NZ718242B2 - System and method for patient data processing during diagnosis and therapy - Google Patents

Abstract

system and method for patient data processing during diagnosis and therapy of a patient's sleep disorder breathing. The system and method includes providing diagnostic providers and therapy device providers with a simple and fast way to generate a clinical diagnosis from a diagnostic device and to transfer that patient's record and diagnostic data to the therapy provider responsible for the patient's ongoing care. The patient may be automatically assigned therapy devices having predetermined therapy settings that are based on the patient's record and diagnostic data. transfer that patient's record and diagnostic data to the therapy provider responsible for the patient's ongoing care. The patient may be automatically assigned therapy devices having predetermined therapy settings that are based on the patient's record and diagnostic data.

Description

SYSTEM AND METHOD FOR PATIENT DATA PROCESSING DURING DIAGNOSIS AND THERAPY 1 BACKGROUND Ll FIELD OF THE TECHNOLOGY The present technolcigy relates to the diagnosis and treatment of respiratory-related disorders. 1.2 DESCRIPTION OF THE RELATED ART 1.2.1 Human atory System and its Disorders {0063] The atory system of the body facilitates gas exchange. The nose and mouth form the entrance to the s 017a patient. {0003] The airways include a series of branching tubes, which becmne narrower, short-er and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the air into {he venous bleed and carbon dioxide to meve out. The trachea divides into right and. left main brenehi, Which r divide ally into al hmnehioies. The bronchi make up the conducting s, and do not take part in gas exchange. Further divisions; of the airways lead to the respiramry hronehiolesq and eventually to the alveeli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory mne. See “Reepiratox‘y Physiology”, by John B. West, Lippincott Williams 85 Wilkins, 9th edition published 2011. {0004] A range of respiratory disorders exist. Some examples of respiratory disorders include: Ohetruetive Sleep Apnea (GSA), Clieyne Stokes Respiration (CSR), Obesity llyperventilation Syntlreme (OHS), Chronic Obetructive ary Disease (COPD), Neuromuseular 'Diseaee (NMD) or ehest wall dimmers. {0005] Otherwise healthy individuals may take advantage of systems and devices. to prevent atory diserders from arising.

WO 48857 1.2.2 Diagnosis and Therapy {0006] Patients’ interaction with the health system generally ses two main stages or phases w a diagnostic stage and a treatment (also referred to as “titer-amt”) stage {0007] During the diagnostic stage a patient is tested and the pati.ent"s condition is diagnosed, In the area of sleep and, respiratory disorders, the diagnostic: providers, as well as the therapy prr‘ividers can be qualified medical practitioners. also referred to as physicians or doctors, or assisting tioners ed to as clinicians. Instead of ting a. sleep test in a sleep lap or sleep clinic, a diagnostic providers increasingly use le take home testing devices to diagnose patients with sleep disorder breathing. Once the patient is diagnosed, they may he put on a suitable fhfi‘l‘flpy. {0008] The application of the atory therapy defines the therapy stage, during which the patient is treated for the purpose of managing the patient’s condition and/or ameliorating its symptoms. The services to supply the CPAP s used for such therapy and monitor the progreas of the patienfs therapy may be provided by a therapy provider organisation, such as a Home l Equipment (HME) company.

A therapy provider from the therapy provider company such as a therapy clinician, may configure the device. as per directions from the prescription, and put, the patient on a m to monitor their ongoing adherence to therapy and the patient’s therapy progress. For example, patients suffering from sleep apnea may be diagnosed via a Home. Sleep Test. by a diagnostic provider and prescribed a therapy device, such as a continuous positive airway pressure ("CPAP") device, for home respiratory therapy that, is prescribed to operate at a ular pressure. The therapy er for this patient will provide the device and set the required re and other settings.

Alternatively, the therapy device may be configured for automatic initial setup, based on the prescription settings in the diagnostic prescription issued by the diagnostic provider, Thus, the therapy provider may be responsible for setting the patient for therapy. This may involve ion of a treatment. mask, humidifier, crmd‘uits and other accesseries, which may or may not be specified in the prescription issued by the diagnostic prtwider. Apart from the initial setup, the therapy provider will also monitor the y data from the patient y sessions. if the patient’s therapy progress is unsatisfactory or there are other problems with the y, the therapy provider may refer the patient. hack to the diagnostic provider for review and modification. to the therapy. {0010] Insrrrance companies. or other assessing or reimbursing entity computer 103., often require evidence that the patient has been diagnosed in an appropriate manner before paying tor the diagnosis. in order for a determinatirm to be made of whether a t was riately diagnosed, a diagnostic provider will need to present the appropriate data from a Home Steep Test device {which will also be referred loin this specification as a diagnostic device) and a diagnosis needs to he made available that is signed by a qualified physician. Furthermore, insurance companies often want to track whether a patient. once diagnosed with a medical. condition successfully proceeds to and s on the therapy for which they are prescribed. This process can be inefficient and time consuming, with very poor t traceahiiity during the transfer of the patient between the. diagnostic and therapy provider. The transfer may he inconvenient and disruptiv :, because le records of the patient (eg. one during the diagnostic stage patient management. and another one during the therapy stage) are being created on different software packages and in different software environments. The communication between the two stages also currently involves paper records and/or faxed doc s. This may cause inconvenience to the patients and the diagnostic and therapy service providers. as well as cause errors in the patient"s records. 1.2.3 Systems {0013] A therapy system may comprise a Respiratory Pressure Therapy Device {RPT device), an. air circuit, a humidifier. a patient i'ntettaee. and data ment. 1.2.4 Patient Interface {0012] A patient interface may be used to interface respiratory equipment to its user, for example by providing a flow of breathahie gas. The flow of breathable gas may be ed via a mask to the nose and/or month a tube to the month or a trachoostotny tube to the trachea of the user. Depending upon the y to be applied the t interface may form a seat. eg. with a face region of the patient, to facilitate the delivery of gas at .3 pressure at sufficient variance with ambient pressure to effect therapy. eg. a. positive pressure of about ermHZO. For other forms of therapy. such as the delivery of oxygen. the patient interface may not include a seal Sufficient to facilitate delivery to the airways of a supply of gas at a positive re of nbnut lilomH'LZO, {0013] The design of a patient interface presents a number of challenges. The face has. a complex threewdimensional shape. The size and shape of noses varies erably between individuals. Since the head includes" bone. cartilage and soft tissue. different regions of the face d differently to mechanical. forces. The jaw or mandible may move relative to other bones of the skull. The whole head may more during the course of a period of respiratory therapy.

