WO2011123823A1

WO2011123823A1 - Systems and methods for managing treatment of a chronic disease

Info

Publication number: WO2011123823A1
Application number: PCT/US2011/031002
Authority: WO
Inventors: Edward Kitfield; Marcio Souza; Karthik Kalyanam; Sriram Subramanian
Original assignee: Shire Human Genetic Therapies, Inc.
Priority date: 2010-04-02
Filing date: 2011-04-01
Publication date: 2011-10-06

Abstract

A system for managing treatment of a chronic disease of a patient by a user includes a mobile device and a program stored thereon. The mobile device is constructed and adapted to communicate with at least one server. The program stores one or more parameters related to the treatment of the chronic disease, tracks the parameters, and communicates information related to the treatment of the chronic disease with a health care provider, a company, and/or a case manager.

Description

SYSTEMS AND METHODS FOR MANAGING TREATMENT OF A

CHRONIC DISEASE

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application Serial No. 61/320,557, entitled "SYSTEMS AND METHODS FOR MANAGING

TREATMENT OF A CHRONIC DISEASE," filed on April 2, 2010, which is herein incorporated by reference in its entirety.

BACKGROUND

1. Technical Field

The present disclosure relates generally to the field of health care

management.

2. Background

An individual with a chronic disease may be required to monitor various health parameters on a continuous basis in support of any treatment or therapy.

Today, there is a range of therapeutic options available to treat various chronic diseases and their symptoms. Several therapies are intended to target the biochemical process of the disease. Also, options are available or are being developed for treating symptoms of the disease, such as pain, anemia, and joint problems.

Certain therapies for treating chronic diseases may be administered by the patient, a family member, or a treatment facility under the direction of a health care professional. Because these treatments may occur outside the presence of a health care provider or other provider (e.g., between doctor visits), the patient or family member assumes responsibility for administration of the treatments. The patient may also require on-going support for managing the treatments between health care provider visits. SUMMARY OF INVENTION

An application for a mobile device, such as a smart phone having a processor and wireless networking capability, enables users to manage and track treatments of a disease, for example, a chronic disease. In one implementation, the application includes software that is stored on a memory of the mobile device and executed by the processor.

One embodiment of the application includes a disease tracking feature that enables patients to record and review various parameter data related to their disease. The parameters may include testable and quantitatively measureable aspects of certain symptoms associated with the disease. For example, a symptom of pain may be recorded on a recurring basis (e.g., daily) by the patient ranking the extent of the pain on a fixed scale, such as 0 (for no pain) to 10 (severe pain). The application provides reports and/or graphs of the recorded data such that trends may be identified, or such that the data may be correlated with treatments for further evaluation.

Another embodiment of the application includes a calendar feature for scheduling administrations of treatments and/or appointments, for example, infusions and health care provider visits. For example, treatment of a disease may involve administration of a drug on a recurring basis, and the calendar feature allows the patient to schedule such administrations. The calendar feature may provide the user with a reminder for each scheduled administration or appointment.

In another embodiment, the application provides news and other information related to the disease and/or treatments, which is viewable on the mobile device. The news and other information may, for example, be received by the mobile device by wireless communication from, for example, a server or a website. The news and other information may, for example, be stored on the memory of the mobile device and displayed on a display of the mobile device when, e.g., selected by the user.

In yet another embodiment, the application provides a support feature that enables the user to communicate with, for example, a health care provider or case manager. For example, the user may use the support feature to request insurance and/or reimbursement assistance from the case manager. In other examples, the user may use the support feature to select a case manager from a list of case managers, to ask questions related to the treatment of the disease, and/or to request other support services.

According to one embodiment, a system for managing treatment of a chronic disease of a patient by a user includes a mobile device having a processor and a memory coupled to the processor. The mobile device is constructed and adapted to communicate with at least one server. A program is stored on the memory. The program is executable by the processor and comprises a data storage module for storing one or more parameters related to the treatment of the chronic disease, a tracking module for tracking the parameters, and a communications module for communicating information related to the treatment of the chronic disease with a health care provider, a company, and/or a case manager. The mobile device may be a smart phone having a wireless network device, or a personal digital assistant having a wireless network device. The information may include news, company alerts, and/or the parameters. The parameters and/or the information may be displayed to the user in an interface of the mobile device.

The program may also include a calendar module for scheduling treatment administrations and/or appointments. The information may include the treatment administrations and/or the appointments.

The parameters may include parameter data acquired from a medical test of the patient. The parameters may include a parameter type, a parameter value, and/or a test date. The parameter type may be bone pain, hemoglobin level, liver volume, platelet count, and/or spleen volume.

In another embodiment, a method for managing treatment of a chronic disease of a patient by a user using a mobile device includes storing, on a memory of the mobile device, one or more parameters related to the treatment of the chronic disease, tracking the one or more parameters, and communicating information related to the treatment of the chronic disease with a health care provider, a company, and/or a case manager. The mobile device may be a smart phone having a wireless network device, or a personal digital assistant having a wireless network device.

The information may include news, company alerts, and/or the parameters. The method may also include scheduling treatment administrations and/or appointments. The appointments may be health care related. The information may include the treatment administrations and/or the appointments.

The method may also include displaying, to the user in an interface of the mobile device, the parameters and/or the information.

The parameters may include parameter data acquired from a medical test of the patient. The parameters may include a parameter type, a parameter value, and/or a test date.

The method may also include displaying the parameters on a display of the mobile device.

In another embodiment, a computer readable storage medium embodies a program having instructions executable by a processor of a mobile device. The instructions are executed to perform a method for managing treatment of a chronic disease of a patient by a user including storing, on a memory of the mobile device, one or more parameters related to the treatment of the chronic disease, tracking the one or more parameters, and communicating information related to the treatment of the chronic disease with a health care provider, a company, and/or a case manager. The mobile device may be a smart phone having a wireless network device, or a personal digital assistant having a wireless network device. The method may also include scheduling treatments and/or appointments.

In another embodiment, a system for managing treatment of a chronic disease of a patient by a user includes a mobile device having a processor and a memory coupled to the processor, the mobile device constructed and adapted to communicate with at least one server, and a program stored on the memory. The program is executable by the processor and includes a news module for receiving and displaying news related to the chronic disease, where the news may be generated by a news provider and disseminated through the at least one server, a calendar module for scheduling treatments of the chronic disease and/or health related appointments, a tracking module for storing and displaying health related data of the patient, and a support module for exchanging messages between the patient and a case manager through the server. The mobile device may be a smart phone having a wireless network device, or a personal digital assistant having a wireless network device.

The news module may provide a news screen for displaying one or more headlines, a news feed screen for displaying a news story, and/or a company alert screen for displaying information generated by at least one of a company and a support service.

The calendar module may store and/or display at least one appointment related to the treatment of the chronic disease. Each appointment may be a one time appointment or a bi-weekly appointment.

The health related data may include parameter data acquired from a medical test of the patient. The parameter data may include a parameter type, a parameter value, and a test date.

The tracking module may also store and/or display a weight, an age, and a gender of the patient. The tracking module may display parameter data in a tabular format and/or a graphical format.

The support module may store and/or display a list of case managers. The list of case managers may have a plurality of case manager names. The support module may store and/or display a patient profile. The patient profile may include a patient name, a patient street address, a patient telephone number, and/or a patient e-mail address. The support module may generate the messages based on the patient profile, the case manager, and/or a message type. The message type may be an address change notification, an insurance notification, and/or a vacation notification.

In another embodiment, a method for managing treatment of a chronic disease of a patient by a user using a mobile device includes scheduling, in a calendar stored on the mobile device, one or more appointments related to the treatment of the chronic disease, and tracking, in a repository stored on the mobile device, one or more parameters acquired from a medical test of the patient, each of parameters having a parameter type, a parameter value, and a test date.

The method may also include receiving, through a network interface of the mobile device, and displaying, through a graphical user interface of the mobile device, one or more news items related to the chronic disease. Each of the news items may include a news story and/or a company alert.

The method may also include communicating, through the network interface, one or more messages between the patient and a case manager.

Each of the appointments may include a one time appointment or a recurring appointment.

Tracking the parameters may include prompting a user to select a parameter type. In response to the parameter type being selected, tracking may include prompting the user to enter the parameter value, the parameter representing a discrete measurement of one parameter of the patient. In response to the parameter value being entered, tracking may include storing the parameter type, the parameter value, and/or the test date in the repository. Tracking may further include prompting the user to request a history of the parameters. In response to the history being requested, tracking may include retrieving at least one of the parameters from the repository, and displaying the retrieved parameter in a tabular and/or graphical format.

Any one of the messages may be an address change notification, an insurance notification, and/or a vacation notification.

BRIEF DESCRIPTION OF DRAWINGS

The accompanying drawings, are not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is illustrated in various figures is represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

FIG. 1 is a schematic illustration showing exemplary relationships among entities in accordance with various embodiments of the disclosure.

FIG. 2 is a schematic illustration showing an exemplary system in accordance with one embodiment of the disclosure.

FIG. 3 is a schematic illustration showing an exemplary system in accordance with one embodiment of the disclosure. FIG. 4 is a flow diagram showing an exemplary flow of data and other information in accordance with one embodiment of the disclosure.

FIGS. 5A-5E are a state diagrams representing one or more exemplary applications in accordance with various embodiments of the disclosure.

FIGS. 6 and 7 illustrate exemplary screen displays relating to an application in accordance with various embodiments of the disclosure.

FIGS. 8A-8G illustrate exemplary screen displays relating to a news feature of the application in accordance with various embodiments of the disclosure.

FIGS. 9A-9J illustrate exemplary screen displays relating to a calendar feature of the application in accordance with various embodiments of the disclosure.

FIGS. 1 OA- ION and FIGS. 10P-10Q illustrate exemplary screen displays relating to a tracker feature of the application in accordance with various

embodiments of the disclosure.

FIGS. 11A-11E illustrate exemplary screen displays relating to a support feature of the application in accordance with various embodiments of the disclosure.

