FORM - 2
THE PATENTS ACT, 1970
(39 OF 1970)
PROVISIONAL SPECIFICATION
(See Section 10)
TITLE OF INVENTION
"Networked Healthcare and Wellness Management System "
(a) Bilcare Limited (b) a company registerd under the companies Act 1956 and (c) having its office at 601 ICC Trade Tower, Pune 411 016, India
The following specification particularly describes the invention.

Field of the Invention
The present invention relates to a system for management of healthcare and well being that includes acquiring, collecting, processing, distributing and transmitting healthcare related information ranging from personal, physiological and/or clinical data of person (s), processing the same and providing value added services including guidance to the said person(s) in a comprehensive intelligent online / offline, integrated and networked healthcare and wellness management system involving healthcare stake holders, health care beneficiaries, healthcare providers and caregivers.
Background of the invention
Healthcare has become a major concern in today's fast paced society. With changing lifestyles, habits and living conditions, the societal focus needs to shift from post disease treatment to prevention of diseases and proactive personal health care. Such approaches will need person centric proactive health related processes leading to enhanced quality of societal health and wellbeing. Such an approach will need the involvement of all concerned to network in a concerted synergized process that would enable the person (s) to receive personalized early health care related guidance in his effort to proactively prevent and / or delay or even overcome the onset of diseases, health problems, based on time based relational inputs./outputs involving healthcare stake holders, health care beneficiaries and healthcare providers in a healthcare and wellbeing value chain.
It should be appreciated that rising healthcare costs are becoming a personal burden and more importantly an enormous burden on the State that bears the cost of healthcare of its citizens. Further current healthcare systems have been not been cost effective both in terms of the unnecessary consumption of services and the unnecessary deterioration of a person's health. Further organisations delivering a set of services under 'Disease Management, are not intelligently or synergistically networked


with other entities involved with the delivery of healthcare thereby leading to ineffectiveness and duplication of services and wastage of significant resources.
Various attempts to achieve the same are reported in the literature, they are as follows:
US Patent 6,021,392 discloses a system and method for drug and health care supply distribution and replenishment wherein a Health care provider / hospital having a, drug dispensing machine / 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. This inventory system is not capable of acquiring physiological and clinical information from person / drug processing the same and further providing him / her with comprehensive intelligent proactive solution integrating doctor, caregiver and other stakeholders in the healthcare value chain.
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. This system is restricted to management of health care within an institution / hospital. Further the management system does not facilitate acquiring physiological and clinical information from person / drug processing the same and further providing him / her with comprehensive intelligent proactive solution integrating doctor, caregiver and other stakeholders in the healthcare value chain.
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. It may be noted that this system allows for the collection of information from the patient through sensors on the patients and does not facilitate processing the said information from various sources in the healthcare value chain and further providing the person with comprehensive intelligent proactive solution integrating doctor, caregiver and other stakeholders in the healthcare value chain.
It is evident from the available prior art that localized networks for management of treatment of patients is possible but none of the solutions provided thus far involves all healthcare stake holders, health care beneficiaries and healthcare providers in a healthcare and wellbeing value chain to enable person(s) to receive personalized appropriate health care related guidance in his effort to maintain his / her well being and good state of health and also proactively prevent and / or delay or even overcome the onset of diseases, health problems, based on time based relational inputs./outputs involving an array of tools, devices, products, systems and services.
The present invention addresses that shortcomings of the prior art and provides a system for acquiring, collecting, storing, distributing, transmitting physiological and/or clinical information of person(s), processing the same and providing personalized health guidance to the said person(s) in a comprehensive, networked integrated healthcare and well being value chain.
Summary of the Invention
The main object of the invention is to provide a system for management of healthcare and well being that includes acquiring, collecting, processing, distributing and transmitting wellness and healthcare related information ranging from personal, physiological and/or clinical data of person (s) using array of devices, processing the same and providing value added services including guidance to the said person(s) in a


comprehensive intelligent online / offline, integrated and networked healthcare and wellness management system involving healthcare stake holders, health care beneficiaries, healthcare providers and caregivers.
Another object of the invention is to provide a device communicably linked with the said system, capable of acquiring, incorporating, communicating and receiving processed information from external agency / remote location.
Yet another object of the invention is to provide a device communicably linked with the said system, capable of acquiring, incorporating, communicating and receiving processed information and authenticating the product that is consumed by the person / patient.
Another object of the invention is to provide a device communicably linked with the said system capable of acquiring, storing the information and communicating / dissipating the same to the user with the aid of external device.
Yet another object of the invention is to provide a device communicably linked with the said system working in conjunction with at least one other multifunctional device providing packaged-product authentication, registration, product dispensation and recording real-time product dispensation information, facilitating user compliance and optionally communicating product dispensation and user / product usage related information via the said primary device to external devices for information processing and management.
Yet another object of the invention is to provide package-companion-user interactive system communicably linked with the said system facilitating and providing user a means for his/her registration with the companion device, authentication, registration of the product package with his real-time feedback vide an interactive means and capturing the product-user feedback information.