As a consequence of theee ngea Some masks suffer from being one or more of obtrusive, aesthetically rable, costly, poorly g. difficult to use and uncomfortable especially when won} for long s of time or when a patient is: unfamiliar with a system. For example, masks designed solely for aviatore, mask designed as part Of personal protection equipment (eg. filter masks)g SCUBA masks or for the administration of annerstiieties may he tolerable for their original application. but nevertheless be rably ortable to be worn for extended periods of time, eg. several hourn This; is even more so if the mask. is to be worn during sleep. {0015] Nasal CPAP therapy is highly effective to treat certain respiratory disordersi provided patients comply with y. If a mask is uncomfortable, or difficult to use a, patient may not comply with therapy. Since it is often recommended that a, patient regularly wash their mask, if a mask is difficult to clean (eg. ult to assemble or dieassemble). patients may not. clean their mask and this may impact. on patient ance. {0016] While a mask for other applications (6.3;. aviators) may not. be suitable for use in treating sleep disordered breathing. a mask designed for use in treating sleep disordered breathing may be suitable for other applications. {0017] For these reasons, masks for delivery of nasal CPA]? during, sleep form a distinct field. 1.2.4.1 Seal-forming portion {0018] Patient interfaces may include a orming portion. Since it. is in direct contact with the patient’s face. the shape and configuration of the seal—forming portion can have a direct impact the effectiveness and t of the patient. interface. {0019] A patient interface may be partly characterised ing to the design intent of where the seal—ferming portion is to engage with the face in use In one form of patient interface, a seahi‘orniing pnrtion may cemprise two submertions' to engage with tive left. and right hares. In one fame of patient. interface, a seal—ferming portion may comprise a. single element that surrounds both name in use. Such single element may he designed to for example overlay an upper iip region and a ,nzztenl bridge region {If a face. In tine fem“: of patient. interface a. seaivferming portien may comprise an element that Surrounds a month regien in use, eg. by forming. a seal on a lower lip .regien of a face. In one farm of patient inter ace, 3. orming poflion may comprise a, single element that sun‘ounds both name and a mouth region in use. These ent types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, ace masks, nasal piliews, nasal puffs and ore—nasal masks. {0020] A sealdi‘n‘riiiiig portion that. may be effective in one region of a t’s face may be. in riate in r region. eg. because of the different Shape, stmcture. variability and Sensitivity regime of the patient‘s face. For example, 21 Seal on swimming goggles that overlays a patienfis ferehead may not. be appropriate to use on a patient’s nose. {0021] Certain seal—fanning pertione may be designed fer mass manufacture such that one design [it and be ernnfoitabie and effective for a wide range of different face shapes and sizes; To the extent to which there is a mismatch between the shape (if the patient‘s face, and the seal—forming, portion of the mass—mzsnulfnetured patient interface-i one {31“ both must adapt in order for a seal to form. {0022] One type of seal-forming portion extends mound the periphery of the patient interface and is intended to 581211 against the user's face when force is applied tn the patient interface with the seat-forming portion in confronting engagement with the user‘s face. The orming portion may include an air or. fluid filled cushion, 0r a moulded or formed surface of a resilient seal element made of an mer such as a rubber. With this type of seal-forming {30111.01}, if the fit is not adequate, there will be gaps between the seal—forming portion and the face, and additional force will he required to force the patient interface against the face in order to achieve a seal. {0023] Another type of seal—forming portion incorporates a flap seal of thin al so positioned about the periphery of the mask so as to provide a. selfvscaling action against the face of the user when positive pressure is applied within the mask.

Like the previous style of seal forming portion, if the match between the face and the mask i s not good, additional force may he ed to effect a seal, or the mask may leak. Furthermore, if the shape of the ing n does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

Another type of seal—forming portion may comprise a friction-fit element, eg. for insertion into a naris. {0025] Another form, of orming portion may use adhesive to effect a seal.

Some patients may find it. inconvenient to constantly apply and remove an adhesive to their face. {0026] A range of patient inteii‘aee seal—forming portion technologies are. disclosed in the following patent applications, ed to RSSNIBd Limited: WO 1993004310; ‘NO 2006/0745133VC) 2010M 35.785. [0027'] One form of nasal pillow is found in the Adam Circuit manufactured by n Bennett. Another naaal pillow, or nasal puff is the subject of US Patent 4,782,832 (Triniblc et 31.), assigned to n—B ennett ation. {0028] ResMed Limited has manufactured the following products that. incomt‘n‘ate nasal pillows: SWIFT nasal pillows mask, SWIFT ll nasal pillows mask, SWIFT LT nasal a mash SWIFT FX nasal pillows mask and LIBERTY full— face mask. The following patent applications, assigned to ResMcd Limited, describe nasal. pillows masks: International Patent Application VVOZUEMIURJ’YS (describing annonga‘t other ; aspects of ResMcd SWIFT natal pillows), US Patent Application 2.0091(ltl44808 (describing amongst other things; aspects of Resh’led SWIFT LT nasal pillows); International Patent Applications W0 2.005X063,328 and WO 48857 W0 20061130903 ibing amongst other things aspects of ResMed LIBERTY full-face mask): International Patent Application WC) 52560 (describing amongst other things s. of Rest/led SWIFT FX nasal pillows). 2 Positioning and stabilising {0029] A seal—forming portion of a patient interface used For positive air pressure therapy is subject to the corresponding force of the air pressure. to disrupt a seal. Thus a variety of techniques have. been used to position the senhforming portion, and to maintain it in sealing relation with the appropriate portion of the face. {0030] Cine technique is the use of adhenivee. See for e U5 Patent publication US EMU/0000534. [003i] Another technique is the use of one or more straps and ising harnesses. Many such harnesses suffer from being one or more of illefitting, bulky, uncomfortable and awkward to use. 1.2.5 Respiratory Pressure Therapy (RPT) Device {0032] One known RPT device used for ng Sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators such an. the RenMed t‘3tellanM Series of Adult and Paediatric Ventilators may provide support for invasive and nominvaaiue new dependent ventilation for a range of patients for treating a number of conditions such as but not d to NMD.‘ ()HS and COPD. RPT devices have also been known as flow generators.

Kit 33] The ResMed EliséeTM 150 ventilator and Flesh/ted V5 111"“ ator may provide support for invasive and noninvasive dependent ation suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volumetric and barometric ventilation. modes with a single or double limb circuit.

RPT devices typically comprise a pressure generator, such as a motor— driven blower or a compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above. {0035] RPT devices typically also include an inlet filter, various sensors and a microprocessor-‘based controller. A blower may include a Servo—controlled melon a voiute and an impeller. In some cases a brake for the motor may be ented to more rapidly reduce. the speed of the blower so as to overcome the inertia. of the motor and impeller. The braking can permit the blower to more rapidly achieve a lower ’pI‘ESSUYG condition in time for synchronization with expiration despite the inertia. in some cases the pressure generator may also include a valve capable of ‘ging generated air to atmosphere as a means for altering the pressure delivered to the patient as an alternative to motor speed control. The senders measure, amongst other things, motor speed, mass flow rate and outlet pressure, such as with a pressure ucer or the like. The controller may include data storage capacity with or without integrated data retrieval and display functions. {0036] Table of noise output levels of prior devices (one specimen only, ed using test method Specified in 1503744 in CPA? mode at llktnIHEO).