DETAILED DESCRIPTION

Embodiments of this invention are not limited in their application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. Embodiments of the invention are capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," or "having," "containing", "involving", and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

According to one aspect of the present invention, it is appreciated that tools that allow patients to manage their disease and health enable the patient to receive higher quality health care, improved access to health care support, lower health care costs, greater adherence to treatment, and a better quality of life. To this end, systems and methods are described herein that permit, among others, patients, their families, and health care professionals to more effectively manage diseases, especially chronic diseases.

According to at least one embodiment, an application program is provided that may be used by a patient having a chronic disease to receive current information regarding their disease, schedule treatments, track progress towards a therapeutic goal, and communicate with support personnel, such as a case manager, in matters relating to their treatment. For example, an application for a mobile device may be provided that integrates one or more of the above features in a single package that is easily and readily accessible to patients having such mobile devices. The application may be used by, for example, patients, family members, caregivers, healthcare professionals (e.g., health care providers), and case managers who are involved in the treatment of the patient.

Orphan Diseases

As used herein, a disease which afflicts less than 200,000 individuals in the

United States, or less than 5 per 10,000 individuals in the European Union, is considered to be an orphan disease (also referred to herein as a rare disease).

The underlying cause of an orphan disease and/or one or more parameters that are commonly monitored during treatment of an orphan disease can be managed and/or monitored with systems and methods that include the technology described herein.

Examples of orphan diseases include hereditary angioedema, Gaucher disease, Hunter syndrome, Sanfilippo A syndrome, Globoid Cell Leukodystrophy (Krabbe), and Metachromatic Leukodystrophy (MLD).

Other Diseases

The underlying cause of a disease, or one or more parameters associated with the treatment of a disease, may be managed and/or monitored with systems and methods described herein. Such diseases include those that require continued therapy, e.g., for at least one year, 2 years, 3 years, 4 years, 5 years, 6 years, 7 years, 8 years, 9 years, 10 years, or for the rest of the patient's life. For example, the disease may be a chronic disease.

For example, the disease may require continued therapy, e.g., may require that a treatment be administered to a patient every three or four weeks, every other week, weekly, twice a week, three times a week, every other day, daily, or more than once a day (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 times a day) over the course of the continued therapy. The therapy can include a monotherapy or a combination therapy. The term "combination" refers to the use of the two or more agents or therapies to treat the same patient, wherein the use or action of the agents or therapies overlap in time. The agents or therapies may be administered at the same time (e.g., as a single formulation that is administered to a patient or as two separate formulations administered concurrently) or sequentially in any order. In the case of a combination therapy, the amounts and times of administration may be those that provide, e.g., a synergistic therapeutic effect, or an additive therapeutic effect.

As another example, the disease may also or alternatively require continued evaluation of the patient, e.g., the patient undergoes evaluation on a continued basis. For example, the disease requires that the patient is evaluated annually, several times a year (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 times a year), every other month, monthly, every other week, weekly, twice a week, three times a week, every other day, daily, or more than once a day (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, or 12 times a day). For example, based on the result of an evaluation, the therapy may be adjusted (e.g., the dose and/or frequency of administration and/or the treatment (e.g., drug) may be adjusted). The evaluation may include, for example, one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound).

The disease may be, for example, a chronic disease. Examples of chronic diseases include diabetes, cancer, hepatitis (e.g., hepatitis C), HIV (human immunodeficiency virus) infection, high blood pressure, heart disease, high cholesterol, lupus, colitis, multiple sclerosis, cystic fibrosis, chronic obstructive pulmonary disease, chronic renal failure, and a disease that requires dialysis (e.g., renal failure or impairment, or liver failure or impairment).

The diseases described herein do not include orphan diseases such as lysosomal storage disorders.

Diabetes

Diabetes mellitus (DM) is a condition in which a person has a high blood sugar (glucose) level as a result of the body either not producing enough insulin, or because body cells do not properly respond to the insulin that is produced. If the body cells do not absorb the glucose, the glucose accumulates in the blood

(hyperglycemia), leading to various potential medical complications.

The most common types of diabetes are type 1 diabetes; type 2 diabetes; and gestational diabetes. Other forms of diabetes include congenital diabetes, cystic fibrosis-related diabetes, steroid diabetes induced by high doses of glucocorticoids, and several forms of monogenic diabetes.

Diabetes without proper treatment can cause many complications. Acute complications include hypoglycemia (e.g., after insulin therapy), diabetic

ketoacidosis, and/or nonketotic hyperosmolar coma. Serious long-term complications include cardiovascular disease, chronic renal failure, and/or retinal damage.

Symptoms of diabetes include, e.g., polyuria, polydipsia, polyphagia, fasting plasma glucose level at or above 7.0 mmol/L (126 mg/dL), plasma glucose at or above 11.1 mmol/L (200 mg/dL) two hours after a 75 g oral glucose load as in a glucose tolerance test, symptoms of hyperglycemia and casual plasma glucose at or above 11.1 mmol/L (200 mg/dL), glycated hemoglobin (hemoglobin AIC) at or above 6.5, diabetic ketoacidosis (DKA), Kussmaul breathing, nausea, vomiting, abdominal pain, altered state of consciousness, rapid yet significant weight loss, vision changes, blurred vision, irreducible mental fatigue, diabetic dermadromes, and/or rarely hyperosmolar nonketotic state.

One or more symptoms of diabetes (e.g., hyperglycemia, ketacidosis, fasting plasma glucose levels, plasma glucose levels two hours after a 75 g oral glucose load as in a glucose tolerance test, and/or glycated hemoglobin) may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a health care provider, using one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). The health care provider or patient may record the parameter and the parameter value using systems and methods described herein.

Treatments for diabetes include one or more of the following: lifestyle modification (e.g., diet and/or exercise programs), and/or administration of one or more of insulin, secretagogues (such as sulfonylureas and meglitinides), sensitizers (such as biguanides and thiazolidiones), alpha-glucosidase inhibitors, and peptide analogs (such as incretin mimetics (such as glucagon-like peptide (GLP) analogs and agonists and gastric inhibitory peptide (GIP) analogs), DPP-4 inhibitors, and amylin analogues). Systems and methods described herein may be used to provide information or news about one or more of these treatments. In addition, systems and methods described herein may be used to track one or more parameters of a patient being treated with one or more of the treatments listed above.

Side effects of treatment of diabetes may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. Side effects of the treatment of diabetes include, e.g., hypoglycemia, lactic acidosis, nausea, cramps, diarrhea, and hepatic necrosis. The parameter can be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). Treatment of the side effects may be managed and/or monitored using systems and methods described herein.

The symptoms, side effects of treatment, and/or treatments (e.g., when a treatment(s) is administered, the dose at which a treatment is administered, and how a treatment is administered (e.g., route and/or duration of administration)) of diabetes may be recorded, managed and/or monitored using systems and methods described herein.

Cancer

Cancer is a class of diseases in which a group of cells display uncontrolled growth, invasion, and sometimes metastasis. Cancers are classified by the type of cell that resembles the tumor and, therefore, the tissue presumed to be the origin of the tumor. Cancer is a diverse class of diseases which differ widely in their causes and biology.

Roughly, cancer symptoms can be divided into three groups:

Local symptoms: unusual lumps or swelling/presence of a tumor, hemorrhage, pain and/or ulceration. Compression of surrounding tissues may cause symptoms such as jaundice.

Symptoms of metastasis: enlarged lymph nodes, cough and hemoptysis, hepatomegaly (enlarged liver), bone pain, fracture of affected bones and neurological symptoms. Although advanced cancer may cause pain, it is often not the first symptom.

Systemic symptoms: weight loss, poor appetite, fatigue and cachexia, excessive sweating, anemia and specific paraneoplastic phenomena, i.e. specific conditions that are due to an active cancer, such as thrombosis or hormonal changes.

One or more symptoms of cancer (e.g., tumor presence or size, blood cell counts) may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT scan, X-rays, endoscopy, and ultrasound).

Treatments for cancer include one or more of the following: chemotherapy, radiation therapy, surgery, immunotherapy, monoclonal antibody therapy and other methods. Which treatments are used depends upon the location and grade of the tumor and the stage of the disease, as well as the general state of a person's health. Experimental cancer treatments are also under development.

Side effects of treatment of cancer include, e.g., hair loss, nausea, diarrhea, neuropathy, myelosuppression, neutropenia, mucositis, edema, and alopecia. One or more side effects of cancer treatment may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare professional, using one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). Treatment of the side effects may be managed and/or monitored using systems and methods described herein.

The symptoms, side effects of treatment, and/or treatments (e.g., when a treatment(s) is administered, the dose at which a treatment is administered, and how a treatment is administered (e.g., route and/or duration of administration)) of cancer may be managed and/or monitored using systems and methods described herein. Therapy with Dialysis

Dialysis is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturbance in kidney function or for those with progressive but chronically worsening kidney function-a state known as chronic kidney disease stage 5 (also referred to as chronic renal failure or end-stage kidney disease).

When healthy, the kidneys maintain the body's internal equilibrium of water and minerals (e.g., sodium, potassium, chloride, calcium, phosphorus, magnesium, sulfate). Acidic metabolism end products that the body cannot get rid of via respiration are also excreted through the kidneys. Dialysis treatments replace some kidney functions through diffusion (waste removal) and ultrafiltration (fluid removal).

The types of dialysis include hemodialysis, peritoneal dialysis, hemofiltration, and intestinal dialysis. Hemodialysis is a method for removing waste products such as creatinine and urea, as well as free water from the blood when the kidneys are in renal failure. In some embodiments, the dialysis is hemodialysis.

Examples of indications for dialysis in a patient with acute kidney injury include: metabolic acidosis in situations where correction with sodium bicarbonate is impractical or may result in fluid overload; electrolyte abnormality, such as severe hyperkalemia; intoxication, e.g., acute poisoning with a dialysable drug, such as lithium, or aspirin; fluid overload not expected to respond to treatment with diuretics; and/or complications of uremia, such as pericarditis, encephalopathy, or

gastrointestinal bleeding. Chronic indications for dialysis include: symptomatic renal failure; low glomerular filtration rate (GFR); and/or difficulty in medically controlling fluid overload, serum potassium, and/or serum phosphorus when the GFR is very low.

Parameters to evaluate in a patient undergoing dialysis include, e.g., electrolyte levels, creatinine levels, urea levels, levels of a dialyzable drug, and/or glomerular filtration rate. In some embodiments, creatinine levels and/or urea levels are evaluated. One or more parameters may be evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, urine test, and/or enzyme assay.

