Personalized Healthcare Management System

• US 20100036681A1
• Filed: 12/13/2007
• Published: 02/11/2010
• Est. Priority Date: 02/21/2007
• Status: Active Grant

• Current Assignee: Bilcare Limited
• Original Assignee: Bilcare Limited
• Inventors: Naik, Praful Ramachandra, Bhandari, Mohan Harakchand
• Granted Patent: US 8,234,127 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

Personalized healthcare management system. The personalized integrated healthcare anti-counterfeit management system provides pack authentication, user (5) feedback and compliance, documentation of the dosage uptake by the users (5), maintenance of user (5) related data and displaying compliance and feedback information, and liaising with healthcare agencies, users'"'"' nominated persons and/or medical practitioners (6). It further provides real-time and authentic data in raw and analysed form to diverse agencies in the healthcare chain. Moreover, a method for delivering pharmacovigilance related information in clinical trials is disclosed. Authentication of diverse healthcare agencies in the healthcare value chain such as medical practitioners (6), users (5), pharmacists (7), pharmaceutical companies (9), and clinical researchers is taken care of.

Claims

1-57. -57. (canceled)

58. A method of providing an integrated healthcare management system relating to a patient which is interactive between a first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency, the method comprising:

i. registering a defined healthcare regime for the patient in a remote system and optionally other data relating directly or indirectly to the healthcare regime;

ii. providing to the patient a patient medication system comprising

a. a package comprising a product for dispensing and information relating to the identity of the package;

b. an associated device with which the package is engagable so as to be readable by the associated device;

iii. the patient medication system being communicably linked to the remote system through the associated device;

iv. recording information relating to the identity of the package in the patient medication system or remote system and whereby upon dispensing of the product the said recorded information is comparable with the information of the package to determine whether or not the information of the said product dispensing system corresponds with the said recorded information;

v. providing to the at least one healthcare agency a communication port communicably linked to the remote system;

vi. periodically providing information relating to the identity of the patient and/or the status of the package from the patient medication system to the remote system;

vii. comparing the information periodically transmitted to the remote system with the healthcare regime recorded for the patient in the remote system to ascertain whether the information corresponds with the recorded healthcare regime;

viii. optionally providing information from the remote system to the patient medication system to indicate whether the status of the patient medication system and/or identity of the patient corresponds with the information relating to the healthcare regime and/or the identity of patient;

ix. providing information from the remote system to the at least one healthcare agency indicating that a periodic transmission of information has been received by the remote system;

whereby the first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency transmit and/or receive via the remote system information relating directly or indirectly to the healthcare regime of the patient.

59. A method according to claim 58 wherein the patient medication system comprises a package system comprising:

a dispensing system with an optional product outlet provision;

an embedded system comprising data logging and storing means comprising optionally a data processing means, communication/interaction means;

a power source built-in or optionally induced;

non-accessible compartment for the said operating system;

a separate non-accessible product containment;

a means for authentication such as an encoded chip or a pattern or a random pattern or a marker or combinations thereof;

optional display/interactive means;

a sensing means that activates/deactivates upon dispensing of the product from the package;

means to establish connection of the power source with the said operating system;

wherein the said operating system is configured with the sensing means and optionally with authentication means and is housed in the said compartment wherein the said compartment is operably connected with the said containment;

wherein the said package is authenticated by the remote system;

optionally prompting product consumption;

the said sensing means senses the product dispense, the said operating system records and transmits/communicates real time product dispense data via said interaction/communication means to the remote device, rendering the package un-authentic in case of compromise/tampering.

60. A method according to claim 58 wherein the patient medication system comprises:

a) a package containing medication and which has information relating to the identity of the package; and

b) an associated device with which the package is engagable, the associated device being communicably linked to the remote system and registrable with the remote system; and

recording information relating to the identity of the package in the associated device or remote system whereby upon engagement of the package and associated device the said recorded information is comparable with the information of the package to determine whether or not the information of the engaged package corresponds with the said recorded information; and

optionally providing information from the remote system to the associated device to indicate whether the status of the package and/or identity of the patient corresponds with the information relating to the healthcare regime and/or the identity of patient.

