WO2010125561A2

WO2010125561A2 - Mpic (medical pharmaceutical identification card) - (healthcardinternational)

Info

Publication number: WO2010125561A2
Application number: PCT/IL2010/000328
Authority: WO
Inventors: Yaniv Granat; Leon Granat
Original assignee: Individual
Current assignee: Individual
Priority date: 2009-04-27
Filing date: 2010-04-22
Publication date: 2010-11-04
Anticipated expiration: 2011-10-27
Also published as: WO2010125561A3

Abstract

This present invention provides a pharmaceutical information system comprising: a. an end-user data card bearing pharmaceutical data concerning an end-user; b. a data card reader/writer communicating with said data card for reading and writing pharmaceutical data upon said data card c. a networked server communicating with said data card reader /writer adapted to transfer said data to said data card reader, receive said data from said data card reader and store said pharmaceutical data wherein said data card reader is adapted for reading and writing said data according to permissions determining the right of a given system user to read and write pharmaceutical data upon said data card thereby ensuring the integrity of the data stored on said data card.

Description

MPIC (MEDICAL PHARMACEUTICAL IDENTIFICATION CARD) - (HEALTHCARDINTERNATIONAL)

FIELD OF THE INVENTION

The present invention relates to a method and apparatus for portable pharmacological data cards and associated information systems.

BACKGROUND OF THE INVENTION

In the prior art, U.S. Pat. No. 7,395,215 issued to Grushka, discloses a health information package that a person carries with him at all times bearing all his health data. This card enables him to grant caregivers instant access to all or any part of his health data, whenever the information is needed, at all points of care anywhere in the world, in computer readable and human readable forms. A database management software program is contained in a portable computer readable storage device of the package. A blank data recording form and an updated health overview, organized by body organ systems, problems, types and sub-types of data can be printed when desired. With the package, any standard personal computer can be used to record, update, link, integrate and display health data from birth to death. The owner has absolute control on the availability, completeness, accuracy, integrity, privacy, confidentiality, security, backups and access to his health data that are stored on the package.

U.S. App. No. 2003/0037065 applied for by Svab discloses a personalized smart card encoded with medical patient information, including patient identification, and a Uniform Resource Locator (URL) of an insurance provider's and/or pharmaceutical service provider's extranet or a web site to facilitate health care insurance transactions and administration. In one implementation, a computer-implemented method uses such a smart card to provide digital ID, data storage and automatic navigation to a web or extranet site and/or issuer database. An authorized member of medical, health or other organization inserts the smart card into a smart card reader that is connected to a computer or other computing device capable of accessing the web, extranet or a targeted database. An exchange of an encryption formula, card media with a reader/writer occurs prior to a response from the system host device. After encryption is verified, an access to the particular server is allowed. In response to the insertion of the smart card into the smart card reader, an issuer specific program and/or a browser is launched. As a result, the authorized user may automatically navigate to the targeted site simply by inserting the smart card into the smart card reader, without having to type any information, use the computer's mouse, or provide any other user input.

A number of similar services can be found in the field of medical identification systems, such as Google Health. This is an online service that allows a user to upload his or her personal health records onto the Goole Health servers, where in principle they can be shared with health care providers anywhere in the world that is connected to the internet.

Users can also find doctors, explore online health services, and the like through this service.

However it will be appreciated that the access to such medical records, involving as it does sensitive private information, involves complex issues of rights management. In particular, it may not be wise to allow the patient/user of such medical information systems to change records at will, since these records may influence insurance rates, access to drugs, etc.

Therefore a system for digital rights management is a long felt need in portable pharmaceutical information systems.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

FIG. 1 presents a possible embodiment of a data card of the current invention,

FIG. 2 presents a flow chart showing steps for initial entry of data onto a data card of the present invention,

FIG. 3A, B presents a flow chart detailing steps involved in filling a prescription by means of the current invention.

SUMMARY OF THE INVENTION

The present invention comprises a system and method for a pharmaceutical information system including a data card carried by the end user, and associated methods for read/write permissions management. In particular, write access is restricted to health care practitioners such as doctors or pharmacists who have demonstrated a particular set of qualifications and subscribe to the given service. The end-user data may include such information as phenotypic data - height, weight, body mass index, blood pressure, etc. and genotypic data - DNA sequences, etc. One particular advantage of the system is that permissions can be retricted to users who have a known background, such as doctors or pharmacists who have undergone accreditation. By suitable encryption methods, reading/writing data on the card can be restricted to this group of accredited system users. In this way for instance a prescription bearing Medical Pharmaceutical Identification Card cannot be faked, a common enough practice amongst the habitually medicated.

