FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
" A personalized healthcare management system"
(a) Bilcare Limited (b) a company registered under the companies Act 1956 and (c) having its registered office at 1028, Shiroli, Rajgurunagar, Khed, Pune -410505, India
The following specification particularly describes the nature of the invention and the manner in which it is to be performed.

Field of Invention
The present invention relates to personalized healthcare anti-counterfeit management system providing pack authentication, user feedback and compliance, documentation of the dosage uptake by the users, maintenance of user related data and displaying compliance and feedback information, liaising with users' nominated persons / medical practitioner, providing real-time and authentic data in raw and analysed form to diverse agencies in the healthcare chain.
Background of the Invention
The health care sector is becoming increasingly demanding. The ultimate end user / drug consumer that is patient is the focal point / hub in the healthcare system. At the same time related entities such as doctors, pharmacies, insurance agency, pharmaceutical company, distributor etc. form important links / stakeholders and are integral part of the healthcare circle and their cognitive effort plays vital role in maintaining patient's healthcare and providing value added services to him/her. Conventionally, these links are isolated and not integrated with the patient to understand his/her usage pattern of drug and related feedback. If these entities appropriately and authentically liaison with patient and work in tandem with the information generated by and from the patient's end using means to link the patient and his/her compliance process such as his compliance with drug schedule, feedback about symptoms etc., synergistic effect could be produced resulting in patient compliance thereby enhancing quality of health care and providing value addition to all the links in this healthcare system. Various healthcare management systems are reported in the literature. They are as follows:
The US patent 6961285 discloses a system and process for assisting patients in taking medication and assisting third parties in accumulating information regarding patient medication intake. The instrumented medication package along with a portable medication package is communicably connected to the third parties via computer network. However, the process is restricted to only accumulating and transmitting data related to patient medication intake. The process does not provide any value addition to the third parties.
The US Patent 5,781,442 discloses patient management system capable of monitoring, controlling and tracking the administration of care in a health care institution. The invention provides a modular management system that processes the functional information from the hospital and its administration such as patient list and their data, ongoing procedures. However, this management system suffers from the drawback that it is primarily used in (within) a health care institution / hospital and it does not facilitate authenticated interactions / feed backs of the patient with doctor, pharmacies, insurance agency, pharmaceutical company etc.
The US Patent 6,021,392 discloses a system and method for drug and health care supply distribution and replenishment. Health care provider / hospital, drug
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dispensing machine at the hospital, hand held drug dispensing unit and second computer located at a drug supplier facility are in electronic communication with each other providing records of drugs received by the health care provider, drugs dispensed to patients at the health care provider, and an ongoing inventory of drugs stored at the health care provider. However this system and method are primarily used at the health care provider and drug supplier end. The system and method does not link / use the authenticated information generated by patient in terms of drug consumption, feed back to various links such as doctor, pharmacies, insurance agency, pharmaceutical company etc. of the health care circle. The technical problem addressed is related to supply distribution and replenishment of medication.
The US Patent 5,390,238 discloses health care support method and system for
health care support. The system comprises of health support unit for monitoring
and supporting a patient, monitoring terminal, and a network server coupled
between the health support unit and monitoring terminal for exchanging
information between health support units and monitoring terminal. The method
comprises the steps of:
ü inputting a medication delivery schedule to the health support unit,
ü synthesizing speech in the health support unit to inquire a wellness status
of the patient at predetermined intervals and to remind the patient to take
medication as scheduled
ü recognizing patient speech in the health support unit,

ü recording patient data concerning the patient's compliance with the
medication delivery schedule and the patient's wellness check results,
ü transmitting patient data to a central network server for access by the
patient's health care provider. However the system and the method disclosed is limited to monitoring the patient's compliance with medication delivery schedule. Further It does not provide facility and method of liaison / interaction with the other entities in the health care circle such as doctors, pharmacies, insurance agency, pharmaceutical company, distributor
The US patent US 5,558,638 discloses a system for monitoring the health and medical requirements of plurality of patients at remote sites and providing these requirements to a care center. The system comprises a sensor for monitoring the patient's medical state, the sensor generating a parameter indicative of the patient's medical state; a data base located at a remote location from the sensor for storing the patient's medical state; a means for communicating the parameter to the data base; a means for retrieving the parameter from the data base; and a means for providing medical procedure to the patient in response to the retrieved parameter. However the system is limited to patient interaction of the patient with only care center. It does not integrate other entities in the healthcare system.
