Last week I published an essay that gave GS1 some advice on how to trigger interest in adoption of their Global Data Synchronization Network (GDSN).  Those of you who read that essay in the first two days read my snarky comments about GS1 seemingly attempting to commandeer the term “Data Quality” to include the need for GDSN.  That was based on a mis-interpretation of their marketing materials for their “Data Quality Framework” and as soon as I discovered my mistake I removed that part of the essay, leaving the core point of the essay intact (see “An Open Letter to GS1, RE: GDSN Marketing”).

In fact, GS1 is saying exactly the opposite of what I originally thought regarding Data Quality and GDSN.  That is, before you start publishing your supply chain master data (SCMD) through GDSN you should ensure that the quality of your data is high.  As GS1 points out, “Good quality data is foundational to collaborative commerce and global data synchronisation.”  I couldn’t agree more.

The GS1 Data Quality program is centered on the “Data Quality Framework”, which is maintained by GS1 but, according to them, was originally developed by AIM, CIES, ECR Europe, FMI, GCI and GMA.  These organizations are predominantly focused on the food supply chain which is ahead of the healthcare supply chains in their use of automatic identification and data capture (AIDC) and in the use of GS1 GDSN.

The Data Quality Framework appears to be a giant “lessons learned” resource provided by the members of the food supply chain to other companies and other supply chains who might want to follow in their footsteps.  As such, it could be very valuable to companies in the healthcare supply chains to help streamline their move to more efficient AIDC and data exchange.  From my experience, healthcare has a long way to go.

You can download the GS1 Data Quality Framework from this GS1 webpage.  It consists of a ZIP file that contains a self-assessment scorecard, a Data Quality Presentation (2010), a Data Quality KPI Checklist and two PDF files.  One called “Implementation Guides for the Data Quality Framework”, and “Data Quality Framework”.

In my experience within the healthcare supply chains, companies resist the idea of data synchronization, but I haven’t heard anyone who thinks the quality of their master data couldn’t be improved.  In fact, it’s a perennial problem.  Of course, you will find that the Data Quality Framework that GS1 is offering expects you to make use of GS1 identifiers like GTIN and GLN.  No surprise, but somewhere the case has to be clearly made in support of all members of a given supply chain benefiting from the use of the same identifier for a given thing.  Is this it?  Maybe.  Maybe not.  Why not give it a chance?  No one knows better than you that your master data isn’t perfect.

Dirk.

Dear GS1,

How have you been?  I’ve been fine, done a bit of writing since we last met and gotten a little greyer.  How are the kids?  My two kids are doing great but I have to admit, after raising two I don’t know how you do it with 125 kids, or whatever the number of M.O.s there are today.

The reason I’m writing to you today is to offer you my thoughts on your Global Data Synchronization Network (GDSN) Marketing campaign.  That campaign would be more effective if it focused on demonstrating the distinction between internal master data (and programs associated with improving its quality), and externally shared master data (and the significantly different kinds of programs needed to improve its quality).  And especially to show that many (most?) of company master data is, in reality, externally shared master data, either incoming or outgoing.  That’s the step that I see missing from your campaign.

Companies who are already familiar with the kind of programs that are designed to improve their internal master data need to be taught to see the special characteristics of the externally shared master data which they could publish for the benefit of their trading partners, or which they could consume from the trading partner who “owns” that data.  These are the characteristics that make the externally shared master data unique from the purely internal master data.  This is the epiphany that your marketing campaign should seek to impart.

Your campaign should acknowledge the existence of internal master data—the kind that benefits from the traditional data quality management programs but which would not benefit from the use of GDSN.  By separating this kind of data from the externally shared kind of master data you will help companies recognize on their own why they may have had so much difficulty elevating and sustaining the quality of this class of data in past data quality efforts.  Once that realization occurs, the need for, and the value of GDSN will become obvious and you will no longer need to “sell” anyone on it.  They would seek it out instead.

HERE’S HOW YOU DO IT

It’s really pretty simple.  All you need to do is to define a new term for the externally shared master data, a term that makes it clear that it is distinctly different from internal master data.  I have proposed the term “Supply Chain Master Data” (SCMD) in the past (here, here, here and here) because I believe it accomplishes that goal.  SCMD is MD that is shared within a supply chain.  I offer that term to you (it isn’t protected as far as I know)—or make up your own.  As long as you talk about SCMD as a special class of MD and how it’s quality can benefit from the application of GDSN I think you will get a lot more agreement because it will finally make sense to people, especially those who are new to GS1.

Whether you pick up my suggestion or not I wish you luck in your current marketing campaign.  I look forward to see you at our next meeting.  Say hi to the spouse and kids.

Sincerely, Your Friend,

Dirk.

The title is a paraphrase of a TV commercial from the 1960′s, ’70′s and ’80′s for Lay’s Potato Chips but the sentiment is the same.  You really can’t get away with using only a single GS1 standard.  That’s why they are sometimes referred to as “The GS1 System of Standards“.  It’s a “system” of standards.  Multiple standards that are designed to work for you together in concert; as a whole; not independently.

So when your customer demands that you make use of Global Location Numbers (GLN) and/or Global Trade Item Number (GTIN), they are starting you down the path of adoption of much more than just those two “entry-level” standards (see my essay “So a customer demands that you use GLN’s and GTIN’s. What next?”).  Here is a partial list of other GS1 standards that you may benefit from adopting once you fully embrace GLN and GTIN:

• GS1 UPC barcode symbology
• GS1 element strings encoded in a barcode symbology such as:
• GS1-128
• GS1 DataMatrix
• GS1 DataBar
• GS1 EANCOM EDI standard
• GS1 EPC RFID in frequencies such as
• UHF
• HF
• GS1 Electronic Product Code Information Services (EPCIS)
• GS1 Drug Pedigree Messaging Standard (DPMS)
• GS1 Global Data Synchronization Network (GDSN)

GS1 Healthcare is a community organization of end users within GS1 who are members of the global healthcare industry.  That organization created the following figure to show how GLN and GTIN are foundational to patient safety and supply chain efficiency, the ultimate end goals of its members.  At the top of that foundation is GDSN and above it are the five pillars of patient safety, which support the ceiling of supply chain efficiency and the overall roof of patient safety.  (See “Change has finally come:  U.S. Healthcare industry to implement common data standards to improve safety, reduce costs” by Joe Pleasant, CIO and SVP, Premier, Inc.)

