Title of Invention	"DISEASE MANAGEMENT SYSTEM"
Abstract	A comprehensive disease management system providing advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers is disclosed. Additionally, a method of managing disease in a patient located remotely relative to interpretation and therapeutic dispensing services is provided including methods of data collection, data interpretation and therapeutic dispensing. An algorithm is disclosed to provide non-physician healthcare workers in remote, rural and resource-poor urban centers to manage disease in patients with human immunodeficiency virus (HIV) disease.

Title of Invention

"DISEASE MANAGEMENT SYSTEM"

Abstract

A comprehensive disease management system providing advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers is disclosed. Additionally, a method of managing disease in a patient located remotely relative to interpretation and therapeutic dispensing services is provided including methods of data collection, data interpretation and therapeutic dispensing. An algorithm is disclosed to provide non-physician healthcare workers in remote, rural and resource-poor urban centers to manage disease in patients with human immunodeficiency virus (HIV) disease.

Full Text	FORM 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 COMPLETE SPECIFICATION (See section 10, rule 13) 'DISEASE MANAGEMENT SYSTEM' DISEASE MANAGEMENT SERVICES, PLC, 65 Enterprise, Aliso Viejo, CA 92656, U.S.A; The following specification particularly describes the invention and the manner in which it is to be performed. 2- Docket 52023-00001 DISEASE MANAGEMENT SYSTEM RELATED APPLICATIONS [0001] This application claims priority to United States provisional patent application serial number 60/536,947 filed January 16, 2004. COMPUTER PROGRAM LISTING APPENDIX [0002] A computer program listing appendix containing the source code of a computer program that may be used with an embodiment of the present invention is incorporated herein by reference and appended hereto as one (1) original compact disk, and an identical copy thereof, containing a total of 1 file as follows: Date of Creation Size (Bytes) Filename January 16, 2004 3,382 KB 5202300001 Source Code FIELD OF THE INVENTION [0003] The present invention relates to a comprehensive patient management system. Specifically, the present invention provides advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers. More specifically, the present invention provides physician and non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing patients with chronic diseases, such as human immunodeficiency virus (HIV)-infected persons. BACKGROUND OF THE INVENTION [0004] Medical care in developing countries and rural communities presents a challenge to public health officials in that highly efficacious therapies are often not available. In some of these areas the only health care workers available are not physicians but rather nurses or other aid workers who are not trained to prescribe today's complex treatments for many diseases. One disease that has proven to be particularly difficult to manage in resource-poor countries or rural areas is human immunodeficiency virus (HIV) infection/Acquired Immune Deficiency Syndrome (AIDS) or HIV-related disease. / 3 Docket 52023-00001 [0005] Human immunodeficiency virus was first identified in 1981 and has since spread in epidemic proportions throughout the world. In the early years, the diagnosis of AIDS was an automatic death sentence, and the scientific community embarked on an aggressive search for a vaccine and a cure. [0006] While these goals are still elusive, treatments have been devised that have resulted in HIV/AIDS becoming a treatable, chronic disease. Anti-retroviral drugs are taken in various combinations and according to a range of schedules, for the remainder of the patients' lives. This regime is called High Activity Anti-Retroviral Therapies (HAART; also known as Anti-Retroviral Therapy [ART or ARVJ). The ideal result is a lowering of the virus in the bloodstream to undetectable amounts. In this case, the patients' immune systems recover, or do not deteriorate, and they can live healthy and productive lives. This scenario is a reality for most in the USA, Canada and Europe. These developed countries have the political will to deal with this disease, and a complex medical infrastructure to diagnose and treat their population. The public health message of prevention is also emphasized. In addition, from a public health standpoint it is hypothesized that lowering many individual's viral load effectively lowers the viral load of the entire community and may slow transmission. [0007] In stark contrast, many developing countries across Africa, Asia and South America have unsophisticated medical infrastructure. South Africa, for example, holds the dubious distinction of having the highest AIDS infection rate/death rate in the world, with other southern African nations in close contention. In late 2003, the South African Government released a plan to roll out HAART as part of an HIV/AIDS management plan. [0008] South Africa has become an example for how devastating the AIDS epidemic can become when left unchecked. In this area of Africa, HIV is primarily transmitted through unprotected heterosexual sex. It can take many years for a person infected with HIV to become ill. During this period, sexually active adults spread the virus through the population; HIV is also transmitted from mother to infant in utero. Once a patient's immune system begins to deteriorate to full-blown AIDS, they easily contract opportunistic infections like tuberculosis, pneumonia and cancer. A significant proportion of the South African Department of Health ("DOH") budget of 1 Docket 52023-00001 US$3 billion is currently spent on treating these secondary diseases with costly hospitalization and medication. [0009] Without the rollout of an HIV/AIDS management plan which includes universal access to HAART, by 2008 the current life expectancy for a South African male will fall from 54 to 36 years, and the estimated number of AIDS orphans will rise from 420,000 to 1.6 million. The social cost is a catastrophe of grave proportion; the indirect economic cost would be a devastating 17% (US$ 22 billion) of the South African GNP. [0010] The health care budget of the DOH currently spent on treating the opportunistic diseases and end-stage infection could more effectively be focused on providing HAART to the infected population as an integral part of a comprehensive management plan. The factors that prevented aggressive HAART treatment of the infected population in South Africa in the past are complex. Recent legal developments have obliged the DOH to administer the anti-viral drug Nevirapine to pregnant mothers and their newborn babies, and settlement has been reached regarding patents of many of the anti-viral drugs. Even as the political will has evolved toward an aggressive management plan, there is limited infrastructure to administer HAART to the urban population, even less so to those dispersed in remote rural areas. SUMMARY OF THE INVENTION [0011] The present invention provides a therapeutic management system comprising advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and underdeveloped urban centers. More specifically, the present invention provides non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing diseases including, but not limited to, human immunodeficiency virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS). The present invention provides a practical solution to managing disease in remote resource-poor population centers by providing individualized patient care without having highly trained infectious disease physician specialists located at each site. 5 Docket 52023-00001 [0012] The algorithm and database of the system of the present invention, updated regularly with state-of-the-art diagnostic protocols and therapeutic regimens, directs the non-physician healthcare worker's selection of diagnostic tests and instructs them as to what medical procedures to conduct. Additionally, the system of the present invention provides continually revised and updated instructions to the healthcare worker based on the new patient data entered after each clinic visit. The system of the present invention additionally provides systems for medication disbursement and other ancillary services to the patient. [0013] In developed countries, even though sophisticated medical infrastructures may already exist, there are limitations to their efficiencies and availability. Managed care organizations, for example, as well as publicly-funded health systems, will all benefit from the cost-control, data collection and the comprehensive, current, state-of-the-art disease management system offered by the present invention. [0014] In one embodiment of the present invention, a disease management system is provided comprising data collection means, data interpretation means and therapeutic dispensing means. The data collection means is used to obtain disease state information from a patient having a disease when the patient is located remotely relative to the data interpretation means and the therapeutic dispensing means. The interpretation means is located on a computer-readable medium and provides diagnostic, prognostic and therapeutic information useful for the management of the patient's disease. [0015] In another embodiment of the present invention, the data collection means is a non-physician healthcare worker or a laboratory. [0016] In an embodiment of the present invention, the data interpretation means is an algorithm or a physician specialist. [0017] In another embodiment of the present invention, the therapeutic dispensing means is a pharmacy. [0018] In yet another embodiment of the present invention, the computer-readable medium can be a hard drive, floppy disk, CD-ROM, zip drive or flash drive. 