Device name Aa weighted sound power Year (approx) level dBtA) (3—Series Tango (3-Series Tango with Humidifier .2007 ‘58 Ban-ape II 2005 S8 Escape. I] with H4i Humidifier S9 AutoSct 39 AutoSet with H51 Humidifier 1.2.6 fier {0037] Delivery of a flow of breathable gas without humidificatlon may cause drying of airways. Medical humidifiers are used to increase ty andlor temperature of the flow of able gas in relation to ambient air when ed: typically where the patient. may be aaleep or renting leg. at a hospital). As a result, a medical humidifier is ably small for bedaide placement, and it is preferably configured to only humidify andfor heat the flow of breathable gas delivered to the patient without humidifying andfor heating the patient’s surroundings. Room—based systems tag a sauna, an air conditioner, an evaporalive cooler), for example, may also humidity air that is breathed in h}; the patient, r they would also humidity andjor heat the entire room which may cause discomfort. to the occupants. {0038] The one of a humidifier with a flow tor or RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases t: airway comfort. 1an addition, in cooler climates warm air applied generally to the face area. in and about the patient interface is more table than cold air. {0039] Respiratory humidifiers are available in many forms and may he a standalone device that is coupled to a respiratory apparatus via an air circuit, is integrated with or configured to be coupled to the relevant respiratory apparatus. While known passive humidifiers can provide some relief, generally a heated humidifier may be used to provide sufficient humidity and temperature to the air so that, the patient will be comfortable. Humidifiers typically comprise a water reservoir or tub having a capacity of several d milliliters , a heating element for heating the water in the reservoir, :1 control to enable the level of humidificutiou to be varied, a gas inlet to receive gas from the. flow generator or RPT device and a gas outlet, adapted to be connected to an air t that: delivers the humidified gas to the patient interface. {0040] Heated passover humidification is one common form of hurnidification used with a RPT device. In such humidifiers the heating element may be incorporated in a heater plate which sits under, and is in thermal contact with, the water tub. Thus, heat is transferred from the healer plate to the water reservoir primarily by conduction. The air flow from the EFT device passes over the heated water in the water tub resulting in water vapour being taken up by the air flow. The ResMed H4?“ and FliiiTM Humidifiers are examples of such heated passover humidifiers that are used in combination, with ResMed SS and S9 CPAP s tively.

{DOM} (lather humidifiers may also he used such as a bubble or er humidifier, a jet humidifier or a Melting humidifier. In a bubble or er humidifier the ' z ' is conducted below the e of the water and allowed to bubble back to the top. A jet humidifier produces an aerosol of water and baffles or filters may be used so that the particles are either removed or evaporated before leaving the humidifier, A wire-hing humidifier uses a water absorbing material, such as sponge or: paper, to absorb water by capillary action. The writer absorbing material, is placed within or adjacent at least a n of the air flow path to allow evaporation of the water in the ing material to be taken up into the air flow. {0042] An alternative form of humidifieatinn is presided by the ResMed HumiCare‘l‘M 13900 humidifier that uses a {InunterStresm‘l‘M technology that directs the air flow over a large surface area in at first direction whilst supplying heated water to the large surface area in a second opposite direction. The ResMed HumiCaiel'M D900 humidifier may be used with a range of invasive and non-invasive ventilators. 2 BRIEF SUMMARY OF THE LOGY {0043] The present teehnnlngy relates tn the diagnosis and treatment 01“ sleep disorder breathing patients and d atory insufficieneies. Currently the diagnostic stage and the therapy stage of patient management are snmewhal disconnected. and incoherent. What is needed, is an integrated electrnnic system which links the diagnostic er and therapy provider to the same patient database. and allows for easy generation, management, and transfer of a patient’s diagnostic. information directly in the prescribed flow tor (which will also be referred to in herein as a therapy device). {0044] The t technology therefnre relates to a. method and system for an integrated processing and management nf the patient data during the stic and therapy stages. in ular, the described system, provides stic providers and therapy device providers with a simple and first way to generate a clinical. diagnosis from a diagnnstie device and tn transfer that. pafient’s reenrd and diagnostic data directly to the therapy {prnvider responsible for the patient’s ongoing care. {0045] In accordance with nne aspect iii the logy a server enntains memory configured to store medical device dirt-at and a processnr in communication with the memnry. {0046] The processor is configured to receive. diagnostic and therapy data for a plurality of medical device users, and to process diagnostic. report data and therapy device usage. data. A successful dnwnload of data. may he Pissed on whether the received stic data from the device contains a predetennined duration of recording information and conforms to acceptable clinical ranges. Therapy compliance may be "based on r the received medical device usage data satisfies predetermined usage criteria, such an a number of hours of continuous usage or another predetermined criterion.

