In a recent essay I discussed GS1 Healthcare’s proposed Network Centric ePedigree (NCeP) models that are currently available for review and discussion by the industry. By the way, GS1 is giving everyone until December 15 to respond to a survey to provide them with your thoughts on the various NCeP models. To review the videos and respond to the survey click on this link.
In a somewhat related news item, Pharmaceutical Commerce recently published an online article by Nick Basta about the Global Healthcare Exchange’s (GHX) project to build a new prototype for a track and trace data exchange hub called “GHX updates progress on a prototype data exchange for track-and-trace“. That article was an update to a more in-depth article by Nick about the project from last April in the same online magazine called “Healthcare Exchange Bids for Prototyping a Track-and-Trace System“. Combined, the two very interesting articles describe the prototype that is now complete and ready for piloting.
In fact, the GHX prototype implements a track and trace event data exchange hub that would allow companies in the pharmaceutical supply chain to store and exchange GS1 EPCIS event data that comprise the full chain of custody for drugs as they move down the supply chain. Effectively, the GHX prototype implements an NCeP where GHX provides connection pooling and all of the centralized services inherent in the ePedigree model. Larger companies would probably still want to have their own EPCIS-based applications in-house but it appears to me that smaller enterprises might only need a small data capture application that relies on the GHX service to hold all of their data.
GHX has a lot of experience with receiving, holding and sending sensitive company data between supply chain companies as an Electronic Data Interchange (EDI) exchange ecommerce hub, among many other services, primarily aimed at the U.S. medical/surgical supply chain. According to the original Pharmaceutical Commerce article the company has an interesting history which has resulted in it being owned today by about 20 different companies who are members of that same supply chain. A few of them are important members of the pharmaceutical supply chain as well (full disclosure: one of them is my day-job employer).
Keep in mind, as I pointed out in the essay, “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 2”, the GS1 NCeP models are not intended to meet existing ePedigee laws so the GHX service isn’t going to help with any of those today. The apparent assumption is that the Congress and/or the FDA will embrace one of the GS1 NCeP models and pre-empt the existing state laws in the next year or so and in that case, GHX will be ahead of the game with a service that is designed to handle data volumes in the range of what social media sites like Twitter and Facebook handle. According to Margot Drees, Director of Corporate Strategy at GHX, the service can already handle a sustained rate of more than 1,000 messages per second and burst rates of more than 5,000 per second. I’m told they expect to go well beyond those stats in the very near future. Contact Margot if you want more information.
WHAT DOES IT MEAN?
Pay close attention to what GHX has done with this new prototype and where they end up taking it in the future. It will likely be significant to the industry. The GHX prototype turns out to be a cloud-based service that they could mold into one of several of the NCeP models that have been defined by GS1, including either of the two Centralized models and at least one of the Distributed models (maybe more). The core functions in the GHX prototype are currently setup to implement a Semi-Centralized model but they could fairly easily be tailored to one of the others if future federal regulations turn out to favor one of the others. See my essay from last spring, “The Viability of Global Track & Trace Models” for more on pedigree models.
Because of their existing ecommerce business, GHX already has over 12,000 companies in the pharma and medical products supply chains connected to their infrastructure, according to one of the Pharmaceutical Commerce articles. What that means is that the setup costs for those companies to begin using a GHX NCeP could be minimal. The “pipe” to GHX—and by extension to up to 11,999 of their potential trading partners—already exists in the GHX “community”. This represents an advantage that would likely give GHX a leg up on any competitive NCeP service provider.
It is also very likely that the companies that are joint member-owners of GHX could be counted on to purchase their future NCeP exchange services from GHX. Take another look at the list of companies who fall into that category and you will see that they would represent a considerable portion of the transactions that would likely occur under a full, nationwide pedigree requirement. These are probably the reasons GHX was willing to invest the significant resources it must take to develop a cloud-based service that has the performance capability in the neighborhood of modern social media sites in such a short time.
But there are risks for GHX. First, what happens if Congress doesn’t enact a nationwide pedigree law that embraces an NCeP approach, or if they take so long to do so that the industry is forced to be ready for the California effective dates first? While the GHX prototype is only aimed at an NCeP approach right now it may be possible for them to redesign it to help companies store, validate and exchange DPMS pedigrees if the NCeP concept doesn’t take hold.
Another risk is the possibility that the NCeP model that the government and industry settle on could be one of the fully distributed versions that do not have any need for centralized components. In that case the value of the GHX service would be significantly decreased, but I think they could still attract customers because of the value of the connection pooling service they could offer. (See my essay, “Impact of RxUSA v. HHS On Future Pedigree Legislation“ for my thoughts on the likely failure of a distributed pedigree model in the U.S.)
Whatever ultimately happens I think GHX is a company to watch. What do you think? Leave a comment below and tell us.
2012: IT’S GOING TO BE A GREAT YEAR!
I’m planning on making this my last posting for 2011 so I can enjoy the holidays with my family and friends. I hope you all can do the same.
Keep reading RxTrace in 2012. A lot is going to happen and I will continue to provide you with my perspectives. Here is a short list of topics that I am already planning for 2012:
- FDA UDI proposed guidance
- The real pro’s and the real con’s of DPMS
- The complexities of pedigree compliance faced by kit makers
- More about applying standards to solve pharma supply chain problems
- A history of pharma supply chain security regulations and technology
Plus, analysis of:
- Whatever the FDA decides to do about updating their barcode rule
- Any action taken by Congress on Track & Trace or ePedigree
- Action by any state on ePedigree
- Industry preparations for California pedigree compliance