GS1 Healthcare Patient Safety "House of Standards"

Many U.S.-based hospital Group Purchasing Organizations announced a number of years ago that they would require the use of GLN and GTIN by December 2010 and 2012 respectively.  Apparently at least one of those GPO’s also requires the use of GDSN but without specifying a date.

GS1 GLOBAL DATA SYNCHRONIZATION NETWORK (GDSN)

GS1’s GDSN is a standard that can be used by supply chains to communicate product class-level supply chain master data (SCMD) to all of the companies who participate in it.  Here is how I described it in my essay, “Supply Chain Data Synchronization and Patient Safety”:

“Generally, [GDSN’s] use requires all trading partners in a given supply chain to subscribe to a GDSN-conformant Data Pool service provider.  Unilateral adoption of GDSN by a single company doesn’t make any sense.  It’s a high bar for a large and complex supply chain to achieve through voluntary means.  Right now the pharma supply chain in the U.S. has not achieved it and so the quality of SCMD in the supply chain is currently dependent on ad hoc relationships and data passing.  Some of this includes manual data entry into the local master data systems at many points in the supply chain.”

Here is one way GS1 draws GDSN.  This view emphasizes the plumbing and shows the “how” of GDSN.  (See “Global Data Synchronization Network® (GDSN) Operating Roadmap for GS1, Version 7.3” November 2011.)

Click image to enlarge

Here is my rendition of GDSN use in healthcare.  I show it as a cloud-based repository where the manufacturer publishes their product master data and where downstream trading partners can subscribe to it.  That way everyone in the supply chain—right down to the healthcare professionals at the points of care—are using the exact master data as published by the manufacturer.  Admittedly this rendition doesn’t show how GDSN is implemented, but I happen to think that’s less important that showing what it is.  See GS1 for the details.

Click image to enlarge

Up to this point in time there still hasn’t been any significant use of GDSN in the U.S. medical supplies and devices supply chain and it is tough to get an entire industry to adopt something so large without some kind of incentive.  The GPO’s are trying to provide that incentive by mandating its use, so at some time after the GTIN is widely adopted on medical supplies and devices, SCMD may be synchronized between manufacturers and hospitals, and perhaps distributors as well.

USE OF GDSN IN THE U.S. PHARMACEUTICAL SUPPLY CHAIN

GDSN is also not currently used in the U.S. pharmaceutical supply chain, but in my view, it will be a necessity if/when GS1’s EPCIS standard is ever used for track and trace applications like ePedigree.  In my view, EPCIS alone can’t be used for compliance with the existing pedigree regulations in the U.S. (see my essays, “Why GS1 EPCIS Alone Won’t Work For California Pedigree, Part 1” and “…Part 2”).

But EPCIS just might become the basis for the track & trace standard that the FDA will publish by the end of this year (see me essay “InBrief: FDA To Publish Track & Trace Standard By Year End”).  Many people believe that standard will be based on EPCIS, similar to the way FDA aligned their sNDC standard with GS1’s GTIN (see my essay “FDA Aligns with GS1 SGTIN For SNDC”).  Include me in that group.

But, by design, EPCIS events do not carry SCMD (see my essay, “Pedigree Models and Supply Chain Master Data”), so if EPCIS events form the basis of an ePedigree, it will be a absolute necessity that all parties who are consuming and updating those pedigrees use the identical product class-level master data.  That would be necessary because everyone would need to agree on exactly what constitutes the drug that is referenced by the GTINs in the EPCIS events.  Without that common agreement on exactly what the GTINs mean, how can there be a true pedigree?

Here is a drawing that shows how GDSN could be used in conjunction with a semi-centralized ePedigree system that is built on top of EPCIS events.

Click image to enlarge

Notice how each trading partner in the supply chain communicates with both the GDSN cloud and the Semi-Centralized ePedigree cloud.  In actual implementation these clouds might not be so distinct because the same vendors might offer both, but I show them separate here because they are serving distinctly different purposes.

The GDSN cloud is serving as the common source of product SCMD as published by the manufacturer—keyed off of the GTIN—and the Semi-Centralized ePedigree cloud, based on EPCIS, is serving as the common repository for all supply chain events that occur to the actual unit-level instances of those products—keyed off of the serialized GTIN, or SGTIN.  The clouds also communicate with each other because, to produce a usable ePedigree report the ePedigree engine would need to obtain the SCMD from the GDSN cloud.

As I said, I think something like this will be a necessity if EPCIS is used as the basis of an ePedigree system.  So far when people in the industry talk about using EPICS for ePedigree they almost always forget the SCMD.  The ePedigree solution I show in the figure above is a very efficient model since the SCMD does not travel along the same path as the instance data (the EPCIS events).  This is in stark contrast to DPMS which needs to carry that data along with each ePedigree document—a big negative for that standard that many have pointed out over the years.

All pedigree models have trade-offs.  One of the trade-offs of ePedigree models based on EPCIS is that GDSN will probably have to be adopted throughout the U.S. pharma supply chain over a fairly short period of time, but no doubt patients would benefit greatly from that.

BETCHA CAN’T USE JUST ONE

There you have it.  Not only would pharma trading partners need to adopt GLN and GTIN, in this scenario they would also need to adopt EPCIS and GDSN shortly afterward.  In the pharma supply chain you can’t use just one!

Can you see any alternatives to this scenario besides adding DPMS in some way?  Leave a comment below.

Dirk.

GS1 US is dedicated to expanding the adoption of GS1 Global’s standards for supply chain interaction in the U.S. market.  Almost every country in the world has a GS1 “Member Organization” (M.O.) that is dedicated to the same thing within their borders.  With the local M.O.’s primary focus on driving adoption, their most valuable tool is that country’s government.  If they can get the government to reference GS1 standards in their laws, their work is much easier. 

This isn’t unique to GS1, or course.  All standards organizations know this and they all have various approaches to getting the attention of each country’s government.  There is nothing wrong with this.  In fact, it makes perfect sense since, unlike standards organizations themselves, countries always have very large enforcement wings.

But what happens when those governments are too big to sway easily?  What if it costs too much and takes too long to get them to see the light?  This is when a standards adoption organization needs to get creative.  In my opinion, that’s what has led GS1 Healthcare US to create the “2015 Readiness Program”.  It was out of frustration with the California State Government and with the U.S. Food and Drug Administration (FDA) and their, so far, unwillingness to create laws and regulations that mandate the use of GS1 standards.  Let me explain.