Side effects of treatment of dialysis include side effects caused by removing too much fluid and/or removing fluid too rapidly including low blood pressure, fatigue, chest pains, leg cramps, nausea, and headaches; and infection, such as sepsis, endocarditis, or osteomyelitis. One or more side effects of dialysis may be evaluated before, during and/or after the treatment, and may be used as a parameter of systems and methods described herein. The evaluation may include one or more medical exams or tests, e.g., blood test, urine test, and/or enzyme assay. Treatment of the side effects (e.g., antibiotic administration) may be managed and/or monitored using systems and methods described herein.

The parameters, side effects of dialysis, and/or dialysis (e.g., duration and frequency) may be managed and/or monitored using systems and methods described herein.

Human Immunodeficiency Virus Infection

Human immunodeficiency virus (HIV) is a lenti virus that causes acquired immunodeficiency syndrome (AIDS), a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections. Infection with HIV-1 is associated with a progressive decrease of the CD4⁺ T cell count and an increase in viral load. The stage of infection can be determined by measuring a patient' s CD4⁺ T cell count, and the level of HIV in the blood.

HIV infection has four stages: incubation period, acute infection, latency stage, and AIDS. The initial incubation period upon infection is asymptomatic and usually lasts between two and four weeks. The second stage, acute infection, lasts an average of 28 days and can include symptoms such as fever, lymphadenopathy, pharyngitis, rash, myalgia, malaise, mouth and esophagal sores, and may also include, but less commonly, headache, nausea and vomiting, enlarged liver and/or spleen, weight loss, thrush, and neurological symptoms. The latency stage, which occurs third, shows few or no symptoms and can last anywhere from two weeks to twenty years and beyond. AIDS, the fourth and final stage of HIV infection shows as symptoms of various opportunistic infections.

In AIDS, the first symptoms often include moderate and unexplained weight loss, recurring respiratory tract infections (such as sinusitis, bronchitis, otitis media, pharyngitis), prostatitis, skin rashes, and oral ulcerations. Common opportunistic infections and tumors, most of which are normally controlled by robust CD4⁺ T cell- mediated immunity, then start to affect the patient. Typically, resistance is lost early on to oral Candida species and to Mycobacterium tuberculosis, which leads to an increased susceptibility to oral candidiasis (thrush) and tuberculosis. Later, reactivation of latent herpes viruses may cause worsening recurrences of herpes simplex eruptions, shingles, Epstein-Barr virus-induced B-cell lymphomas, or Kaposi's sarcoma. Pneumonia caused by the fungus Pneumocystis jirovecii is common and often fatal. In the final stages of AIDS, infection with cytomegalovirus (another herpes virus) or Mycobacterium avium complex is more prominent.

One or more symptoms of HIV infection or AIDS (e.g., low CD4⁺ T cell count (e.g., less than 200 cells per microliter), rate of CD4⁺ T cell decline, and/or level of HIV in the blood (viral load)) may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, enzyme or antibody assay, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). Opportunistic infections and/or tumors may be evaluated before, during and/or after the treatment, and treated. The treatment of such opportunistic infections and/or tumors may be managed and/or monitored using systems and methods described herein. Treatment for HIV infection includes highly active antiretroviral therapy (HAART). Current HAART options are combinations (or "cocktails") consisting of at least three drugs belonging to at least two classes of antiretroviral agents.

Typically, these classes are two nucleoside analogue reverse transcriptase inhibitors (NARTIs or NRTIs) plus either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor (NNRTI). New classes of drugs such as entry inhibitors are also available, e.g., for patients who are infected with viruses resistant to common therapies. Systems and methods described herein may be used to provide information and/or news about one or more of the treatments described above. In addition, systems and methods described herein may be used to track one or more parameters of a patient being treated with one or more of the treatments listed above.

Side effects of treatment of HIV infection and/or AIDS include, e.g., lipodystrophy, dyslipidemia, insulin resistance, and an increase in cardiovascular risks. One or more side effects of HIV infection and/or AIDS treatment may be evaluated before, during and/or after the treatment. The evaluation may include one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). Treatment of the side effects may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein.

The symptoms, side effects of treatment, and/or treatments (e.g., when a treatment(s) is administered, the dose at which a treatment is administered, and how a treatment is administered (e.g., route and/or duration of administration)) of HIV infection and/or AIDS may be managed and/or monitored using systems and methods described herein.

Hepatitis Infection

A viral hepatitis infection (e.g., hepatitis A, hepatitis B, hepatitis C, hepatitis D, or hepatitis E infection) can be managed and/or monitored with an application described herein. In some embodiments, the hepatitis infection is a hepatitis B, hepatitis C, or hepatitis D. In some embodiments, the hepatitis infection is a hepatitis C infection. Hepatitis C is an infectious disease affecting the liver. The infection is often asymptomatic, but once established, chronic infection can progress to scarring of the liver (fibrosis), and advanced scarring (cirrhosis) which is generally apparent after many years. In some cases, those with cirrhosis will go on to develop liver failure or other complications of cirrhosis, including liver cancer or life threatening esophageal varices and gastric varices.

Acute hepatitis C refers to the first 6 months after infection with hepatitis C virus (HCV). Between 60% to 70% of people infected develop no symptoms during the acute phase. In the minority of patients who experience acute phase symptoms, they are generally mild and nonspecific, and rarely lead to a specific diagnosis of hepatitis C. Symptoms of acute hepatitis C infection include decreased appetite, fatigue, abdominal pain, jaundice, itching, and flu-like symptoms. Hepatitis C genotypes 2A & 3A have the highest cure rates.

The hepatitis C virus is usually detectable in the blood within one to three weeks after infection by PCR, and antibodies to the virus are generally detectable within 3 to 15 weeks. Spontaneous viral clearance rates are highly variable and between 10-60% of persons infected with HCV clear the virus from their bodies during the acute phase as shown by normalization in liver enzymes (alanine transaminase (ALT) and aspartate transaminase (AST)), and plasma HCV-RNA clearance. However, persistent infections are common and most patients develop chronic hepatitis C.

Chronic hepatitis C is defined as infection with the hepatitis C virus persisting for more than six months. Clinically, it is often asymptomatic (without symptoms). Although almost all people infected with HCV have evidence of inflammation on liver biopsy, the rate of progression of liver scarring (fibrosis) shows significant variability among individuals. Symptoms specifically suggestive of liver disease are typically absent until substantial scarring of the liver has occurred. Generalized signs and symptoms associated with chronic hepatitis C include fatigue, flu-like symptoms, joint pains, itching, sleep disturbances, appetite changes, nausea, and depression.

Once chronic hepatitis C has progressed to cirrhosis, signs and symptoms may appear that are generally caused by either decreased liver function or increased pressure in the liver circulation, a condition known as portal hypertension. Possible signs and symptoms of liver cirrhosis include ascites, bruising and bleeding tendency, varices (enlarged veins, especially in the stomach and esophagus), jaundice, and hepatic encephalopathy. Hepatic encephalopathy is due to the accumulation of ammonia and other substances normally cleared by a healthy liver.

In some patients, liver enzyme tests show variable elevation of ALT and AST. Prothrombin and albumin test results may be abnormal once cirrhosis has developed. Liver biopsy is the best test to determine the amount of scarring and inflammation. Radiographic studies such as ultrasound or CT scan do not always show liver injury until it is fairly advanced. Non-invasive tests (blood sample) such as FibroTest and ActiTest, respectively, can estimate liver fibrosis and necrotico-inflammatory activity.

Chronic hepatitis C can be associated with extrahepatic manifestations associated with the presence of HCV such as porphyria cutanea tarda,

cryoglobulinemia, and glomerulonephritis, specifically membranoproliferative glomerulonephritis (MPGN). Hepatitis C is also rarely associated with sicca syndrome, thrombocytopenia, lichen planus, diabetes mellitus and with B-cell lymphoproliferative disorders.

Hepatitis C testing includes serological blood tests to detect antibodies to HCV and RNA testing. Persons with positive anti-HCV antibody tests can undergo additional testing for the presence of the hepatitis C virus itself to determine whether current infection is present. The presence of the virus can be tested using methods such as polymerase chain reaction (PCR), transcription mediated amplification (TMA), or branched DNA (b-DNA) signal amplification assay. HCV nucleic acid molecular tests have the capacity to detect not only whether the virus is present, but also to measure the HCV viral load. In people with confirmed HCV infection, genotype testing is generally recommended. HCV genotype testing is used to determine the required length and potential response to interferon-based therapy.

One or more symptoms of hepatitis C infection (e.g., presence of antibodies to hepatitis C, viral load, ALT levels, AST levels, prothrombin levels, albumin levels, liver fibrosis, and necrotico-inflammatory activity) may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, polymerase chain reaction (PCR), transcription mediated amplification (TMA), and medical imaging (e.g., MRI, CT, X- rays, and ultrasound).

Treatments for hepatitis C infection include one or more of the following:

Pegylated interferon-alpha-2a , Pegylated interferon-alpha-2b, an anti- viral drug (e.g., a nucleoside antimetabolite drug (for example, ribavirin), a viral protease inhibitor, and/or a viral polymerase inhibitor), or a combination of Pegylated interferon- alpha- 2a or Pegylated interferon-alpha-2b and the antiviral drug ribavirin, e.g., for a period of 24 or 48 weeks (response can vary depending on virus genotype). Systems and methods described herein can be used to provide information and/or news about one or more of these treatments. In addition, the application described herein can be used to track one or more of a patient' s parameters for a patient being treated with one or more of the treatments listed above.

Side effects of treatment for hepatitis C infection can include a flu-like syndrome, anemia, cardiovascular events, and psychiatric problems. One or more side effects of hepatitis C infection treatment may be a parameter that is evaluated and/or recorded in a tracking feature of systems and methods described herein. The parameter may be evaluated, e.g., by a healthcare provider, using one or more medical exams or tests, e.g., blood test, urine test, enzyme assay, bone marrow aspiration, biopsy, cell analysis, and medical imaging (e.g., MRI, CT, X-rays, and ultrasound). Treatment of the side effects may be managed and/or monitored using systems and methods described herein.