Thus review of the prior art reveals following drawbacks:
ü The systems and methods do not address patient centric, interactive, authenticated integration of the complete cross section right from the medication package, insurance agency to pharmacists of the health care system wherein the interaction between them brings value to each of the
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entities and produces synergistic effect to ensure patient compliance and enhance value of the total healthcare system.
Methods and systems restricted to hospitals / health care institutions only
The information generated by the patient at his/her end regarding drug consumption , its symptoms etc. is not been accessed / used / transmitted as a primary source to various links of the health care system.
The methods and systems do not provide the facility for patient registration and identification with the system, authentication & registration of the medication package and authentication of the facilitators such as medical practitioners, pharmacist etc. are not reported in the prior art
There is a need to develop a integrated method and a system thereof wherein patient is at the focal point (patient centric method) and facilitators / stakeholders such as medical practitioners, health insurance agency, healthcare regulators, pharmaceutical companies, pharmacies and medication package are integrated with the patient and also are in interaction / communication / liaison with each other via authenticated and registered process to provide the technical effect of user compliance to doctors prescription, recording user compliance to medication and acquiring feedback from the patient, maintaining data and displaying compliance and feedback information, liaising with users' nominated persons and medical practitioner, providing real-time and authentic data to insurance agencies, creating statistical and other reports which can be accessed by stake holders' groups by means including websites / ftp sites.
Summary of the Invention
The main object of the invention is to provide a comprehensive personalized healthcare anti-counterfeit management system capable of pack authentication, user feedback and compliance, documentation of the dosage uptake by the users, maintenance of user related data and displaying compliance and feedback information, liaising with users' nominated persons / medical practitioner, providing real-time and authentic data in raw and analysed form to diverse agencies in the healthcare chain.
Another object of the invention is to provide a method for authentication of medical package against counterfeit.
Yet another object of the invention is to provide authentication of diverse agencies in the healthcare value chain such as medical practitioners, users, pharmacists, pharmaceutical companies.
Yet another object of the invention is to provide a method for user compliance of medication intake as prescribed by medical practitioner and feed back regarding the same from / to the user.
Yet another object of the invention is to provide a method for creating a database of maintenance of user related health records / feedback.
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Yet another object of the invention is to provide a method for maintaining secure databases and interactions between user, the package containing the dosage, and diverse agencies in the healthcare value chain.
Thus in accordance with the invention the system comprising an exclusive
networking system in a secured environment comprising a central processing unit;
web based portals; communication means; associated device and the medication
package operates to integrate patient with the stakeholders in steps of:
registration and authentication of the associated device, stakeholders including medical practitioners, pharmacists and users through a web portal or other means to the central processing unit (CPU) that is used to receive, store, process and feed information in the system and make information accessible,
interaction of the patient with the associated device and product package;
communication of the associated device with the server;
interaction of the patient with the doctor / medical practitioner;
interaction of the server with the medical practitioner;
interaction of the patient with the pharmacist;
interaction with the pharmacists and distributor;
interaction with the insurance agency;
interaction with the distributor and pharma company;
wherein
· interaction of the patient with the associated device and product package in steps of:
> registration of the associated device by the patient / user to the central server;
> receiving the confirmation receipt of the registration from the central server
> registration of the patient with the associated device
> inputting medication schedule and setting alarm times in predetermined range with reference to the prescription by the patient
by the patient in the associated device
> insertion of the package into the associated device
> registration of the package with the associated device
> authentication of the medication package identify and confirm the source of the package and access information such as manufacturing date, expiry date, place of manufacture, geographical validation in that area etc.
