Special Report on Pharma & Healthcare

Many of the major pharmaceutical manufacturers have begun aggressive testing of RFID solutions within their supply chains and the US Food and Drug Administration (FDA) is pushing to mandate its use. However, the industry has not agreed upon many of the standards necessary to push these initiatives forward and it now recognizes that without securing the RFID tag itself – the supply chain will only be marginally safer.

To help the pharmaceutical industry address these issues, SecureRF Corporation offers a consulting package specifically for pharma. This includes a site visit, analysis of RFID plans from a security perspective and a report that documents RFID security options for pharmaceutical application, addressing such issues as how to securely support e-Pedigree with RFID, signing and enhancing certifications and compliance of the RFID deployment. It is necessary for systems to provide strong authentication of all players in the supply chain, including the RFID tag, and completely protect the data stored on each transponder. Security protocols need to cover all situations including delivery from the manufacturer to the pharmacy - and meet health industry regulations.

SecureRF’s battery-assisted passive (BAP) RFID tag, which meets EPCglobal Class 1, Gen 2 standards, help pharmaceutical manufacturers and distributors provide a tamper-proof record right down to the item level that will establish the packaged drug is authentic, and ensure privacy by allowing only authorized readers access to sensitive information. The Lime tag (for LIghtweight, Multistream Encryption) provides data authentication at the reader, tag, and data level. Pharmaceutical manufacturers can use the authentication and data protection features of these tags to address problems of drug counterfeiting by using a range of recognized cryptographic methods to create an unalterable electronic “seal.”

In addition, battery-assisted passive RFID tags with temperature sensors, are designed for cold chain management. The product temperature is monitored and recorded at a set interval. The consumer can push a button on the tag to see if the product has been maintained at a temperature within the set limits and the data can be retrieved later.

Recently, SecureRF Corporation announced they have been awarded a Phase II Small Business Innovation Research (SBIR) grant from the National Science Foundation (NSF) to develop a secure radio frequency identification (RFID) tag for the $231 Billion U.S. Pharmaceutical supply chain. The company will initially receive $500,000 to develop and demonstrate a secure passive RFID tag that will address the $40 Billion in annual counterfeiting and divergence now occurring in the pharmaceutical supply chain worldwide. The company is partnering with the National Council for Prescription Drug Programs, Inc. (NCPDP) and a major US pharmaceutical distributor in their development effort. The development of a secure passive RFID tag will provide the pharmaceutical industry, which handles nearly four billion prescriptions in the U.S. annually, with onboard authentication and data protection features to address the growing number of counterfeit and illicit drug cases and help ensure the safety and integrity of their products.

In this Phase II project, SecureRF will focus on developing an RFID system which will meet the pharmaceutical industry’s need for confidentiality, integrity, availability, and authentication. The resulting UHF passive RFID tag will comply with EPCglobal, Class 1, Generation 2 UHF (Gen 2) protocols, have ultra low power requirements and yet allow secure cryptography to run on the chip itself, an industry innovation. Methods developed in this project will also be applicable to passive HF RFID tags too. Potential customers include pharmaceutical manufacturers, distributors, wholesalers, and pharmacies that need to ensure patient safety and privacy along with drug integrity. In Phase I of this project, which was completed in 2008, SecureRF proved the feasibility of using their patent-pending algebraic eraser security protocol, a linear-based cryptographic method on a passive Gen2 tag enabling an RFID reader to securely authenticate the tags.

They also proved that the tag can create a shared secret with the reader and support various security protocols including the onboard encryption of data. Today’s RFID tags and other embedded, resource-constrained or performance-sensitive devices cannot protect users from unauthorized reading, copying, or tracking due to the lack of on-board computing resources. The security methods developed in this project are also applicable to high value asset tracking, contactless payment systems, wireless sensor networks, smart grid microcontrollers, and defense/homeland security border security systems. Last year, SecureRF also received an SBIR grant from the US Air Force to develop a secure global active RFID solution for use by both land-based and satellite systems.

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