6 Docket 52023-00001 [0019] In an embodiment of the present invention, the disease is human immunodeficiency (HIV) disease or acquired immune deficiency syndrome (AIDS) and the patient is a human. [0020] In another embodiment of the present invention, the data interpretation means is the algorithm of FIG. 4. [0021] In an embodiment of the present invention, an HIV-related disease management system is provided including a data collection means for collecting data, a data interpretation means for interpreting data and a therapeutic dispensing means for providing therapy useful for treating HIV-related disease, wherein the data collection means is used to obtain disease state information from a patient having a HIV-related disease. In one embodiment of the present invention, the patient is located remotely relative to the data interpretation means and the therapeutic dispensing means and the data interpretation means is located on a computer-readable medium and provides diagnostic, prognostic and therapeutic information useful for the management of the patient's disease. In another embodiment of the present invention, the data includes patient history and CD4 levels. In yet another embodiment of the present invention, the therapy is High Activity Anti-Retroviral Therapy (HAART). [0022] In an embodiment of the present invention, a method for managing disease in a patient located remotely relative to a data interpretation means and a therapeutic dispensing means is provided comprising collecting a first set of data from the remotely located patient, interpreting the first set of data in order to determine an appropriate first therapeutic regimen for the remotely located patient, dispensing the first therapeutic regimen to the remotely located patient, collecting at least one second set of data from the remotely located patient and interpreting the at least one second set of data in order to determine the appropriateness of continuing or stopping the first therapeutic regimen or altering the first therapeutic regimen for the remotely located patient. In another embodiment of the present invention, the first and at least one second interpreting step comprises an algorithm located on a computer-readable medium that provides diagnostic, prognostic and therapeutic information useful for the management of disease in patients. In another embodiment of the present invention, the disease is HIV disease or AIDS. 7 Docket 52023-00001 [00231 In another embodiment of the present invention, the data is collected by a non-physician healthcare worker or a laboratory. [0024] In an embodiment of the present invention, the data interpretation means is an algorithm or a physician specialist. In another embodiment of the present invention, the therapeutic dispensing means is a pharmacy. [0025\| In yet another embodiment of the present invention, the computer-readable medium can be a hard drive, floppy disk, CD-ROM, zip drive or flash drive. [0026] In an embodiment of the present invention, a method for disease management is provided including collecting data, interpreting data and dispensing a therapeutic useful for treating disease, where the interpretation of data is performed according the algorithm of Figure 4. BRIEF DESCRIPTION OF THE DRAWINGS [0027] FIG. 1 graphically depicts a flow chart of an illustrative embodiment of the operating system loop of the disease management system of the present invention. [0028] FIG. 2 is an assessment form for evaluating readiness for Anti-Retroviral Therapy (ART) that may be utilized in one embodiment of the disease management system of the present invention. FIG. 2.1 and FIG. 2.2 are the same form. FIG. 2.2 is a continuation of FIG. 2.1. [0029] FIG. 3 is a follow-up form for ART that may be utilized in one embodiment of the disease management system of the present invention. FIG. 3.1 and FIG. 3.2 are the same form. FIG. 3.2 is a continuation of FIG. 3.1. [0030] FIG. 4 illustrates the main flow algorithm representing an Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) embodiment of the disease management system of the present invention. FIGs. 4.1, 4.2 and 4.3 are three pages of the same figure. [0031] FIG. 5 illustrates the "Determine Age Category" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0032] FIG. 6 illustrates the "Confirm HIV Status" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. 8 Docket 52023-00001 [0033] FIG. 7 illustrates the "Determine HAART Candidate" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0034] FIG. 8 illustrates the "HAART Candidate Readiness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0035] FIG. 9 illustrates the "Status Active TB" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0036] FIG. 10 illustrates the "Status Latent TB" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0037] FIG. 11 illustrates the "TB Prophylaxis" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0038] FIG. 12 illustrates the "Isoniazid" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0039] FIG. 13 illustrates the "Efivarenz" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0040] FIG. 14 illustrates the "Contraindications Efivarenz* sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0041] FIG. 15 illustrates the "Nevirapine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0042] FIG. 16 illustrates the "Contraindications Nevirapine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0043] FIG. 17 illustrates the "Stavudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0044] FIG. 18 illustrates the "Contraindications Stavudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0045] FIG. 19 illustrates the "Lamivudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0046] FIG. 20 illustrates the "Zidovudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. Docket 52023-00001 [0047] FIG. 21 illustrates the "Contraindications Zidovudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0048] FIG. 22 illustrates the "Didanosine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0049] FIG. 23 illustrates the "Contraindications Didanosine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0050] FIG. 24 illustrates the "Lopinavir/Ritanovir" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0051] FIG. 25 illustrates the "Contraindications Lopinavir/Ritanovir" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0052] FIG. 26 illustrates the "Cotrimoxazole" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0053] FIG. 27 illustrates the "Status Liver" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0054] FIG. 28 illustrates the "Status Anemia" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0055] FIG. 29 illustrates the "Status Neutrophils" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0056] FIG. 30 illustrates the "Status Pancreas" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0057] FIG. 31 illustrates the "Status Kidney" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0058] FIG. 32 illustrates the "Status Malnutrition" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0059] FIG. 33 illustrates the "Status Regimen 1ab Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. 10 Docket 52023-00001 [0060] FIG. 34 illustrates the "Status Regimen 2 Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0061] FIG. 35 illustrates the "Status Adherence" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0062] FIG. 36 illustrates the "Status Regimen Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention. [0063] FIG. 37 illustrates the "Master Patient" computer screen shot of the HIV/AIDS embodiment of the Disease Management System of the present invention. [0064] FIG. 38 illustrates the "Clinical Data Form," part 1, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0065] FIG. 39 illustrates the "Clinical Data Form," part 2, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0066] FIG. 40 illustrates the "Clinical Data Form," part 3, computer screen shot of the HiV/AIDS embodiment of the disease management system of the present invention. [0067] FIG. 41 illustrates the "Clinical Data Form," part 4, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0068] FIG. 42 illustrates the "HAART Prep Form" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0069] FIG. 43 illustrates the "Labs Form," part 1, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0070] FIG. 44 illustrates the "Labs Form," part 2, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0071] FIG. 45 illustrates the "Patient Flow Analysis" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. 11 Docket 52023-00001 [0072] FIG. 46 illustrates the "Patient Flow Analysis Report" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0073] FIG. 47 illustrates the "Display Patient" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0074] FIG. 48 illustrates the "Appointment Status" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0075] FIG. 49 illustrates the "Analytics" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. [0076] FIG. 50 illustrates the "Display Log" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention. DETAILED DESCRIPTION OF THE INVENTION [0077] The present invention provides advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and underdeveloped urban centers. More specifically, the present invention provides non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing diseases including, but not limited to, human immunodeficiency virus (HIV) disease and Acquired Immune Deficiency Syndrome (AIDS). The present invention provides a practical solution to managing disease in remote resource-poor population centers by providing individualized patient care without having highly trained infectious disease physician specialists located at each site. [0078] Human immunodeficiency virus causes a complicated life-threatening infection that is presented in this application as a non-limiting example of the scope of the disease management system of the present invention. Human immunodeficiency virus infection presents as a complex multi-factorial disease that is challenging to manage even in modern urban centers where state-of-the-art teaching hospitals and highly trained physician specialists are readily available. Patient management becomes considerably more difficult when infected individuals are located in underdeveloped urban centers and remote rural locations (herein after referred to as remote patient management). Remote patient management is further 12 Docket 52023-00001 exacerbated when the most highly trained healthcare worker is, for example, a community nurse or Red Cross-Red Crescent aid-worker. [0079] In many remote patient management environments, laboratory facilities, pharmacies and diagnostic imaging facilities are located hundreds of miles away. Moreover, even when these facilities are located within a reasonable proximity, patient transportation to and from testing and drug dispensing centers may be unavailable or at best unreliable. [0080] Persons infected with HIV can often have a series of HIV-related diseases which require regular medical evaluations in order to monitor disease progression and therapy efficacy. Test interpretation and therapeutic recommendations often require the expertise of a trained infectious disease specialist. Consequently, persons located in remote patient management environments are less likely to volunteer for testing for HIV because they have learned from experience that treatment options are not readily available. Therefore, there is no benefit to the patient to know their HIV status. As a result a culture of fear and ignorance has proliferated in underdeveloped urban centers and remote rural locations that feed an ever growing HIV pandemic. [0081] The present invention provides a solution to the problem of unavailability of specialized medical services in underdeveloped urban centers and rural locations. Recent telecommunication advances have made modem access to centralized computer databases available even in the most remote and disadvantaged areas. The present invention utilizes this global communication phenomena to bring cutting edge patient management tools directly to the patient. In one embodiment of the present invention, a non-physician healthcare worker is provided with questionnaires and protocols developed by physician experts. Using these tools, combined with rudimentary physical examination skills, the non-physician healthcare worker becomes a virtual infectious disease diagnostician. Answers to the patient questionnaire and the results of the physical examination are entered into the database locally or remotely and the algorithm feature of the present invention collates and analyzes the individualized patient data. Appropriate biological samples, principally blood, are collected and sent to a designated testing facility where the samples are tested and the results are entered into the same database I 3 Docket 52023-00001 and the algorithm of the present invention applied. Based on the combined results of the laboratory