61. A method according to claim 60 for registering the patient with the patient medication system comprising:

i. providing a unique identifier for the associated device of the patient and recording the identifier with the healthcare regime of the patient in the remote system to register the associated device;

ii. optionally receiving a confirmation signal of the registration from the remote system;

iii. registering the patient with the associated device in the remote system;

iv. registering the healthcare regime of the patient in the remote system;

v. engaging the package of the patient medication system into the associated device;

vi. comparing the recorded information which relates to the identity of the package and which is stored in the associated device or remote system with the information of the package engaged with the associated device to determine whether or not the information of the engaged package corresponds with the said recorded information; and

vii. provided the information of the package corresponds to the stored information relating to the identity of the package, registering the package with the associated device in the remote system;

whereby information is provided to the remote system linking the package and associated device with the healthcare regime of the patient so as to enable authentication and registration of the medication package identity.

62. A method according to claim 58 for detecting compliance of the patient with the healthcare regime, the healthcare regime requiring administration of medication at a predetermined time, the method comprising:

i) storing the healthcare regime of the patient in the remote device;

ii) periodically checking that the patient medication system is communicably linked to the remote system;

iii) where the patient medication system has not been communicably linked to the remote system after a predetermined time to validate adherence to the healthcare regime, generating and transmitting a message to the patient to link the patient medication system to the remote system;

iv) where the patient medication system is not communicably linked to the remote system after a pre-set delay from the time of transmission of the message in step iii), generating and transmitting a message to at least one of the medical practitioner of the patient or a nominated individual indicating non-compliance of the patient with the healthcare regime; and

v) where the patient medication system is communicably linked to the remote system, recording information in the remote system relating to the time of the link and the identity and status of the package and providing access to the said information to the medical practitioner.

wherein the healthcare regime is stored in the remote device by inputting the healthcare regime in the patient medication system and communicating the healthcare regime from the patient medication system to the remote system and storing the regime in the remote system.

63. A method according to claim 58 for generating a prescription identifier for a patient to whom a medical prescription has been issued by a health care agency, preferably a medical practitioner comprising:

i) either;

a) generation by a pharmacist of a prescription identifier on presentation of the prescription the identifier comprising the healthcare regime and information relating to the patient;

or

b) generation by the medical practitioner of a prescription identifier comprising the healthcare regime and information relating to the patient;

ii) communicating the prescription identifier to the remote system via a communication port to which the pharmacist or medical practitioner has access.

wherein the prescription identifier is retrieved by the pharmacist from the remote system upon presentation of the prescription identifier and used to make up the medication package of the patient.

64. A method according to claim 58 for monitoring compliance of the patient with the healthcare regime comprising:

i) providing information relating to the date, time and medication taken by the patient to the remote system by communicably linking the patient medication system to the remote system;

ii) communicating information relating to the date, time and status of the medication in the package to the remote system and comparing that information with the healthcare regime to determine compliance or otherwise by the patient with the healthcare regime.

65. A method of providing an integrated healthcare management system relating to a patient which is interactive between a first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency,

the method comprising:

i) registering a defined healthcare regime for the patient in a remote system and optionally other data relating directly or indirectly to the healthcare regime;

ii) providing to the patient a patient medication system comprising;

a) a package containing medication and which has information relating to the identity of the package; and

b) an associated device with which the package is engagable so as to be readable by the associated device, the associated device being communicably linked to the remote system and registrable with the remote system;

iii) recording information relating to the identity of the package in the patient medication system or remote system and whereby upon dispensing of the product the said recorded information is comparable with the information of the package to determine whether or not the information of the said product dispensing system corresponds with the said recorded information;

iv) providing to the at least one healthcare agency a communication port communicably linked to the remote system;

v) periodically providing information relating to the identity of the patient and/or the status of the package from the patient medication system to the remote system;

vi) comparing the information periodically transmitted to the remote system with the healthcare regime recorded for the patient in the remote system to ascertain whether the information corresponds with the recorded healthcare regime;

vii) optionally providing information from the remote system to the patient medication system to indicate whether the status of the patient medication system and/or identity of the patient corresponds with the information relating to the healthcare regime and/or the identity of patient;

viii) providing information from the remote system to the at least one healthcare agency indicating that a periodic transmission of information has been received by the remote system;