WOW] The sor in also configured to receive a request from the diagnostic provider or health providers for the stic stage. as well as a. compliance status for one or more of the patients using medical devices, and to er access to those patients from one provider to another. {0048] In accordance with r aspect of the technology, a medical device can either be u Diagnmtic l-Iotne Sleep Testing Device or a Therapy Device (eg. a Flow Generator) used for respiratory y. In. addition, the memory of the server may be further configured to Store device identifiers, e.g., a unique ID number, wherein the l device data for each of the plurality of medical device users includes a device identifien which may be a unique device identifier, and n the processor of the Server is further configured to associate the medical device usage data with. a. medical device user based on the received device identifiers. {0049] in another aspect of the technology, the server’e processor is further configured to regenerate medical device diagnostic data from at least one of the ity of medical device user-st based on a user determined change in analysis parameterg. {0050] In another aspect, a clinical diagnostic summary report may he. provided, the report being of a fomiet that allows an ing entity to accept the report as verification of diagnosis, For example. the report may contain summary statistics from the diagnostic test date, a. physician’s interpretation. of the test. results and an electronic signature, as proof of review or acceptance. {0051] In another aspect! a prescription based on u clinical. diagnostic report may be provided. The prescription may he of a format that allows a therapy er to Supply a device, configure it. for therapy and begin monitoring 21 schedule for reimbursement, For example, the prescription may contain a specified therapy device {eg CPAPL an itemised lint of accessories (eg. mask type), re settings for the device and an, electronic signature. This document may he used by a Therapy Provider to legally supply the patient with the listed therapy items. {0052] in another aspect of the technology, diagnontie and compliance indications are generated and displayed as selectable icons on the screen QE 3. user. {0053] In another , a compliance report may he provided. The report may be of a format that allows an assessing entity to accept the report as cation of compliance. For example, the report may contain a. numerical or graphical indication of compliance. {0054] in another aspect of the technology, 21 healthenre professional associated with a diagnostic provider may access a website and select on the website one or more l device users (patients) for which diagnostic information is available. The user may then select a therapy provider from a list of eligible organizations within the system and send the selected patients" diagnostic information to the selected organization. A user Within the therapy provider will then receive. a notification of the availability of diagnostic information for each of the one or more n‘misfened l device users, as well. as the prescription informatimi required to set up the patients on therapy. {0055] In accordance with another aspect, a, method for patient data processing during diagnosis and therapy of sleep er breathing may be performed. The method may include generating, by one or more computing devices, an eleetronic patient record for a patient; during a diagnostic stage of the patient, storing, by the one or more computing devices, eticsrelated data in the electronic patient record; providing by the one or more computing devices, a diagnostic medical practitioner with access to the electronic patient ; during a y stage of the patient, providing, by the one or more computing devices, a treating l practitioner with access to the electronic patient record; and updating, by the one or more computing devices, the electronic patient record to include tliierapy'related data. {00:36] In r aspect, the method may include storing at. least one of reports and prescriptions, generated during either the diagnostic stage or the therapy stage. in the onic patient . When the diagnostic stage is at an end? the treating medical practitioner is notified and provided access to at least one of diagnostic data and prescription, data of the t. Therapy settings from a therapy prescription may be retrieved from the electronic patient record and used to automatically configure a therapy device for the patient. The tic uration may be effected by way of a network connection or a memory card. in addition, the data storage, processing, and access during the diagnostic stage and the y stage are performed on a single software platform and on a single physical system of servers. {0057] Once the electronic patient record is created, l, practitioners associated with either the diagnostic stage or the therapy stage may he ed access to the electronic patient record during both the diagnostic stage and the the. ‘apy stage. In addition, the diagnostic stage may include receiving data from a diagnostic device and the therapy stage may include receiving data from a therapy medical , the therapy medical device being a flow generator for respiratory therapy. {0058] in accordance with another aspect, a disclosed method may include receiving, by one or more ing devicesi medical device data for a plurality of medical device users; storing, by the one or more computing devicea the medical device data; determining, by the one or more ing devices, whether to s the medical device data as diagnostic information or as compliance information, based on a predetemiined criterion related to identification data, of the medical devices; it the medical device data is processed as diagnostic data generating, by the one or more computing deviCes, diagnostic information based on predetermined analysis criteria; enabling, by the one or more. computing devices, an electronic transfer of at least one of an clinical diagnosis report to an associated therapy provider, wherein the diagnosis repott is based on. the diagnostic infonnation; and itting by the one or more computing devices, a y settings to a therapy device associated with the diagnosis report. {0059] In accordance with another aspect, ing the medical device data further comprises receiving a signal that. one of the medicai devices has data available for uploading. In addition, the medicai device may he a. home steep testing device or a flow generator used for respiratory therapy. {0060] A generated diagnostic report may contain statistical, indications which assist diagnosis and provide an area where a care professional may input their WO 48857 Clinical interpretation. The diagnostic report may also include a, prescription [or therapy that identifies one or more therapy devices and one or more therapeutic settings to be used by a patient. The diagnostic report for therapy may be displayed as HTML on a web browser or as a Portable Document Format (PDF). {0063] The method may also include assigning a therapy er to a patient that is ready for therapy; transferring diagnostic information for the t to the assigned therapy provider; and electronically importing therapy settings from the diagnostic information onto the therapy device to be used by the patient. {0062] In another aspect, an apparatus for integrated electronic management of diagnostic and therapy data of a plurality of sleep disorder ing patients may include; a memory configured to store medical data, and one or more processors in communication with the mommy. The one or more processors may be configured to receive medical device data. for a plurality of medical device users; ate the received inedi :al device data with at corresponding patient records; determine whether ed medical device data is diagnostic or usage data; update the t records in accordance with the determination of whether the received medical device data is diagnostic or usage data; store a list of therapy providers within a system of therapy providers; receive a t: to display the list from a diagnostic provider; receive diagnostic data from the plurality of medical devices; generate summary statistics by processing the diagnostic data using a set of predetermined analysis criteria; e a request generated by a clinical uner; and transmit, in respon se to the request, a diagnostic report. comprising the summary statistics. l0063] The processors may also be configured to store a list of medical devices and ntcessory items; e a request to display the list by a, clinical user; receive al settings information generated by the clinical user; receive text generated by the clinical user; transmit a iption for therapy report displaying a selected item manifest and clinical settings; securely allow access to diagnostic and prescription data of a patient record by the selected therapy provider; dynamically update the. therapy er" 5 ble t list with at least one patient record; display the additional patient record in the patient list; securely display patient information, diagnostic reports and prescription for therapy s as selected by a therapy provider user; receive a request to assign a patient with n therapy device ID that canesponds to the prescription; and autmnaticnlly tran slur clinical satl‘ings ation into the niemnry from the prescriptiun. 3 BRIEF DESCRIPTION OF THE DRAWINGS {0064] The pressnt tuchnology is illustrated by way of example, and not by way of tion, in the figures of the accompanying drawings, in which liks refs-rams numerals refer to similar elements including: 3.1 THERAPY SYSTEMS {0065] Fig. 1A slinws a system in mammalian with the t. technnlogy. A patient 1000 wearing a patient interfacs: 3000,, in the form of nasal pillows. receivss a supply at" air at pnsitive pressure from a RPT device 4000. Air from the EFT device is fied in a lmmidifier 5000, and passes airing an air circuit 4179 to the patient 1.900, {0066] Fig. 1B shows a system including a patient 1000 wearing a psiisnt interface 3600, in the farm m“ a nasal mask receives a, supply 0f air at pnsitive prssmre from a RPT device 4000. Air fmm the EFT device. is humidified in a humidifier 5000. and passes along an air C’iI‘Cuit 4170 to the patient 1000. {0067] Fig. 1C shows s system including a t 1000 wearing a. patient interface 3000,, in the form of a full-face mask, receives a supply 0f air at positive pressure from a RPT device. Air from the EFT device is humidified in a humidifier 5000, and passes along an air circuit 4170 in the. t 1000. 3,2 THERAPY 3.2.1 Respiratory system {0068] Fig. 2A shows an ovci'vicw of a human respiratory system including. tlu: nasal and oral cavities, the larynx. vocal folds, oesophagus, Hashes, bronchus. lung, ar sacs, heart and disphrsgm. {0069] Fig. EB shows a vinw of a human upsr airway including lht': nasal cavity, nasal E30116, latsrnl nasal cartilaga r slur cartilage, nnstril, lip superior, lip inferior, larynx, lurid palate, soft , ompharynx, tongue, epiginttis, vocal fold-s, oesnphngus and trachea. 3.2.2 Facial anatmny {0070] Fig. 2C is a front View of a fee-e with several features (if surface eneterny identified including the lip or. upper ve‘i‘millien, lower vermillion. lip inferitrr. mouth width. endocanthien. a nasal ala, namlabiel 31110113 and cheilitm. 3,3 PATIENT INTERFACE Fig. 3:1 ehewe an example of a. patient interface known in the prier art. 3.4 RESPIRATORY PRESSURE THERAPY (RPT) DEVICE {0072] Fig. 4A shows a RPT‘ device in aceerdance with me form of the t technology. {0073] Fig. 4B shows a schematic. diagram of the pneumatic circuit Of a RPT device in acem‘rlz‘mce with one form of the present technology. The directitme‘s of upstream and downstream are indicated. {0074] Fig. 4C shows a schematic. diagram of the electrical components of a RPT device in ance with one respect Of the present technelegy. 3 .5 HUMIDIFIER {0075] Fig. 5A shows a humidifier in accordance with one aspect of the present technelegy. 3.6 BREATHING WAVEFORMS {0076] Fig. 6A skews a mode} typical breath mi of a persen while sleeping. the herizmitsrl axis is time and the vertical axis l8 respiratory flew. While the parameter vaiues may vary, a typical breath may 131th: the fellewing approximate : tidal velume, Vt. 0.5L. inhalation time. Ti. 1.63., peak inspiratmy flew. Qpeali, 0.4 Us, exhalation time, Te. 5.2.45.4y peak expiratory flew, Qpeak, 415 Us. The {01211 duratien 0f the breath. T‘tet, is about 4s. The person typically breathes at a rate of about. 15 breaths per minute (BPM). with atieni Vent. about 7.5 US. A typical duty cycle, the ratio of Ti to Ttot is fiber“. 40%., WO 48857 3.7 DIAGNOSIS AND Y DATA MANAGEMENT {0077] Fig. 7 shows a system 100 that. may be used in sing and treating a patients sleep cliaorder. breathing. Figs. 8a] 4 elevations 'wehpages that may be displayed in accordance with aspects of the disclosed system. {0078] Fig. 15 is a schematic diagram of aspect of the disclosed system and. methods 4 DETAILED DESCRIPTION OF ES OF- THE TECHNOLOGY {0079] Before the present technology is described in further detail,_ it is to be understood that the technology is: not limited to the particular exmnples described herein, which may vary. It is also to be understood that the terminology used in this discloeure is; for the purpose of describing only the particular examples discussed , and is not intended to be limiting. 4.1 THERAPY SYSTEMS {0080] In one form. the present. system composes an apparatus for treating a respiratory disorder. The tus may comprise a. flow generator or blower for supplying pressurised respiratory gas, such as air, to the patient 1000 Via an air delivery tube g to a patient ace 3000. 4.2 THERAPY {0031] In one form. the present technology comprises a method for treating a respiratory disorder comprising the step of applying positive pressure to the entrance of the s of a patient .1000. 4.2.1 Nasal CPAP for USA {0082] In one form, the present technology composes a method of treating Obstructive Sleep Apnea. in .21 patient by applying nasal continuous positive airway pressure to the patient.