THE GS1 HEALTHCARE US 2015 READINESS PROGRAM

The GS1 Healthcare US 2015 Readiness Program is a voluntary program that is open to any company that is a member of the U.S. pharmaceutical supply chain.  You don’t have to be a GS1 US subscriber to participate in most of the program activities or to benefit from it.  The program was conceived by GS1 U.S. about a year ago and it was kicked off in January of 2010.  The program includes a series of weekly teleconferences where representatives from the member companies collaborate to document the many business processes necessary to package, distribute and dispense pharmaceuticals within the U.S. supply chain, including the many exceptions that can happen along the way.  The group then figures out how to apply GS1 Electronic Product Code Information Services (EPCIS) standard in a way that GS1 Healthcare US believes would make the whole process more efficient and would hopefully increase the safety and security of the supply chain. 

That is, it would do these things IF every company that participates in the U.S. pharmaceutical supply chain were to adopt the EPCIS standard in a uniform way by purchasing and deploying products based on that standard.  It’s a big “IF”.

But here’s the best part about the program.  As the idealized supply chain model is being developed, GS1 Healthcare US has used a third-party simulation tool to actually simulate the EPCIS data exchange that would occur in it.  Participants are allowed to take home a copy of the simulation runtime environment and they can actually make some configuration changes to the model to help them study what might happen in that world under their own special circumstances.  It’s pretty powerful stuff.

GS1 Healthcare US is offering two 1 ½ day workshops that are open to anyone wishing to learn about the program, learn how to use the simulation and get a copy of it for their own use.  These workshops are:

October 12-13, 2010 • Hotel Kabuki • San Francisco, CA

November 10-11, 2010 • Gaylord National Resort & Convention Center • National Harbor, MD
(Co-located with HDMA Track-and-Trace Technology Seminar, my favorite serialization and ePedigree event)

You can find out more about these GS1 Healthcare US events and register by clicking here.

I’m pretty excited about it and I encourage anyone who is interested to participate in the group that is continuing the development of the simulation and/or these workshops.  I’m pretty confident that GS1’s EPCIS will be used by many in the U.S. supply chain and this workshop is a great way to really understand what it can do when it is applied in a specific supply chain context.  In fact, members of other supply chains might even want to take note of this excellent piece of work and consider asking GS1 US to develop one for your supply chain.

SO WHAT’S THE PROBLEM?

The problem is, I think GS1 US is crossing the line between just advocating adoption and inducing it through mis-characterization.  Let’s start with the name itself:  “2015 Readiness Program”.  Ready for what?  What happens in 2015?  Oh, that’s the year that the first of multiple requirements of the California Pedigree Law goes into effect.  But no one has yet figured out exactly how to apply EPCIS-only to comply with that law.  In fact, even GS1 US will admit that they are not saying that use of EPCIS would make you compliant with that, or any other law, but you have to press them to hear that.

So what would you be “ready” for?  Perhaps you would be ready to deal with the serialization component of the California law?  Now that I would agree with.  Serialization is a big part of the California law, and it’s arguably the most complex and expensive component.  So, yeah, that must be it.  To say nothing of compliance with the law, you could at least be “ready” for part of the pedigree law by 2015 if you made use of EPCIS to help you deal with serial numbers on drug packages and shipping containers.

But the way the program is constructed, and the solution is implemented for simulation, it results in a distributed pedigree system—one where you have to query all the previous owners of a drug to collect the various components necessary to assemble your pedigree.  The implication is that you would only need to do that whenever a California State inspector shows up at your door and asks to see the pedigree for “this bottle”.  The GS1 Healthcare US program doesn’t try to interpret the law to make sure the proposed solution would comply with it.  That’s up to the end users. 

The introductory paragraph of the GS1 Healthcare US “2015 Readiness Program Guide” starts this way: 

“The 2015 Readiness Program was established by GS1 Healthcare US to help members of the U.S. pharmaceutical supply chain prepare for state drug pedigree requirements beginning in 2015 and learn how to leverage the same data stream used for regulatory compliance to realize additional business benefits.”

That implies that I should expect to be ready to comply with state drug pedigree laws if I participate, but so far, that won’t happen.

The ruse will be carried one step farther because GS1 Healthcare US has included speakers from the California Board of Pharmacy and the FDA in their workshops, giving the appearance of full support and an acknowledgement of compliance.  Virginia Herold, Executive Officer of the California Board of Pharmacy will be a guest speaker at the California workshop and Connie T. Jung, RPH, senior advisor for pharmacy affairs of the FDA will speak at the Maryland workshop. 

ASK THESE QUESTIONS

Those of you who will attend these workshops should ask these questions:

• Ask these guest speakers if the agency they work for would accept a distributed pedigree as compliant with their pedigree law 
• Ask GS1 Healthcare US how the system being simulated will comply with the California requirement that the pedigree you receive from your supplier, and the pedigree you provide to your customer, must include all prior supply chain ownership history, including all certifications
• Will California accept that approach? 
• Ask GS1 how you would include a certification that the necessary collection of events are true and correct
• Is that approach acceptable to California? 
• While you’re at it, ask your legal department if they will allow you to buy drugs from a supplier who would not typically provide you with the entire pedigree as defined by California once the law goes into effect
• Will your own company accept the risk that the full pedigree data might not be available from the previous owners at the time that inspector shows up?

GS1 will tell you that these things have not yet been worked out.  I say that they haven’t been worked out because GS1’s approach to pedigree using only EPCIS won’t work very well once you add the necessary steps to make it fully compliant.  They are simulating the popular track and trace part of the law, but not the unpopular pedigree compliance parts.  A simulation of an EPCIS pedigree system that included features necessary to fully comply with California wouldn’t be very compelling or generate as much interest as one without those “complex” features.

MY VIEW OF THE SITUATION

Serialization systems based on the GS1 EPCIS standard will very likely be valuable for pharmaceutical manufacturers who must keep track of all of the serial numbers they apply to their products—pedigree law or not.  It will probably be valuable for pharmaceutical distributors to keep track of which drug packages were received and shipped and when using EPCIS.  But there is no certainty that systems based on EPCIS will be justifiable for use in systems aimed at pharmacies. 