> setting up alarm times in the said associated device by the user
> tablet detection (presence /absence) of tablet in the package by the associated device
wherein
· interaction / communication of the associated device with the server wherein
> schedules set by the user are transmitted to the server; compliance data
such as drug accession time / delay / early dosage / multiple dosage
communication through GPRS, GSM;
> pinging the device every 15 minutes to check whether the device is online;
> SMS is generated and sent to the patient if the associated device is not found to be online at the time of medication;
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> SMS is sent to the medical practitioner and people nominated by the
patient at the time of registration if the associated device is found not to be online even after 20 minutes of dose time;
> user enters post medication feedback in the said associated device that is time stamped and transferred to the server wherein the said data is available for a authenticated practitioner in real time;
> list of pharmacists with contact details including name, phone number, address and the map in the area where the device is located is sent to the associated device upon request from the user;
> SMS is sent from the server to the user to remind him of the medication to be taken to his cellular phone and/or to the cellular phones of nominated persons by the user in the registration form till such time the associated device is repaired or replaced and re-registered;
wherein
· interaction of the patient with the doctor / medical practitioner wherein
> registered medical practitioners /doctor with the said server enters prescription on prescription interface provided to him on his local machine / computer with patients name and the prescription number is generated at the doctor's end;
> the said prescription is logged in the said server;
> the said prescription is also stored in the local machine / computer of the medical practitioner;
> the said machine generates and prints insurance form, the medical practitioner takes a signed copy of the same from the patient
> printout of the said prescription number is given to the patient, patient takes the prescription number to the pharmacist to get the medicine;
> unregistered medical practitioner with the server gives (hand) written prescription to the patient wherein the prescription number is generated at the pharmacist end when he enters the information in the system;
wherein
· interaction of the server with the medical practitioner wherein
> the said medical practitioner is provided with the information various dates and times for the medication taken by the user, received from the said associated device with the help of the GSM / GPRS service to the local machine of the medical practitioner;
> customized and pre-programmed reports are generated and transmitted to the medical practitioners local machine through the internet in a pre determined format;
> the medical practitioner views a particular patient's compliance and feedback data on his local machine;
wherein
· Interaction of the patient with the pharmacist wherein
> the patient gives the said prescription number generated at the medical practitioner to the pharmacists registered with the said server;
> the pharmacists enters the said number in his machine / computer on the web-based interface;
> the said server facilitates the pharmacists see the medicine and dosages entered by the medical practitioner for the said patient along with information such as medical practitioner's name, patient's name, insurance company information etc. on his local machine
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· bill, form and relevant documents are printed; patient signs the same; wherein
· interaction with the pharmacists and distributor via the said server wherein
> distributor registers on the said server based on the order of pharmaceutical company;
> the registered has access to the list of pharmacies that are also registered with the said server;
> the said distributor is alerted on his local machine/ computer through desktop cookie information about "low stock" at particular pharmacy for particular brand;
> the said distributor has access to the database on the said server about the sell pattern of particular brand of medicine and volumes of the same;
wherein
· interaction with the distributor and pharma company via said server
wherein registered pharama company can track stocks available with all
distributors and replenish stock through the database
wherein
· the insurance agency interacts directly with the patient and through the central processing unit as well
to facilitate authentication, compliance and liaising and integration of the patient with various stake holders such as medical practitioner, pharmacists, distributor, pharma company, health insurance agency and their liaising with each other.
Description of the Invention
The features and advantages of the present invention will become apparent in the following detailed description and the preferred embodiment with reference to the accompanying figures.
Figure 1 Schematic of the system (Sheet 1)
Figure 2 Steps of system operation (Sheet 2)
Figure 2a Steps of interaction of the patient with the associated device (Sheet 3)
Figure 2b Steps of interaction of the associated device with the CPU (Sheet 4)
Figure 2c Steps of Interaction of the patient with the registered doctor / medical
practitioner (Sheet 5) Figure 2d Steps of Interaction of the CPU with the registered medical practitioner
/ doctor (Sheet 6) Figure 2e Steps of interaction of the patient with the registered pharmacist
(Sheet 7) Figure 2f Source of the associated device to the patient (Sheet 8)
Figure 1a illustrates conventional healthcare system wherein patient 5 interacts with various stakeholders such as medical practitioner 6, pharmacists 7, distributor 8, pharmaceutical company 9 and health insurance agency 10. The said stakeholders are isolated and there is one way interaction with the patient.
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The patient is not liked with all the stakeholders and the stakeholders are also not liked with each other in the conventional system / process.
