Patent Application
20070278285
The invention refers to a secure data management device comprising an electronic module and attached to a product, for collection of generated data and transfer of data from a multitude of distributed products, whereby the data is transferred in a secure way from the electronic module to a host computer via a data network.
Recent developments in microelectronics have reached the point, where it has become technically and commercially feasible to integrate microprocessor-based systems into low cost, disposable items. The development of small, inexpensive sensors and lab-on-chip technologies has also increased the possibilities for making a large number of in-situ analyses and thus generating a lot of geographically spread out data. Sensor systems have also been developed for detecting opening or tampering with packages or disposing of medicaments or other items from special containers. However, little attention has been addressed to basic data security matters in handling the remotely generated data.
Embedding an electronic data collection device into a packaging or the like enables the packaging to become “intelligent” and collect information from external sources and transmit the information via a data network to a database or databases for further evaluation of the information.
In U.S. Pat. No. 6,616,035 a secure transaction between a service provider and a mobile electronic transaction device via a transaction terminal and a computer network is described. The transaction device comprises means for transmitting information to and receiving information from the transaction terminal, data input means, data processing means, data storage means storing an externally accessible device identity, non-retrievable user identification and a non-retrievable secret key and means for supplying electric energy to the device. The secure transaction described comprises authentication of a user holding the card, by the user entering a PIN code on the card and if the code is determined to be correct, the processing means will perform a cryptographic transformation of a transaction using the secret key.
The electronic transaction device can be in the form of a multi-layer plastic card about the size of a credit card or a small calculator and is especially useful for performing transactions and identification in a general form for example for bank cards, club member, fund member or access control cards.
EP 1299788 describes a small portable low-cost card which is capable of storing information related to the holder of the device and to communicate a selection of the information to a requester in a data network via a host computer. The card can carry and communicate a number of single use secret codes to securely authorize or entitle a service from a service provider provided a correct PIN code is entered.
It is also known that packages can be provided with integrated electronics for registering an event affecting the package, such as for example opening the package or dispensing an item out of a blister package. In U.S. Pat. No. 6,244,462 is described a sheet-like envelope of a disposable material and an electric circuit printed onto the envelope and operatively connected to a sensor for detecting dispense of a medicament.
U.S. Pat. No. 6,628,199 shows a response form containing input means which on manual influence can switch a conducting electrical circuit incorporated into the response form for registration of the influence.
In US 2003/00335539 is described a system and a method for electronic distribution of paper-based secure documents to a remote location, in which a specialty paper includes an integral authentication code derived from a RFID. The system allows an intended recipient to print secure data using a home or office desktop printer by having a detector integrated into the desktop printing platform and the detector reads the authenticating code from the specialty paper, which is communicated to a transaction processor. The processor provides a second authentication code and any other secure data pertinent to the transaction, which is communicated back to the requester of the secure document and printed on the specialty paper.
In many applications several concerns arise in terms of data security and integrity. The growth of the Internet and intranets has made it attractive to remotely update and retrieve information from a large number of devices, potentially scattered over a large geographical area. The typical security issues addressed are:
Identity Authentication
To identify a unique item from a host system, each item needs to hold a unique identity. In order to prove the identity, a form of authentication scheme is required to prevent counterfeiting and other identity fraud mechanisms.
Confidentiality
Transmitting information over public networks always involves the risk of eavesdropping. In order to prevent transmitted information from being used by unauthorized, the information needs to be encrypted.
Authenticity
Information being transmitted is vulnerable to different forms of fraudulent modification. By adding a cryptographic checksum, involving a cryptographic operation, a “watermark” is created, which can be used to detect any illegal modification of the data.
Non-Repudiation and Proofing
A more specialized form of authentication involves proofing, where a piece of information needs a digital signature, which can be verified. In order to assure that only the creator of the information should be able to create the signature, but potentially a large number of receivers should be able to verify it. In order to enforce non-repudiation, asymmetric encryption schemes are typically used. Although the above described security issues can be handled by a client computer, retrieving information from the device, that scheme adds some concerns:
Distributing encryption keys to a wide number of users is a major undertaking and possesses threats of keys being compromised.
Invalid keys used by end-users can typically render collected information unusable.
Key management strategies to maintain key integrity in a remote environment are often not practically feasible to implement, nor enforce.
The risk of an unintended (“lack of knowledge”) or indented (“fraud”) key compromise can render the security of the system practically worthless.
Non-repudiation schemes involving digital signatures require a very tight control over the private key in order to fulfill its scope.
The user in possession of a private key may use the private key outside its scope, thereby making the digital signatures worthless.
The user itself may pose a security threat, where data generated by a product, is intentionally manipulated or otherwise unintentionally changed before transmitted to a central server. The incentive to follow strict data security may in some cases be in the interest of one party only.
