 2007, Congress mandated that the U.S. Food and Drug Administration (FDA) establish a system whereby medical devices are labeled with a unique device identifier (UDI). While the proposed rule has not yet been issued, the FDA has indicated that Global Trade Item Numbers (GTINs) and HIBC-Labeler Identification Codes (LICs) for product identification will qualify as UDIs.

Q. What plans are there for electronic health records to incorporate product standards?
In the healthcare reform bill passed by the House of Representatives (H. R. 3962), there was language requiring the inclusion of unique device identifiers (UDIs) for “covered devices” (primarily Class III devices) in certified electronic health records (EHRs). This requirement was tied to other language in the House bill calling for establishment of a "national medical device registry to facilitate analysis of post-market safety and outcomes data on each covered device" (again referring primarily to Class III devices). Neither of these sections made it into the final bill that was signed into law by President Obama, but there are still efforts under way to document UDIs in EHRs. The FDA is working with the Office of the National Coordinator for Health IT to potentially require the UDI for specific devices as part of Phase II/III of meaningful use for EHRs.