Abstract:
A method and apparatus for securely transferring medical information is provided, which included storing information relating to a medical prescription item on a smart card using an encryption method that provides independent verification as to the source of the information, verifying the source of the information by the provider of the medical prescription item and modifying the stored information relating to the medical prescription item when the prescription is filled, and storing the modified information on the smart card using an encryption method that provides independent verification of the source of the modified information.

Description:
FIELD OF THE INVENTION 
     The present invention generally relates to methods and apparatus for storing information, and more particularly relates to storing medical information on electronic transfer media. 
     BACKGROUND OF THE INVENTION 
     Prescriptions for medicines, drugs, or other medical items are presently written or typed on pieces of paper. The paper is then submitted to a pharmacist or other fulfiller of medical prescriptions to be filled. Where the prescription has been hand-written, it is left to the pharmacist to interpret the handwriting, sometimes poor, of the prescribing medical practitioner. Furthermore, the pharmacist must determine whether the prescription may have been modified, or, indeed, whether the prescription is valid or has been written on a stolen or otherwise illegally acquired prescription form. 
     In the case of typewritten prescriptions, the handwriting legibility is less of a problem, but the questions regarding modification and validity may still remain. 
     In a highly mobile society such as the one in which we presently reside, it is becoming increasingly difficult to have prescriptions filled in areas where the particular medical practitioner is not located, for reasons such as unfamiliarity with the medical practitioner, his signature, and other indicia upon which pharmacists or other entities for filling prescriptions may rely to judge the validity of a particular prescription. 
     Accordingly, it is desirable to provide a secure method and apparatus for holding medical prescription and other sensitive medical data, perhaps provided by a medical practitioner to a patient, and allowing the secure transfer of such data to others that may have a reason to access the data. In addition, it is desirable for a receiver of such sensitive medical data or prescriptions to be able to validate the origin of the information and the validity thereof. Furthermore, other desirable features and characteristics of the present invention will become apparent from the subsequent detailed description of the invention and the appended claims, taken in conjunction with the accompanying drawings and this background of the invention. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The present invention will hereinafter be described in conjunction with the following drawing figures, wherein like numerals denote like elements, and 
     FIG. 1 is a partially schematic drawing showing certain aspects of a smart card that may be used in conjunction with the present invention; 
     FIG. 2 is a flow diagram showing how a smart card of FIG. 1 could be used for entering and filling a prescription while practicing the present invention; and 
     FIG. 3 is a flow diagram showing how a smart card of FIG. 1 could be used for initiating a refill of a prescription remotely while practicing the present invention. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description of the invention is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Furthermore, there is no intention to be bound by any theory presented in the preceding background of the invention or the following detailed description of the invention. 
     FIG. 1 shows a schematic representation of a smart card  10  as used in the instant invention. For purposes of describing a preferred embodiment of the invention, a smart card is shown, but it is understood that any equivalent data transfer device other than a smart card could be used, for example, smart card  10  may be encapsulated in any convenient form so long as the functions performed by the smart card  10  are similar in operation to that shown in FIG.  1 . 
     The use of a smart card has several advantages, including portability, a known and accepted form factor, existing packaging technology, existing semiconductor technology for use in smart cards, and existing card reading technology. 
     Smart card  10  has embedded therein a microprocessor or microcontroller unit (MCU)  12  which is coupled to a memory  14 . The memory  14  is shown here as being a device that is independent of the MCU  12 , but it is understood that the memory  14  may be a circuit that actually resides on the same chip as the MCU  12  or is included within the same package as the MCU  12 . The memory  14  is also shown as comprising three separate sections for storing different types of information, but, again, memory  14  may be a single memory circuit which is partitioned electronically by the MCU  12 . The memory is shown here having an information section  16 , a control section  18  and an “other” information section  20 , the significance of which memory sections will be described later in conjunction with the explanation of the operation of the invention. Memory  14  may also contain a control program (not shown) for controlling the operation of the MCU  12 , or the control program may be formed as a separate circuit that resides on the MCU itself as ROM  22 . An input-output circuit  24  is coupled to the MCU  12  to provide access for a user of the card to the contents of memory  14 . 
     Further shown in FIG. 1 is a data entry/reader  26  which may be used to upload or download information to or from memory  14 . Smart card  12  has contacts thereon (not shown) which are coupled to the input output circuit  24  to facilitate the transfer of information to and from memory  14  from an external source. Data entry/reader device  26  may be coupled to the computer  28  of a user of the smart card  10 , and information from the computer  28  may be downloaded through entry/reader device  26 , through input output circuit  24  and MCU  12  to the memory  14 . Likewise data from memory  14  may be downloaded through MCU  12  and input/output device  24  and data entry/reader  26  to the computer  28  of a user. 
     FIG. 2 is a flow diagram showing how the smart card  10  of FIG. 1 could be used for entering and filling a prescription while practicing the present invention. A doctor or medical practitioner prescribes a drug to a patient at  30 . For example, the doctor may prescribe Valium, 60 doses, 20 mG, refillable three times. The patient gives his personal smart card  10  to the doctor who, by using the doctor&#39;s computer  28  loads a portion of the prescription information at  32 , (for example: Valium, 20 mG, twice a day), together with the doctor&#39;s name and the date of the transaction into the information section  16  of the smart card  10  by downloading the information through entry/reader device  26 , through input output circuit  24  and MCU  12  to the memory section  16  of memory  14 . 
     A duplicate of the encrypted prescription information plus the number of times the prescription is authorized to be filled  34  is entered into the control section  18  of memory  14  along with the number of refills authorized. This information is encrypted in the doctor&#39;s computer  28  with the private security key of the doctor, part of a private key/public key security system. 