It is within the core of the present invention to provide a pharmaceutical information system comprising: a. an end-user data card bearing pharmaceutical data concerning an end-user; b. a data card reader/writer communicating with said data card for reading and writing pharmaceutical data upon said data card c. a networked server communicating with said data card reader /writer adapted to transfer said data to said data card reader, receive said data from said data card reader and store said pharmaceutical data wherein said data card reader is adapted for reading and writing said data according to permissions determining the right of a given system user to read and write pharmaceutical data upon said data card thereby ensuring the integrity of the data stored on said data card.

It is within the core of the invention to provide the aforementioned system wherein said pharmaceutical information is encrypted by means selected from a group consisting of: symmetric cryptography, asymmetric cryptography, public-key cryptography.

It is within the core of the invention to provide the aforementioned system wherein said reading/writing means comprises a digital computer.

It is within the core of the invention to provide the aforementioned system wherein said pharmaceutical data is selected from a group consisting of: prescriptions, date of birth, sex, race, current medical conditions, prior medical conditions, medication history, allergies, medical procedures undergone, medical procedures planned, height, weight, body mass index, blood pressure, phenotypic data, and genotypic data. It is within the core of the invention to provide the aforementioned system wherein said read/write permissions are granted to system users who have been accredited. It is within provision of the invention to provide a method for providing pharmaceutical information comprising steps of: a. providing data cards bearing pharmaceutical data concerning end-users; b. providing a set of read/write permissions determining the right of a given system user to read and write pharmaceutical data upon said data card; c. providing reading/writing means adapted to read and write pharmaceutical data upon said data card in accordance with said read/write permissions; d. providing a networked server adapted to store said pharmaceutical data; e. reading and writing pharmaceutical data upon said data cards; whereby only specific system users with read/write permission are able to read/write information upon said data card, ensuring the integrity of the data stored on said data card.

It is within provision of the invention to provide the aforementioned method wherein said pharmaceutical data is encrypted by means selected from a group consisting of: symmetric cryptography, asymmetric cryptography, public-key cryptography.

It is within provision of the invention to provide the aforementioned method wherein said reading/writing means comprises a digital computer.

It is within provision of the invention to provide the aforementioned method wherein said pharmaceutical data is selected from a group consisting of: prescriptions, date of birth, sex, race, current medical conditions, prior medical conditions, medication history, allergies, medical procedures undergone, medical procedures planned, height, weight, body mass index, blood pressure, phenotypic data, and genotypic data.

It is within provision of the invention to provide the aforementioned method wherein said read/write permissions are granted to system users who have been accredited.

It is within provision of the invention to provide a method of generating trustworthy pharmaceutical data comprising steps of: a. accrediting pharmacists by means of an accrediting procedure; b. providing said accredited pharmacists with read and write permissions; c. providing pharmaceutical data cards to end users; d. providing encryption means for reading and writing pharmaceutical data upon said pharmaceutical data cards; whereby data written on said pharmaceutical data cards is encrypted, and readable and writable only by accredited pharmacists.

While the invention is susceptible to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that it is not intended to limit the invention to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a medical pharmaceutical identification information card.

In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. However, those skilled in the art will understand that such embodiments may be practiced without these specific details. Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The term 'data card' hereinafter refers to any object upon which data may impressed, including a printed card, , credit-card sized plastic card with magnetic strip, USB key, compact disc (CD), DVD, minidisc (MD), external hard disc, smart card (SC), flash memory card, flash disk, combinations thereof, and the like.

The term 'end users' refers to carriers of the data card of the system, who are generally medical patients, users of pharmacies, members of health plans, and/or users of other medical services. The term 'system users' hereinafter refers to pharmacists, doctors, managers, and information technologists of the present invention. Some of these users have read access to end users' information, and some have write access. The term 'non users' hereinafter refers anyone who is not an end user or system user. This may include for instance paramedics who are not system users, doctors who are not system users, lawyers, etc.

The term 'plurality' refers hereinafter to any positive integer e.g, 1,5, or 10.

The term 'MPIC refers hereinafter to 'medical pharmaceutical information card'.

The term 'CVC refers to a Card Verification Center, where the contents of an MPIC can be verified. This will pharmacist—a.card creation center or b.pharmacy )

The present invention comprises a system and method for a pharmaceutical information system including a data card carried by the end user, and associated methods for read/write permissions management. In particular, write access is restricted to pharmacists who have demonstrated a particular set of qualifications and/or passed a course of accreditation. The data card, which is generally carried or worn by end users, may include such information as:

1. date of birth

2. sex

3. race

4. medical conditions

5. medication history - current and prior

6. medical procedures undergone

7. phenotypic data - height, weight, body mass index, blood pressure, etc.