tests, questionnaire and physical examination, a preliminary diagnosis is established and an appropriate treatment regimen proposed. As used herein, an appropriate treatment regimen is defined as any treatment which a person skilled in the art of disease management would consider useful in the management of patient's disease state. In a non-limiting example, HAART is an appropriate therapeutic regimen for a patient suffering from HIV disease. Patients presenting with symptoms consistent with secondary infections or disorders can then be further examined and additional tests run as indicated, or referred to tertiary centers. [0082] Each time the patient is examined and tested the resulting data is collated, entered and analyzed by the algorithm of the present invention. The non-physician healthcare worker is then provided with an individualized prognostic determination and recommended changes to the therapeutic regimen if required. Consequently, persons in resource-poor urban centers and remote rural settings will now have access to modern diagnostic, prognostic and therapeutic capabilities similar to those available to citizens of countries with sophisticated health care systems. The system of the present invention provides training to the non-physician healthcare worker thereby improving healthcare in general. [0083) Thus, the system of the present invention offers an elegant and practical solution which will allow, as an example, wide and cost-effective High Activity Anti-Retroviral Therapy (HAART, ART or ARV) for HIV/AIDS in the developing world. In an illustrative embodiment, a national or regional health agency in a country in need of disease management support will use the HIV/AIDS disease management system of the present invention that includes transport of blood samples to laboratories, input of data, drug prescription generation and dispensing, as well as psychosocial and nutrition support, education and pharmacovigilance. [0084] Laboratory services, data input, drug packaging and drug dispensing currently exist in many countries and disadvantaged areas, but not as part of an integrated system. The importance of offering national or regional health agencies an integrated management package cannot be overemphasized. In addition, the collection of data that this system facilitates is invaluable for financial, demographic and scientific projections. 14 Docket 52023-00001 [0085] Data collection using the disease management system of the present invention also provides critical pharmacovigiiance information. Adverse drug reactions can be frequent or rare but information on these reactions is critical in disease management by physicians or non-physician healthcare workers. Once data is collected by the system of the present invention and analyzed by algorithms disclosed as embodiments of the present invention, the data is collected into a pharmacovigiiance database where it is available to influence future drug therapy regimens. [0086] Pharmacovigiiance embodiments of the system of the present invention include: • determine the burden of drug-related morbidity and mortality in patients • provide training and information to healthcare workers and patients on the safe use of drugs • provide information on risks and benefits of disease treatments, including over the counter medications. • identify, assess and communicate new safety concerns associated with the use drugs • minimize the impact of misleading or unproven associations between adverse events and drug therapy • to detect, assess and respond to safety concerns related to complementary, alternative and traditional medicines • to establish an early warning system for resistance to drugs • to respond to unfounded and unsubstantiated claims of efficacy of untested products and treatment modalities. [0087] In an illustrative embodiment, the present invention includes a specialized algorithm to assist health care workers with the medication management of HIV/AIDS and related opportunistic infections such as tuberculosis (TB). The major features of the disease management system of the present invention include: • medication protocols for specific/individual patients based on evidence-based treatment algorithms • seamless, rapid implementation of new drug protocols • support and tracking of drug reaction mitigation 15 Docket 52023-00001 • tracking of drug resistant viral mutations • treatment regardless of geographic location and distance from urban centers • automatic monitoring of high-risk patients • complex cases referred for medical specialist consultation • pharmacovigilance - tracking and monitoring of adverse reactions to HAARTorART • reliable geographic health statistics for public and private sector health planners [0088] In one embodiment of the present invention, an algorithm provides a disease management system for HIV/AIDS using approved anti-retroviral treatment protocols. The algorithms of the present invention: • are based on World Health Organization (WHO) standards • are easily modifiable to accommodate local standards • recommend a treatment protocol as approved by local payors/government • monitor and report the patient's immune function • monitor and report adverse events and drug reactions • alert clinical staff to clinical parameters outside of normal • schedule appointments • schedule and monitors laboratory tests and medical procedures • schedule delivery of pre-packaged drugs • monitor and report compliance with drug regimen [0089] Among the benefits which may be obtained by the system of the present invention are that public and private healthcare service workers will be enabled to implement and operate a cost-effective system to diagnose and treat patients with HIV/AIDS and related diseases. This will hold true even within limitations of poor medical infrastructure. This system does not require significant increase in the number of doctors needed to treat disease and can coexist with many of the present treatment systems. Such a system will effectively result in a reduction in opportunistic infection rates, as well as lower overall usage of medical services by patients. The algorithm of the present invention is an effective tool to ensure 17 Docket 52023-00001 a nurse. The innovation of the present invention will enable the resource-poor settings to act as if a specialist were present. [0094] The present invention will dramatically improve the efficiency of the primary health care system to deliver care to its constituency, both in the urban areas, and to the large percentage of the population that live in rural conditions. The primary health care nurses, with the innovative support of the system, can more efficiently provide care for a larger number of patients, and only those who fall outside of the parameters of the algorithm will need to be referred to hospitals or medical specialists. [0095] The challenge of compliance with complex drug therapy regimens is faced in both developing and developed countries, and is enhanced in uneducated populations. This lack of compliance in HIV/AIDS, for example, is particularly dangerous due to the resultant development of resistant HIV, as well as opportunistic diseases associated with AIDS. This system is innovative in its approach to increased compliance by enhancing monitoring, systematic feedback and automated recordkeeping. In addition to the clinical education provided directly to the patient, the system will note deviations in patterns that indicate low compliance, either through altered immune response, or missed appointments. Communicating this information to the local health care worker will facilitate intervention and increased compliance. [0096] The system of the present invention allows all personnel and patients to benefit from advances in the treatment of disease. This is a rapidly evolving field, with advances in all areas, from pharmaceuticals to education interventions, being published oh an ongoing basis. As these changes are vetted by, for example, a medical advisory board, and approved by the governmental authorities, they can be implemented almost immediately in the remotest rural location by altering criteria in the central algorithm. One aspect of the novelty of the invention lies in the flexibility inherent in its design to deal with the rapidly evolving science. On the level of the individual patients, the system will enable a rapid response to their changing treatment needs, such as in the development of resistance, or toxicity from anti-retroviral drugs. 19 Docket 52023-00001 and implemented to be culture-specific, country-specific and region-specific, and easily adapted to the most current scientific and medical knowledge as agreed to by the provider. [0101] In another illustrative embodiment, the system of the present invention includes a multi-tiered fully redundant highly available architecture. The system is able to accept input from a variety of existing sources, such as client computers running programs including, but not limited to, the various Windows, Unix or Linux desktop operating systems, laboratory-based computer systems, voice interactive systems and other potential devices including cell phones or specialized medical diagnostic devices. Various communication protocols including, but not limited to, TCP/IP are used to communicate to the servers. The servers may be based locally and/or remotely and are also run in a fully redundant and recoverable manner using current standard computing standards. The servers utilize database systems including, but not limited to, Oracle or Microsoft SQL or IBM DB II. A variety of programming tools, languages and interfaces are used to implement the solution including, but not limited to, C#, C++, Visual Basic, HTML, XML, SSL, Data Base queries, Visio and add-on packages are used in development of the system. A proprietary source code is utilized in the system of the present invention and which can be found in the computer program listing appendix filed on compact disk with this application. The multi-tiered architecture and database design implements a security architecture to provide safeguards to protect the algorithms and patient information from being accessed in a malicious or unauthorized manner. All transactions are logged and tracked and communications are encrypted using the latest standards including 48 bit SSL or 128 bit where possible. The database servers and application servers are placed behind a firewall and use industry accepted standards to protect against unauthorized access. [0102] The system algorithm of the present invention is built upon a state-of-the-art medical knowledge database. The most current peer-reviewed treatment protocols are included. The system supports customizations from end-users arid local healthcare personnel to ensure that local requirements are taken into account. The system includes a focus on education, communication and prevention options that are integrated with the algorithm implementation. The system is capable of 21 Docket 52023-00001 timeframe compatible with the tests required. The system will be able to optimize and utilize this network for pathology, as well as for data input. In a novel approach, the transportation system will also be used to deliver pre-packaged drugs to the clinic to be dispensed by the nurse. Additionally, in areas where lack of telephone or wireless services prevent data entry and transmission directly into a computerized database, paper