Yet another object of the invention is to provide a package communicably linked with the said system with a dispensing system that integrates the aspects of authentication, prompting the consumer to consume a product from the package as per a prescribed plan, real time recording of the history of product dispensed from the package, communicating / interacting with an external device, establishing and converting the package into a non-authentic package after the validity period / expiry period has elapsed or the package has been tampered with or after the entire contents of the package has been dispensed.
Another object of the invention is to create relational databases of health care and well being information to provide a personalized guidance to person(s) based on time-based inputs-outputs from healthcare stake holders, health care beneficiaries, healthcare providers and caregivers.
Yet another object of the invention is to provide intelligent system to acquire, process person related information from various stakeholders in the healthcare value chain and further offer comprehensive information, proactive corrective solution, guidance and suggestion to the person for his / her better health and well being.
Yet another object of the invention is to provide an intelligent networked system involving stakeholders in the healthcare value chain to provide patient centric value added services including disease related treatments and guidance for better disease management, improved health and well being.
Yet another object of the invention is to provide an intelligent online networked system involving stakeholders in the healthcare value chain to provide patient centric value added services including disease related treatments and guidance for better disease management, improved health and well being.
Yet another object of the invention is to provide an intelligent system via a set of networked kiosks accessible to a person(s) and/or patients wherein all health and well


being related information is made available through structured portals operating in a relational manner so that the said person(s) and /or patient(s) receive personalized guidance and advice related to his health/well being and / or treatment from the healthproviders / stakeholders.
Yet another object of the invention is to provide a design and architecture of networked Healthcare related devices that would transform the Physician-Patient-Caregiver relationship to improve the quality of patient care by intelligently collecting and distributing physiological and other clinical and healthcare information.
Yet another object of the invention is to provide a networked health care system for value creation for chronic care patients customized care plans and ensuring patient adherence to these plans thereby improving the feeling of well-being for a patient and delaying/avoiding the onset of complications and hospitalization expenses.
Yet another object of the invention is to provide a networked health care system for disease management by among other services, improving patient compliance resulting in better health outcomes and reducing overall care costs.
Yet another object of the invention is to provide a networked health care system that operationally integrates the patient / beneficiary with his health care takers such as doctors and healthcare stake holders such as the hospitals, health care centres, insurance companies, state agencies, pharmacies, etc operating in a concerted dynamic workflow based on personalized inputs of the beneficiaries, healthcare stake holders and health care providers.
Yet another object of the invention is to provide a networked health care system that operationally integrates the patient and a clinical research agency to monitor pharmacovigilence during clinical trials.
Thus in accordance with the invention the system comprises of


input and information access means;
device/s to acquire physiological, medical information related to person / patient;
centralized data repository and processing unit communicably linked with the said input and information access means to acquire / incorporate the said information, process the same and communicate processed information to the said input and information access means
wherein
the system operates in steps of:
Ö registration and authenticate of the stakeholders, caregivers, person/s, patients
and the said input and information access means with the said centralized data
repository processing means;
Ö acquiring information from the person / patient, stakeholder, diagnostic lab,
hospital, doctor, caregiver healthcare provider;
Ö processing and storing the said information in the said centralized data repository
processing unit;
Ö communicating on demand the said information via said input and information
access means to the person/ patient, healthcare provider and optionally to the
caregiver;
thereby providing personalized appropriate health care related guidance in effort to maintain his / her well being and good state of health and also proactively prevent and / or delay or even overcome the onset of diseases, health problems, based on time based relational inputs./outputs.
DETAILED DESCRIPTION OF THE INVENTION
Features and advantages of this invention will become apparent in the following detailed description and the preferred embodiments with reference to the accompanying drawings.


Figure 1 Schematic of system configuration (Sheet 1) Figure 2 Schematic of system configuration (Sheet 2)
Explanation of terms:
Well being / wellness: Healthy normal state of an individual that can be attributed by good lifestyle, appropriate dietary needs and information, appropriate physical and mental fitness needs and requirements.
Information: information related to wellness of a person / patient that includes physiological, clinical, habitual, hospitalization, hereditary, dietary, compliance. Wherein physiological information includes somatic and pathological data monitored by diagnostic instruments and personalized diagnostic devices.
Stakeholder: include facilitators such as medical practitioners, pharmacists, clinical researchers, insurance agencies, distributors and others in the healthcare system.
Figure 1 depicts one of the configurations of the system. It comprises of an input and information access means 5 that comprises of various devices indicated as 6, 7, 8, 9,10 communicably linked with the centralized data repository and processing unit 1. The said input devices are configured and adapted to acquire and store the input information such as basic patient / person inputs, doctor's input, caregiver inputs, diagnostic lab inputs. Hospitalization inputs etc. The said centralized data repository and processing unit 1 processes the said information and helps person provide various services indicated as a, b, c, d such as integrated healthcare service that includes medical service, compliance reminder, aspiration reminders, medication compliance graph, diet compliance details etc. The person 15 can access the said information through the handheld device 16 or through various portals (not shown). Further, the person and/ or the device 16 can also communicate to the external stakeholder (represented by 12) such as medical practitioner /doctor for advice or counterchecking the guidance provided from 1.