In summary, a device and method to address the data security issues described above would enable a wider usage and acceptance of intelligent devices and packaging.
An object of the invention is to provide communication between a remote item in a chain of logistics and a host computer via a data network which ensures the identity, authenticity, integrity and confidentiality of collected information. This is provided by an item which is attached to a product subjected to a chain of logistics. The item can collect information about the product or use of the product and communicate such information to a host computer via a data network in a secure manner, which will assure the recipient of the information that the communication is made with the correct item and that the information communicated has not been manipulated and the transmission is protected from eavesdropping. The information collected by the item can be generated by sensors integrated or attached to the product.
The item or secure data management device can take many forms. It can be an electronic module (EM) integrated into a bearing substrate which can be attached to the product in many different ways, such as adhered to it or the substrate being an integral part of the product or a product enclosure. One important aspect of the attachment of the item to the product is that the item shall be capable of collecting and storing information generated by the sensors.
The item has an integrated electronic module comprising a cryptographic processor enabling identification and authorization of the item and providing for secure transmission of information between the item and a host computer via a computer network and which also provide for enclosing an electronic signature.
The item can be seen as a data collection device for communication with the host computer through a data network. The electronic module have time-keeping means, non-volatile memory means, a device unique identity code, data processing means, cryptographic processing means and data communication means and having sensor means connected to it.
The electronic module includes a unique identity identifying each item individually and a non-retrievable cryptographic key and non-volatile memory for collecting, storing and processing data related to the product or use of the product. The cryptographic key of the item is used for performing a cryptographic process on the collected data exchanged between the item and the host computer. The item can also receive data from the host computer. The cryptographic key is then used for decrypting the information to be stored by the item. The unique identity of the item can be exchanged with the host computer in encrypted form or in clear text depending on the circumstances.
The item can receive data to be stored in the memory before the product to which the item is attached is first sent out. Such pre-stored data can also be exchanged with the host computer in encrypted form or in clear text depending on circumstances.
The item is primarily intended for one-time use, but it may also be an item which can be re-used a limited number of times. The item is advantageously disposable and made of paper or a material comprising one or more paper-layers.
The cryptographic processor must have storage for at least one cryptographic key. The basic requirement of the cryptographic processor is to perform encryption and decryption, using a symmetric algorithm, such as DES, 3DES, AES or similar. In order to fully support the capability of making digital signatures in a Public Key Infrastructure (PKI) setting, the cryptographic processor can also support an asymmetric algorithm, such as RSA, ECC or similar.
The nature of the EM key storage must be “write only”, i.e. the key can be written to the EM, but not retrieved. The key is only used for cryptographic operations and shall be securely stored in a secure storage of the EM. Cryptographic keys should be entered in a secure environment where there is minimum risk for eavesdropping or other ways of compromising the keys.
Additional cryptographic keys can be generated in order to support a third party audition or a later verification of the collected data.
The item could be attached to a product being a package containing goods where authenticity of the goods needs to be checked because of a large inflow on the market of pirating copies of the goods. Or goods that may only be kept under certain conditions, such as a specific temperature interval, which may then be monitored by an integrated sensor and checked without risking fraudulent manipulations of the data. The disposable item can also be a ticket for an event, an admission card or the like where it is beneficial to be able to check the authenticity of the item and information stored on the item. The item can also be useful for collecting information from instruments, sensors or electronic forms that are distributed to many recipients.
The sensors can comprise printed conductive traces which can be printed to form circuits or patches specially adapted for detection of tampering with the item or for detection of a specific event involving the product, like disposing of a medical dose or taking out a component from a compartment of the product.
The sensors can also comprise any type of measuring- or sensing device which is intended to be distributed to a large amount of users, for example a so called “lab-on-chip” for measuring medical data, environmental data, quality control data or hazardous elements.
The product can be a packaging for a drug with inbuilt capacity to register and time-stamp withdrawal of an individual tablet and a response form for direct input of data by the person treated by the tablet. Such products are described in U.S. Pat. Nos. 6,244,462 and 6,628,199, which are hereby integrated into this description. The basic purpose of the microelectronics is to monitor the state of a plurality of printed circuit lines printed onto the packaging material. A change in the resistive properties of a circuit line, signals a possible event that is processed by the EM, where a stable detected event is typically stored in a non-volatile means, together with a time-stamp. A contact-less communication transceiver embedded in the packaging material is used to exchange information with a host computer system. An example of a suitable implementation of a communication interface is described in patent U.S. Pat. No. 6,615,023.
The product could also be an item for which the original producer certification is important, like a watch, handbag or other items which are prone to counterfeiting. It can also be a repair or replacement component where it is of importance to secure that the component is provided by an authorized source. Other examples include products that are sensitive to the handling conditions and where selected properties can be monitored, for example temperature monitoring of transported food.