The symptoms, side effects of treatment, and/or treatments (e.g., when a treatment(s) is administered, the dose at which a treatment is administered, and how a treatment is administered (e.g., route and/or duration of administration)) for hepatitis C infection may be managed and/or monitored using systems and methods described herein. Overview of Various Embodiments of the Disclosure According to various embodiments, it is appreciated that techniques for planning, scheduling, and tracking the treatment of a chronic disease, which are convenient and accessible to the patient, are desirable. According to one embodiment, it is appreciated that providing the patient with more information and control of their health care leads to an improved quality of life. For example, by using the techniques disclosed herein, the patient may be able to lead a more independent lifestyle, as well as be able to reduce the frequency of visits to a health care provider.

Empirical evidence suggests that many patients now own or have access to mobile computing devices having network and Internet connectivity capabilities, including laptop computers, tablet computers, personal digital assistants, cellular telephones, and smart phones, such as the iPhone®, iPod touch®, and iPad® by Apple Inc. of Cupertino, Calif. Such mobile devices offer users a wide variety of features, including voice communication, e-mail, web browsing, address and contact books, calendaring and appointment scheduling, audio recorders and players, as well as access to an ever-growing library of customized applications. Furthermore, it is appreciated that a mobile device-based software application is one convenient mechanism for patients to receive information regarding their disease, schedule treatments, track progress towards a therapeutic goal, and communicate with support personnel, such as a case manager, in matters relating to their treatment.

Aspects of the disclosure are described in a general context of computer- executable instructions and may be embodied a general-purpose computer, such as a personal computer (PC), server computer, or other processor-based device. Aspects of the disclosure may also be embodied in a special-purpose computer, such as a personal digital assistant (PDA), mobile or cellular telephone (including "smart phones"), embedded processors, mainframe computers, multi-processing systems, distributed systems, and the like. The terms "computer," "wireless device," "mobile device," and other terms describing any device that may be programmed, configured, or constructed to perform computer-executable instructions are used interchangeably and refer to any such device and system.

According to various embodiments, the disclosed techniques may be used by a patient to receive current information regarding their disease, schedule treatments, track progress towards a therapeutic goal, and communicate with support personnel, such as a case manager, in matters relating to their treatment using an application on their mobile device. In one embodiment, an application may be provided that integrates one or more of the above features in a single package that is easily and readily accessible to patients having such mobile devices. The disclosed techniques may be used, for example, by patients, family members, caregivers, healthcare professionals (e.g., health care providers), and case managers who are involved in the treatment of the patient. As used herein, "patient" refers to any user of the disclosed techniques, including the above-listed persons.

In one embodiment, an application is installed on the mobile device by downloading a program configured to execute on the processor of the mobile device from a third party service. For example, for the iPhone®, iPod touch®, or iPad® mobile devices, the application may be downloaded from the well-known Apple Store® site using the well-known iTunes® application program by Apple Inc.

In one embodiment, an application is provided that includes a news feature.

The news feature may allow current news articles or other educational information relevant to other chronic diseases such as the diseases described herein, to be downloaded to the mobile device. For example, the news articles and other information may be related to the treatment of other chronic diseases such as the diseases described herein, which treatment may include drugs or other therapies as disclosed herein. The information available for download may be pre-selected or authored by a third party, such as a provider of support services for the patient or a company, e.g., a company involved in the manufacture and/or distribution of a therapeutic treatment. The articles may be chosen for their timeliness and usefulness in assisting patients with on-going treatments of the disease.

The articles may be initially stored on a remote server and retrieved by the mobile device, either automatically or upon demand, whenever the mobile device is connected to a network, such as the Internet. Once retrieved, the articles may be stored on the mobile device for future access, even if the network connection is no longer available. In one example, the news feature allows the patient to retrieve and view a news feed provided from a website such as, for example, bravecommunity.com. Such websites may provide news or information about disease-related disorders, drug products, dietary recommendations, developments in medical research, case studies, profiles of patients, their families, and volunteers, advocacy efforts, legal issues, insurance, health care resources, and general advice relating to disease management or health care.

In another example, the news includes information provided by the support service or the company, e.g., a company involved in the manufacture and/or distribution of a therapeutic treatment, called company alerts, to be downloaded to the mobile device. The company alerts may contain information generated by, for example, the company relevant to a particular drug or therapy being used by the patient, e.g., a company which manufactures and/or distributes a therapeutic treatment and/or drug as described herein. Company alerts may be customized or triggered, for example, by information stored about the patient (e.g., the type of disease, type of treatment, prescribed drug). Alerts may be defined by the company, the user, or both.

In another example, headlines relating to the news articles and company alerts may be displayed on the mobile device, allowing the patient to select those headlines of interest. Upon selecting a headline, the corresponding full article or alert is displayed. Headlines may be customized or triggered, for example, by information stored about the patient (e.g., type of disease, type of treatment, prescribed drug), or by information stored about the viewing history of other headlines. For example, headlines may be selected for display on the device based on the disease being managed, the treatments being tracked, or headlines related to headlines previously viewed by the patient.

In another embodiment, an application is provided that includes a calendar feature. The calendar feature enables the patient to schedule treatments of the disease, for example, infusions of a drug, e.g., a drug described herein such as velaglucerase alfa. The treatments may be self-administered, administered by a family member, care giver, health care professional, or other person (e.g., a clinician at an infusion center or hospital). Treatments may be scheduled on a one-time or a recurring basis (e.g., bi-weekly). In one implementation, the calendar feature displays scheduled treatments on the mobile device for convenient review by the patient. The patient may add, modify, or delete any scheduled treatment using the user interface of the mobile device. In one example, treatment schedule templates may be provided (e.g., by the pharmaceutical company) having a predefined treatment schedule customized for the patient. Once selected, the treatment schedule may then be modified or deleted by the patient. In another example, treatment schedules for the patient may be reviewed by a case manager or health care provider for, e.g., compliance with a prescribed or recommended schedule.

In another example, the calendar feature enables the patient to schedule appointments to call or meet with a health care provider or case manager.

In another example, the patient may elect to share calendar information with a case manager, a health care provider, or other service provider. Scheduled treatments and appointments on the calendar are communicated to a health care provider or case manager for review. The health care provider or case manager may use this information to evaluate the course of treatment and recommend appropriate modifications. Further, compliance with, for example, a prescribed or recommended treatment schedule may be determined based on the calendar information.

In another embodiment, an application is provided that includes a tracking feature. The tracking feature may enable the patient to record and review certain treatment related data, including parameters that are commonly monitored during treatment of the disease. A parameter refers to a specific characteristic used to measure or indicate the effects or progress of a disease or condition, e.g., a disease or condition described herein. The data collected may be used, for example, to analyze progress toward a therapeutic goal established by a health care provider. Therapeutic goals may also be defined by the company that provides the drug or other medication used by the patient in the course of therapy. The data may, in some instances, be acquired through medical testing.

According to one embodiment, the data may be manually entered, or logged, into the application and stored on the mobile device or uploaded to a server.

According to one example, the application may provide customized screens for entering, modifying, deleting, and viewing the data associated with one or more parameters relevant to the disease. Parameters relevant to various chronic diseases are described herein. The date on which each parameter was recorded may also be automatically stored. Additional information useful for managing treatments may also be stored, such as the age, weight, and gender of the patient. Any of the above data and information may be modified or deleted by the patient.

In another example, the tracking feature may enable the patient to display the stored (e.g., historical) data including the parameter values. The data may be displayed in a tabular format, for example, in a list showing each data point (e.g., biometric value) and the date on which the data point was evaluated and/or recorded. The data may be displayed in a graphical format to visually represent trends, for example, in a graph where individual data points are plotted against the corresponding recording date.

Frequently, a patient may be served by multiple health care providers, especially in the case of treating a chronic disease. To this end, according to one embodiment, the patient may be provided tools to send personal treatment related data to different health care providers. The tools may include, for example, the ability to send the stored data to a case manager, who in turn may forward the data to an appropriate health care provider. In another example, the tools may include the ability to send the stored data directly to a health care provider.

In another example, the patient may elect to share parameter values and other health data with a health care provider or other service provider. The data are communicated to a health care provider or case manager for review. The health care provider or case manager may use this information to evaluate the course of treatment and recommend appropriate modifications. The data may include dosage and infusion information for one or more treatments, e.g., one or more treatments described herein.

In another example, the tracking feature may enable the patient to upload the stored (e.g., historical) data to a server, where it may be retrieved by a third party (e.g., a health care provider) for review. Because, according to one embodiment, the patient can more easily provide historical information that can be accessed by a health care provider, more accurate assessments and treatment may be given by the health care provider. In another embodiment, an application is provided that includes a support feature. The support feature may be integrated with a third-party service provider that provides patient support services. Support services include, but are not limited to, providing advice and guidance regarding treatments to the patient (e.g., regarding self-administered infusions), arranging and coordinating insurance coverage for the drugs or other prescriptions used by the patient, arranging and coordinating reimbursement assistance for the drugs, prescriptions, and/or health care services used by the patient (e.g., co-pay reimbursement), and identifying treatment centers for the patient when he or she is traveling. For example, the support feature enables the patient to select a case manager from a list of available case managers. Case managers are persons who are assigned to provide support to the patient. The application may display a list of available case managers, along with biographical and contact information of the case manager, and allow the patient to select one case manager from the list. Contact information for the selected case manager may be used to facilitate communications between the patient and the case manager by, for example, automatically addressing messages composed by the patient to the selected case manager.

In another example, the support feature may enable the patient to exchange messages with the case manager. Messages may be composed on the mobile device and uploaded to a server, where they are subsequently routed to the case manager by e-mail or another messaging service. The application may provide one or more message templates to assist the patient in composing the message. For example, the templates may include customizable messages that allow the patient to notify the case manager of an address change, a change in insurance, a request for reimbursement of disease-related expenses, a scheduled appointment, or vacation plans. In another example, messages are automatically addressed to the case manager previously selected by the patient.