forms can be sent to the pathology lab along with samples to be entered into the disease management system by lab personnel. [0108] 3. Opportunistic infections will be treated. [0109] 4. HIV Treatment. The algorithm of the present invention will be applied to the patient data, with several possible outcomes: [0110] a. Patient's immune system is not compromised enough to require HAART. Patient receives education on the natural history of the disease, nutrition and preventing transmission of HIV. Depending on their nutritional status, supplemental vitamins, minerals, and protein will be dispensed by the system. A novel feature of the system lies in its ability to begin to empower the patient to be compliant with a regular regimen of pills/supplements and follow-up appointments, to have them benefit from support groups, and to keep them within the system of the present invention so that they receive social and emotional support, and antiretroviral therapy as soon as they require it. These patients will be reevaluated according to the intervals outlined in the protocol. An exemplary, non-limiting example is re-evaluation every three months. [0111] b. Patient is severely immune compromised and acutely ill with a severe or life-threatening opportunistic infection. Patient is referred to a hospital or tertiary center, and enters the system of the present invention on their discharge to their community. [0112] c. Patient's immune system is compromised enough to require HAART, but they fall within the extremes of the parameters of the system algorithm of the present invention, or they present with unusual signs and symptoms. The algorithm would refer all cases at the borders of the parameters to be reviewed by a physician, who would enter orders into the system of the present invention. Through this mechanism, the parameters 23 Docket 52023-00001 the algorithm become wider and wider. Patient data remains within system, even when they are referred to a different hospital. [0119] 7. Communication of data and treatment plans back to healthcare worker. There will be communication back to the healthcare worker regarding the patients status, lab results and treatment/care plan as reflected in the database and interpreted by the algorithm of the present invention. Communication can be in the form of SMS, or hard copies of reports delivered with the medication. Batch reporting can include such information such as upcoming visits, and those patients who missed appointments and require intervention. [0120] This feedback of processed information to healthcare workers can be used to empower them by increasing their level of knowledge about the management of HIV and associated diseases, and supporting them in the care of these patients. [0121] 8. Patient re-evaluation per protocol. Patients will be re-evaluated according to the protocol and algorithm of the present invention. For example, when beginning HAART, patients will be recalled within a shorter duration than those who have proven their compliance and tolerance for the drugs over a period of time. If testing reveals a patient is non-compliant the patient would be placed on a shorter interval between scheduled tests. [0122] At each step of the operating system loop, patient data can be accessed remotely by healthcare workers at any site where the patient is seeking medical attention. This feature allows the successful management of nomadic patients or in instances when patients require treatment or follow-up away from their home provider. [0123] An exemplary, non-limiting algorithm useful in an embodiment of the invention is depicted in the flow chart diagram of FIG. 4. (Note that FIGS. 4.1, 4.2 and 4.3 are part of the same flow chart.) [0124] The exemplary algorithm of FIG. 4 presents a disease management system for HIV/AIDS. It would be reasonable to one skilled in the art to use this algorithm in the treatment of other diseases besides HIV/AIDS. Therefore the use of HIV/AIDS in the algorithm of the present invention is for exemplary purposes only and the present invention is intended to be used for the treatment of a wide range of 26 Docket 52023-00001 Alert Code Alert Type Alert Value Alert Priority Alert Description R41 Report 41 5 Sputum negative for TB R42 Report 42 5 TB prophylaxis> 9 months R43 Report 43 5 Isoniazid contraindicated - status liver R44 Report 44 5 TB prophylaxis not indicated - on HAART R45 Report 45 5 Isoniazid contraindicated - treated for active TB in past 2 years R46 Report 46 5 TB prophylaxis no indicated R47 Report 47 5 TB prophylaxis start date unknown R48 Report 48 5 TB prophylaxis indicated R49 Report 49 5 TB skin test positive R50 Report 50 1 Get TB skin test R51 Report 51 5 Non-reactive TB skin test R52 Report 52 1 Get sputum for TB smear and culture R53 Report 53 1 TB prophylaxis complete - 6 month supply within 9 months R54 Report 54 1 Complete TB treatment, then evaluate for HAART R55 Report 55 5 Active TB treatment start date unknown R56 Report 56 5 One viral load > 5,000 R57 Report 57 1 Low level viremia (400 - 5,000) R58 Report 58 1 Clinical evidence of 2"° line therapy failure R59 Report 59 9 No contraindications to Isoniazid R60 Report 60 1 Mismatch between previous and current status R61 Report 61 5 No signs of active TB R62 Report 62 5 Cotrimoxazole prophylaxis not indicated R63 Report 63 5 Cotrimoxazoie prophylaxis indicated R64 Report 64 5 Currently on Isoniazid R65 Report 65 5 Height not recorded - BMI not calculated, nutrition status unknown SOW Schedule Emergency callback (0 weeks) S11W Schedule 11 WCCKS S12M Schedule 12 month S12W Schedule 12 weeks S15W Schedule 15 weeks S16W Schedule 16 weeks S1M Schedule 1 month S1W Schedule 1 week S23W Schedule 23 weeks S24W Schedule 24 weeks S2M Schedule 2 months S2W Schedule 2 weeks S3M Schedule 3 months S3W Schedule 3 weeks S4M Schedule 4 months S4W Schedule 4 weeks S5M Schedule 5 months S6M Schedule 6 months S7W Schedule 7 weeks S8W Schedule 8 weeks [0126] Data input into the system of the present invention can be achieved using methods including, but not limited to, computers, hand-held devices such a personal digital assistant (PDA), or paper forms. The data is then transmitted to the computer 28 Docket 52023-00001 [0130] It is to be expressly understood that the claimed invention is not to be limited to the description of any single embodiment but encompasses other modifications and alterations within the scope and spirit of the inventive concept. We claim: 1. A disease management system comprising: data collection means; data interpretation means operatively coupled to the data collection means; and therapeutic dispensing means operatively coupled to the data collection means, wherein said data collection means is configured to obtain disease state information from a patient having a disease, the said patient being located remotely relative to said data interpretation means and said therapeutic dispensing means and wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient. 2. The disease management system as claimed in claim 1, wherein said data collection means comprises a non-physician healthcare worker or a laboratory. 3. The disease management system as claimed in claim 2, wherein said data collection means comprises a non-physician healthcare worker. 4. The disease management system as claimed in claim 2, wherein said data collection means comprises a laboratory. 5. The disease management system as claimed in claim 1, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information or a physician specialist having access to a computer. 30 The disease management system as claimed in claim 5, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information. The disease management system as claimed in claim 5, wherein said data interpretation means comprises a physician specialist having access to a computer. The disease management system as claimed in claim 1, wherein said therapeutic dispensing means comprises a pharmacy. The disease management system as claimed in claim 1, wherein said disease is human immunodeficiency (HIV) disease or acquired immune deficiency syndrome (AIDS). The disease management system as claimed in claim 1 wherein said patient is a human. A disease management system comprising: data collection means; data interpretation means operatively coupled to the data collection means; and therapeutic dispensing means operatively coupled to the data interpretation means, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient. The disease management system as claimed in claim 11, wherein said data collection means comprises a non-physician healthcare worker or a laboratory. 13. The disease management system as claimed in claim 12, wherein said data collection means comprises a non-physician healthcare worker. 14. The disease management system as claimed in claim 12, wherein said data collection means comprises a laboratory. 15. The disease management system as claimed in claim 11, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information or a physician specialist having access to a computer. 16. The disease management system as claimed in claim 15, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information. 17. The disease management system as claimed in claim 15, wherein said data interpretation means comprises a physician specialist having access to a computer. 18. The disease management system as claimed in claim 11, wherein said therapeutic dispensing means comprises a pharmacy. 19. The disease management system as claimed in claim 11, wherein said disease is HIV disease or AIDS. 20. The disease management system as claimed in claim 11, wherein said patient is a human. 21. An HIV-related disease management system comprising: a data collection means for collecting data; a data interpretation means operatively coupled to the data collection means and being configured for interpreting said data; and 32 a therapeutic dispensing means operatively coupled to the data interpretation means and being configured for providing therapy useful for treating said HIV-related disease, wherein said data collection means is configured to obtain disease state information from a patient having a HIV-related disease the said patient being located remotely relative to said data interpretation means and said therapeutic dispensing means and wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient. 22. The disease management system as claimed in claim 21, wherein said data comprises a patient history and CD4 levels. 23. The disease management system as claimed in claim 21, wherein the therapy comprises High Activity Anti-Retroviral Therapy (HAART). 24. A disease management system substantially as herein described with reference to the detailed description, embodiments, examples & drawings. Dated this 20th day of July, 2006 G. DEEPAK SRINIWAS OF K & S PARTNERS AGENT FOR THE APPLICANT(S) 33 Docket 52023-00001 ABSTRACT A comprehensive disease management system providing advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers is disclosed. Additionally, a method of managing disease in a patient located remotely relative to interpretation and therapeutic dispensing services is provided including methods of data collection, data interpretation and therapeutic dispensing. An algorithm is disclosed to provide non-physician healthcare workers in remote, rural and resource-poor urban centers to manage disease in patients with human immunodeficiency virus (HIV) disease.