The pedigree system that would result from EPCIS event exchange would require so many undefined contortions to get it to comply with California’s existing law that the industry is unlikely to accept it, especially when all you really need to do to make those systems compliant is to simply add the use of the GS1 Drug Pedigree Messaging Standard (DPMS).  DPMS would give you the ability to comply with the law and EPCIS would give you the non-regulatory benefits that GS1 is simulating. 

Should you attend the GS1 Healthcare US 2015 Readiness Program Workshops?  Yes.  Should you expect to be ready for the California Pedigree Law by 2015 as a result?  No.  At least not yet.

In the healthcare supply chain a significant number of hospital group purchasing organizations (GPO’s) have stipulated, to varying degrees, that their suppliers begin making use of GS1 Global Location Numbers (GLN’s) in all of their trade with their member hospitals by the end of 2010 (Sunrise 2010) and GS1 Global Trade Item Numbers (GTIN’s) by the end of 2012 (Sunrise 2012).  Here are the announcements from Novation, Premier, MedAssets and Amerinet.  From the wording of their announcements it appears that you have little choice, especially if you have competitors who are planning to comply with their requirements.

Companies who supply these hospitals are faced with how to comply with those requirements.  The best advice I can give to companies that are facing these requirements is to contact the respective GPO offices and get their specific direction.  Each GPO may have a different interpretation of their own requirements.  GS1 U.S. is the second place you can go for additional information about the proper way to establish the necessary capability in your IT systems.

Here is a list of questions you may want to ask of each GPO to help you understand what you have to do to comply:

1. Do they require the use of GLN’s in addition to HIBCC’s Health Industry Number (HIN) or instead of it?
   
   
2. Do the GTIN requirements only cover medical devices or does it include everything a hospital purchases including pharmaceuticals and over-the-counter (OTC) products?  Does it include implants?  As I understand it, most implants currently use HIBCC product codes because they use alphanumerics which offers an expanded number of possible codes.  I’ve heard people speculate that the GPO requirements only cover medical devices, but when I read their announcements it sounds to me like they mean everything they purchase.
   
   
3. Are the 2010 and 2012 dates the earliest time you are allowed to begin using GLN’s and GTIN’s respectively in transaction documents, or can you begin using them as soon as you are ready?  In other words, can the GPO assure you that their member hospitals are ready to accept them whenever you are ready to supply them, or do you have to wait until the actual sunrise date, or worse, selectively turn on the capability, one hospital at a time, as they become capable of receiving them?
   
   
4. If you have every intention of making the necessary system changes to comply, but you just can’t get the resources necessary in time (remember, GLN by the end of this year), can you continue to do business with the member hospitals after the sunrise dates?  This is a test of how “hard” these deadlines really are.
   
   
5. The point of GLN’s and GTIN’s is to allow you to remove all of the supply chain master data (SCMD) elements that are associated with these numbers from all transaction documents.  But it’s unclear if that’s what the GPO’s are really asking for.  SCMD elements for GLN’s include things like the company name, street address, phone numbers ,etc.  SCMD elements for GTIN’s include things like the product name, size, color, form, weight, temperature requirements, etc.  Do they expect you to remove all of the master data elements that are associated with your GLN’s and GTIN’s from your transaction documents (printed and electronic), or do they want to keep all of that data in your documents, but just add the GLN numbers and GTIN numbers?
   
   
6. Do they require you to subscribe to and register your GLN’s in the GS1 U.S. GLN Registry for Healthcare, or can you just provide them with your GLN(s) and their associated supply chain master data?  If they don’t require you to use the GLN Registry, what mechanism will they accept for transmitting your supply chain master data?
   
   
7. Similarly, do they require you to subscribe to a GS1 GDSN data pool and maintain your product’s supply chain master data there?  If not, what mechanism will they accept for conveying your product master data?  (Depending on their answer to #5 above, they may not need you to give them your SCMD, yet.)
   
   
8. What if you are a wholesaler and the manufacturer’s of the medical devices and pharmaceuticals you supply to their member hospitals do not even have GS1 GTIN’s defined for their products but have HIBCC-based product codes instead?  (GS1 GTIN allocation rules prevent you from creating GTIN’s on behalf of the original manufacturers.)  Will the HIBC code fulfill the requirement? 
   
   Be aware that the GS1 U.S. GLN Registry for Healthcare will not accept HIN’s and GDSN data pools will not accept HIBC codes.  Will the GPO’s accept the use of HIBCC’s HIN System database in addition to the GS1 Registry?  Will they accept the use of HIBCC’s UPN Repository in addition to GS1’s GDSN?  Don’t get your hopes up, but these are important questions for you to ask just to get clarity on what is expected of you.

I’m told that many ERP systems are able to define a custom set of item number aliases for each of your customers.  That’s one way to force the use of GTIN’s for each SKU on your transaction documents for GPO members.  Of course, GS1 is hoping you decide to cascade the GPO requirements to all of your internal systems and then to your suppliers as a GPO-like requirement.  That approach would spread the use of GS1 identifiers throughout all of your IT systems that deal with supplier and customer addresses (GLN’s) and item information (GTIN’s).

That might be a pretty big change, but you should evaluate the pros and cons of both approaches before you decide which way is best for you.  One thing to keep in mind is that the Sunrise dates are not regulatory requirements and GS1 has no authority to place requirements on anyone.  At this writing, it’s only a requirement of some GPO’s.  On the other hand, it’s hard to imagine that the supply chain can achieve a steady state with a mixture of HIBCC and GS1 location and product identification codes once the GPO mandates are operational.  More than likely the switch from HIBCC standards to GS1 standards will accelerate until only GS1 remains.

GS1 U.S. RESOURCES

GS1 U.S. has prepared a number of documents to help GPO suppliers meet the Sunrise requirements.  Most of them can be found in the GS1 U.S. Healthcare Document Library.  I’ve already provided hyperlinks to some of these resources above but here are a few more that you will find helpful:

• JUST RELEASED!  2010 GLN Sunrise Explained:  Industry Implementation Plan 
• Mayo Clinic – Cardinal Health GLN White Paper
• GS1 U.S. Healthcare Industry Sunrise Dates web page with links to toolkits and white papers
• Introduction to GS1 Standards in Healthcare
• GS1 U.S. Healthcare web site

SO YOUR SUPPLIER HAS ANNOUNCED THAT THEY ENDORSE GS1 STANDARDS, WHAT DOES THAT MEAN TO YOU?