     The patient then proceeds to fill the prescription  36 . The patient presents his smart card  10  to a pharmacist or other dispenser of medications or prescription filler. 
     The pharmacist reads the information file stored in the information section  16  of memory  14  and, using his computer  28  and data entry/reader  26 , transfers the data from control section  18  of memory  14  to his computer  28 . This transfer may proceed in the same manner in which money may be transferred from a smart card to another device to pay for a transaction of some sort. 
     The pharmacist then retrieves the public key of the prescribing doctor from a database of such public keys and decrypts the data of the control section  18  of memory  14  at  40 . The pharmacist then proceeds to fill the prescription and, using computer  28 , modifies the information section  16  of memory  14  indicating that one fill of the prescription has been accomplished. The pharmacist appends his name and the date of the transaction to the modified. 
     The modified control information including information that the prescription has been once filled is then encrypted at  44  using the pharmacist&#39;s private key and the encrypted, modified control information is transferred at  46  from the computer  28  through the data entry/reader device  26  and the input/output circuit  24  and MCU  12  of smart card  10  back into the control information section  18  of memory  14 . 
     This process may be repeated several times at the same or different pharmacies. Each time a pharmacist would modify the data in the information section  16  and the control section  18  of memory  14  to indicate what action has been taken, until there are no more refills remaining on the prescription. 
     The system described above provides increased security over present prescription filling systems in which it is very difficult for a pharmacist to determine with certainty that a prescription is legitimate and has not been tampered with. This is accomplished by the use of an encryption model based on the public key-private key system or something equally easy to use and difficult to corrupt. The pharmacist, for example, by the very ability to use the public key of the prescribing doctor to decrypt the original prescription is given assurance that the prescription was, in fact, written by that doctor and has not been maliciously or illegally altered. The filling pharmacist, on the other hand, by encrypting his change (a reduction in the remaining number of refills available) in his private key, give assurance to a subsequent filler of prescriptions that the information of the smart card is genuine and has not been altered. 
     Furthermore, in a highly mobile society such as the one in which we presently reside, it is becoming increasingly difficult to have prescriptions filled in areas where the particular medical practitioner is not located, for reasons such as unfamiliarity with the medical practitioner, his signature, and other indicia upon which pharmacists may rely to judge the validity of a particular prescription. 
     Accordingly, it is an important feature of the instant invention to provide a secure method and apparatus for holding medical prescription and other sensitive medical data provided by a medical practitioner to a patient, and allowing the secure transfer of such data to others that may have a reason to access the data. In addition, it is desirable for a receiver of such sensitive medical data or prescriptions to be able to validate the origin of the information and the validity thereof. 
     Referring again briefly to FIG. 1, the portion of the memory  14  identified as “other” information may be used to store items regarding the health of the user of the card, such as illnesses, medical history, drugs being taken, allergies to medicines or other substances, insurance information, and the like, any of which may be of interest to emergency medical personnel in the event of an accident or unconsciousness of the card holder. This information may not be encrypted so as to allow easier access to the information by emergency or treating personnel. 
     As noted above, in a highly mobile society such as the one in which we presently reside, it is becoming increasingly difficult to have prescriptions filled in areas where the particular medical practitioner is not located, for reasons such as unfamiliarity with the medical practitioner, his signature, and other indicia upon which pharmacists may rely to judge the validity of a particular prescription. Presently available systems are not secure enough to allow the transmission of sensitive prescription information over the public airway, for example through a cellular telephone system. 
     FIG. 3 is a flow diagram showing how a smart card of FIG. 1 could be used for initiating a refill of a prescription remotely. If a patient chooses to refill  50  his prescription by mail order, the patient may access a person or entity for filling prescriptions over the internet, for example, where a reader/entry device  26  may be connected to the patient&#39;s computer  28 . Alternatively, the patient may utilize a “smart” cellular telephone  52  with a provision for accepting the smart card  10  to transfer the appropriate information on the smart card to the prescription filling entity or on-line pharmacy. In either case, the information section  16  of the memory  14  is copied at  54  to the on-line pharmacy, as is the control information in section  18  of the memory  14 . 
     The pharmacy then decrypts the control information using the most recent pharmacist&#39;s public key  56 , in the case of a refill, or only the prescribing doctor&#39;s public key if the transaction is a first filling. (If the transaction is a first filling of the prescription, the on-line pharmacy would, of course, decrypt the control information using only the prescribing doctor&#39;s public key as set forth in the description of FIG. 2.) The public keys are obtained from a public key database. The on-line pharmacy fills the prescription  58 . 
     The on-line pharmacy then appends the information section data  60  with the on-line pharmacy&#39;s information as above with reference to FIG. 2, and the information section as modified is transmitted back to the patient&#39;s smart card. The on-line pharmacy then updates the control information  62  that a second filling of the prescription has taken place. The modified control information is encrypted using the on-line pharmacy&#39;s private key, and the new control information is transmitted back to the patient&#39;s smart card  64 . 
     The remote system described above has the same security attributes as the system and method described in FIG.  2 . Since a secure and verifiable encryption system is used in both cases, a pharmacist, even a remote pharmacist has a great deal of confidence that the prescription with which he is working is valid and unaltered. 
     While an exemplary embodiment has been presented in the foregoing detailed description of the invention, it should be appreciated that a vast number of variations exist. It should also be appreciated that the exemplary embodiment or exemplary embodiments are only examples, and are not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the foregoing detailed description will provide those skilled in the art with a convenient road map for implementing an exemplary embodiment of the invention. It being understood that various changes may be made in the function and arrangement of elements described in an exemplary embodiment without departing from the scope of the invention as set forth in the appended claims.