In another example, the support feature may enable the patient to store profile information, including, but not limited to, name, street address, telephone number, and e-mail address. The profile information may be automatically included in the messages sent to the case manager. Exemplary Entity Relationships

FIG. 1 illustrates exemplary relationships among entities 100 in which various embodiments of the disclosure can be utilized. A service provider 101 provides one or more services to one or more consumers 102, health care providers 103, and/or companies 104. Examples of services include providing health related news, company alerts and information, product support, and health care case management. One service provider 101 is the OnePath^SM service, which is a comprehensive and individualized support system for patients, families, and healthcare providers, provided by Shire Human Genetic Therapies, Inc. (Shire HGT). Consumers 102 may include, for example, patients, family members of patients, and caregivers. Health care providers 103 may include, for example, physicians, registered nurses, ambulatory care facilities, and infusion centers. Companies 104 may include biotechnology and pharmaceutical companies, companies that, for example, develop, manufacture and/or market a drug or other therapeutic products. Service provider 101 may, in certain circumstances, be the same entity as health care provider 103 or company 104; however, for purposes of the present disclosure, service provider 101 is generally referred to as a separate functional entity even if service provider 101 is organizationally integrated with another entity.

The services provided by service provider 101 may include, but are not limited to, collecting and distributing news relevant to the treatment of a disease (e.g., a disease described herein) among consumers 102, health care providers 103 and pharmaceutical companies 104; facilitating the scheduling of certain medical treatments; tracking and monitoring health related data for individual patients, including parameter values; and facilitating individual communications, including exchanging messages between entities 100, various embodiments of which will be described in greater detail below. Service provider 101 may provide hosting services for various embodiments of the systems described herein, including the physical infrastructure of servers and communications services, or the hosting services may be provided by another entity.

According to an aspect, service provider 101 includes one or more case managers, who may be individuals specially-trained to assist patients and health care providers with the treatment of certain chronic diseases described herein, and the provisioning of other services, including insurance and reimbursement assistance. In one example, a case manager is assigned to a patient. The case manager may, among other tasks, assist the patient with arranging health insurance, arranging payment and/or reimbursement of costs associated with the treatment, answering questions about treatments, and locating an infusion center that is convenient for a patient, for example, a patient who is away from home (e.g., traveling). In another example, the case manager may assist the health care provider in recommending a course of therapy and/or identifying therapeutic goals for the patient.

Exemplary Systems

FIG. 2 illustrates an exemplary system 200 in accordance with one embodiment of the disclosure. System 200 includes a patient application 201, a physician application 202, and a case manager application 203. The term "physician application," as used herein, refers to an application which may be used by a health care provider, including but not limited to a physician, nurse practitioner, or other qualified health care professional, and should not be construed strictly to physicians. Any of the applications 201, 202, or 203 may be installed and executed on a computer. The applications 201, 202, and 203 communicate data through a network 204 with at least one server 205. Network 204 may be the Internet, or may comprise any number of separate, interconnected and cooperative networks, such as intranets, wide-area networks, local area networks, and the like. Server 205 may be a single device, or a collection of devices, such as in a distributed processing system. In one embodiment, each application 201, 202, and 203 may operate as a stand-alone application where certain features are operational if the network communications are unavailable. For example, each a calendar of scheduled treatments may be stored locally (e.g., in a memory of a mobile device) and therefore is accessible to the user even in the absence of a network connection, for example, when the user is away from his or her home or office. Other features of the applications 201, 202, and 203 may depend upon server 205 to store, provide, and/or process data.

According to one embodiment, patient application 201 is used by a patient, family member, or caregiver to manage treatment of a chronic disease such as a disease described herein. Patient application 201 may include a news feature, a calendar feature, a tracking feature, and a support feature, various embodiments of which will be described in greater detail below.

According to another embodiment, physician application 202 is used by a health care provider, such as a physician, nurse practitioner, or nurse, to manage treatment of a chronic disease such as a disease described herein. Physician application 202 may include one or more of the following features: receive dosage and infusion information for a particular drug, e.g., a drug described herein;

communicate with one or more patients using data generated by each patient; receive news related to the treatment of the chronic disease and information produced by a company regarding treatment of the disease; and receive support from a service provider, such as OnePath^SM.

In one embodiment, physician application 202 includes a dosage calculator for determining a dosage of a particular drug, and an infusion guide describing infusion procedures for the drug, for example, the infusion rates for intermittent subcutaneous injection and prolonged infusion. In one example, physician application 202 may display dosage and/or infusion information for one or more drugs or treatments, such as VPRIV® (velaglucerase alfa), REPLAGAL® (agalsidase alfa), and ELAPRASE® (idursulfase), each by Shire HGT.

In another embodiment, patients who are using a service provider, such as

OnePath^SM, may elect to share clinical performance data and calendar data with their health care providers. By "opting-in" to such data sharing, health care providers may use, for example, physician application 202, to access the shared data. In one example, physician application 202 provides a "My Patients" tab for accessing shared data for each patient.

In another embodiment, physician application 202 may provide one or more of the features substantially as described below, such as a news feature, a calendar feature, a tracking feature, and a support feature. In yet another embodiment, physician application 202 may incorporate one or more other applications, such as a VPRIV® calculator by Shire HGT. Application Overview

FIG. 3 illustrates an exemplary system 300 in accordance with one embodiment of the disclosure. System 300 is an example of a mobile device-based system for managing and tracking the treatment of a chronic disease such as a disease described herein. However, system 300 may be implemented on other types of devices, such as PCs and PDAs.

In one embodiment, system 300 includes a mobile device 301 (e.g., smart phone, PDA, tablet computer, or wireless laptop) in communication with a wireless network 302 (through, for example, a Wi-Fi™ certified wireless local area network device based on the IEEE 802.11 standards). Mobile device 301 may execute a patient application or a physician application. Wireless network 302 provides a two- way communication path between mobile device 301 and the Internet 304. System 300 includes a server 305, which exchanges information with mobile device 301 through wireless network 302 and the Internet 304.

In another embodiment, mobile device 301 communicates with a wireless service network 303, for example GSM (global system for mobile communications), PCS (Personal Communications Service), UMTS (universal mobile

telecommunication system), EDGE (enhanced data rates for GSM evolution), or CDMA (code division multiple access). Wireless service network 303 provides a two-way communication path between mobile device 301 and the Internet 304.

System 300 includes a server 305, which exchanges information with the mobile device 301 through wireless service network 303 and the Internet 304.

FIG. 4 illustrates an exemplary flow diagram showing the flow of data and other information within the systems illustrated in FIGS. 2 and 3. This and all other flow diagrams disclosed herein do not show all functions or exchanges of data, but are merely intended to provide a representative description of an exemplary system. It will be understood that certain functions, controls, data or other information may be supplemented, omitted, or varied in accordance with a particular application.

According to one embodiment, illustrated in FIG. 4 are several entities, including a patient 401, a case manager 402, and a news provider 403. Other entities may be included, such as a health care provider, family member, caregiver, or infusion center. Certain information and messages may be communicated between patient 401 and case manager 402 through a direct communication path 410. Direct communication path 410 may include postal mail, electronic mail, telephone, or a web site or other data exchange service.

Other information and messages may be communicated between patient 401 and case manager 402 through a patient application 412, implemented substantially as described above (e.g., on a smart phone or other mobile device). Patient 401 interacts with patient application 412 through a user interface 414, which may include graphical, textual, visual or audible components, to generate one or more messages 416. For example, user interface 414 may be implemented graphically using a touch screen input device and liquid crystal display (LCD) output device, such as found in the iPhone® or iPod touch®. Patent application 412 sends messages 416 to a server 418, which in turn sends messages 416 to case manager 402.

News provider 403 generates news 420, which may include one or more news headlines, articles, or feeds and sends them to server 418. It will be understood that server 418 may be the same server or a different server as described above. Server 418 in turn sends news 420 to patient application 412, which patient 401 may retrieve and view through user interface 414.

FIG. 5A illustrates a representative state diagram in accordance with one embodiment of a patient application 500. Patient application 500 may be a standalone application or may be integrated with an external service provider, such as OnePath^SM. Furthermore, patient application 500 may be executed, for example, by a smart phone, wireless mobile device, or PC. It will be understood that aspects of patient application 500 may be used by a patient, or by a health care provider, such as a physician, nurse practitioner or nurse, in conjunction with or independently from the patient. For example, certain features, such as the news feature, the calendar feature, the tracker feature, and the support feature, which are described in detail below, may be used by a health care provider in a physician application to monitor and manage the treatment of a patient who uses patient application 500.

According to one embodiment, patient application 500 may be implemented as a what-you-see-is-what-you-get (WYSIWYG) system. For example, patient application 500 may store, e.g., on a memory of the mobile device, data and information substantially as received from a server, entered by the user, or as displayed on the mobile device. In one example, a news article may be received from the server and stored on the memory. When the user requests the patient application 500 to display the news article, it is displayed substantially as it is stored, e.g., as a text document.

According to one embodiment, at block 510 patient application 500 is started or launched by a user (e.g. a patient). This may be accomplished by selecting an icon for application 500 on a display of a mobile device 600, as illustrated in FIG. 6. Once started, application 500 enters a welcome state 512. In welcome state 512, an application welcome or splash screen 710 may be displayed, as illustrated in FIG. 7. Welcome screen 710 may include information about application 500 and/or other information related to the service provider or mobile device 600.

From welcome state 512 application 500 transitions to a news state 514. The transition may occur automatically, e.g., after a predetermined period of time has elapsed, or manually by the user, e.g., by touching the display of the mobile device 600. According to one example, in news state 514, a news screen 810 is displayed, as illustrated in FIG. 8 A. As will be described in further detail below, news screen 810 may include a news feed and company alerts, among other information.

Below news screen 810 is a feature selector screen 812. It will be understood that feature selector screen 812 may be positioned anywhere on the display of mobile device 600. Furthermore, it will be understood that a feature selector may be implemented in other manners, for example through different screens or through a different user interface (e.g., buttons on mobile device 600 or voice command). Feature selector screen 812 may include icons representing one or more features of application 500, for example, news 814, calendar 816, tracker 818, and support 820. One or more of the features may be displayed, highlighted, hidden, or disabled (e.g., "grayed-out"). Other features may be represented by additional icons.