WO 48857 4.3. PATIENT INTERFACE 3000 {0083] A nen~=invasive patient interface 3.000 in aeeerdnnee with one aspect 0f the present technnlegy comprises the fellewing funetitmnl aspects: 21 seal—forming structure BIOI), a, plenum chamber 3200., a. positioning and stabilising structure 330i), a. vent. 3400 and a connection pert 3600 for eennectien tn air circuit 4170. In seine forms a funetinnal aspect may he ed by one er more physical. enmpnnents. In some forms, ene physical component. may preside ene (11' more funetienel s. In use the seal—forming structure 3100 is arranged. tn surround an entrance to the s of the patient so as tn tate the supply of air at positive pressure to the airways. 4.3.1 Seal-forming structure 3103 {0084] In tine form of the present technelegy, 21 seal,~fenning structure 310$ provides a sealing—forming surface, and may additionally provide a cushiening function. {0085] A seal~f0nning stmettn‘e 3100 in accordance with the present technology may be constructed fmm a soft. flexible, resilient material Such as silicone. {0086] In nne farm, the sealafm‘ming structure 3l0i) comprises a sealing flange and a suppen flange. Preferably the g flange eemnrises a relatively thin member with a thieknese Of less than about 1mm, fer example nbeut (3.25111111 to about 0415111111, that. extends around the ter 3310 of the plenum Chamber 3200.

