Tag Archives: Blockchain

data ownership

Data Ownership In The Track And Trace Cloud, Reprised And Updated

Back in January of 2013 I wrote an important essay called “Data Ownership In The Track And Trace Cloud” which analyzed a potential future where members of the pharma supply chain would need to deposit and maintain track and trace data in a centralized or semi-centralized data repository in the “cloud”.  As the title implies, my main focus was on who would own that data, which was, and continues to be, a hot topic.

But now, five years on, things are getting less “potential” and more real. Continue reading Data Ownership In The Track And Trace Cloud, Reprised And Updated →

DSCSA

Blockchain Will Not Be Used For DSCSA Data Exchange

That’s right.  I have now concluded that Blockchain will never be used in the US supply chain to fulfill the DSCSA requirement for sellers to provide buyers with Transaction Information (TI) and Transaction Statements (TS) (see also “Could Blockchain Technology Be Used For DSCSA Compliance?”).  So if you are currently planning to do a pilot to test a proposed architecture to do that, I recommend that you adjust it to test something else (see also “What Should FDA Pilot?”).

In fact, the thing to test is whether or not it can be used to facilitate gathering the TIs for a given Standardized Numerical Identifier (SNI) going back to the original manufacturer, as needed after November 27, 2023 during a suspect product investigation or recall.  Those are rare events compared with the number of drug sales and shipments where the TI and TS will need to be exchanged.

How and why did I come to this conclusion?  Let me explain. Continue reading Blockchain Will Not Be Used For DSCSA Data Exchange →

Data Exchange, DSCSA

EDDS: The New Data Exchange Requirements

The Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA) is due to begin on November 27, 2023.  That’s the first day that the US pharma supply chain is supposed to fully operate with serial numbers.  Yes, serial numbers in human readable and encoded into 2D barcodes will be on every drug packaged after November of this year, but there is only limited use of those serial numbers in the supply chain until 2023.  But when the EDDS starts, everything changes.  From that point on, every Transaction Information (TI) document must include the full DSCSA Unique Identifiers—including the serial numbers for the first time—that are physically included in the shipment, the Transaction History (TH) no longer needs to be exchanged, and the data exchange requirements change.  Let’s focus in on those data exchange changes. Continue reading EDDS: The New Data Exchange Requirements →

Blockchain, DSCSA

Blockchain Reigns At GS1 Connect 2017

Maybe I’m just hyper sensitive to all things blockchain right now, but it sure seemed like the topic of blockchain permeated the sessions and the halls at last week’s GS1 Connect conference, GS1 US’s annual membership event.  Oddly, all of the official blockchain content was outside the Healthcare track.  The technology is certainly applicable in all industries and apparently there is interest in it outside of the healthcare vertical within GS1 US.  But what I observed there leads me to think we are very close to an important tipping point. Continue reading Blockchain Reigns At GS1 Connect 2017 →

Center For Supply Chain Studies, DSCSA

Could Blockchain Technology Be Used For DSCSA Compliance?

c4scs-logoIf your email inbox is anything like mine it has recently been swamped with articles and webinar notices about the possible use of blockchain technology to solve multiple challenges in healthcare.  I recently attended a very interesting day-long workshop on that very topic. 

So is blockchain a real solution, or is it just the latest over-hyped buzzword that is being promoted by people who don’t understand the real needs of healthcare companies?  I’ll tell you what I think.  But first, a little background.

Blockchain technology is a way of encapsulating information within a layer of structured data that multiple parties can use as the basis for trust in the accuracy of the source of that information.  It’s all about adding trust to information that is shared between parties.  Trust is just one of the many Continue reading Could Blockchain Technology Be Used For DSCSA Compliance? →