The user may select one of the features to transition to another state of application 500. For example, if the user selects calendar 816, application 500 transitions to a calendar state 516; if the user selects tracker 818, application 500 transitions to a tracker state 518; or if the user selects support 820, application 500 transitions to a support state 520. It will be understood that the states illustrated in FIG. 5A are exemplary, and that one or more of these states may be omitted, varied, or supplemented by additional states. Furthermore, it will be understood that the states enumerated above are merely exemplary, and that other states may be included in the application 500 to represent additional features.

News

Each of the states enumerated above will now be described in further detail with respect to their corresponding features. In one embodiment, a news feature or module includes a news feed of information related to the chronic disease such as the diseases described herein, to keep the patient updated on various events in the therapeutic area. For example, the information may include articles about disease- related disorders, drug products, dietary recommendations, developments in medical research, case studies, profiles of patients, their families, and volunteers, advocacy efforts, legal issues, insurance, health care resources, and general advice relating to disease management or health care. In another embodiment, the news feed may include news relating to a specific treatment used by the patient, such as the enzyme therapy velaglucerase alfa or other treatment described herein. In one embodiment, the news feed may include news related to velaglucerase alfa. It will be understood that the news function may contain other types of information that may be of interest to the patient or other user. In another embodiment, the news feature includes one or more company alerts, including information generated by, for example, the biotechnology or pharmaceutical company relating to products for treatment of the chronic disease.

Application 500 may automatically download the news feed and/or company alerts from a server. The automatic download may occur at any time during execution of application 500. The user may also request application 500 to download the news feed and/or company alerts from the server (e.g., on demand refresh of news feed). The news feed and/or company alerts may reside in a database on the server. The news feed and/or company alerts may be used for other purposes, such as on a website (e.g., bravecommunity.com). FIG. 5B illustrates a representative state diagram for the news feature in accordance with one embodiment of the patient application 500. In news state 514, news screen 810 is displayed, as illustrated in FIG. 8A. News screen 810 may include a news feed screen 822 and a company alerts screen 824, among other information. Within news feed screen 822 may be one or more news headlines 826. Within company alerts screen 824 may be one or more company alert headlines 828.

To view an article related to one of news headlines 826, the user may select one of news headlines 826 displayed in the news screen 810 by, for example, touching the display in the area where the headline is visible, or through another user input device (e.g., touchpad, mouse, keyboard, or voice command). When the user selects one of news headlines 826, application 500 transitions to a news feed state 530. In news feed state 530, news feed screen 830 is displayed, as illustrated in FIG. 8B. News feed screen 830 may include all or part of the article related to one of news headlines 826, or other information. The information displayed on news feed screen 830 may be textual and/or graphical (e.g., HTML-based content). The article or other information displayed on news feed screen 830 may be supplied by news provider 403, as illustrated in FIG. 4, or by another entity, for example, a company or other news service.

Optionally, feature selector screen 812 may be displayed below news feed screen 830 to enable the user to select a different feature of application 500 (e.g., calendar, tracker, or support).

To return to news screen 810, the user may select news icon 832. When the user selects news icon 832, application 500 transitions to news state 514.

To view an article related to one of company alert headlines 828, the user may select one of company alert headlines 828 displayed in news screen 810. When the user selects one of company alert headlines 828, application 500 transitions to a company alerts state 532. In company alerts state 532, company alerts screen 840 is displayed, as illustrated in FIG. 8C. Company alerts screen 840 may include all or part of the article related to one of company alerts headlines 828, or other information. The article or other information displayed on company alerts screen 840 may be supplied by news provider 403, as illustrated in FIG. 4, or by another entity, for example, a pharmaceutical company or other news service.

Optionally, feature selector screen 812 may be displayed below company alerts screen 840 to enable the user to select a different feature of application 500 (e.g., calendar, tracker, or support).

To return to news screen 810, the user may select news icon 842. When the user selects news icon 842, application 500 transitions to news state 514.

FIG. 8D illustrates another embodiment in which a news screen 850 includes a Latest News selector 852, a Saved News selector 854, a Search selector 856, a Saved Status indicator 858, and an Unsave Selector 860. In one example, if the user selects the Latest News selector 850, the system may sort the display of items in the news screen 850 according to date, for example, to show the latest or most recent news items first. In another example, if the user selects one or more news items 862 (including, for example, news feed items and company alert items, such as described above with respect to FIGS. 8A-8C) by selecting the Saved News selector 854, the system may save the selected news items into an archive for later retrieval. The save status of each news item 862 may be indicated by the Saved Status indicator; for example, a horizontal icon to indicate news items that are not saved and a vertical icon to indicate news items that are saved. The news items may, for example be saved locally on the device or remotely on a server. News items 862 that were previously saved may be "unsaved" by selecting the Unsave Selector 860.

FIG. 8E illustrates another embodiment in which news feeds may be searched by entering a search query into the search entry field 870. The user may, for example, enter a search query such as "infusion assistance," and all news items stored locally on the device or remotely on a server will be searched accordingly by the system. The search may include searching a headline or body of each news item for terms that match or are similar to terms provided by the user in the search query. One or more results of the search may be displayed on the device.

FIG. 8F illustrates another embodiment in which news items may be saved and/or transmitted to another person using a user interface 872, such as through an electronic mail service. FIG. 8G shows another user interface 874 that may be used to enter addressee information and other information for the purpose of composing a message. The message may include the news item and/or other data that the user may optionally attach to the message.

Calendar

In one embodiment, the calendar feature includes a calendar for organizing therapeutic treatments, such as infusions, and other disease related appointments, such as appointments with a health care provider or case manager.

FIG. 5C illustrates a representative state diagram for the calendar feature in accordance with one embodiment of patient application 500. In calendar state 516, calendar screen 910 is displayed, as illustrated in FIG. 9A. Calendar screen 910 may include a date selector screen 912 and an appointment information screen 914, among other information. Within date selector screen 912 may be one or more dates. The dates may be shown in, for example, a daily, weekly, monthly, or yearly format. Within appointment information screen 914 may be one or more appointment details, such as a time of the appointment and other text describing the appointment. The appointment details may correspond to one or more of the dates selected by the user.

According to an embodiment, dates on which one or more appointments are scheduled may be displayed, for example, with a marker, such as a dot, or in a contrasting color (e.g., background or text color). In one example, as illustrated in FIG. 9B, a date 916 on which a one time infusion appointment is scheduled is displayed as a yellow tile having a dot within. In another example, as illustrated in FIG. 9C, multiple dates 916 on which a recurring, bi-weekly infusion appointment is scheduled are each displayed as yellow tiles having a dot within. In yet another example, as illustrated in FIG. 9D, a date 916 on which another type of appointment is scheduled is displayed as a blue tile having a dot within. It will be understood that the colors, symbols, styles, and other indicators used to identify and characterize scheduled appointments on the calendar may vary. It will also be understood that dosing regimens that can be scheduled on the calendar may vary.

To add an appointment to the calendar, the user may select one of the dates displayed on date selector screen 912 by, for example, touching the display in the area where the date is visible, or through another user input device. When the user selects one of the dates, application 500 transitions to an add appointment state 540.

In add appointment state 540, an appointment type selector screen 920 is displayed, as illustrated in FIG. 9E. Appointment type selector screen 920 may include several buttons or selectors representing various appointment types, such as infusion, bi-weekly infusion, or other. Appointment type selector screen 920 may include a cancel button or selector. To select an appointment type to be associated with the appointment being added, the user may select one of the various appointment types displayed on appointment type selector screen 920 by, for example, touching the display in the area where the button or selector is visible, or through another user input device. In one example, selecting "Infusion" will create a one-time infusion appointment for the selected date. In another example, selecting "Bi-weekly

Infusion" will create recurring, bi-weekly appointments beginning on the selected date. In another example, selecting "Other" will create a one-time appointment for the selected date. Optionally, the user may select "Cancel" to terminate the addition of the appointment to the calendar, and application 500 transitions to calendar state 516.

If an appointment type is selected by the user, an appointment time selector screen 930 is displayed, as illustrated in FIG. 9F. Appointment time selector screen 930 may include several buttons or selectors for approving or terminating the addition of an appointment to the calendar. Appointment time selector screen 930 may include a time selector 932 for selecting a time of day. To select an appointment time to be associated with the appointment being added, the user may select, using time selector 932, the time of day for the appointment. In one example, selecting "4:00 PM" will create an appointment at 4:00 PM for the selected date (or multiple dates, if the appointment is recurring). When the time of day has been selected, the user may select "OK" to approve the selection, or "Cancel" to terminate the addition of the appointment, in which case application 500 transitions to calendar state 516.

If an appointment time is selected by the user, an appointment details screen 940 may be displayed, as illustrated in FIG. 9G. Appointment details screen 940 may include several buttons or selectors for approving or terminating the addition of an appointment to the calendar. Appointment details screen 940 may include a text entry box 942 for entering details related to the appointment being added. To add details to be associated with the appointment being added, the user may enter, using the text entry box, a text string using, for example, a virtual keyboard on the mobile device. In one example, entering "Call OnePath" will create an appointment having the detail "Call OnePath" for the selected date (or dates, if the appointment is recurring). When the details have been entered, the user may select "OK" to approve the entry, or "Cancel" to terminate the addition of the appointment. If the entry is approved, the appointment will be stored by application 500 (e.g., into the memory of the mobile device), and application 500 transitions to calendar state 516. If the entry is terminated, application 500 transitions to calendar state 516 without storing the appointment.

To modify or delete an appointment on the calendar, the user may select one of the dates, for which at least one appointment is scheduled, displayed on date selector screen 912 by, for example, touching the display in the area where the date is visible, or through another user input device. When the user selects one of the dates, application 500 transitions to a modify/delete appointment state 542.

In modify/delete appointment state 542, an appointment action selector screen 960 is displayed, as illustrated in FIG. 9H. Appointment action selector screen 960 may include several buttons or selectors representing various appointment action types, such as delete, delete series, or edit. Appointment type selector screen 960 may include a cancel button or selector. To select an action for the appointment on the selected date, the user may select one of the various appointment action types displayed on appointment type selector screen 960 by, for example, touching the display in the area where the button or selector is visible, or through another user input device. In one example, selecting "Delete" will delete a one-time appointment for the selected date. In another example, selecting "Delete series" will delete a recurring, bi-weekly appointment occurring on the selected date and all other dates in the recurring series of appointments, both past and future. In another example, selecting "Edit" will allow the user to change the details of a one-time or recurring appointment for the selected date. Optionally, the user may select "Cancel" to terminate the addition of the appointment to the calendar, and application 500 transitions to calendar state 516.