Suppt‘n‘t flange may be lelntively thicker than the sealing flange. The t flange is disposed between the sealing flange and the marginal edge elf the plenum r 3200., and extends at least part of the way around the ter 3210. The support flange is. UT includes a. spring—like element and functions to support. the scaling flange from buckling in use. In use the sealing flange can readily respond. in system pressure in. the plenum chamber 320i} acting On its underside It) urge it into tight: sealing engagement with the face. {0087] In one form the sealal‘nrming pertien (if the nen‘invasive patient. interface % comprises. a pan" of nasal puffs, or nasal pillows, each nasal. puff 01' flElSal pillow being censtmcted and ed to form a seal with a respective earls of the nese Di :1 patient. {0088] Nasal. pillows in accordance with an aspect of the preeent technology include: a haste-cone; at least a portion of which forms a seal on an underside of the patients nose; a stalk, a flexible region on the underside of the cone and. connecting the cone to the stalk, in addition, the structure to which the na sail pillow of the present technology is; connected includes a flexible region adjacent the bane of the stalk. The flexible regions can act in concert to facilitate a. sal. joint structure that is acconunodating of relative movement— both displacement and angular— of the frustc— cone and the ure to which the nasal pillow is ted. For e, the HUSH)“ cone may he axially displaced towarde the Structure to which the stall; is connected. {0089] In one form the nonsinvasive patient interface 3000 comprises a scab forming portion that forms a seal in use on an upper lip region (that. is¥ the lip superior) of the patients. face. {0090] In one form the nominvauive patient interface 300() comprises a 5eal~ fanning portion that forms a seal in use on a chin—region of the ts face. 4.3.2 Plenum chamber 3200 {009.1} Preferably the plenum chamber 320() has a perimeter 3210 that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in. tree. in. use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent. surface of the face. Actual t with the face is provided by the seal—forming structure 3106. Preferably the seal- g structure 3100 extends in use about the entire perimeter 32H) of the plenum r 3200.. {0092] In one form, the plenum chamber 3200 may surround and/or be in fluid communication with the cares of the patient where the plenum chamber 3200 is a part of a nasal mask (cg. shown in Fig lb). In another form, the plenum chamber 3200 may nd audios? he in fluid ication with the name and the mouth of the patient. where the plenum chamber 3200 is a part of a full—face mask. leg shown in Fig. 1C). In yet another form, the plenum chamber 3200 may engage andfor be in fluid communication with one or more of the hares of the patient where the plenum chamber 320i} is a part of nasal pilluws. 4.3.3 Positioning and stabilising structure 3300 {0093] Preferably the seal~fonning structure 3100 of the patient. interface 3000 of the present technology is held in sealing position in nee by the positioning and stabilieing ure 3300. 4.4 RPT DEVICE 4000 {0094] An example RPT device 4000 that may be suitable for implementing aspects of the present: technology may include mechanical and pneumatic components 4100-, electrical components 4200 and may be programmed to execute one or more of the control methodologies or algorithms described throughout this specification. The RPT device may have an external g 4010, preferably formed in two parts, an upper portion 4012 of the external housing 4010, and a lower portion 4014 of the external homing 40,10. In alternative forms, the external g 4010 may include one or more s) 4Ql 5. ably the EFT device 4000 comprises a Chassis 40,16 that supports one or more al. components of the RPT device 4000. In one form a tic: block 4020 is supported by, or formed as. part of the chassis; 4016. The RPT device 4000 may include a handle 4018i {0095] The pneumatic path of the RPT device 4000 ably comprises an inlet air filter 4.112, an inlet muffler 4122, a controllable pressure device 4141') capable of Supplying air at positive pressure (preferably a, blower 4142), and an outlet muffler 4.124. One or more flow s 4272 and pressure sensors 4274 are included in the pneumatic path, {0096] The preferred pneumatic block 4020 ses a portion of the pneumatic path that is located within. the external housing 4010. {0097] The RPT device 4000 preferably has an, electrical power supply 42“), one or more input devices 4220, a, central controller 4230, a, therapy device controller 4240 andinr any of the controllers previously described, a pressure device 4140* one or more protection circuits 4250, memory 4260, transducers (also referred to as sensors) 4270, data ication interface 428.0 and one or more output devices 4290. Electrical erm‘tponenta 4300 may be mounted on, a single Printed Circuit Board Assembly (PCBA) 4202. In an altemative form, the EFT device 4000 may include more than one PCBA 42,02, {0098] The central controller 42.30 of the RPT device 4000? which may include one or more processors, can he pi‘ogmnuned to execute one or more algorithm s, preferably including a pro—processing module, a therapy engine module. a pressure control module, anti further preferably a fault condition module. It. may further include a vent control module that may be configured with one or more of the vent, control methodologies described throughout. this ication. 4.4.1 RPT device mechanical & pneumatic eomnonents 4100 4.4.1.1 Air t‘s) 4110 A RPT device in ance with one form of the present technology may include on air filter 41 .10, or a ity of air filters 4110. {0100] In one form, nu. inlet air filter 4112» is located at the beginning of the pneumatic path upStrezun of a blower 4 142. See Fig, 4B. {0101] In one form, an outlet air filter 41.14, for example an antibacterial filter, is d between an outlet of the pneumatic block 4020 and a patient ace 3000.

See Fig. 413. 4.4.1.2 Mul‘fler(s) 4120 {0102] In one form of the present technology! an inlet muffler 41.22 is located in the pneumatic path am of a blower 4142. See Fig. 4B. {0103] In one fonn of. the present logy an outlet muffler 4124 is located in the pneumatic path between the blower 4.142 and a patient interface 3000. See Fig. 413. 4.4.1.3 Pressure device 4140 {Dill-4] In a profound 'lforin of the present technology, a pressure device 4140 for producing a flow of all at positive presume is a controllable blower 4142“ For example the blower may include :1 brushless DC motor 4144 with one or more impellers housed in a volute. The blower may he preferably capable of delivering a supply of air, for example about 1:20 litres/minute, at a. positive pressure in a iuuge from about 4 omH30 to about 20 cull-[2Q or in other forms up to about. 30' cmHgfi {0105] The preasure device 4140 is under the control of the therapy device controller £1240. 4.4.1.4 Transducefls) 4270 In one form of the present technology, one or more transducers 4270 are located upstream of the pressure device 4140. The one or more tzranaducers 4270 are constructed and arranged to measure properties of the air at that. point in the tic path. {0167] In one form of the preoent technology, one or more ucers 4-2th are located downstream of the pressure device 414(L and upstream of the air t 4170.

The one or more transdueers 4270 are constructed and an‘anged to measure ties of the air at that point: in the pneumatic path. {0108] In one form of the t technology, one or more transducera 427i) are located proximate to the patient. interface 300G. 4.4.1.5 pill back valve 416“ [010,9] In one form of the present technology, on anti—spill book value is located between the humidifier 5000 and the pneumatic block 4020. The antiatspill. hack valve is construoted and arranged to reduce the risk that: water will flow upstream from the humidifier 5000, for example to the motor 4144. 4.4.1.6 Air circuit 4170 {0110] An air circuit. 4170 in accordance, with an aspect. of the present technology is nonstructed and arranged to allow a flow of air or breathable gasses between the pneumatic block 4020 and the. t. ace 3300 4.4.1.7 Oxygen delivery {0111] in one form of the present technology, supplemental oxygen 4180 is delivered to a point in the pneumatic path. {0112] In one form of tho present technology, supplemental oxygen 4l.80 is delivered upstream of the pneumatic block 4020. {0113] In one form of the present technology, supplemental. oxygen 4181) is delivered to the air circuit 4170;. {0114] in one form of the present technology, supplemental oxygen 418i) is delivered to the patient interface 3000. 4.4.2 RPT device electrical ents 4200 44.2.1 Power supply 4210 {(11 15] In one form of the present: teefltnology, power supply 4210 is internal of the extremal housing 4010 of the RP? device 4000. In another form of the present technology, power supply 4210 is external of the external] housing 4010 of the EFT device 4000. {0116] In one form of the present technology, power supply 4210 provides ical power to the RPT device 4080 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 50th The power supply may also optionally provide power to any or, controller andfor sensors for a vent arrangement as described throughout. this specification 4.4.2.2 Input devices 42-21) {0117] In one form of the present technology, a RPT device 4000 includes one or more input devices 4221) in the form of buttons, switches or dials to allow a person to interact with the device. These may be implemented for entering settings for ion of the components of the RPT device such as the vent arrangement. The buttons, switches or dials may be al devices, or software devices accessible via a. touch screen. The buttons, Switches or dials may, in one form, be physically connected to the al housing 4010, or may in another form, he in wireless communication with a receiver that is in electrical, tion to the central ller 4230. {(11 18] In one thou the input device 4220 may be constructed and arranged to allow a permit to select a value antifor a. menu option, 4.4.2.3 Central controller 4230 {0119] In one form of the present logy, the central controller 4230 is a dedicated onic circuit configured to receive input. signalts) from the input device 4220, and to provide output Sigiial(n) to the output device 4290 and I or the therapy device controller 4240. {0120] In One form, the central ller 42.30 is an application-specific integrated circuit. In, another form, the central controller 4230 compriSes discrete onic components. {0121] In another form of the present technology, the central controller 4230 is a processor suitable to control. a RPT device 4000 such as an X86 INTEL- sor.