Figure 1b illustrates comprehensive healthcare system of the present invention comprising associated device 1, medication package 2, web based portals 3, communication means (not shown) and a central processing unit (server) 4 which is used to receive, store, process and feed information in the system and make information accessible. The patient 5 inserts the medication package 2 in the associated device 1. The patient 5 along with the device 1 and the said package 2 is integrated with various stake holders such as medical practitioner 6, pharmacists 7, distributor 8, pharmaceutical company 9 and health insurance agency 10 via central data processing unit 4 and web portals 6p-10p respectively.
Further, the said stake holders may also be in liaison with each other through the said central processing unit 4. The said system results in the (useful, tangible and concrete) technical effect of authentication of the medication package 2 against counterfeit, authentication of the said stakeholders; compliance of medication intake at prescribed times by the medical practitioner; maintaining health diary that includes health indicators such as maintenance of health records / feedback of a user including indications like blood pressure, heart rate, blood sugar level, headache, nausea, dizziness etc.; data and Information wherein secured database is maintained at various terminals including said associated device 1, local machine of the medical practitioner, the said web portals and the said central data processing unit 4; liaisoning with the said stakeholders including medical practitioners, users, persons nominated by the user, pharmacists, pharmaceutical companies, insurance agencies etc.
Figure 2 and subsequent figures from Figure 2a to Figure 2f depicts the steps of the system operation. Figure 2 indicates the interactions of the patient with various stake holders such as doctor, pharmacist, insurance agency, distributor etc. in the healthcare chain. The subroutines indicated as A, B, C etc. corresponding to each of the step are separately elaborated in sub figures 2a to 2f. It is implied that all the said stakeholders are registered with the central processing unit 4 of the system illustrated in Figure 1. As shown in the Figure 2 the associated device 1 is registered with the said CPU 4. In the further step, the registration is confirmed from the CPU. Further, the system operates in various steps as shown in the figure from steps 101 to 107 in terms of interactions of the patient with the said stake holders via said CPU 4 and corresponding said web portals 6p-10p
Figure 2a depicts steps of interaction of the patient with the associated device. The patient can access the associated device 1 only if his/ her registration is carried out with the said associated device. After registration of the patient with the said associated device, as indicated by step 201 in the figure, the patient inputs medication schedule and sets alarm times in predetermined range with reference to the prescription in the associated device. Further, patient inserts medication package 2 into the said associated device 1 as indicated in step 202. In the further step, 204, registration of the said package 2 with the said associated device 1 is carried out and further authentication of the said package 2 is checked in the associated device 1. The process continues only if the package
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authentication is confirmed by the said associated device. In the next step 205, the compliance with the medication schedule is monitored by sensing presence / absence of the medication in the said package by the said associated device. Further, the device also provides reminders at the medication timing to the patient. The process concludes with the step 206 wherein post medication feed back by is entered in the said associated device by the patient.
Figure 2b illustrates process steps in the interaction of the associated device 1 with the CPU 4. The system operates in steps of transmission of the schedules set by the patient mentioned in the previous step from the associated device to the CPU 4 as shown in step 301; pinging the device intermittently to check whether the associated device 1 is online in step 302; SMS generation and transmission to the patient if the associated device 1 is not found to be online at the time of medication in step 303; sending SMS to the medical practitioner / doctor and persons nominated by the patient if the associated device 1 is not found online even after stipulated time of dose time in step 304; receipt of the time stamped user feedback data from the associated device 1; making the feedback data available to the authenticated medical practitioner in real time as shown in step 305; making the feedback data available to the authenticated medical practitioner in real time as shown in step 306; sending list of pharmacists with contact details including name, phone number, address and the map in the area where the device is located to the associated device upon request from the user as shown in step 307.
Figure 2c illustrates process steps in the Interaction of the patient with the registered doctor / medical practitioner. If the doctor is registered with the CPU 4, he enters prescription on prescription interface provided at his local machine / computer as indicated in step 401. Further, Generation of the patients name and the prescription number takes place at the doctor's end as indicated in step 402. the said prescription is logged in the said CPU 4 in step 403. The prescription is also saved in the local machine of the doctor as shown in step 404. As shown in step 405, insurance form is generation and printed at the doctor's machine / computer. The printout is handed over to the patient (step 406). If the doctor is not registered with the CPU 4, he/she provides hand written prescription to the patient wherein the prescription number is generated at the pharmacist end when he enters the information in his local machine/ computer (step 407).