whereby the first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency transmit and/or receive via the remote system information relating directly or indirectly to the healthcare regime of the patient;

the package and associated device being interactive and comprising;

a smart package for carrying a product and which package is adapted to communicate with an associated device, the package comprising a plurality of containments adapted to receive a product, each containment being closed or optionally with closure means, the said plurality of containment/s and/or closure/s being non-electrically interconnected;

signal generating means adapted to convey to an associated device information relating to one or more of the containments;

a chip, the said chip being optional when signal generating means itself is a chip and optionally transmitter and/or receiver means;

the said associated device comprising;

a housing adapted to communicate with the smart package;

signal sensing for detecting a signal from the signal generating means said signal sensing optionally comprising acquiring means configured with data input, storing, output, decoding and processing and communicating means adapted to communicate with an external data record;

wherein said signal generating means is disposed in the said package such that, on communication with the device, the signal generating means provides information relating to one or more of the containments to the signal sensing means in the said associated device and optionally the information is communicated externally of the said system for the purpose of comparison of the information with the external data record;

and the method further comprising;

recording information relating to the identity of the package in the associated device or remote system whereby upon engagement of the package and associated device the said recorded information is comparable with the information of the package to determine whether or not the information of the engaged package corresponds with the said recorded information; and

optionally providing information from the remote system to the associated device to indicate whether the status of the package and/or identity of the patient corresponds with the information relating to the healthcare regime and/or the identity of patient.

66. A method according to claim 65 wherein the smart package is selected from comprising containment/s in the form of one or plurality of enclosed spaces formed in a first lamina to contain the product closed with second rupturable lamina attached to the first lamina to form a closure so as to seal the product in the said enclosed spaces;

the said containment/s and/or closure/s being non-electrically interconnected;

a form wherein product containment in the form of a flexible material wherein part of the same material is sealed to form a pouch and a closure means in the form of a product entrapment and dispensing provision;

signal generating means provided in the said product entrapment and dispensing provision means such that removal of the product from the said containment portion results in generation of signal and/or alteration of the signal;

chip and optionally transmitter and/or receiver means,

a form wherein carding comprising;

a first lamina provided with openings corresponding to the said formed enclosed spaces of the said package such that the said formed enclosed spaces pass through the said openings;

a second lamina provided with perforated peelable portions provided corresponding to or aligned with the locations of the said rupturable lamina of the package such that when the product in the package is removed, the said perforated portion corresponding to that product is also removed;

the package comprising;

a plurality of containments in the form of a first package lamina in which one or a plurality of enclosed spaces are formed to contain the product(s) closed with a second package rupturable lamina attached to the unformed portion of the first package lamina to seal the product(s) in the said enclosed spaces;

the said containment/s and/or closure/s being non-electrically interconnected;

chip and optionally transmitter and/or receiver means;

wherein the said package is placed between the first and the second lamina of the said carding;

signal generating means in or optionally on the containment/s, or in or optionally on the said closure/s.

67. A method according to claim 65 wherein the smart package comprises a first sheet having multiple containment capsules upstanding from a first surface thereof and dimensioned to receive individual product items and multiple corresponding openings in a second surface of the sheet to the upstanding capsules;

a second sheet secured to the second surface of the first sheet so as to provide closures over the multiple openings in the first sheet; and

components having individual signatures and being disposed adjacent corresponding closures such that respective signatures are substantially detectable only if their corresponding closures are intact;

wherein the respective components include respective discrete magnets respectively secured to the second sheet opposite openings to corresponding upstanding containment capsules; and

wherein the substantially detectable signatures comprise respective magnetic fields;

respective components include respective magnetic layers disposed upon the second sheet opposite openings to corresponding upstanding containment capsules; and

wherein the substantially detectable signatures comprise respective magnetic fields.

68. A method according to claim 65 wherein the smart package for carrying a product comprises:

a product package that includes;

an entrapment region to contain a product;

a removable closure that encloses the product within the entrapment region prior to its removal and that allows passage of the product from the entrapment region upon its removal;

a component having signatures and being disposed adjacent the closure such that the signatures is substantially detectable only if the closures is intact;

a reader that includes, a sensor to sense signature when a product is disposed within the entrapment region; and

a receptor region contoured to receive at least a portion of the product package that includes the entrapment region and to align the sensor with the entrapment region to permit sensing of the signature prior to removal of the closure while the product is disposed within the entrapment region.