A processor of a central controller 423G le to control a RPT device 4000 in accordance with another form of the present technology includes a proceseor based on ARM Cortex~M proceesor from ARM Holdinge. For example, an STMBE Bert es microcontroller from ST MICROEILJECTRONICS may be used. {0123] Another processor suitable to control a. RPT‘ device 4000 in accordance with a further alternative form of the present technology ineludes a member selected from the family ARM9-based 32—bit IRlSC‘I CFUS. For example an STR9 series microcontroller from ST MICROELECTRONICS may be used. {0124] In certain alternative forms of the present technology, a .lfi—hit RlSC CPU may be used as the processor for the RPT device 4000. For example a processor from the MSP430 family of microcontrollers, ctured by TEXAS INSTRUMENTS, may be used. {0125] The processor is configured to receive input signalts) from one or more transducers 4270, and one or more input devices 4220.

The processor is configured to provide output signalts) to one or more of an output device 4290'~ a. therapy device controller 4240? 2-1 data. eomirl’unication ace 4280 and humidifier controller 52.50. {0127] In some forms of the preeent technology the processor of the central controller 4230. or multiple such processors, is ured to implement the one or more methodologies described herein such as the one or more algorithms 4300 expressed .as computer programs stored in a non-transitory computer readable storage medium such as memory 4260. In some cases, as previously discussede such processorts) may be integrated with a RPT device 4000, However, in some forms of the present, [Echl‘lfliflgy the processortjs) may be implemented. discretely from. the flow generation components of the EFT device 40m such as for e of performing any of the methodologies described herein without. directly controlling delivery of a respiratory therapy. For examine, such 21 processor may perform any of the methodologies described herein for purport-:5 of determining control settings for a ator or other atory related events by analysis of stored data such as from any of the sensors described herein. rly, such 21 processor may perform any of the methodologies described herein for purposes controlling ion of any vent arrangement clescribed in this specification. 4.4.2.4 Clock 4232 {0128] Preferably RPT device 40th includes a clock 4232 that. is connected to plTJCCSiSOI. 43.2.5 Therapy device controller 4240 {0129] In one form of the present technology, therapy device controller 4240 is a pressure control module 4330 that forms [part of the algorithms 4300 executed by the processor of the central controller 4230.. {0130] In one form of the present technology, therapy device controller 42,40 is a ted. motor control integrated circuit. For example. in one form a MC33035 broshlcss DC motor controller, manufactured by {)NSEMI is used, 6 tion circuits 425i} {013l] Preferably a RPT device 4000 in accordance with the present technology comprises one or more tion circuits 4250. {0132] One form of P‘rotection circuit 4250 in accordance with the Present technology is an electrical protection t.

One four: of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit. 4.4.2.7 Memory 4260 {0134] In accordance with one term. of the present technology the EFT device 4000 includes memory 4260, ably non—volatile memory. In some forms, memory 4260 may e battery powered static RAM. In 80.1116 farms, memery 4260 may include volatile RAM. {0135] Preferably memew 4260 is located on PCBA 4202. Memow «$260 may be in, the form of EEPROM. 0r NAND flash. {0136] Additionally 01’ alternatively. RPT device 4000 includes renmvable form of memory 4,260, fer example a memory card made in accordance with the Secure l {SD} standard. {0137] In one form of the present technelegy, the memory 4260 acts as a non- transitnty computer readable storage medium. on which is stored computer program instructiens expressing the one 01‘ mere ologies described herein. such as the one or mere ulgerithms 4300. 4.4.2.8 Transducers 4270 {0138] ucere may be internal 0f the device, 01' external of the RPT device.

Extemnl transducers may be leceted for example on at form part of the air delivery circuit, eg. the patient interface. External transducers may be in the farm of neu— eentact sensors such as a r radar movement sensor that transmit or ttmisfer data to the RPT device. 4.4.2.3.]. Flew {0139] A flow sensor 4272. in accordance with the present technelngy may be based on a differential pressure transducer. for example. an SDPéGO Series differential pressure ucer {item SENSIRIION, The differential pressure transducer is in fluid ication with the pneumatic circuit. with one of each of the pressure transducers etinnected to respective first. and second points in a flew restricting element. {0140] In use? a signal ent.ng total flow Qt fI'Gfl'l the flew senser 4272. is received by the processor.

WO 48857 4.42.8.2 Pressure {0143] A pressure transducer 4274 in accerdance with the preeent techneiegy is lecated in fluid communication with the pneumatic circuit. An example of a suitable pressure transducer is a seneor from the ELL- ASDX series. An alternative le pressure transducer is a sensor frem the NPA Series from GENERAL ELECTRIC. {0142] In Use, a Signal item the pressure transducer 42?4 is, received by the l controller preeeeser. In ene tonne the Signal from the pressure transducer 4274 is filtered prier in being received by the central centreller 423i}. .3 Meter speed {0143] In one term. of the present technology a motor Speed signal is generated. A meter speed signal is preferably provided by therapy device lier 4240‘ Meter speed may, for example, be generated by a speed sensor £1276, such as a Hall effect 33118011 4.4.2.!) Data communication interface 4230 In one preferred form of the present, technology, a data communication interface 4280 is provided, and is ted to central controller processor. Date communication interface 4280 is preferably cennectable to remete external communication, network, 4282. Data cennnunicatien interface 42.80- is preferably connectable to local external cennnnnieation k 4284. Preferably remete external communication network 4282 i3 cennectable to remote al device 4286.

Preferahly lace} external icatien network 4284 is table to local external device 4288,. {0145] In ene term, data eotnmunicatien interface 4280 i5 part of processor of, central controller 4230. In another form, data et‘nnmunicatien interface 4280 is an integrated circuit. that. is separate from. the central controller processor. {0146] In one term. remote external communieatien netwerk 42.82 is the Internet.

The data communication interface 4280 may use wired communication (eg. via Ethernet, er optical fibre) or a wireless pretoeel to connect to the Internet. {0147] In one form. local external ication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol. {0148] in one form, remote external device 4286 is one or more computers, for example a cluster of networked computers. in one form, remote external device 4286 may he virtual computers: rather than physical ers. In, either case: such remote external device 4286 may be accessible to an appropriately authorised person such as a clinician. {0149] Preferably local external device 4288 is a personal computer, mobile phone, tablet or remote control. 4.4.2.10 Output s including optional display, alarms An output device 4290 in ance with the present technology may take the form of one or more of a visual, audio and liapi‘ic unit. ,A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display. 4.4.2.10J Display driver 4292 [015i] A display d1iver 4292 receives as an input the characters, symbols? or images intended for display on the display 4294 and converts them to commands. that cause the display 4294 to display those charactera, symbola, or . 4.4.2.102 Display 4294 {0152] A display 42.94 is red to Visually display Characters, symbols, or images in se to commands received from the display driver 4292'. For example! the display 4294 may be an eight—segment display, in which case the display driver 4292 converts each character or symboL Such as the figure “0", to eight logical signals indicating r the eight respective segments are to be activated to display a ular character or symbol. 4.5 COMMUNICATION AND DATA MANAGEMENT SYSTEM {0153] Fig. 7 depicts an example- systcm fill) in which aspects ol‘the disclosure trial}; be implemented. This example should not be considered as limiting the scope of the disclosure or usefulness of the features described herein. The system is compatible with, and procesSes data from both diagnostic and therapy devices. As provided above, patient medical diagnostic device .101 may he any steep testing device used in connection with diagnosis of the patients steep-related breathing disorder. Therapy device 105 may be any device used in connection with providing therapy for the ts; sileepq'eiated breathing disorder. The diagnostic device till and therapy device 105 may each include the EFT device 4000, fier 5000, and patient interface 3000 described herein. Thus, when receiving data from, a medical device, the system may be configured to not onl}i associate the ed medical device data with a corresponding patient record, but also determine whether the received medical device data is diagnostic usage data or therapy usage data and update the patient records accordingly, based on predetermined one or more criteria.