The below scenario describes an intelligent pharmaceutical packaging that is used to collect clinical data and to ensure that collected data is effectively and securely collected and transferred to a central database holding the clinical trials data. The scenario is likewise applicable to the distribution of many other products in a chain of logistics, where the issuer of the product is interested in collecting information about the product or use of the product which is stored by an item attached to the product and receive the information via a data network in a secure way that verifies that it is the right product communicating the information and that the information has not been manipulated with.
An advantage with using a container as described is that it is not possible to retrieve any meaningful information from the package without access to the appropriate key for decryption of the data. A central characteristic of the invention is that the encryption is performed internally in the container itself, thereby protecting the encryption key from illegal or unintended usage. Further, the container itself is a carrier of the encryption key, thus reducing the need for separate distribution of encryption keys. There is also no need for further cryptographic means to be used and the users out in the field do not have to think or care about data security aspects of data transmitted to the centralized database.
Further, in order to strengthen the integrity of the data, the digital signature ensures that data generated by the patient has not been modified anywhere in the chain. Also, the signature, being derived from both the identity and the data, serves as an authentication method for the container identity itself.
It is also possible to have an auditor verifying that the data has not been manipulated from where it was generated to the point where it reaches the centralized clinical trials database.
In order to enable an external auditor to prove the overall clinical trials data generation and storage process, a third-party arbitrator or another “trusted party” can be engaged to further strengthen the data integrity Such a protocol could include the below steps:
In addition, other clinical trials aspects, such as environmental factors, affecting the container and its contents, like temperature, can be monitored and logged. This can also be part of an auditor scheme and for example an auditor can verify the signed temperature span for the container.
By using two different keys, KA and KB, both data security requirements of an issuing organization and auditing requirement of a regulatory body can be fulfilled. The trusted party need not be in possession of KA to be able to verify the signatures generated by KB, thereby effectively splitting the security requirements and responsibilities of the different organizations.
If necessary, it could be possible to implement additional levels of keys, for example where a study sponsor utilizes a third-party clinical trials organization to perform the study. Together with auditing requirements, three different cryptographic keys can be used.
The below described embodiment states a security approach which is made as an integral part of a product itself, and describes necessary enhancements needed to ensure a range of data security issues, when exchanging data between the packaging and a host computer system over an insecure communication channel.
Below is a basic scheme to securely exchange information between a host computer (Host) in a computer network (Network), and an intelligent packaging (Device), for example a product with an attached item. In reality, the intelligent packaging cannot be directly connected to the computer network. This typically occurs through a network-connected terminal, further featuring an interface to exchange data with the intelligent packaging (Reader). In order to simplify the description from a conceptual viewpoint, the details of the “proxy terminal” and interface is omitted in the following text.
Considering an automated scheme like this, interactive products can be supported in a very simple way. Depending on the automated evaluation of the data received, different screens may be presented to the user, such as “There is only one dose left in your packaging. Would you like to order a new one now?” or “The regimen has not been followed properly. Please contact your physician now”.
In order to implement a “zero knowledge protocol”, i.e. avoiding to reveal any information at all, a mutual challenge protocol extension can be implemented as:
Using asymmetric encryption allows generation of qualified digital signatures, with different keys for signature generation and verification. The keys are generally known as “private” for signature generation and “public” for signature verification. The private key is stored in a tamper resistant device and cannot be read-out. The public key is given to all parties involved in verifying the signatures created by the private key.
A typical scheme may look like:
It is important to understand the implication of having two different keys stored in the EM, one for confidentiality (and potentially for integrity) and one for creating a legally viable signature.
By including a time reference generated by the EM at time of information retrieval further enables resolution in non-repudiation matters, as each data transmission then implicitly contains a digitally signed time reference.
For applications where asymmetric encryption is not feasible, an arbitrated scheme can be implemented as:
3. A copy of the key is kept in a secure storage, accessed by the trusted party only.
All the protocols described above are described in one direction. From a conceptual viewpoint, the protocols are symmetric, i.e. information transmitted from the host to the device can be secured in the same fashion.
In summary, the device and method implementation details described in the present invention serves the purpose of ensuring several aspects of information security. By storing cryptographic keys in the device itself, both the key distribution and management is solved in a straight-forward manner.
This scheme is not limited to clinical trials. In any logistic operation where many parties are involved and data needs to be secured from an identity, authenticity, confidential and integrity point of view, benefits are gained by performing all security operations within the item being a data carrier and collection device itself.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/SE05/00230 | 2/18/2005 | WO | 5/21/2007 |
| Number | Date | Country | |
|---|---|---|---|
| 60545870 | Feb 2004 | US |