Figure 2d indicates interaction of the CPU 4 with the registered medical practitioner / doctor. The steps comprises of the following: provision of the information regarding various dates and times for the medication taken by the patient, received from the said associated device 1 with the help of the GSM / GPRS service to the local machine of the medical practitioner / doctor by the said CPU 4 (step 501); generation and transmission of the customized and pre-programmed reports to the medical practitioners / doctor local machine through the internet in a pre determined format by the CPU 4 as shown in step 502 and transmission of the compliance and feedback of the patient to the
medical practitioner / doctor on his local machine as shown in step 503.
Figure 2e illustrates steps in the interaction of the patient with the registered pharmacist. The steps comprises of entry of the prescription number (that is
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generated at the doctor's end) in the pharmacists machine / computer on the web-based interface as shown in step 601; access to the pharmacists to the data related to the medicine and dosages entered by the doctor for the said patient along with information such as medical practitioner's name, patient's name, insurance company information etc. on his local machine (step 602); generation and printing of bill, form and relevant documents that are signed by the patient (step 603).
Figure 2f depicts the source of the associated device 1 to the patient. The associated device 1 may be subscribed to the patient by the insurance agency. In this case, patient registers the associated device 1 with the CPU 4 (step 701); the patient visits pharmacists, purchases the medication package (step 702-705) and the process continues as illustrated in Figure 2a. The case wherein the associated device 1 is not subscribed by the insurance agency, the patient visits doctor, collects prescription and purchases the said associated device 1 from the pharmacists end (step 710) followed by registration of the patient with the said associated device 1 (step 709); the patient can also purchase the associated device from doctor (step 706, 707); patient registers with the associated device 1 (step 711); the patient inserts the medication package in the said associated device 1 and the process continues as illustrated in Figure 2a.
Thus it is evident that the present invention provides a comprehensive personalized healthcare anti-counterfeit management system wherein patient is at the focal point (patient centric method) and facilitators / stakeholders such as medical practitioners, health insurance agency, healthcare regulators, pharmaceutical companies, pharmacies and medication package are integrated with the patient and also are in interaction / communication / liaison with each other via authenticated and registered process to provide the useful technical effect of:
· authentication of the medication package against counterfeit wherein the system identifies and confirms the source of the medication package and accesses information such as manufacturing date, expiry date, place of manufacture, geographical validation in that area etc.;
· registration and authentication of the associated device and various stakeholders including medical practitioners, pharmacists and users to the central processing unit (CPU);
· user compliance to doctors prescription wherein SMS is generated and sent to the patient if the associated device is not found to be online at the time of medication; SMS is sent to the medical practitioner and people nominated by the patient at the time of registration if the associated device is found not to be online even after substantial time lapse after dose time;
· patient feedback wherein user enters post medication feedback in the said associated device that is time stamped and transferred to the server wherein the said data is available for a authenticated practitioner in real time;
· generation of the prescription at the doctors end and further storage of the same at the CPU level and doctors end;
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· generation and transmission of customized and pre-programmed reports
for the medical practitioners at his /her local machine through the internet in
a pre determined format;
· maintaining secured data and Information for various stake holders at
including said associated device;
· providing real-time and authentic data in raw and analysed form to diverse
agencies in the healthcare chain; creating statistical and other reports that
can be accessed by stake holders' groups by means including websites /
ftp sites;
· creating documentation of the dosage uptake by the users;
· facility at the pharmacists end to see the medicine and dosages entered by
the medical practitioner / doctor for the patient along with information such
as medical practitioner's name, patient's name, insurance company
information etc.;
· reminder / alert provision to distributor on his local machine/ computer
through desktop cookie information about "low stock" at particular
pharmacy for particular brand;
· access to the distributor to the database on the said CPU about the sell
pattern of particular brand of medicine and volumes of the same;
· provision for pharama company to track stocks available with all
distributors and replenish stock through the database;
· liaisoning with the said stakeholders including medical practitioners, users,
persons nominated by the user, pharmacists, pharmaceutical companies,
insurance agencies etc.;
· registered pharama company can track stocks available with all distributors
and replenish stock through the database;
· interaction of insurance agency directly with the patient and through the
central processing unit as well;
to the patient.

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