Yet another configuration of the system is depicted in Figures 2a and 2b. The system as illustrated in Figure 2a comprises of personalized diagnostic devices 30, 31, 32, 33 and 34 for monitoring for example blood pressure, blood sugar, cholesterol, body temperature, the input and information access means 5, the centralized data repository and processing unit 1 networked with 5. These devices are configured to share / transmit data with the said input and information access means 5 which is networked with the said centralized data repository and processing unit 1. In one of the variants of this embodiment, the said personalized diagnostic devices can further be adapted to interface with the said input and information access means 5. In yet another variant of this embodiment, the personalized / general diagnostic devices capable of monitoring, processing, time stamping and further communicating / transmitting the physiological / diagnostic personalized data to the said input and information access means 5 which is in networked with the said centralized data repository and processing unit 1.
The system as illustrated in Figure 2b comprises of an interfacing device 50, personalized / general diagnostic devices 40, 41, 42, 43 and 44 such as blood pressure, blood sugar, cholesterol, body temperature means, the input and information access means 5, the centralized data repository and processing unit 1 networked with 5. The said interfacing device 50 is adapted and configured to receive data from diagnostic devices. The said interfacing device 50 acquires, processes and timestamps the physiological data from a person / patient and in communicates / transmits it to the said input and information access means 5 which is networked with the said repository and processing unit 1. In one of the variants of this embodiment, the said interfacing device is adapted to removably fit in the said input and information access means 5.
The input and information access means in one of the embodiments is a device capable of acquiring, incorporating, communicating and receiving processed information from external agency / remote location. In one of the variants of this embodiment the said device comprises of camera, full key pad / stylus , touch screen or a combination thereof; storage card; networking and data transmission means such as phone, infrared,


GPS, USB, GPRS, Blue tooth, SMS, MMS, 3G, WAP, Wi-fi authentication means such as 2D bar code reading from package, smart-chip reader, magnetic stripe reader;
In yet another embodiment the input and information access means is capable of acquiring physiological and clinical data from external device/s.
In yet another embodiment the input and information access means is a device capable of acquiring, incorporating, communicating and receiving processed information and authenticating the product that is consumed by the person / patient.
In yet another embodiment the input and information access means is a device capable of acquiring, storing the information and communicating / dissipating the same to the user with the aid of external device such as kiosk.
In yet another embodiment the input and information access means is a device working in conjunction with at least one other multifunctional device providing packaged-product authentication, registration, product dispensation and recording real-time product dispensation information, facilitating user compliance and optionally communicating product dispensation and user / product usage related information via the said primary device to external devices / centralized data processing unit for information processing and management.
In yet another embodiment the input and information access means is a package-companion-user interactive system facilitating and providing user a means for his/her registration with the companion device, authentication, registration of the product package with his real-time feedback vide an interactive means, capturing the product-user feedback information and further communicating to the said centralized data processing unit.
In yet another embodiment the input and information access means is a package with a dispensing system that integrates the aspects of authentication, prompting the


consumer to consume a product from the package as per a prescribed plan, real time recording of the history of product dispensed from the package, communicating / interacting with an external device/ centralized data processing unit, establishing and converting the package into a non-authentic package after the validity period / expiry period has elapsed or the package has been tampered with or after the entire contents of the package has been dispensed.
In yet another embodiment the input and information access means is a web based system comprising of portal/s.
In yet another embodiment the stakeholders include facilitators such as medical practitioners, pharmacists, clinical researchers, insurance agencies, distributors and others in the healthcare system.
In yet another embodiment the input information includes basic patient/ person information. In one of the variants of this embodiment the said patient / person information includes data related to health history, personality, aspirations, preferences, activity record wherein the health history includes data related to health record, family medical history; wherein preferences include preferences related to medical practitioner, pharmacy etc.; wherein the said activity record includes data related to medical compliance, diet compliance, fitness compliance, lifestyle management compliance record; wherein
In one of the embodiments of the invention the Clinical Data Repository (CDR) acts as the core of the network with direct inputs from a physician electronic medical record (EMR), patient personal health record (PHR), a handheld, and a call center or patient services arm. The inputs into the CDR range comprises encounter data, to diagnosis and prescription data, care plan data elements, and compliance, well-being, and demographic data.


The network components such as portals are equipped with a variety of analytics engines and tools. These provide physicians and patients with longitudinal care records, trending reports, summary and comparative reports, intervention alerts, compliance reminders, drug utilization review, and recommended care plans - including therapeutics, exercise, diet, and lifestyle management which serves as the basis of a patient/cost management-based system.
In yet another embodiment of the system is endowed with a capability for authenticating drugs in the supply chain, with a special focus on validation at the pharmacy or the point of consumption, or both. Among other aspects, the system includes a secure database of drug package identifiers with associated validation codes, and a device capable of reading and transmitting package-borne codes and receiving a validation signal.
In yet another specific embodiment of the invention, an agency such as a Healthcare Insurance Agency effectively participates in the network of the healthcare stake holders, beneficiaries and health providers with timely interventions to ensure optimization of healthcare expenses through monitoring of patient compliance and treatment protocol.

It is evident that the synergistic combination of the system components and their configuration provides online, intelligent,
system.

Date