At least one medical products wholesaler has recently stated that they endorse GS1 standards, specifically GLN and GTIN.  See a copy of their statement on page 3 of this report.  It appears that they are not requiring their suppliers or customers to support these standards, but if you are from a company who buys medical supplies from a company who has made an announcement like this and you prefer to continue using HIN for location codes and HIBC product codes, make sure you read their statement yourself and decide what it means to you.  If you have any questions you should contact them directly.

WHY ARE COMPANIES MAKING THESE ANNOUNCEMENTS ANYWAY?

There are two primary goals that underlie the movement to GS1 identifiers in the healthcare supply chains:  Patient Safety and Efficiency.  In my observation, companies who have decided to throw their weight behind the GS1 sunrise dates are doing it to remove as much ambiguity as possible from supply chain transactions.  Ambiguity is the enemy.  Ambiguity causes inefficiencies and it can harm patients, or worse.  And we have tolerated way too much ambiguity in the supply chain for too long.

Most of the ambiguity in the healthcare supply chains today occurs when companies use different master data than their trading partners are using for the same product or location.  That is, each company is maintaining their own local master data (MD) for each product code and each customer and supplier location.  They are using MD when they should be using Supply Chain Master Data (SCMD).  SCMD removes ambiguity because there is a single version of the truth across the entire supply chain for each product and location.  With SCMD, there is only one company responsible for maintaining the master data for each identifier on behalf of the entire supply chain, and that company is the owner of the data.  That is, each manufacturer is responsible for maintaining the SCMD for the products they manufacturer, and all of the other companies in the supply chain are provided that data, along with each update as soon as it occurs.  The same for each location in the supply chain.

GS1’s standard for the synchronization of supply chain master data (SCMD) is Global Data Synchronization Network (GDSN).  So why are we hearing about requirements for the adoption GLN and GTIN and not for GDSN?   The reason is simple.  The adoption of GS1’s GDSN standard for the synchronization of supply chain master data (SCMD) can only occur when there is a surge of trading partners who agree to implement it all at once, and who then put pressure on their other trading partners to adopt it at the same time.

It’s a very high threshold that must be overcome before GDSN can provide benefits to the supply chain.  So the first thing you have to do is get your supply chain to use the same standards for product and location identifiers.  That’s a prerequisite to GDSN.  GLN and GTIN are the only identifier standards that work with GDSN so that’s why we have Sunrise 2010 and 2012.  I will be very surprised if we don’t eventually see a Sunrise date issued for the adoption of GDSN by the same GPO’s once the supply chain is using only GLN’s and GTIN’s.  Use of a single standard for SCMD is the least complex way to remove ambiguity, which will finally elevate patient safety and supply chain efficiency, the ultimate goals.

HOW DOES HIBCC FIT INTO THE GLN, GTIN AND GDSN WORLD?

Short answer:  it doesn’t.  As I pointed out in my previous essay, the success GS1 has had in capturing the attention and support of the GPO’s is the biggest blow to HIBCC’s future.  GS1’s standards are currently designed to work only with GS1 identifiers, and that’s unlikely to ever change.  Part of the removal of ambiguity is narrowing the supply chain to a single set of standards and GS1 has the upper hand right now.  The fact that the block that is driving toward GS1 standards is composed of hospitals is significant.  Hospitals are large consumers of medical devices that have traditionally been identified with HIBC codes, more so than pharmaceuticals anyway.  Once that domino falls, it’s hard to imagine where HIBCC’s support will come from.

This is not my last word on the war between GS1 and HIBCC but I’m not sure if I will have time to complete the subject before the FDA releases their Serialized Numeric Identifier (SNI) guidance, which is due by the end of this month.  I hope to post my thoughts on SNI shortly after they publish.  Watch for it.

Dirk.

For more RxTrace essays related to this topic see:

• “WAR: GS1 Vs. HIBCC “
• “Anatomy of a GTIN“,
• “FDA Aligns with GS1 SGTIN For SNDC “,
• “Updated HDMA Bar Code Guidance: A Must Read “
• “Anatomy Of The National Drug Code“.

Does the supply chain itself make any contribution to patient safety?  The legitimate pharmaceutical supply chain is that complex web of companies that move drugs from the manufacturers to the pharmacies that dispense them to patients.  The supply chain always includes both of those end points (manufacturer and pharmacy) and, in the U.S., normally also includes at least one wholesaler.  The supply chain is typically viewed as “Manufacturer to Wholesaler to Pharmacy”, whether the pharmacy is within a hospital, clinic, retail independent, chain store, grocery store, or mail order.  The great majority of prescription drugs arriving in the hands of U.S. patients have passed through this supply chain.

So what contribution does this chain make toward the safety of those patients?  In my view, it comes in three ways:

1. Supply Chain Integrity
   This includes the responsibility of each supply chain company—and by extension to each of their employees—to be ever vigilant for attempts by criminals to introduce illegitimate drug products into the legitimate supply chain.  Trading partners should know their suppliers very well (to prevent the introduction of counterfeit, tampered or stolen drugs) and they should also know their customers (to detect and stop diversion).  The protection of patients here is fairly obvious.  They can trust that the prescriptions they receive at any legitimate pharmacy in the U.S. will contain exactly the legitimate drug their Doctor or Pharmacist prescribed.  When supply chain integrity breaks down, very sad things happen.
2. Recall Execution
   This includes extremely fast (near instant?) blockage of any shipment of units covered by a recall, communication of the recall notice to supply chain customers who have been shipped the recalled units any time in the past, and a tight quarantine of the recalled units to ensure that they cannot make their way back into regular stock.  Once a recall is issued—especially a safety recall—there should be no way for these units to move forward in the supply chain again.  Patients are protected by the immediate removal of a large pool of the recalled items from their availability, thereby reducing the problem to those remaining units that have already been dispensed to patients by pharmacies (and those drugs are outside the supply chain).  When this breaks down, patients may end up being dispensed prescriptions that contain the recalled medicine even after the recall has been issued.
3. Data Quality
   This includes the use of accurate data about each drug by every company in the supply chain.  The drug manufacturer creates this data and each successive owner in the supply chain must ensure that they are using that exact data as part of their buying, selling and dispensing.  Patients are protected mostly by their pharmacy’s use of accurate data, but because the supply chain arm of a pharmacy company may rely—at least in part—on data received from their supplier, in those instances, the quality of the data supplied will have a direct impact on patient safety.  When this breaks down there is a slight, but unnecessarily elevated risk that a patient somewhere could receive the incorrect dosage, the incorrect drug entirely, or a drug that is covered by a known recall.