Full Text

FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
COMPLETE SPECIFICATION (See section 10, rule 13)
'DISEASE MANAGEMENT SYSTEM'
DISEASE MANAGEMENT SERVICES, PLC, 65 Enterprise, Aliso Viejo, CA 92656, U.S.A;
The following specification particularly describes the invention and the manner in which it is to be performed.

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Docket 52023-00001 DISEASE MANAGEMENT SYSTEM
RELATED APPLICATIONS
[0001] This application claims priority to United States provisional patent application serial number 60/536,947 filed January 16, 2004.
COMPUTER PROGRAM LISTING APPENDIX
[0002] A computer program listing appendix containing the source code of a computer program that may be used with an embodiment of the present invention is incorporated herein by reference and appended hereto as one (1) original compact disk, and an identical copy thereof, containing a total of 1 file as follows:
Date of Creation Size (Bytes) Filename
January 16, 2004 3,382 KB 5202300001 Source Code
FIELD OF THE INVENTION
[0003] The present invention relates to a comprehensive patient management system. Specifically, the present invention provides advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers. More specifically, the present invention provides physician and non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing patients with chronic diseases, such as human immunodeficiency virus (HIV)-infected persons.
BACKGROUND OF THE INVENTION
[0004] Medical care in developing countries and rural communities presents a challenge to public health officials in that highly efficacious therapies are often not available. In some of these areas the only health care workers available are not physicians but rather nurses or other aid workers who are not trained to prescribe today's complex treatments for many diseases. One disease that has proven to be particularly difficult to manage in resource-poor countries or rural areas is human immunodeficiency virus (HIV) infection/Acquired Immune Deficiency Syndrome (AIDS) or HIV-related disease.
/

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[0005] Human immunodeficiency virus was first identified in 1981 and has since spread in epidemic proportions throughout the world. In the early years, the diagnosis of AIDS was an automatic death sentence, and the scientific community embarked on an aggressive search for a vaccine and a cure.
[0006] While these goals are still elusive, treatments have been devised that have resulted in HIV/AIDS becoming a treatable, chronic disease. Anti-retroviral drugs are taken in various combinations and according to a range of schedules, for the remainder of the patients' lives. This regime is called High Activity Anti-Retroviral Therapies (HAART; also known as Anti-Retroviral Therapy [ART or ARVJ). The ideal result is a lowering of the virus in the bloodstream to undetectable amounts. In this case, the patients' immune systems recover, or do not deteriorate, and they can live healthy and productive lives. This scenario is a reality for most in the USA, Canada and Europe. These developed countries have the political will to deal with this disease, and a complex medical infrastructure to diagnose and treat their population. The public health message of prevention is also emphasized. In addition, from a public health standpoint it is hypothesized that lowering many individual's viral load effectively lowers the viral load of the entire community and may slow transmission.
[0007] In stark contrast, many developing countries across Africa, Asia and South America have unsophisticated medical infrastructure. South Africa, for example, holds the dubious distinction of having the highest AIDS infection rate/death rate in the world, with other southern African nations in close contention. In late 2003, the South African Government released a plan to roll out HAART as part of an HIV/AIDS management plan.
[0008] South Africa has become an example for how devastating the AIDS epidemic can become when left unchecked. In this area of Africa, HIV is primarily transmitted through unprotected heterosexual sex. It can take many years for a person infected with HIV to become ill. During this period, sexually active adults spread the virus through the population; HIV is also transmitted from mother to infant in utero. Once a patient's immune system begins to deteriorate to full-blown AIDS, they easily contract opportunistic infections like tuberculosis, pneumonia and cancer. A significant proportion of the South African Department of Health ("DOH") budget of

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US$3 billion is currently spent on treating these secondary diseases with costly hospitalization and medication.
[0009] Without the rollout of an HIV/AIDS management plan which includes universal access to HAART, by 2008 the current life expectancy for a South African male will fall from 54 to 36 years, and the estimated number of AIDS orphans will rise from 420,000 to 1.6 million. The social cost is a catastrophe of grave proportion; the indirect economic cost would be a devastating 17% (US$ 22 billion) of the South African GNP.
[0010] The health care budget of the DOH currently spent on treating the opportunistic diseases and end-stage infection could more effectively be focused on providing HAART to the infected population as an integral part of a comprehensive management plan. The factors that prevented aggressive HAART treatment of the infected population in South Africa in the past are complex. Recent legal developments have obliged the DOH to administer the anti-viral drug Nevirapine to pregnant mothers and their newborn babies, and settlement has been reached regarding patents of many of the anti-viral drugs. Even as the political will has evolved toward an aggressive management plan, there is limited infrastructure to administer HAART to the urban population, even less so to those dispersed in remote rural areas.
SUMMARY OF THE INVENTION
[0011] The present invention provides a therapeutic management system comprising advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and underdeveloped urban centers. More specifically, the present invention provides non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing diseases including, but not limited to, human immunodeficiency virus (HIV) infection and Acquired Immune Deficiency Syndrome (AIDS). The present invention provides a practical solution to managing disease in remote resource-poor population centers by providing individualized patient care without having highly trained infectious disease physician specialists located at each site.

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[0012] The algorithm and database of the system of the present invention, updated regularly with state-of-the-art diagnostic protocols and therapeutic regimens, directs the non-physician healthcare worker's selection of diagnostic tests and instructs them as to what medical procedures to conduct. Additionally, the system of the present invention provides continually revised and updated instructions to the healthcare worker based on the new patient data entered after each clinic visit. The system of the present invention additionally provides systems for medication disbursement and other ancillary services to the patient.
[0013] In developed countries, even though sophisticated medical infrastructures may already exist, there are limitations to their efficiencies and availability. Managed care organizations, for example, as well as publicly-funded health systems, will all benefit from the cost-control, data collection and the comprehensive, current, state-of-the-art disease management system offered by the present invention.
[0014] In one embodiment of the present invention, a disease management system is provided comprising data collection means, data interpretation means and therapeutic dispensing means. The data collection means is used to obtain disease state information from a patient having a disease when the patient is located remotely relative to the data interpretation means and the therapeutic dispensing means. The interpretation means is located on a computer-readable medium and provides diagnostic, prognostic and therapeutic information useful for the management of the patient's disease.
[0015] In another embodiment of the present invention, the data collection means is a non-physician healthcare worker or a laboratory.
[0016] In an embodiment of the present invention, the data interpretation means is an algorithm or a physician specialist.
[0017] In another embodiment of the present invention, the therapeutic dispensing means is a pharmacy.
[0018] In yet another embodiment of the present invention, the computer-readable medium can be a hard drive, floppy disk, CD-ROM, zip drive or flash drive.

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[0019] In an embodiment of the present invention, the disease is human immunodeficiency (HIV) disease or acquired immune deficiency syndrome (AIDS) and the patient is a human.
[0020] In another embodiment of the present invention, the data interpretation means is the algorithm of FIG. 4.
[0021] In an embodiment of the present invention, an HIV-related disease management system is provided including a data collection means for collecting data, a data interpretation means for interpreting data and a therapeutic dispensing means for providing therapy useful for treating HIV-related disease, wherein the data collection means is used to obtain disease state information from a patient having a HIV-related disease. In one embodiment of the present invention, the patient is located remotely relative to the data interpretation means and the therapeutic dispensing means and the data interpretation means is located on a computer-readable medium and provides diagnostic, prognostic and therapeutic information useful for the management of the patient's disease. In another embodiment of the present invention, the data includes patient history and CD4 levels. In yet another embodiment of the present invention, the therapy is High Activity Anti-Retroviral Therapy (HAART).
[0022] In an embodiment of the present invention, a method for managing disease in a patient located remotely relative to a data interpretation means and a therapeutic dispensing means is provided comprising collecting a first set of data from the remotely located patient, interpreting the first set of data in order to determine an appropriate first therapeutic regimen for the remotely located patient, dispensing the first therapeutic regimen to the remotely located patient, collecting at least one second set of data from the remotely located patient and interpreting the at least one second set of data in order to determine the appropriateness of continuing or stopping the first therapeutic regimen or altering the first therapeutic regimen for the remotely located patient. In another embodiment of the present invention, the first and at least one second interpreting step comprises an algorithm located on a computer-readable medium that provides diagnostic, prognostic and therapeutic information useful for the management of disease in patients. In another embodiment of the present invention, the disease is HIV disease or AIDS.

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[00231 In another embodiment of the present invention, the data is collected by a non-physician healthcare worker or a laboratory.
[0024] In an embodiment of the present invention, the data interpretation means is an algorithm or a physician specialist. In another embodiment of the present invention, the therapeutic dispensing means is a pharmacy.
[0025| In yet another embodiment of the present invention, the computer-readable medium can be a hard drive, floppy disk, CD-ROM, zip drive or flash drive.
[0026] In an embodiment of the present invention, a method for disease management is provided including collecting data, interpreting data and dispensing a therapeutic useful for treating disease, where the interpretation of data is performed according the algorithm of Figure 4.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] FIG. 1 graphically depicts a flow chart of an illustrative embodiment of the operating system loop of the disease management system of the present invention.
[0028] FIG. 2 is an assessment form for evaluating readiness for Anti-Retroviral Therapy (ART) that may be utilized in one embodiment of the disease management system of the present invention. FIG. 2.1 and FIG. 2.2 are the same form. FIG. 2.2 is a continuation of FIG. 2.1.
[0029] FIG. 3 is a follow-up form for ART that may be utilized in one embodiment of the disease management system of the present invention. FIG. 3.1 and FIG. 3.2 are the same form. FIG. 3.2 is a continuation of FIG. 3.1.
[0030] FIG. 4 illustrates the main flow algorithm representing an Human Immunodeficiency Virus (HIV)/Acquired Immunodeficiency Syndrome (AIDS) embodiment of the disease management system of the present invention. FIGs. 4.1, 4.2 and 4.3 are three pages of the same figure.
[0031] FIG. 5 illustrates the "Determine Age Category" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0032] FIG. 6 illustrates the "Confirm HIV Status" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.