FIG. 9J illustrates another embodiment in which appointments or other events can be added to a calendar, modified, and/or deleted. For example, fields may be provided that enable the user to enter a start and/or end date and/or time for an appointment or event, to schedule a recurring appointment or event, to enable or disable an alert or alarm associated with the appointment or event, to add notes to the appointment or event, or to add or modify other relevant information. Appointments may include, for example, one-time infusion events, recurring (e.g., bi-weekly) infusion events, or other events such as appointments with doctors, case managers, insurance companies, or other health care -related events. Various type of events may be presented in different colors, such as blue for an infusion event and yellow for another type of appointment.

In one embodiment, some or all data associated with appointments and events that are stored in the calendar may be shared or synchronized with a database residing on a remote server. In this manner, calendar data may, for example, be archived, backed-up, or made available to users through other interfaces, such as through a web browser connected to a web site.

According to one embodiment, the patient may elect ("opt-in") to share certain calendar data with a health care provider and/or service provider. For example, if the patient opts-in, infusion schedules may be communicated to a health care provider, who may use the schedules to provide medical advice to the patient. The schedules may be communicated, for example, by one or more messages sent through a server to the health care provider using a secure e-mail system. In another example, the schedules may be communicated through a server to a physician application for a mobile device configured to receive and display the schedules. Other methods of sharing the calendar data may be used.

Tracker

In one embodiment, the tracker feature enables a patient to log and view one or more parameters and other medical data obtained from, for example, test results related to their disease, a health care provider or other source. For example, each parameter may include a parameter type, a parameter value, and a test date.

According to another embodiment, one or more symptoms of the disease may be associated with the parameter type. For example, a symptom of an enlarged spleen may be associated with spleen volume; a symptom of an enlarged liver may be associated with liver volume; a symptom of a low platelet count may be associated with platelet count; a symptom of low hemoglobin level may be associated with hemoglobin level; and a symptom of bone pain may be associated with bone pain. It will be understood that these and other symptoms may be associated with one or more parameter types. The parameter value may be, for example, a quantitative measure of the corresponding parameter type (e.g., spleen volume measured in cubic

centimeters). The test date may be, for example, the date on which the corresponding parameter type was measured or evaluated. Other health data may include, but is not limited to, weight, age, and gender of the patient, which may be used to determine specific therapeutic goals for the patient. In one embodiment, the parameters and other medical data may be entered by the user directly into the mobile device using, for example, a user interface of the device. In another embodiment, historical data may be imported into the mobile device from a file, database, or other data storage location through, for example, a wireless network device.

In yet another embodiment, the tracker feature enables the patient to record data associated with one or more treatments. For example, a patient using velaglucerase alfa may record the start and, if applicable, end dates of velaglucerase alfa treatment.

FIG. 5D illustrates a representative state diagram for the tracker feature in accordance with one embodiment of patient application 500. In tracker state 518, a tracker screen 1010 is displayed, as illustrated in FIG. 10A. Within tracker screen 1010 may be one or more options, including, but not limited to, log data and view data.

To log data in the tracker, the user may select "Log Data" displayed on tracker screen 1010 by, for example, touching the display in the area where the corresponding text is visible, or through another user input device. When the user selects "Log Data", application 500 transitions to a parameter state 550. In parameter state 550, a parameter screen 1012 is displayed, as illustrated in FIG. 10B. Within parameter screen 1012 may be one or more options corresponding to various parameters, including, but not limited to, bone, hemoglobin, liver, platelet, and spleen. It will be understood that other parameters or data points may be included. It will also be understood that the parameter or parameters can vary depending on the disease. Parameters for various chronic diseases, such as the diseases described herein, are known and described herein.

FIG. 10M illustrates another embodiment similar to that shown in FIG. 10B, except that the parameter screen 1012 includes a Log Selector 1030, a View Selector 1032, an E-mail Selector 1036, and a Synchronization Selector 1036. The Log Selector 1030 may be used to access the parameter state 550, such as described above with respect to FIGS. 15D and 10B. The View Selector 1032 may be used to access the view data state 556. The E-mail Selector 1036 may be used to electronically transmit the log data from the system to another person, for example, by electronic mail. One exemplary configuration user interface for transmitting log data is shown in FIG. 10N, which includes fields for enabling a user to enter an electronic mail address and/or other data.

The Synchronization Selector 1036 may be used, for example, to transmit the log data from the system to a remote server for archival, storage, or other purposes (including sharing the log data with a case manager or health care provider).

Similarly, the log data may be received by the system from the remote server. An exemplary user interface for configuring the synchronization is shown in FIG. 10P, wherein the user may provide a username and/or password for synchronizing the log data with the remote server.

To log data for one parameter or other data point, the user may select the corresponding option displayed on parameter screen 1012 by, for example, touching the display in the area where the corresponding text is visible, or through another user input device. When the user selects a parameter or other data point, application 500 transitions to log data state 552. In log data state 522, a data entry screen 1014 is displayed, as illustrated in, for example, FIG. IOC, which shows an exemplary data entry screen 1014 for entering a data value for bone pain. It will be understood that data entry screen 1014 may be configured and arranged in other ways to provide for entry of data. For example, the data entry screen 1014 may be configured to enable the user to provide a ZScore, which is a number representing a bone mineral density z-score. The ZScore data may be subsequently displayed on the device, for example, as a graph or as a text listing.

To enter data for the selected parameter or other data point, the user may type the data into mobile device 600 using the touch screen or other user input device. For example, to enter a data corresponding to bone pain, the user first selects "Bone" from parameter screen 1012, as described above with respect to FIG. 10B. The user is then presented with a data entry screen 1014 customized to accept data pertaining to bone pain, as illustrated in FIG. IOC. The user may then enter the data corresponding to the bone pain parameter. The user may indicate that data entry is complete by selecting, for example, a "Done" button displayed on the screen. The data is then logged into the memory of mobile device 600 along with the current date and, optionally, the current time.

In another example, to enter data corresponding to hemoglobin level, the user first selects "Hemoglobin" from parameter screen 1012, as described above with respect to FIG. 10B. The user is then presented with a data entry screen 1014 customized to accept data pertaining to hemoglobin levels, as illustrated in FIG. 10D. The user may then enter data in a substantially similar manner to that described above with reference to bone pain. In other examples, data may be entered for other parameters or data points in a substantially similar manner, as illustrated in FIGS. 10E (liver volume), 10F (platelet count), and 10G (spleen volume).

According to one embodiment, in log data state 552, the user may enter data corresponding to certain physical attributes of the patient, including, but not limited to, weight, age, and gender. In one example, data entry screen 1014 may include a selector "User Info." To enter information including, but not limited to, weight, date of birth, and gender, the user may select the "User Info" selector. When the user selects the "User Info" selector, application 500 transitions to a user info state 554. In user info state 554, a user information screen 1024 is displayed, as illustrated in FIG. 10H. User information screen 1024 may include one or more entry fields for entering the user information, such as a text box for entering weight, a date picker for selecting date of birth, and one or more buttons for selecting gender (e.g., "M" for male and "F" for female).

According to one embodiment, data entry screen 1040 includes a "View data in tabular format" button or selector 1016 to request viewing historical parameter data, as illustrated in FIG. 101. When the user select the "View data in tabular format" button 1016, application 500 transitions to a view data state 556. In view data state 556, a tabular display 1018 of all data for the selected parameter is displayed, as illustrated in FIG. 10J. Each data point includes the parameter value and the date the parameter value was evaluated and/or recorded. Any of the data points may be edited or deleted by selecting the data point. When the user selects one of the data points, application 500 transitions to an edit/delete state 558. In edit/delete state 558, the user is presented with the option of editing or deleting the data point, for example, as illustrated in FIG. 10K. When the editing or deleting is complete, application 500 transitions to view data state 556.

According to another embodiment, data entry screen 1040 includes a "View data in graphical format" button or selector 1016 to request viewing historical parameter data. When the user selects the "View data in graphical format" button 1016, application 500 transitions to a view data state 556. In view data state 556, a graphical display 1020 of all data for the selected parameter is displayed, as illustrated in FIG. 10L. To exit graphical display 1020, the user may select the "Parameter" button or selector 1022, and application 500 transitions to parameter state 550.

FIG. 10Q shows a user interface 1050 for displaying log data according to another embodiment. In user interface 1050, log data is displayed as a series of data points 1052 that are connected by straight lines. The log data may be displayed in chronological order (e.g., by ascending dates corresponding to each data point 1052). A goal marker 1054 may optionally be displayed to indicate, relative to the data points 1052, a preset goal value (e.g., a therapeutic goal) associated with the type of data value displayed (e.g., hemoglobin in g/dL, as shown). Further, a data balloon 1056 may be displayed for each of the data points 1052. Data balloon 1056 may include a data value associated with the respective data point 1052, a date associated with the data point 1052 (e.g., the date on which the data point was created or entered), or other relevant information. It should be appreciated that the user interface 1050 may be configured to display the data points 1052 in other ways, such as in a bar graph or pie chart. It should be further appreciated that the data may represent any type of data collected.

Support

In one embodiment, the support feature includes various utilities that enable the user (e.g., patient) to choose a case manager and communicate with the selected case manager.

FIG. 5E illustrates a representative state diagram for the support feature in accordance with one embodiment of patient application 500. In support state 520, support screen 1110 is displayed, as illustrated in FIG. 11 A. Support screen 1110 may display one or more of the following options: enter profile information 1112, case manager information 1114, update address 1116, vacation schedule 1118, and update insurance information 1120.

To enter, modify, delete or view profile information, the user may select enter profile information option 1112 on support screen 1110. When the user selects enter profile information option 1112, application 500 transitions to a profile state 560.