Interestingly, all of these contributions to patient safety become much easier to implement and are much more reliable in execution when the drug packages are serialized and all companies in the supply chain make use of those serial numbers to maintain pedigrees.  For downstream trading partners to be able to make use of these serial numbers it is essential that manufacturers also supply two types of data for each product they serialize:  Supply Chain Master Data (SCMD) for each Stock Keeping Unit (SKU), and Instance Data (IData) for each serial number.

SUPPLY CHAIN MASTER DATA SYNCHRONIZATION

SCMD is the data that describes each product that is traded in the supply chain.  The synchronization of that data requires the creator (with a lower case “c”…I’m referring to the drug manufacturer here, not God) to pass it to every potential supply chain owner of their products, and keep it up-to-date, so that they always have the correct information.  The product code is the identifier that is used by supply chain members to link to, and reference, the SCMD.  In the case of drugs in the U.S., that product code is the NDC.

As you might expect, GS1 has a series of standards that can be used to implement SCMD.  They include the Global Trade Item Number (GTIN) and Global Data Synchronization Network (GDSN) standards.  In the pharmaceutical supply chain a GTIN can be composed from the combination of an FDA-issued Labeler Code and FDA-registered Product Code (the two components of the NDC) as a base, although manufacturers are expected to register with GS1 and pay a fee before doing so.

GS1’s GDSN is a standard that can be used by supply chains to communicate SCMD to all of the companies who participate in it.  Generally, its use requires all trading partners in a given supply chain to subscribe to a GDSN-conformant Data Pool service provider.  Unilateral adoption of GDSN by a single company doesn’t make any sense.  It’s a high bar for a large and complex supply chain to achieve through voluntary means.  Right now the pharma supply chain in the U.S. has not achieved it and so the quality of SCMD in the supply chain is currently dependent on ad hoc relationships and data passing.  Some of this includes manual data entry into the local master data systems at many points in the supply chain. 

INSTANCE DATA COMMUNICATION

Instance data is data that describes the unique and specific identity of individual units, or a relatively small collection of units of a given SKU.  For the pharmaceutical supply chain this always includes the lot and expiration date of each unit, but in the future it could also include covert security elements that could vary and therefore could be unique by the individual unit.  Like SCMD, only the creator (again, the manufacturer, but also repackagers) can create the instance data.  The unique identifier—typically composed of the product code plus a serial number—is the identifier that is used by supply chain members to link to, and reference, the instance data.  Some instance data, like information about individualized covert security elements, are not shared with downstream trading partners but are kept by the creator for use in their product or package authentication system, but data like lot and expiration date must be shared with downstream trading partners.

Again, as you might expect, GS1 has a standard to help supply chains exchange instance data.  The Electronic Product Code Information Services (EPCIS) standard can be adopted by supply chains for this purpose.  Unlike GDSN, there may be reasons a company can find value in applying EPCIS unilaterally, but the adoption of EPCIS for communicating instance data with trading partners only makes sense if all of your trading partners agree to adopt it as well.  So far the pharma supply chain in the U.S. has not yet adopted EPCIS widely for the purpose of exchanging instance data, but the standard has caught the attention of a number of the larger corporations within the supply chain.  Some of those companies are working with GS1 U.S. to figure out how this instance data can be exchanged in an interoperable way.  Currently there is no widely adopted alternative approach for communicating instance data because serialization, the enabling prerequisite technology, is only just now starting to be deployed on a handful of products in the supply chain.

MOTIVATION FOR ADOPTION

Deploying applications that serialize units, synchronize SCMD and communicate instance data through the supply chain is expensive.  Generally, companies look for hard financial returns on any investments they consider.  It’s nearly impossible to find a positive ROI from serialization and the associated data synchronization and communication.  That is, depending on how you measure “return”, and that depends on your motivation. 

Richard Feldman, Vice President of Trade and Product Safety at EMD Serono, a manufacturer of biopharmaceuticals, and Ron Bone, Sr. Vice President, Distribution Support at McKesson, a U.S. pharmaceutical wholesaler, both spoke about motivation as it relates to adoption of this type of technology at the Track and Trace Technology Seminar held by the Healthcare Distribution Management Association (HDMA) this past December.  Feldman spoke about his company’s high-level commitment to patient safety and how that commitment motivated the corporation to view funds spent on technologies designed to protect the supply chain as sound investments.  They measured the return on their investments differently than those who looked only for the hard financial returns that are so hard to come by.  Bone spoke of a similar commitment at McKesson.  Both referred to understanding and support from the highest levels of the company leadership. 

These are true supply chain organizations who realize that their very existence as participants in the pharma supply chain comes with a responsibility to contribute to its integrity.  The “return” on those investments may be immeasurable because it is most directly collected by their ultimate customers—the patients.  The result is a more secure supply chain, and a more secure supply chain is a healthier one.  One that will continue to operate well, and that ensures their ongoing participation in it.  Now that’s a “return” that every company should recognize and embrace.

In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”.  The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc.  In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards.  Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States.  It’s well worth reading.

I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry.  There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another.  In effect, it’s a patchwork, yet each user can claim to be using a standard.  This was exactly the case with the railroads 150 years ago as Mike’s analogy implies.  Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard?  I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard.  That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.

Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR).  He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI).  He calls for the use of part of the federal economic stimulus money to be used for standards development. 

SLEEPY PROPOSAL BECOMES HOT TOPIC

Fast forward to January 6, 2010.  On that date, VHA issued a press release calling for actions by the FDA and the Obama Administration that were the same as the Cummins posting from last April.  The title of the press release is “VHA Inc. and 12 of the Nation’s Largest Health Care Systems Call for Government to Mandate GS1 Data Standards to Improve Health Care”.  The press release did not include Mike’s railroad analogy.  While the Cummins essay didn’t appear to get any response on the internet, the VHA press release was widely copied by many news release websites.

The very next day, ModernHealthcare.com published a brief news article based on the VHA press release titled, “VHA, member hospitals push GS1 standards”.  One day later the same website posted a comment from Ted Almon, President and CEO of Claflin Co., a Rhode Island based healthcare distributor, about the press release.  The subject of Ted’s posted comment is “Why the rush for GS1 standards?”.  In it, Ted, a veteran of past standards development efforts which led to the formation of the Health Industry Bar Code Council (HIBCC), reasons, “Many industries much smaller than healthcare have dedicated SDOs, and I’m not entirely sure a single set of standards would even present any advantage with today’s technology.”  (SDO=Standards Development Organization.)  He asks “…why all of a sudden is there this pressure to choose GS1, and eschew our own SDO, which we control?”.