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[0033] FIG. 7 illustrates the "Determine HAART Candidate" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0034] FIG. 8 illustrates the "HAART Candidate Readiness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0035] FIG. 9 illustrates the "Status Active TB" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0036] FIG. 10 illustrates the "Status Latent TB" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0037] FIG. 11 illustrates the "TB Prophylaxis" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0038] FIG. 12 illustrates the "Isoniazid" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0039] FIG. 13 illustrates the "Efivarenz" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0040] FIG. 14 illustrates the "Contraindications Efivarenz* sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0041] FIG. 15 illustrates the "Nevirapine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0042] FIG. 16 illustrates the "Contraindications Nevirapine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0043] FIG. 17 illustrates the "Stavudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0044] FIG. 18 illustrates the "Contraindications Stavudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0045] FIG. 19 illustrates the "Lamivudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0046] FIG. 20 illustrates the "Zidovudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.

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[0047] FIG. 21 illustrates the "Contraindications Zidovudine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0048] FIG. 22 illustrates the "Didanosine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0049] FIG. 23 illustrates the "Contraindications Didanosine" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0050] FIG. 24 illustrates the "Lopinavir/Ritanovir" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0051] FIG. 25 illustrates the "Contraindications Lopinavir/Ritanovir" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0052] FIG. 26 illustrates the "Cotrimoxazole" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0053] FIG. 27 illustrates the "Status Liver" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0054] FIG. 28 illustrates the "Status Anemia" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0055] FIG. 29 illustrates the "Status Neutrophils" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0056] FIG. 30 illustrates the "Status Pancreas" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0057] FIG. 31 illustrates the "Status Kidney" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0058] FIG. 32 illustrates the "Status Malnutrition" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0059] FIG. 33 illustrates the "Status Regimen 1ab Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.

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[0060] FIG. 34 illustrates the "Status Regimen 2 Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0061] FIG. 35 illustrates the "Status Adherence" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0062] FIG. 36 illustrates the "Status Regimen Effectiveness" sub-algorithm of the HIV/AIDS embodiment of the disease management system of the present invention.
[0063] FIG. 37 illustrates the "Master Patient" computer screen shot of the HIV/AIDS embodiment of the Disease Management System of the present invention.
[0064] FIG. 38 illustrates the "Clinical Data Form," part 1, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0065] FIG. 39 illustrates the "Clinical Data Form," part 2, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0066] FIG. 40 illustrates the "Clinical Data Form," part 3, computer screen shot of the HiV/AIDS embodiment of the disease management system of the present
invention.
[0067] FIG. 41 illustrates the "Clinical Data Form," part 4, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0068] FIG. 42 illustrates the "HAART Prep Form" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0069] FIG. 43 illustrates the "Labs Form," part 1, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0070] FIG. 44 illustrates the "Labs Form," part 2, computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0071] FIG. 45 illustrates the "Patient Flow Analysis" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.

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[0072] FIG. 46 illustrates the "Patient Flow Analysis Report" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0073] FIG. 47 illustrates the "Display Patient" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0074] FIG. 48 illustrates the "Appointment Status" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0075] FIG. 49 illustrates the "Analytics" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
[0076] FIG. 50 illustrates the "Display Log" computer screen shot of the HIV/AIDS embodiment of the disease management system of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0077] The present invention provides advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and underdeveloped urban centers. More specifically, the present invention provides non-physician healthcare workers access to advanced diagnostic, prognostic and therapeutic capabilities useful for managing diseases including, but not limited to, human immunodeficiency virus (HIV) disease and Acquired Immune Deficiency Syndrome (AIDS). The present invention provides a practical solution to managing disease in remote resource-poor population centers by providing individualized patient care without having highly trained infectious disease physician specialists located at each site.
[0078] Human immunodeficiency virus causes a complicated life-threatening infection that is presented in this application as a non-limiting example of the scope of the disease management system of the present invention. Human immunodeficiency virus infection presents as a complex multi-factorial disease that is challenging to manage even in modern urban centers where state-of-the-art teaching hospitals and highly trained physician specialists are readily available. Patient management becomes considerably more difficult when infected individuals are located in underdeveloped urban centers and remote rural locations (herein after referred to as remote patient management). Remote patient management is further

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exacerbated when the most highly trained healthcare worker is, for example, a community nurse or Red Cross-Red Crescent aid-worker.
[0079] In many remote patient management environments, laboratory facilities, pharmacies and diagnostic imaging facilities are located hundreds of miles away. Moreover, even when these facilities are located within a reasonable proximity, patient transportation to and from testing and drug dispensing centers may be unavailable or at best unreliable.
[0080] Persons infected with HIV can often have a series of HIV-related diseases which require regular medical evaluations in order to monitor disease progression and therapy efficacy. Test interpretation and therapeutic recommendations often require the expertise of a trained infectious disease specialist. Consequently, persons located in remote patient management environments are less likely to volunteer for testing for HIV because they have learned from experience that treatment options are not readily available. Therefore, there is no benefit to the patient to know their HIV status. As a result a culture of fear and ignorance has proliferated in underdeveloped urban centers and remote rural locations that feed an ever growing HIV pandemic.
[0081] The present invention provides a solution to the problem of unavailability of specialized medical services in underdeveloped urban centers and rural locations. Recent telecommunication advances have made modem access to centralized computer databases available even in the most remote and disadvantaged areas. The present invention utilizes this global communication phenomena to bring cutting edge patient management tools directly to the patient. In one embodiment of the present invention, a non-physician healthcare worker is provided with questionnaires and protocols developed by physician experts. Using these tools, combined with rudimentary physical examination skills, the non-physician healthcare worker becomes a virtual infectious disease diagnostician. Answers to the patient questionnaire and the results of the physical examination are entered into the database locally or remotely and the algorithm feature of the present invention collates and analyzes the individualized patient data. Appropriate biological samples, principally blood, are collected and sent to a designated testing facility where the samples are tested and the results are entered into the same database

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and the algorithm of the present invention applied. Based on the combined results of the laboratory tests, questionnaire and physical examination, a preliminary diagnosis is established and an appropriate treatment regimen proposed. As used herein, an appropriate treatment regimen is defined as any treatment which a person skilled in the art of disease management would consider useful in the management of patient's disease state. In a non-limiting example, HAART is an appropriate therapeutic regimen for a patient suffering from HIV disease. Patients presenting with symptoms consistent with secondary infections or disorders can then be further examined and additional tests run as indicated, or referred to tertiary centers.
[0082] Each time the patient is examined and tested the resulting data is collated, entered and analyzed by the algorithm of the present invention. The non-physician healthcare worker is then provided with an individualized prognostic determination and recommended changes to the therapeutic regimen if required. Consequently, persons in resource-poor urban centers and remote rural settings will now have access to modern diagnostic, prognostic and therapeutic capabilities similar to those available to citizens of countries with sophisticated health care systems. The system of the present invention provides training to the non-physician healthcare worker thereby improving healthcare in general.
[0083) Thus, the system of the present invention offers an elegant and practical solution which will allow, as an example, wide and cost-effective High Activity Anti-Retroviral Therapy (HAART, ART or ARV) for HIV/AIDS in the developing world. In an illustrative embodiment, a national or regional health agency in a country in need of disease management support will use the HIV/AIDS disease management system of the present invention that includes transport of blood samples to laboratories, input of data, drug prescription generation and dispensing, as well as psychosocial and nutrition support, education and pharmacovigilance.
[0084] Laboratory services, data input, drug packaging and drug dispensing currently exist in many countries and disadvantaged areas, but not as part of an integrated system. The importance of offering national or regional health agencies an integrated management package cannot be overemphasized. In addition, the collection of data that this system facilitates is invaluable for financial, demographic and scientific projections.

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[0085] Data collection using the disease management system of the present invention also provides critical pharmacovigiiance information. Adverse drug reactions can be frequent or rare but information on these reactions is critical in disease management by physicians or non-physician healthcare workers. Once data is collected by the system of the present invention and analyzed by algorithms disclosed as embodiments of the present invention, the data is collected into a pharmacovigiiance database where it is available to influence future drug therapy regimens.
[0086] Pharmacovigiiance embodiments of the system of the present invention include:
• determine the burden of drug-related morbidity and mortality in patients
• provide training and information to healthcare workers and patients on the safe use of drugs
• provide information on risks and benefits of disease treatments, including over the counter medications.
• identify, assess and communicate new safety concerns associated with the use drugs
• minimize the impact of misleading or unproven associations between adverse events and drug therapy
• to detect, assess and respond to safety concerns related to complementary, alternative and traditional medicines
• to establish an early warning system for resistance to drugs
• to respond to unfounded and unsubstantiated claims of efficacy of untested products and treatment modalities.
[0087] In an illustrative embodiment, the present invention includes a specialized algorithm to assist health care workers with the medication management of HIV/AIDS and related opportunistic infections such as tuberculosis (TB). The major features of the disease management system of the present invention include:
• medication protocols for specific/individual patients based on evidence-based treatment algorithms
• seamless, rapid implementation of new drug protocols
• support and tracking of drug reaction mitigation