69. A method as claimed in claim 68 further including:

first data storage circuitry secured to the package and encoded with first information;

second data storage circuitry secured to the reader and encoded with second information;

processing circuitry associated with the reader to process the first information and the second information to authenticate the package; and

storage circuitry and the second data storage circuitry and the processing circuitry;

wherein processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the signal generator; and

a communication interface to communicate information externally to the reader that is indicative of the imparting of a signal generated by the signal generator through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region;

wherein processing circuitry coupled to receive a sensor signal indicative of detection of the signature; and

a communication interface to communicate information externally to the reader that is indicative of whether the signature has been detected.

70. A method according to claim 65 wherein the smart package includes

an entrapment region to contain a product;

a reader that includes,

a signal generator to impart a signal across a free space;

a sensor to sense the signal generated by the signal generator across the free space;

a receptor region sized to receive at least a portion of the product package that includes the entrapment region and contoured to align the signal generator and the sensor with the entrapment region to permit the signal generator to impart a signal through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region;

wherein the smart package further comprises first data storage circuitry secured to the package and encoded with first information;

second data storage circuitry secured to the reader and encoded with second information;

processing circuitry associated with the reader to process the first information and the second information to authenticate the package;

a first communication interface to communicate information between the first data storage circuitry and the second data storage circuitry and the processing circuitry;

processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the signal generator; and

a second communication interface to communicate information externally to the reader that is indicative of the imparting of a signal generated by the signal generator through a free space in the entrapment region to the sensor in the absence of the product within the entrapment region.

71. A method according to claim 65 wherein the smart package includes;

an entrapment region to contain a product;

a removable closure that encloses the product within the entrapment region prior to its removal and that allows passage of the product from the entrapment region upon its removal;

a magnetic material associated with the closure;

a reader that includes,

a sensor to sense a magnetic signal imparted by the magnetic material when the product is disposed within the entrapment region; and

a receptor region contoured to receive at least a portion of the product package that includes the entrapment region and to align the sensor with the entrapment region to permit the magnetic material to impart a magnetic signal to the sensor prior to removal of the closure while the product is disposed within the entrapment region;

first data storage circuitry secured to the package and encoded with first information;

second data storage circuitry secured to the reader and encoded with second information;

processing circuitry associated with the reader to process the first information and the second information to authenticate the package;

a first communication interface to communicate information between the first data storage circuitry and the second data storage circuitry and the processing circuitry;

processing circuitry coupled to receive a sensor signal indicative of receipt of a signal imparted by the magnetic material; and

a second communication interface to communicate information externally to the reader that is indicative of the imparting of a signal by the magnetic material to the sensor in the absence of the product within the entrapment region.

73. A method of providing an integrated healthcare management system for conducting a clinical trial which is interactive between at least one patient in the clinical trial and a party carrying out a clinical trial

the system comprising:

i) registering a defined healthcare regime for the patient in a remote system and optionally other data relating directly or indirectly to the healthcare regime;

ii) providing to the patient a patient medication system comprising;

a. a package comprising a product for dispensing, information relating to the identity of the package; and

b. an associated device with which the package is engagable so as to be readable by the associated device;

the patient medication system being communicably linked to the remote system through the associated device;

iii) optionally recording information relating to the identity of the package in the patient medication system or remote system and whereby upon dispensing of the product the said recorded information is comparable with the information of the package to determine whether or not the information of the said product dispensing system corresponds with the said recorded information;

iv) providing to the party carrying out the clinical trial a communication port communicably linked to the remote system;

v) periodically providing information relating to the identity of the patient and/or the status of the package from the patient medication system to the remote system;

vi) comparing the information periodically transmitted to the remote system with the healthcare regime recorded for the patient in the remote system to ascertain whether the information corresponds with the recorded healthcare regime;

vii) optionally providing information from the remote system to the patient medication system to indicate whether the status of the patient medication system and/or identity of the patient corresponds with the information relating to the healthcare regime and/or the identity of patient;

viii) optionally providing information from the remote system to the party carrying out the clinical trial indicating that a periodic transmission of information has been received by the remote system;

whereby the party carrying out the clinical trial may determine whether the patient has complied with the healthcare regime.