8. genotypic data - DNA sequences, etc.

Each end user of the system is supplied with (for instance) a USB key containing the aforementioined data in digital form. In one embodiment of the invention some or all of this data is encrypted such that it can only be read by someone possesing the decryption key for that particular end user. In one embodiment of the invention this decryption key is supplied only to system users with read access, for example only to qualified pharmacists. In a further embodiment of the invention, read/write access to different subsets of the data contained on the card is given to given groups. For instance, basic data may be made readable by all users of the system. This way, in case of emergency, emergency medical personnel will have read access to vital information such as current medicines being taken by the end user, without requiring a decryption key or any other permissions or information. For similar reasons the format of data contained on the data card may be easily accessible, for instance comprising text files in ASCII format and image files in .bmp, .jpg, or .gif formats. Similar common formats will be obvious to one skilled in the art.

According to a preferred embodiment of the present invention, a pharmaceutical information system is provided that allows controlled access to, and control over, pharmaceutical records. In the preferred embodiment a data card is carried by the end user, which bears a set of data concerning the end user and his or her medical condition, history, etc. A set of networked servers is also provided, which carries a superset of this information for all users of the system. The system provides specific read and write permissions that define who may read the information on the data card, who may read information on the networked servers of the system, and who may write to these locations as well.

In the preferred embodiment of the system, pharmacists are employed as system users. Pharmacists that enroll in the system are first audited to ensure their reliability, record, and the like. Those that pass autditing are given access to the system and are allowed to access end user records. They are given a specific set of read and write permissions that allow them to access and change the contents of the data cards. This may include changing the data card contents to reflect changes in the end user's condition, prescriptions filled, time of prescription, and the like.

The end users will comprise inter alia pharmacy customers, medical clinic users, users of managed healthcare organizations (HMOs), hospital admittees, hospice residents, and the like. Each end user is provided with a data card bearing such information as listed above. The card is preferably worn, carried, or otherwise borne by the user. One advantage of such a system is that emergency medical technicians can access the publicly accesible data of the card in case of emergencies.

As mentioned access to data on the data card is given only to a specified subset of system users, end users, and non users. In one embodiment of the invention, these permissions are enforced by means of encryption. In one particular embodiment of the system, public- key cryptographic methods are employed to enforce the permissions. For example, a public and private key pair may be issued for each end user of the system. This key pair will hereinafter be referred to as the 'public read key' and the 'private read key'. The public read key is published for example on a networked server of the system, and furthermore may optionally be included in plain text on the data card. Any information encrypted by the public will only be accessible to someone holding the private key, which is supplied only to persons with read permission. Similarly, write permission may be enforced for example by use of digital signature. For this purpose it is within provision of the invention to provide a second key pair, hereinafter referred to as the 'public write key' and 'private write key'. A unique write key pair is supplied to each accredited system user. When a piece of data is to be changed or added, it is encrypted with the system user's public write key and signed with the associated private write key, which is supplied only to users with write permission. As with the public read key, the public write key is published for example on a networked server of the system, and furthermore may optionally be included in plain text on the data card. Since any private data must be encrypted with the private write key, any information written on the data card but lacking this encryption is suspect, and in fact will not be readable by use of the public write key, if encrypted by any key any other than the private read key. This information is therefore ignored or erased upon periodic check in a data terminal of the system, which will be described below. It should be pointed out as will be obvious to one skilled in the art that encryption and signing of a given data object is possible, thereby allowing reading by one subset of system users and writing by another possibly different subset of system users. System users will access the information contained on the data cards preferably through use of a piece of software adapted for such use This software may include implementations (for example) of public key cryptographic methods, provision for text file display, image file display, and the like. The software will preferably be in communication with networked servers of the system, and be provided with means to upload and download information found on the data cards to the networked servers. An important aspect of the system lies in the reliability of the data contained on the data cards. Since only licensed, audited system users may change data on the data cards, the integrity of this data is ensured. Therefore it may be relied upon by pharmacists, doctors or other health care practitioners in the field. It is within provision of the invention that legal verification and liability issues are resolved by use of the data card of the present invention; for instance, the operator of a network using the current invention stands behind the integrity of the data by taking legal liability for the accuracy of the information contained upon the data cards. This is in stark contrast to other medical information systems such as Google Health, which is not verifiable, and where a given user can change his or her medical profile at will.