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• tracking of drug resistant viral mutations
• treatment regardless of geographic location and distance from urban centers
• automatic monitoring of high-risk patients
• complex cases referred for medical specialist consultation
• pharmacovigilance - tracking and monitoring of adverse reactions to HAARTorART
• reliable geographic health statistics for public and private sector health planners
[0088] In one embodiment of the present invention, an algorithm provides a disease management system for HIV/AIDS using approved anti-retroviral treatment protocols. The algorithms of the present invention:
• are based on World Health Organization (WHO) standards
• are easily modifiable to accommodate local standards
• recommend a treatment protocol as approved by local payors/government
• monitor and report the patient's immune function
• monitor and report adverse events and drug reactions
• alert clinical staff to clinical parameters outside of normal
• schedule appointments
• schedule and monitors laboratory tests and medical procedures
• schedule delivery of pre-packaged drugs
• monitor and report compliance with drug regimen
[0089] Among the benefits which may be obtained by the system of the present invention are that public and private healthcare service workers will be enabled to implement and operate a cost-effective system to diagnose and treat patients with HIV/AIDS and related diseases. This will hold true even within limitations of poor medical infrastructure. This system does not require significant increase in the number of doctors needed to treat disease and can coexist with many of the present treatment systems. Such a system will effectively result in a reduction in opportunistic infection rates, as well as lower overall usage of medical services by patients. The algorithm of the present invention is an effective tool to ensure

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a nurse. The innovation of the present invention will enable the resource-poor settings to act as if a specialist were present.
[0094] The present invention will dramatically improve the efficiency of the primary health care system to deliver care to its constituency, both in the urban areas, and to the large percentage of the population that live in rural conditions. The primary health care nurses, with the innovative support of the system, can more efficiently provide care for a larger number of patients, and only those who fall outside of the parameters of the algorithm will need to be referred to hospitals or medical specialists.
[0095] The challenge of compliance with complex drug therapy regimens is faced in both developing and developed countries, and is enhanced in uneducated populations. This lack of compliance in HIV/AIDS, for example, is particularly dangerous due to the resultant development of resistant HIV, as well as opportunistic diseases associated with AIDS. This system is innovative in its approach to increased compliance by enhancing monitoring, systematic feedback and automated recordkeeping. In addition to the clinical education provided directly to the patient, the system will note deviations in patterns that indicate low compliance, either through altered immune response, or missed appointments. Communicating this information to the local health care worker will facilitate intervention and increased compliance.
[0096] The system of the present invention allows all personnel and patients to benefit from advances in the treatment of disease. This is a rapidly evolving field, with advances in all areas, from pharmaceuticals to education interventions, being published oh an ongoing basis. As these changes are vetted by, for example, a medical advisory board, and approved by the governmental authorities, they can be implemented almost immediately in the remotest rural location by altering criteria in the central algorithm. One aspect of the novelty of the invention lies in the flexibility inherent in its design to deal with the rapidly evolving science. On the level of the individual patients, the system will enable a rapid response to their changing treatment needs, such as in the development of resistance, or toxicity from anti-retroviral drugs.

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Docket 52023-00001
and implemented to be culture-specific, country-specific and region-specific, and easily adapted to the most current scientific and medical knowledge as agreed to by the provider.
[0101] In another illustrative embodiment, the system of the present invention includes a multi-tiered fully redundant highly available architecture. The system is able to accept input from a variety of existing sources, such as client computers running programs including, but not limited to, the various Windows, Unix or Linux desktop operating systems, laboratory-based computer systems, voice interactive systems and other potential devices including cell phones or specialized medical diagnostic devices. Various communication protocols including, but not limited to, TCP/IP are used to communicate to the servers. The servers may be based locally and/or remotely and are also run in a fully redundant and recoverable manner using current standard computing standards. The servers utilize database systems including, but not limited to, Oracle or Microsoft SQL or IBM DB II. A variety of programming tools, languages and interfaces are used to implement the solution including, but not limited to, C#, C++, Visual Basic, HTML, XML, SSL, Data Base queries, Visio and add-on packages are used in development of the system. A proprietary source code is utilized in the system of the present invention and which can be found in the computer program listing appendix filed on compact disk with this application. The multi-tiered architecture and database design implements a security architecture to provide safeguards to protect the algorithms and patient information from being accessed in a malicious or unauthorized manner. All transactions are logged and tracked and communications are encrypted using the latest standards including 48 bit SSL or 128 bit where possible. The database servers and application servers are placed behind a firewall and use industry accepted standards to protect against unauthorized access.
[0102] The system algorithm of the present invention is built upon a state-of-the-art medical knowledge database. The most current peer-reviewed treatment protocols are included. The system supports customizations from end-users arid local healthcare personnel to ensure that local requirements are taken into account. The system includes a focus on education, communication and prevention options that are integrated with the algorithm implementation. The system is capable of

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timeframe compatible with the tests required. The system will be able to optimize and utilize this network for pathology, as well as for data input. In a novel approach, the transportation system will also be used to deliver pre-packaged drugs to the clinic to be dispensed by the nurse. Additionally, in areas where lack of telephone or wireless services prevent data entry and transmission directly into a computerized database, paper forms can be sent to the pathology lab along with samples to be entered into the disease management system by lab personnel.
[0108] 3. Opportunistic infections will be treated.
[0109] 4. HIV Treatment. The algorithm of the present invention will be applied to the patient data, with several possible outcomes:
[0110] a. Patient's immune system is not compromised enough to require
HAART. Patient receives education on the natural history of the disease, nutrition and preventing transmission of HIV. Depending on their nutritional status, supplemental vitamins, minerals, and protein will be dispensed by the system. A novel feature of the system lies in its ability to begin to empower the patient to be compliant with a regular regimen of pills/supplements and follow-up appointments, to have them benefit from support groups, and to keep them within the system of the present invention so that they receive social and emotional support, and antiretroviral therapy as soon as they require it. These patients will be reevaluated according to the intervals outlined in the protocol. An exemplary, non-limiting example is re-evaluation every three months.
[0111] b. Patient is severely immune compromised and acutely ill with a
severe or life-threatening opportunistic infection. Patient is referred to a hospital or tertiary center, and enters the system of the present invention on their discharge to their community.
[0112] c. Patient's immune system is compromised enough to require
HAART, but they fall within the extremes of the parameters of the system algorithm of the present invention, or they present with unusual signs and symptoms. The algorithm would refer all cases at the borders of the parameters to be reviewed by a physician, who would enter orders into the system of the present invention. Through this mechanism, the parameters

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Docket 52023-00001
the algorithm become wider and wider. Patient data remains within system, even when they are referred to a different hospital.
[0119] 7. Communication of data and treatment plans back to healthcare worker. There will be communication back to the healthcare worker regarding the patients status, lab results and treatment/care plan as reflected in the database and interpreted by the algorithm of the present invention. Communication can be in the form of SMS, or hard copies of reports delivered with the medication. Batch reporting can include such information such as upcoming visits, and those patients who missed appointments and require intervention.
[0120] This feedback of processed information to healthcare workers can be used to empower them by increasing their level of knowledge about the management of HIV and associated diseases, and supporting them in the care of these patients.
[0121] 8. Patient re-evaluation per protocol. Patients will be re-evaluated according to the protocol and algorithm of the present invention. For example, when beginning HAART, patients will be recalled within a shorter duration than those who have proven their compliance and tolerance for the drugs over a period of time. If testing reveals a patient is non-compliant the patient would be placed on a shorter interval between scheduled tests.
[0122] At each step of the operating system loop, patient data can be accessed remotely by healthcare workers at any site where the patient is seeking medical attention. This feature allows the successful management of nomadic patients or in instances when patients require treatment or follow-up away from their home provider.
[0123] An exemplary, non-limiting algorithm useful in an embodiment of the invention is depicted in the flow chart diagram of FIG. 4. (Note that FIGS. 4.1, 4.2 and 4.3 are part of the same flow chart.)
[0124] The exemplary algorithm of FIG. 4 presents a disease management system for HIV/AIDS. It would be reasonable to one skilled in the art to use this algorithm in the treatment of other diseases besides HIV/AIDS. Therefore the use of HIV/AIDS in the algorithm of the present invention is for exemplary purposes only and the present invention is intended to be used for the treatment of a wide range of