74. An integrated healthcare management system relating to a patient which is interactive between a first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency, the system comprising:

i) a remote system for storing a defined healthcare regime for the patient and optionally other data relating directly or indirectly to the healthcare regime;

ii) a patient medication system for use by the patient providing medication to be taken by the patient and comprising;

a. a package comprising a product for dispensing, information relating to the identity of the package; and

b. an associated device with which the package is engagable so as to be readable by the associated device;

iii) the patient medication system being communicably linked to the remote system through the associated device;

iv) a communication port for at least one healthcare agency to communicate interactively with the remote system;

wherein;

v) the remote system and the patient medication system are linked and interactively communicable whereby information relating to the healthcare regime is transmissible to the patient medication system and accessible by the patient and information relating to the patient medication system is transmissible to the remote system and comparable with the defined healthcare regime stored in the system; and

vi) the communication port is adapted for the at least one healthcare agency to input information and/or to receive information relating to the healthcare regime of the patient by transmission of information between the communication port and to the remote system;

the arrangement being such that the first healthcare agency and at least one other party, the said other party being selected from the patient and at least one other healthcare agency transmit and/or receive via the remote system information relating directly or indirectly to the healthcare regime of the patient

wherein at least one healthcare agency is selected from the patient'"'"'s medical practitioner, a hospital or other health institution attended by the patient, a pharmacy supplying the patient medication system, clinical researcher, a pharmaceutical company or distributor providing the patient medication system, a healthcare regulator and an insurance company providing insurance to the patient wherein information from at least one of the healthcare agencies is transmissible to the remote system and information is retrievable by the healthcare agency from the remote system

75. A system according to claim 74 wherein the patient medication system comprises a package and associated device comprising a smart package for carrying a product and which package is adapted to communicate with an associated device, the package comprising a plurality of containments adapted to receive a product, each containment being closed or optionally with closure means, the said plurality of containment/s and/or closure/s being non-electrically interconnected;

signal generating means adapted to convey to an associated device information relating to one or more of the containments;

a chip, the said chip being optional when signal generating means itself is a chip and optionally transmitter and/or receiver means;

the said associated device comprising a housing adapted to communicate with the smart package;

signal sensing for detecting a signal from the signal generating means said signal sensing optionally comprising acquiring means configured with data input, storing, output, decoding and processing and communicating means adapted to communicate with an external data record;

wherein said signal generating means is disposed in the said package such that, on communication with the device, the signal generating means provides information relating to one or more of the containments to the signal sensing means in the said associated device and optionally the information is communicated externally of the said system for the purpose of comparison of the information with the external data record.

76. A system according to claim 74 wherein the associated device comprises a housing with package holding provision adapted to receive the package containing a product;

a signal generator adapted to determine information relating to the presence or absence of the product in the package and signal sensing means provided in the said device to detect signals generated by the said signal generator providing information relating to the product;

a patient interface whereby the patient may input information or receive information relating to the healthcare regime from the remote system the arrangement being such that the device is registrable to the patient;

the package is registrable to the device; and

the identity and/or status of the package and device are comparable to the healthcare regime for the patient so as to enable authentication of the identity and/or status of the package to determine compliance or otherwise of the patient with the healthcare regime.

77. A system according to claim 74 wherein the patient medication system comprises:

a dispensing system with an optional product outlet provision;

an operating system comprising data logging and storing means comprising

optionally a data processing means, communication/interaction means;

a power source built-in or optionally induced;

non-accessible compartment for the said operating system;

a separate non-accessible product containment;

a means for authentication such as an encoded chip or a pattern or a random pattern or a marker or combinations thereof;

optional display/interactive means;

a sensing means that activates/deactivates upon dispensing of the product from the package;

means to establish connection of the power source with the said operating system;

wherein the said operating system is configured with the sensing means and optionally with authentication means and is housed in the said compartment wherein the said compartment is operably connected with the said containment;

wherein the said package is authenticated by the remote system;

optionally prompting product consumption;

the said sensing means senses the product dispense, the said operating system records and transmits/communicates real time product dispense data via said interaction/communication means to the remote device, rendering the package un-authentic in case of compromise/tampering.