One particular advantage of the system is that permissions can be restricted to users who have a known background, such as doctors or pharmacists who have undergone accreditation. By suitable encryption methods, reading/writing data on the card can be restricted to this group of accredited system users. In this way for instance prescriptions cannot be faked, a common enough practice amongst the habitually medicated.

It is within provision of the invention that both electronic and nonelectronic methods

(such as microfilm or printing)-erase of data storage be used.

It is within provision of the invention that detailed user information be provided such as genetic information, medical history, allergies, genotype, and phenotype.

It is within provision of the invention that the data cards be highly portable, for example being implemented upon flash memory card within cellular phones or USB keys.

It is within provision of the invention that the data cards employ common data transfer protocols such as wireless LAN, Bluetooth, USB, RFID, and the like as will be obvious to one skilled in the art.

It is within provision of the invention to provide a method of doing business for pharmacists. This method consists of allowing pharmacists who are system users of the current invention to act as consultants when choices between various medical alternatives are available. For instance, a pharmacist may provide a brochure or poster inviting potential end users for a consultancy. Various medicaments, supplements, and the like may be recommended by the pharmacist, as long as these medicaments do not require a physician's prescription. By giving the pharmacist some degree of 'room' for dispensing of intelligent advice, the pressure exerted by large pharmacy chains upon the individual pharmacist may be somewhat alleviated.

It is within provision of the invention that pharmacists who enroll as users of the system of the current invention be authorized to use the system only after undergoing accreditation and education in the use of the system.

It is within provision of the invention that the information added to a given user's card be uploaded at the pharmacy to one or more central servers. This is most easily accomplished by means of a PC available to each participating system user. A particular software program for instance may be provided that deals with the reading and writing of data, optionally implementing the cryptographic methods mentioned above. When a user of the system adds or changes data on the end user's data card, this change is also uploaded to the system servers, which are preferably connected to the internet. In one embodiment of the system, all communication between servers and system users is conducted using 'secure shell' cryptographic methods.

It is within provision of the system that the information so gathered on the system servers be used for medical studies. Such studies generally become more statistically reliable as the number of participants increases. System end users may opt to allow their medical information to be used (for example, anonymously) for the purposes of medical research. When the database of end user medical information becomes large enough, then complex drug interactions (for instance) may become obvious from correlation tables. It is within provision of the invention that an accrediting procedure be used to allow only accredited system users with enhanced access to the system, for example read and write access to the end-user data cards. This accrediting procedure may include requirements such as a minimum number of years of experience as a licensed pharmacist, passing a course designed for the purpose of accrediting users, and the like as will be obvious to one skilled in the art.

It is within provision of the current invention that a patient may be examined at a data terminal of the system by means of camera, microphone, speakers, and text interaction with the patient. Since the data terminal is operated by an accredited user of the system by means of a private password, the doctor is assured that he is seeing a bona fide patient needing an actual examination, and the patient knows he is being examined by a bona fide doctor. In some embodiments of the invention, certain basic procedures may be performed remotely by a pharmacist or nurse, such as taking blood pressure readings, heart rate measurements, blood sugar measurements, and the like. It will be obvious to one skilled in the art that several of electronic meters and automatic measurements may be performed easily by a pharmacist or nurse without requiring the direct physical involvement of a doctor. By means of this 'remote examination' both the doctor and patient save time while remaining sure that the integrity of the examination and diagnosis are unimpaired, in particular, both sides are assured of the identity of the other users due to the use of public key cryptography. With reference to Fig. la,b, a possible embodiment of the data card of the present invention is depicted. Certain basic data 101 such as name, date of birth and the like is printed upon the card. A photo may also printed upon the card. The card stores information on flash memory and is provided with processing means to act as a USB client, allowing communication through USB connector 102.