Why indeed.  I’ve grappled with questions similar to Ted’s for some time now.  I’m not sure I have the answers—especially answers that Ted and others might agree with—but I have some thoughts on the subject.

ARE GS1 OR HIBCC STANDARDS THE RIGHT “GAUGE”?

I think Mike is on the right track (pardon the pun) when he sees similarities between the current standards situation in the healthcare industry and the railroad industry just prior to the adoption of a single track gauge for the Transcontinental Railroad.  Sure, the industry has been able to make do with two different sets of standards, HIBCC and GS1, for quite a few years, but that does cause inefficiencies.  To remove as much cost as possible from healthcare we need to remove as many inefficiencies as possible, thus, wide adoption of a single family of identification standards is important.  In fact, I think adoption of a single family of identification standards in our industry will result in benefits well beyond simple cost reduction, much as the adoption of the single railroad gauge went far beyond it as well.

So which family of identification standards should the industry settle on, HIBCC or GS1?  I don’t know enough about HIBCC standards to provide a full set of pro’s and con’s, but I think perhaps I can cut to the chase by pointing out the following critical differences:

• GS1 standards are truly global, are HIBCC standards?
  Is there a HIBCC affiliate in China? Brazil? Slovenia?  I don’t think so.  GS1 has affiliates—boots on the ground—in over 100 countries.  GS1 standards are receiving increased attention by governments in many places.
• GS1 standards are cross-industry, HIBCC standards are unique to the healthcare industry
  Sure, GS1 is huge in the grocery supply chain, but it’s also huge in the general merchandise supply chain in which retail pharmacies and drug wholesalers participate in a big way.  I think that’s a good thing.
• GS1 standards are more widely adopted than HIBCC standards, even in the healthcare industry
  OK, I’ll grant you that HIBCC’s HIN is currently bigger than GS1’s GLN in the healthcare supply chain, but it’s just one of many location identifiers in use.  GS1’s GTIN is more widely used than HIBBC HIBC for product identification in the healthcare supply chain.  I don’t have an internet link for this bullet.  This one comes from personal observation.

With just these three bullet points I think the picture is pretty clear.  So clear, in fact, that I think, faced with these three points, even the railroadmen from 150 years ago would tell you that the GS1 family of standards are the better candidate for a U.S. standard than the HIBCC family.  In fact, the HIBCC family of standards comes off looking more like just one of the niche railroad gauges that faded away 150 years ago.

SO GS1 WINS?

Does all that mean that GS1 wins and deserves to be selected as the sole family of standards in the healthcare industry?  Maybe, but like many families, there are good relatives and there are bad relatives.  The GS1 location and product identification standards, GLN and GTIN, are not bad, although in my view, there exist unacknowledged but important differences between the allocation rules of GS1 GTINs and those of NDC’s.  I fear that there may be some gotcha’s when using GS1 GTIN’s to carry a regulated identifier, especially when there is no authority who can arbitrate and enforce conformance.  GDSN, EPCIS and even DPMS have problems that need work.  And we don’t know yet how GS1 will implement the Data Discovery Services standard whose development is just getting underway.  Perhaps these are the kinds of things that Ted was talking about when he wrote of the benefits of having “our own” dedicated SDO.

Many people have a problem with the high fees that GS1 charges, making it look as if they are a for-profit company (they are not-for-profit).  I’ve been one of those people in the past but, for the most part, I have come to terms with it and I now recognize that to get the benefits of a truly global family of standards, it’s going to cost some money.  I hope someone is monitoring exactly how the money is being spent, but I now expect that standards development, along with encouraging adoption, is going to have some significant costs associated with it.   The users of those standards should pay for it.  A fully volunteer organization cannot accomplish what GS1 is doing.

So here is where we are.

1. We need a single family of standards to maximize the efficiency of the healthcare industry;
2. From a high level, the family of standards from GS1 seems to have the inside track;
3. But GS1’s family of standards are not yet a perfect fit and some are currently insufficient for use in this industry;
4. The pharma side of the industry is facing a pedigree deadline in 2015 in California where it will be paramount that the industry has this decision well behind them.

Why the rush for GS1 standards?  At least on the pharma side, it’s because we’re behind schedule.

We need to make a clear distinction between traditional Master Data (MD), Supply Chain Master Data (SCMD), and Instance Data (IData). This will help us understand some important differences in various supply chain track and trace technologies.

Master Data

Wikipedia defines “Master Data” like this today:

“…Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the organization.”

This isn’t detailed enough for me. MD must include a data element that serves as an identifier. An identifier that refers to a given MD record must be unique within the organization.

Good candidates for MD are customer information, location information, product information and employee information. The characteristic these all have in common is that the data behind them rarely change. For example, I have been issued an employee number by my company. My employee number is the unique identifier for the MD that describes me to the company. My mailing address, phone number, marital status, social security number rarely change.

Most organizations make use of MD so that they can maintain the definition of these entities in a single place, and they can simply refer to these definitions through the corresponding unique identifier. The identifier provides a quick way to get to the full set of information. In many cases, the identifier can serve as a stand-in for the full set of information.

Supply Chain Master Data

Wikipedia doesn’t yet have a definition for Supply Chain Master Data. I’ve coined the term to describe something that is similar, but distinctly different than Master Data as described above. I’ll define it like this:

“Supply Chain Master Data is that persistent, non-transactional data that defines a business entity for which there is, or should be, an agreed upon view across the supply chain.”

The only difference from the definition of MD above is that the definition of the business entity spans the supply chain, not just a single organization. For that to work, you need a standard so that everyone agrees on the definition of the data elements, the identifier and the rules for maintaining the data.

GS1 has defined the GLN (Global Location Number) standard for location identifiers and GTIN (Global Trade Item Number) for product identifiers. When you combine these standards with their GDSN (Global Data Synchronization Network) standard, you have what I have defined as SCMD. The GLN and GTIN standards are carefully defined to ensure that every identifier created by any entity in the supply chain is unique from every other one.

To learn the full details of these GS1 standards, including the rules that surround them, you have to read the GS1 General Specification. GS1 likes to sell it to you, but you can usually find it for free download by searching for it on the internet.