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Docket 52023-00001

Alert Code Alert Type Alert Value Alert Priority Alert Description
R41 Report 41 5 Sputum negative for TB
R42 Report 42 5 TB prophylaxis> 9 months
R43 Report 43 5 Isoniazid contraindicated - status liver
R44 Report 44 5 TB prophylaxis not indicated - on HAART
R45 Report 45 5 Isoniazid contraindicated - treated for active TB in past 2 years
R46 Report 46 5 TB prophylaxis no indicated
R47 Report 47 5 TB prophylaxis start date unknown
R48 Report 48 5 TB prophylaxis indicated
R49 Report 49 5 TB skin test positive
R50 Report 50 1 Get TB skin test
R51 Report 51 5 Non-reactive TB skin test
R52 Report 52 1 Get sputum for TB smear and culture
R53 Report 53 1 TB prophylaxis complete - 6 month supply within 9 months
R54 Report 54 1 Complete TB treatment, then evaluate for HAART
R55 Report 55 5 Active TB treatment start date unknown
R56 Report 56 5 One viral load > 5,000
R57 Report 57 1 Low level viremia (400 - 5,000)
R58 Report 58 1 Clinical evidence of 2"° line therapy failure
R59 Report 59 9 No contraindications to Isoniazid
R60 Report 60 1 Mismatch between previous and current status
R61 Report 61 5 No signs of active TB
R62 Report 62 5 Cotrimoxazole prophylaxis not indicated
R63 Report 63 5 Cotrimoxazoie prophylaxis indicated
R64 Report 64 5 Currently on Isoniazid
R65 Report 65 5 Height not recorded - BMI not calculated, nutrition status unknown
SOW Schedule Emergency callback (0 weeks)
S11W Schedule 11 WCCKS
S12M Schedule 12 month
S12W Schedule 12 weeks
S15W Schedule 15 weeks
S16W Schedule 16 weeks
S1M Schedule 1 month
S1W Schedule 1 week
S23W Schedule 23 weeks
S24W Schedule 24 weeks
S2M Schedule 2 months
S2W Schedule 2 weeks
S3M Schedule 3 months
S3W Schedule 3 weeks
S4M Schedule 4 months
S4W Schedule 4 weeks
S5M Schedule 5 months
S6M Schedule 6 months
S7W Schedule 7 weeks
S8W Schedule 8 weeks
[0126] Data input into the system of the present invention can be achieved using methods including, but not limited to, computers, hand-held devices such a personal digital assistant (PDA), or paper forms. The data is then transmitted to the computer

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Docket 52023-00001
[0130] It is to be expressly understood that the claimed invention is not to be limited to the description of any single embodiment but encompasses other modifications and alterations within the scope and spirit of the inventive concept.

We claim:
1. A disease management system comprising:
data collection means;
data interpretation means operatively coupled to the data collection means; and
therapeutic dispensing means operatively coupled to the data collection means,
wherein said data collection means is configured to obtain disease state information from a patient having a disease, the said patient being located remotely relative to said data interpretation means and said therapeutic dispensing means and wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient.
2. The disease management system as claimed in claim 1, wherein said data collection means comprises a non-physician healthcare worker or a laboratory.
3. The disease management system as claimed in claim 2, wherein said data collection means comprises a non-physician healthcare worker.
4. The disease management system as claimed in claim 2, wherein said data collection means comprises a laboratory.
5. The disease management system as claimed in claim 1, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information or a physician specialist having access to a computer.

30
The disease management system as claimed in claim 5, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information.
The disease management system as claimed in claim 5, wherein said data interpretation means comprises a physician specialist having access to a computer.
The disease management system as claimed in claim 1, wherein said therapeutic dispensing means comprises a pharmacy.
The disease management system as claimed in claim 1, wherein said disease is human immunodeficiency (HIV) disease or acquired immune deficiency syndrome (AIDS).
The disease management system as claimed in claim 1 wherein said patient is a human.
A disease management system comprising:
data collection means;
data interpretation means operatively coupled to the data collection means; and
therapeutic dispensing means operatively coupled to the data interpretation means,
wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient.
The disease management system as claimed in claim 11, wherein said data collection means comprises a non-physician healthcare worker or a laboratory.

13. The disease management system as claimed in claim 12, wherein said data collection means comprises a non-physician healthcare worker.
14. The disease management system as claimed in claim 12, wherein said data collection means comprises a laboratory.
15. The disease management system as claimed in claim 11, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information or a physician specialist having access to a computer.
16. The disease management system as claimed in claim 15, wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information.
17. The disease management system as claimed in claim 15, wherein said data interpretation means comprises a physician specialist having access to a computer.
18. The disease management system as claimed in claim 11, wherein said therapeutic dispensing means comprises a pharmacy.
19. The disease management system as claimed in claim 11, wherein said disease is HIV disease or AIDS.
20. The disease management system as claimed in claim 11, wherein said patient is a human.
21. An HIV-related disease management system comprising:
a data collection means for collecting data;
a data interpretation means operatively coupled to the data collection means and being configured for interpreting said data; and

32
a therapeutic dispensing means operatively coupled to the data interpretation means and being configured for providing therapy useful for treating said HIV-related disease,
wherein said data collection means is configured to obtain disease state information from a patient having a HIV-related disease the said patient being located remotely relative to said data interpretation means and said therapeutic dispensing means and wherein said data interpretation means comprises a computer or a dedicated firmware or a hardware providing diagnostic, prognostic and therapeutic information useful for the management of said disease of said patient.
22. The disease management system as claimed in claim 21, wherein said data comprises a patient history and CD4 levels.
23. The disease management system as claimed in claim 21, wherein the therapy comprises High Activity Anti-Retroviral Therapy (HAART).
24. A disease management system substantially as herein described with reference to the detailed description, embodiments, examples & drawings.
Dated this 20th day of July, 2006
G. DEEPAK SRINIWAS
OF K & S PARTNERS
AGENT FOR THE APPLICANT(S)

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Docket 52023-00001
ABSTRACT
A comprehensive disease management system providing advanced diagnostic, prognostic and therapeutic capabilities to healthcare workers located in remote, rural and resource-poor urban centers is disclosed. Additionally, a method of managing disease in a patient located remotely relative to interpretation and therapeutic dispensing services is provided including methods of data collection, data interpretation and therapeutic dispensing. An algorithm is disclosed to provide non-physician healthcare workers in remote, rural and resource-poor urban centers to manage disease in patients with human immunodeficiency virus (HIV) disease.

Documents:

893-mumnp-2006-abstract(11-04-2008).doc

893-mumnp-2006-abstract(11-04-2008).pdf

893-mumnp-2006-abstract.doc

893-mumnp-2006-abstract.pdf

893-mumnp-2006-cancelled pages(26-07-2006).pdf

893-mumnp-2006-claims(granted)-(11-04-2008).doc

893-mumnp-2006-claims(granted)-(11-04-2008).pdf

893-mumnp-2006-claims.doc

893-mumnp-2006-claims.pdf

893-mumnp-2006-correspondance-received.pdf

893-mumnp-2006-correspondence(11-04-2008).pdf

893-mumnp-2006-correspondence(ipo)-(17-04-2008).pdf

893-mumnp-2006-description (complete).pdf

893-mumnp-2006-drawing(11-04-2008).pdf

893-mumnp-2006-drawings.pdf

893-mumnp-2006-form 1(21-07-2006).pdf

893-mumnp-2006-form 1(26-07-2006).pdf

893-mumnp-2006-form 13(21-07-2006).pdf

893-mumnp-2006-form 18(26-07-2006).pdf

893-mumnp-2006-form 2(granted)-(11-04-2008).doc

893-mumnp-2006-form 2(granted)-(11-04-2008).pdf

893-mumnp-2006-form 26(05-09-2006).pdf

893-mumnp-2006-form 3(21-07-2006).pdf

893-mumnp-2006-form 3(25-01-2008).pdf

893-mumnp-2006-form 5(21-07-2006).pdf

893-mumnp-2006-form 5(25-01-2008).pdf

893-mumnp-2006-form-1.pdf

893-mumnp-2006-form-13.pdf

893-mumnp-2006-form-2.doc

893-mumnp-2006-form-2.pdf

893-mumnp-2006-form-3.pdf

893-mumnp-2006-form-5.pdf

893-mumnp-2006-form-pct-ib-301.pdf

893-mumnp-2006-form-pct-ib-304.pdf

893-mumnp-2006-form-pct-ib-306.pdf

893-mumnp-2006-form-pct-isa-210(26-07-2006).pdf

893-mumnp-2006-form-pct-isa-220.pdf

893-mumnp-2006-form-pct-isa-237.pdf

893-mumnp-2006-form-pct-search report.pdf

893-mumnp-2006-petition under rule 137(25-01-2008).pdf

893-mumnp-2006-petition under rule 138(10-03-2008).pdf

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Patent Number

220228

Indian Patent Application Number

893/MUMNP/2006

PG Journal Number

33/2008

Publication Date

15-Aug-2008

Grant Date

21-May-2008

Date of Filing

26-Jul-2006

Name of Patentee

DISEASE MANAGEMENT SERVICES, PLC

Applicant Address

Inventors:

#	Inventor's Name	Inventor's Address
1	LAING, Henry, C., J.
2	SENDER, BARRY, J.
3	SENDER, Leonard, S.
4	SENDER, Adele, S.
5	BISHOP, Craig, M.

PCT International Classification Number

G06F19/00

PCT International Application Number

PCT/US2005/002103

PCT International Filing date

2005-01-14

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1	60/536,947	2004-01-16	U.S.A.