In profile state 560, a profile information screen 1122 is displayed, as illustrated in FIG. 11B. Profile information screen 1122 may include several text entry fields representing various profile data, such as name, phone number, street address, and e-mail address. If no profile data is stored, the corresponding entry field(s) will be blank; however, if profile data is stored, the existing profile data will be displayed in the corresponding field(s). The user may enter, modify or delete the profile data by selecting the appropriate entry field and entering or deleting the corresponding data in profile information screen 1122. When entry or modification is complete, the user may select a "Store Info" button 1124 to save the data, and application 500 returns to support state 520. Optionally, the user may choose to exit profile information screen 1122 without saving any changes by selecting a "Support" button 1126.

To select a case manager or view the selected case manager, the user may select case manager information option 1114 on support screen 1110. When the user selects case manager information option 1114, application 500 transitions to a case manager list state 562.

In case manager list state 562, a case manager list screen 1128 is displayed, as illustrated in FIG. 11C. Case manager list screen 1128 may include one or more names of case managers available to the patient. The user may select a name to view a biographical information screen 1130 including biographical information of the respective case manager, as illustrated in FIG. 11D. When the user selects one of the names, application 500 transitions to select case manager state 564.

In select case manager state 564, a biographical information screen 1130 is displayed including one or more items of biographical information for the case manager, including a name, a list of locations served by the case manager, and other information. The user may choose the case manager by selecting "Select Case Manager" button 1132, or the user may return to the case manager list screen 1128 by selecting "Back" button 1134. If the user chooses the case manager, application 500 stores the chosen case manger into the memory of the mobile device for future use, and transitions to support state 520. If the user elects to return to the list of case managers, application 500 transitions to case manager list state 562.

Before the user may communicate with a case manager, one must be chosen using, for example, the procedure described above. Once a case manager is chosen, the user may communicate with that case manager. For example, the user may wish to inform the case manager of an address change. The user may select update address option 1116 from support screen 1110. If the user chooses update address option 1116, application 500 transitions to an update address state 566.

In update address state 566, a message screen 1136 is displayed, as illustrated in FIG. HE. In message screen 1136, application 500 may automatically generate a message template, including the name of the chosen case manager, the name of the patient, and other pertinent information. The user may optionally modify or delete the automatically generated text to customize the message. When the user has completed composing the message, the user may select "Done" button 1138. If the user selects "Done" button 1138, the message is communicated to the case manager by, for example, the techniques described above with reference to FIGS. 2-4. The user may optionally choose to cancel the operation by selecting "Support" button 1126. If the user selects either "Done" button 1138 or "Support" button 1126, application 500 transitions to support state 520.

In another example, the user may wish to inform the case manager of an upcoming vacation. The user may select vacation schedule option 1118 from support screen 1110. If the user chooses vacation schedule option 1118, application 500 transitions to a vacation state 568. In vacation state 568, the user may compose and send a message substantially as described above. Application 500 may automatically generate a message template appropriate for communicating vacation information to the case manager, which the user may modify.

In another example, the user may wish to inform the case manager of a change in insurance information, or request assistance from the case manager in an insurance- , payment-, or reimbursement-related matter. The user may select update insurance option 1120 from the support screen 1110. If the user chooses update insurance option 1120, application 500 transitions to an update insurance state 570. In update insurance state 570, the user may compose and send a message substantially as described above. Application 500 may automatically generate a message template appropriate for communicating an insurance-related message to the case manager, which the user may modify.

Having thus described several aspects of at least one embodiment of this invention, it is to be appreciated various alterations, modifications, and improvements will readily occur to those skilled in the art. Such alterations, modifications, and improvements are intended to be part of this disclosure, and are intended to be within the spirit and scope of the invention. Accordingly, the foregoing description and drawings are by way of example only.

What is claimed is:

Claims

1. A system for managing treatment of a chronic disease of a patient by a user, the system comprising:

a mobile device including a processor and a memory coupled to the processor, the mobile device constructed and adapted to communicate with at least one server; and

a program stored on the memory, the program executable by the processor and comprising:

a data storage module for storing one or more parameters related to the treatment of the chronic disease;

a tracking module for tracking the one or more parameters; and a communications module for communicating information related to the treatment of the chronic disease with at least one of a health care provider, a company, and a case manager.

2. The system set forth in claim 1, wherein the chronic disease is a disease other than an orphan disease.

3. The system set forth in claim 1, wherein the mobile device is one of a smart phone having a wireless network device and a personal digital assistant having a wireless network device.

4. The system set forth in claim 1, wherein the information includes at least one of news, company alerts, and the one or more parameters.

5. The system set forth in claim 1, the program further comprising a calendar module for scheduling at least one of treatment administrations and appointments.

6. The system set forth in claim 5, wherein the information includes at least one of the treatment administrations and the appointments.

7. The system set forth in claim 1, wherein at least one of the one or more parameters and the information is displayed to the user in an interface of the mobile device.

8. The system set forth in claim 1, wherein the one or more parameters includes parameter data acquired from a medical test of the patient.

9. The system set forth in claim 1, wherein the one or more parameters includes a parameter type, a parameter value, and a test date.

10. A method for managing treatment of a chronic disease of a patient by a user using a mobile device, the method comprising:

storing, on a memory of the mobile device, one or more parameters related to the treatment of the chronic disease;

tracking the one or more parameters; and

communicating information related to the treatment of the chronic disease with at least one of a health care provider, a company, and a case manager.

11. The method set forth in claim 10, wherein the chronic disease is a disease other than an orphan disease.

12. The method set forth in claim 10, wherein the mobile device is one of a smart phone having a wireless network device and a personal digital assistant having a wireless network device.

13. The method set forth in claim 10, wherein the information includes at least one of news, company alerts, and the one or more parameters.

14. The method set forth in claim 10, further comprising scheduling at least one of treatment administrations and appointments.

15. The method set forth in claim 14, wherein the information includes at least one of the treatment administrations and the appointments.

16. The method set forth in claim 10, further comprising displaying, to the user in an interface of the mobile device, at least one of the one or more parameters and the information.

17. The method set forth in claim 10, wherein the one or more parameters includes parameter data acquired from a medical test of the patient.

18. The method set forth in claim 10, wherein the one or more parameters includes a parameter type, a parameter value, and a test date.

19. The method set forth in claim 10, further comprising displaying the one or more parameters on a display of the mobile device.

20. A computer readable storage medium embodying a program including instructions executable by a processor of a mobile device to execute a method for managing treatment of a chronic disease of a patient by a user, the method comprising:

tracking the one or more parameters; and

21. The computer readable storage medium set forth in claim 20, wherein the chronic disease is a disease other than an orphan disease.

22. The computer readable storage medium set forth in claim 20, wherein the mobile device is one of a smart phone having a wireless network device and a personal digital assistant having a wireless network device.

23. The computer readable storage medium set forth in claim 20, wherein the method further comprises scheduling at least one of treatments and appointments.

24. A system for managing treatment of a chronic disease of a patient by a user, the system comprising:

a news module for receiving and displaying news related to the chronic disease, the news to be generated by a news provider and disseminated through the at least one server;

a calendar module for scheduling treatments of the chronic disease and/or health related appointments;

a tracking module for storing and displaying health related data of the patient; and

a support module for exchanging messages between the patient and a case manager through the at least one server.

25. The system set forth in claim 24, wherein the chronic disease is a disease other than an orphan disease.

26. The system set forth in claim 24, wherein the mobile device is one of a smart phone having a wireless network device and a personal digital assistant having a wireless network device.

27. The system set forth in claim 24, wherein the news module provides at least a news screen for displaying one or more headlines, a news feed screen for displaying a news story, and a company alert screen for displaying information generated by at least one of a company and a support service.

28. The system set forth in claim 24, wherein the calendar module stores and displays at least one appointment related to the treatment of the chronic disease.

29. The system set forth in claim 28, wherein the at least one appointment is at least one of a one time appointment and a bi-weekly appointment.

30. The system set forth in claim 24, wherein the health related data includes parameter data acquired from a medical test of the patient.

31. The system set forth in claim 30, wherein the parameter data includes a parameter type, a parameter value, and a test date.

32. The system set forth in claim 24, wherein the tracking module further stores and displays a weight, an age, and a gender of the patient.

33. The system set forth in claim 24, wherein the tracking module displays parameter data in at least one of a tabular and a graphical format.

34. The system set forth in claim 24, wherein the support module stores and displays a list of case managers, the list of case managers including at least a plurality of case manager names.

35. The system set forth in claim 34, wherein the support module stores and displays a patient profile, the patient profile including a patient name, a patient street address, a patient telephone number, and a patient e-mail address.

36. The system set forth in claim 35, wherein the support module generates the messages based on the patient profile, the case manager, and a message type.

37. The system set forth in claim 36, wherein the message type is one of address change notification, insurance notification, and vacation notification.

38. A method for managing treatment of a chronic disease of a patient by a user using a mobile device, the method comprising:

scheduling, in a calendar stored on the mobile device, one or more appointments related to the treatment of the chronic disease; and

tracking, in a repository stored on the mobile device, one or more parameters acquired from a medical test of the patient, each of the one or more parameters including a parameter type, a parameter value, and a test date.

39. The method set forth in claim 38, wherein the chronic disease is a disease other than an orphan disease.

40. The system set forth in claim 38, further comprising receiving, through a network interface of the mobile device, and displaying, through a graphical user interface of the mobile device, one or more news items related to the chronic disease.

41. The method set forth in claim 40, wherein each of the one or more news items includes at least one of a news story and a company alert.

42. The system set forth in claim 38, further comprising communicating, through the network interface, one or more messages between the patient and a case manager.

43. The method set forth in claim 38, wherein each of the one or more appointments includes one of a one time appointment and a recurring appointment.

44. The method set forth in claim 38, wherein tracking one or more parameters includes:

prompting a user to select a parameter type;

in response to the parameter type being selected, prompting the user to enter the parameter value, the parameter representing a discrete measurement of one parameter of the patient;

in response to the parameter value being entered, storing the parameter type, the parameter value, and the test date in the repository;

prompting the user to request a history of the one or more parameters; and in response to the history being requested, retrieving at least one of the one or more parameters from the repository, and displaying the retrieved parameter in a tabular or graphical format.

45. The method set forth in claim 38, wherein any one of the one or more messages is at least one of an address change notification, an insurance notification, and a vacation notification.