An important characteristic of SCMD that differentiates it from simple MD is that it has a property of ownership. That is, instances of SCMD may be used by entities throughout the supply chain, but each instance is owned (controlled) by only a single entity–the one that created it in the first place.

For example, the manufacturer of a product will generate (create) a GTIN identifier for that product and they will fill in the pertinent data fields that describe it. The manufacturer will use a GDSN service (or some other means) to distribute the SCMD to its trading partners for their use, but only the manufacturer has the right and the responsibility to maintain the content of the data associated with the GTIN. This is pretty easy because, like MD, SCMD should rarely change.

Also like MD, supply chain transactions will often refer to the product only by its GTIN as a shorthand way of referring to the full set of information contained in GDSN for that product.

Understanding the concept of SCMD and its characteristics is very important when discussing the characteristics of various pedigree models. I will finally return to the discussion of those in one of my next posts.

Instance Data

Instance Data also doesn’t have a definition in Wikipedia yet, but the name and the concept has recently been raised in some of the work groups within GS1. Here is my definition:

“Instance Data is data that is specific to a small set of instances of a particular serialized object class.”

IData is not a type of master data because there is no identifier involved and so there can be no separate set of information that describes it. Instead, it is simply data that can vary across each instance. For example, a serialized pharmaceutical always has a lot/batch number associated with each unit. A finite set of the serialized instances share the same lot/batch number (an “instance” is simply a single unit of the product).

I can’t think of another real example of instance data, but I suspect that once item-serialization becomes widespread there will be more types of IData defined. One possibility would be for a manufacturer to vary some characteristic of their covert anti-counterfeiting mechanism so that each unit of a product would be more unique than it is today. This IData would indicate which units received which polarity, or which color, or whatever characteristic that is being varied. This type of IData would not be shared with supply chain partners but would be retained by the manufacturer for use in an authentication scheme. Of course, IData can only exist if every unit has a unique serial number on it.

I hope this hasn’t been too technical for you. If you’re still reading, well done. You are now prepared for the next level of discussion of pedigree models.

I’ve been an active GS1 participant since EPCglobal was first acquired by GS1 in 2003. It is an interesting organization, often both vital and frustrating at the same time. GS1 is a single source for essential supply chain standards that have global applicability. Rather than attempting to dictate those standards they invite people and companies to work with them on the definitions and the application of their standards. They have really great facilitators for some of their work groups with the very best being Mark Frey and Gena Morgan. The quality of their standards documents is quite high. And they have some really smart people in their EPCglobal Architectural Review Committee (ARC), notably Ken Traub, John Williams and Sanjay Sarma.

My hope is that this blog will be of some value to both members and non-members of GS1, but, I can only cover topics related to the organization and their public documents. Specific details about work group activities cannot be covered. However, I do not think that is too limiting and I think members and non-members will find something of interest.

GS1 is a not-for-profit member organization. The way it is organized reminds me of something out of the UN with affiliate “Member Organizations”, or M.O.’s—one for each country in the world—which participate in developing and maintaining their global standards on behalf of end-user companies within their borders. End-user companies are also able to represent themselves … if they can afford the membership fee which is based on company global revenue (and that’s on top of the fees paid for use of your GS1 Company Prefix). Consequently, standards development proceeds mostly with input from employees of GS1 affiliates and from employees of large corporations. There are notable exceptions and GS1 has made a significant effort to recruit participation from hospitals and smaller pharmacies, traditionally under-represented because they are small.

My own experience as one of those employees of an end-user member company, who has participated in standards-making work groups and the end-user groups within GS1 and EPCglobal, has been very positive. I have met and collaborated with a wide range of very smart people from my own industry and others, from the U.S. and from around the globe. I’ve learned a lot about supply chains in general and about how to perform the kind of “techno-negotiations” necessary to move forward a work group of people with very diverse backgrounds and interests toward a positive conclusion. Sometimes it’s thrilling. Sometimes it’s aggravating. It’s always a lot of hard work, but I highly recommend it to anyone considering it.

GS1 also runs “adoption” end-user groups out of their M.O.’s. The purpose of these groups is to encourage the adoption of GS1 standards within the country that the M.O. represents. For example, the GS1 U.S. Member Organization operates the GS1 Healthcare U.S. group which has work groups targeted at accelerating the adoption of GTIN, GLN, GDSN and Traceability the GS1 way in the healthcare sector. These work groups do not work on standards, but they work on guidelines for use in applying those standards to solve various supply chain problems within the U.S. (also known as “toolkits”).

Actual standards have traditionally been developed in two different sub-organizations of GS1: EPCglobal and GSMP (Global Standards Management Process). GS1 is currently in a state of transition as they move the standards development arm of EPCglobal into GSMP. That’s a good thing, because these two organizations have had different approaches and, at times, seemed to operate as two independent organizations. Unfortunately, in my view, EPCglobal’s process operated better than GSMP. So far I am encouraged by the little evidence I have seen that they are retaining the good parts of the EPCglobal approach. We’ll see how far it goes.

One very commendable thing that EPCglobal has done that GSMP has not is to make their ratified standards documents freely available for download on the internet. The GSMP approach is to roll all of their diverse standards into a single and very large document known as the “GS1 General Specification” (or, “GenSpec”) and they’d like to charge you for a copy of it. Fortunately there are enough M.O.’s around the world that make it available that you can usually find a copy for free download by simply Googling it. I hope that the merged GSMP does not fold the individual EPCglobal specifications into the GenSpec and keep them hidden until you pay, but I must admit, even ANSI and ISO charge for their ratified standards documents.

GS1 also has a lobbying arm which applies pressure to governments around the world to adopt policies that are favorable to GS1 and the technologies that their standards are based on. For example, they applied considerable effort to get governments around the world to open up RF frequency bands around 915MHz so that UHF passive RFID tags could operate worldwide without violating the law somewhere. They have been very successful in that effort, as I understand it.

Another example of GS1 lobbying is when they act as technology experts before U.S. state and federal regulatory agencies. Here GS1 provides guidance toward the adoption of regulations and laws that can be met through the use of their standards. I get a little concerned about this type of lobbying because I fear that GS1 makes themselves out to be unbiased when, in fact, they do have a bias. I hope these agencies are aware of that and take it into consideration.

GS1 will be a frequent topic of this blog since they are focused on the same “intersection” as I am (see the tag line for this blog on the masthead).