December 15, 2006 4:00 AM PST
Big Blue's RFID fix for drugs may stall
IBM is betting on new software to make sense of the reams of data collected by radio frequency identification devices. But some legal maneuvering could dampen enthusiasm for the technology.
On Friday, Big Blue introduced its WebSphere RFID Information Center software, which is designed to let interested parties--manufacturers, distributors, wholesalers and government customs agencies--work with and share the data from the tracking tags.
The technology will be put through its paces in pilot programs by pharmaceutical distribution giants AmerisourceBergen and Cardinal Health; by ITAID, a European Union e-customs initiative; and by multinational giant Unilever, responsible for Lipton, Dove and Knorr products, among others.
RFID tags are computer chips placed on products, whether individually or in containers, to track the movements of those products. Sensors read the tags to monitor the shipments and send alerts on conditions, like temperature and exposure to light, as well as on GPS latitude and longitude.
"The focus has been on tag hardware and software. Granted, you've seen middleware--but we've dealt a lot with how we capture RFID data," said Michael J. Liard, a research director who covers radio frequency identification for ABI Research. "Now we focus on, 'How do we leverage RFID data we collect?' Each industry is going to have to figure that out."
IBM's new software can read and work with either ultra-high-frequency and high-frequency radio tags, or across both radio broadcast frequencies, using EPC Information Services technology, said Christian Clauss, who works on sensor information management for the company's software group. The broadcast frequency used in a device can vary depending on a country's regulations, and EPCIS, which is based on the Electronic Product Code specification for coding products, provides a way to cut across the differences.
"A lot of the problem with RFID to date was that there weren't enough standards to exchange data. And here, EPCIS fixes that," Clauss said. "We have a scaling product that can implement. We see this as an inflection point in the adoption of RFID."
EPCGlobal, the group set up to promote the Electronic Product Code, is not an official standards body. Despite this, Liard believes that the EPCIS offshoot may become a common standard in the radio tag technology industry.
"We (the RFID tech industry) focused on collecting the data, now we are focusing on software and infrastructure. That is how RFID is going to scale," Liard said.
Legal snafu could stall progress
However, a recent court injunction related to the tracking of prescription medications could slow the common adoption of EPCIS, especially among drug distributors.
The Food and Drug Administration set a deadline of December 1, 2006, for U.S. pharmaceutical companies to comply with regulations regarding paper trails, known as "pedigrees," for their drugs. The agency recommended RFID as one of its options for technology that could help them meet this requirement, Liard said. That method, which can also be addressed with one-dimensional and two-dimensional barcodes, is known as ePedigree.
The FDA regulations called for secondary wholesalers to provide pedigree information all the way back to the manufacturer, a rule that could help prevent the sale of counterfeit or stolen medications. But a group of smaller distributors brought a case in the Eastern District Court of New York against the FDA that argued such regulations essentially cut out legitimate secondary wholesalers, who don't usually have access to manufacturing information. As a result, the rules favored primary wholesalers and distributors, the plaintiffs said.
Judge Joanna Seybert agreed and on December 11 granted an injunction against the implementation of the requirements. While the decision does not directly weigh on technology standards, the injunction, along with other state cases that challenge it, could subdue the rush for companies to comply and stall their adoption of RFID technology, Liard said.
"It doesn't stop a pharmaceutical company from adopting it. But those laws mandate certain things for ePedigree, and there has been an injunction against that. It's becoming litigious," Liard said.
IBM said recent rulings won't likely affect adoption one way or the other.
"I think the FDA was very tentative in their recent announcement, saying they could not legislate without Congress telling them what to do," IBM's Clauss said. "Our sense is it's much more the state regulatory bodies that (the pharmaceutical industry) is paying attention to than the federal law,"
Liard added: "But lots of folks are looking at RFID. Pharmaceutical companies and other industry manufacturers and distributors, regardless of ePedigree requirements, are evaluating and deploying RFID for improved supply chain visibility, track and trace, as well as authentication."
The pharmaceutical industry, specifically, has an interest in what RFID technology can do for it to ease the headache of tracking prescription drugs, Liard noted. "How do you share data to satisfy data government requirements or regulations? Using RFID data is a piece of that larger puzzle," he said.
IBM's new software could enable secondary wholesalers to acquire original information from manufacturers' RFID tags, then add their own tracking information, to form a complete ePedigree for a given drug.
IBM already has two products related to RFID technology on the market. WebSphere RFID Device Infrastructure software resides inside the reader of a tag and works with active or passive HF or UHF frequency tags, or both together. WebSphere RFID Premises Servers builds data sets from the functioning tags.
Big Blue is not alone in its interest in providing technology to help distributors and others keep tabs on goods as they move around the warehouse, the country and the globe.
The standard players, Oracle and SAP, will most likely be IBM's competitors in this arena, Liard said, adding that it will be interesting to see how the two will address EPCIS.