With reference to Fig. 2, a flowchart depicting the initial stages of issuing and writing to a data card are shown. First a pharmacist desiring to use the system must pass accreditation. Once accredited, a system user such as a pharmacist receives a public and private write key, and the public write key is provided to all accredited users of the system. Once an end user enrolls in the system he or she too is provided a public and private read key. These keys are provided to accredited system users. The end user's basic information is then entered into a data terminal running software associated with the system. A certain amount of basic information is entered by the pharmacist, and this information is sent to the servers of the system and verified. Once verified this information is encrypted with the end user public key and written to the data card. This information is also optionally uploaded to the servers of the system for backup purposes or verification. In one embodiment of the invention the user data is sent to the server only and not written to the data card; rather, only basic information such as known end-user allergies and identification information is printed on the user data card. With reference to Fig. 3 a flowchart is shown of a possible sequence of events in the operation of the current invention. A doctor becomes an accredited system user and is issued encryption keys. The doctor sees a patient. The doctor prescribes a certain medication for the patient. This list of drugs is printed. The patient takes the list of drugs to the pharmacist. The pharmacist can fill the data's forms and send them to the Card Verification Center. In this way a secure system for adding MPID (medical pharmaceutical information data) is attained; external factors cannot tamper with the MPI list, since it is encrypted. It is within provision of the invention that the MPI list be sent to a central database.

With reference to Fig. 4 a flowchart is shown of a possible sequence of events for issuing a card of the current invention. A patient sees a doctor or pharmacist, and obtains health care and medical history forms to fill out. After filling out and signing these forms, the forms are returned to a card creation center. There, the forms are checked, verified against other sources of medical data such as other doctor's files, public and private databases, and the like. Once verification is complete, a card is created and issued to the patient, for example being sent to the patient's home, or preferably, transmitted at a chosen pharmacy.

The patient can now use the card at the pharmacist's or doctor's office as described above.

Another possible way to issue the card is to have allow the pharmacist to print or otherwise create cards at the pharmacy. This can be done for example on a licensed basis, where the pharmacist buys a certain number of cards which he then resells to customers, or buys a license to produce a certain number of cards for resale.

It is within provision of the invention that the patient has ultimate control over the details provided by the card, with the ability for instance to request that any given piece of information be removed.

It is within provision of the invention that a necessary step of verification be required, which can be accomplished for instance only by a licensed pharmacist (a clinical pharmacist or any pharmacist who has been accredited).

Claims

1. A pharmaceutical information system comprising: a. an end-user data card bearing pharmaceutical data concerning an end-user; b. a data card reader/writer communicating with said data card for reading and writing pharmaceutical data upon said data card c. a networked server communicating with said data card reader /writer adapted to transfer said data to said data card reader, receive said data from said data card reader and store said pharmaceutical data wherein said data card reader is adapted for reading and writing said data according to permissions determining the right of a given system user to read and write pharmaceutical data upon said data card thereby ensuring the integrity of the data stored on said data card.

2. The system of claim 1, wherein said pharmaceutical information is encrypted by means selected from a group consisting of: symmetric cryptography, asymmetric cryptography, public-key cryptography.

3. The system of claim 1, wherein said reading/writing means comprises a digital computer.

4. The system of claim 1, wherein said pharmaceutical data is selected from a group consisting of: prescriptions, date of birth, sex, race, current medical conditions, prior medical conditions, medication history, allergies, medical procedures undergone, medical procedures planned, height, weight, body mass index, blood pressure, phenotypic data, and genotypic data.

5. The system of claim 1, wherein said read/write permissions are granted to system users who have been accredited.

6. A method for providing pharmaceutical information comprising steps of: a. providing data cards bearing pharmaceutical data concerning end-users; b. providing a set of read/write permissions determining the right of a given system user to read and write pharmaceutical data upon said data card; c. providing reading/writing means adapted to read and write pharmaceutical data upon said data card in accordance with said read/write permissions; d. providing a networked server adapted to store said pharmaceutical data; e. reading and writing pharmaceutical data upon said data cards; whereby only specific system users with read/write permission are able to read/write information upon said data card, ensuring the integrity of the data stored on said data card.

7. The method of claim 6, wherein said pharmaceutical data is encrypted by means selected from a group consisting of: symmetric cryptography, asymmetric cryptography, public-key cryptography.

8. The method of claim 6, wherein said reading/writing means comprises a digital computer.

9. The method of claim 6, wherein said pharmaceutical data is selected from a group consisting of: prescriptions, date of birth, sex, race, current medical conditions, prior medical conditions, medication history, allergies, medical procedures undergone, medical procedures planned, height, weight, body mass index, blood pressure, phenotypic data, and genotypic data.

10. The method of claim 6, wherein said read/write permissions are granted to system users who have been accredited.

11. A method of generating trustworthy pharmaceutical data comprising steps of: a. accrediting pharmacists by means of an accrediting procedure; b. providing said accredited pharmacists with read and write permissions; c. providing pharmaceutical data cards to end users; d. providing encryption means for reading and writing pharmaceutical data upon said pharmaceutical data cards; whereby data written on said pharmaceutical data cards is encrypted, and readable and writable only by accredited pharmacists.