The data identification may be associated with the data itself or with a device ID from which it is received. If the medical device data is determined as stic data, the system may be configured to process the diagnostic data and to generate a diagnostic report andlor a prescription based on predetermined analysis criteria. The system may be further ermfigured to display the diagnostic report andlor the prescription to a diagnostic provider for review and to enable an electronic transfer of a diagnosis report or a therapy prescriptiotn based on the diagnostic data, to a therapy provider, {0154] System. 100 has the ability to ssly transfer a patient’s health information (including demographic and medical data) directly from sis through to patient therapy within the same system within a single t record. To facilitate this workflow, system 100 may have the following, functional features: {0'1 9.2; 5] The ability to upload and analyse y management data within the same software system as the diagnostic data. allowing for a single re system for both diagnostic and therapy management users. This may be helpful. in avoiding formatting problems when tioning between different software applications. {0156] The ability to share the patient’s diagnostic record with therapy management users, thus enabling them to save a patieri‘t’s therapy and compliance data directly to the common patient record having the patient’s diagnostic report and prescription data. {0157] Th 2. ability of therapy provider to access the stic data, as well as therapy settings infomiation from the initial iption. data, as saved in the patients record, or even. for the therapy device to be automatically configured via a cable connection, wireless connection, or a memory card, by acceseing this record. {0158] As the patient uses medical diagnostic device .101. diagnostic date lli may he recorded on a. Storage , also referred to as memory, 112. Diagnostic date 111 may include any data relating to the patient’s steer; test, such as date, time and duration of test, as well as physioiogieal data obtained during the test, sueh as recorded respiratory flow data, respiratory effort: ditto, oximetry and pulse date, or other clinical infomintion. Memory 112 may be of any non—transitory type capable of Storing information aeeessible by a prooeseor, including a1emriputer—readabie medium, or other medium that stores date that may be read with the aid of an electronic device, such as a 'hnrd~drive, memory card, ROM, RAM. DVD or other optical disks, as well as other write-capable and nly memories. {0159] Server 20] ineludee a processor 210 and a memory 220 for storing data 230 and. instructions 234. Memory .220 stores information accessible by proeessor 210, ineiuding ctions 234 that may be executed or otherwise used by the processor 21. The mommy 220 may be of any ansitory type e of g ation accessible by the processor, including a eomputemendable medium, or other medium that stores date that may be read with the aid of an electronic device, such as a herd-drive, memory card, ROM. RAM, DVD or other optical disks, as well as other write—capable and read—only memories. Systems and methods may include different combinations of the foregoing, whereby different portions of the ctions and data are stored on difiierent types of media. {0160] The instructions 2'34 may be any set of instructions to be executed ly {Such 213 machine code) or indirectly touch as scripts) by the sor. For example, the instructions may be stored as computer code on. the computer—readable medium.

In that regard, the terms "instructions“ and "programs" may be used interehmigezibly herein. The instructions may be stored in object code format for direct eing by the pn'aeesoor, or in any other computer language including s or collections of independent more code modules that are interpreted on demand or compiled in advance. Functions, methods} and routines of the inetructions are explained in more detail below. Instructions 234 may also contain instructions for operating one or more virtual servers, such as Communication (Comm) server 240. Easy Care Online {ECU} Server 250, and Communication Abstraction Layer (CAL) server 260. {0161] The Communications; Server (Comm) is responsible for eonnnnnicating with wireless Therapy Devices and validating their output. The Cemmnnicatinns Server’s core responsibilities may include, communicating with Flow Generators via a Communication Module or inbuilt Communications ; validating the incoming wireless data; and converting the Wireless data into a format which can be read by the CAL . {0162] The CAL server is responsible for communicating with y Devices.

The CAL sewer’s enre responsibilities may include, ing daily summary data for active patients; retrieving and changing y device settings; and converting raw therapy device data inte an easily digestible i’nrmat.

The ECO Server is responsible for application functionality within the system. The ECU Server’s). core responsibilities includes, ting patient and device information within the user interface, and writing and managing patient health irtation; and running applieatien related processes. {0164] The data 230 may be retrieved, stored or modified. by processor 210 in accordance with the instructions 2.34. For instance, although the syetem and metth is not limited by any particular data structure, the data may be stored in computer registers, in a relational database as a table having a plurality of different: fields and recnrds, XML documents or flat files. The data may also be formatted in any centputerneadable format. The data may comprise any information useful in identifying the; relevant information such as s, descriptive text... proprietary codese references to data stored in. other areas of the same memory or (lifterent memories (“including other ons accessible through other network connections) or infinmatien that is used by a function to calculate the relevant data. Data 230 may include one or mere databases, including a Comm database 231. CAL database 2'32, ECO database 233, and HST database 235} Various types of data may be saved in these databaces. Fer example the Comm. database 231, CAL database. 232 and the ECO se 233 may store data associated with the respective servers. as described above. The HST database may store diagnostic data received from diagnostic devices till. {0165] The proceusor 210 may be any conventional sor, including commercially available proeeusors. Alternatively, the proceeuor muy be a dedicated device such as an ASIC or FPGA. Although Fig. 2. functionally illustrates the sor, memory, and other elements of server 201 as being within the same block, it will he understood by those of t'u‘dinary skill in the art that the processor and memory may actually comprise multiple processors and memories that may or may not be stored within the same phyeicul housing. For example, memory may be :1 hard drive or other storage media located in a housing different from that of server 201.

Accordingly, references to a processor or computer will be understood to include references to a collection of processors or ers or memories that may or may not ope “ate in parallel or even be located at the same site. Rather than using a. single. processor to perft'u'm the steps described herein some of the components Such as steering components and deceleration components may each have their own processor that: only pert‘cmns calculations related to the component's specific function. Thus server .201 may be referred to as both a System and an tus. {0166] Computers 102., 103 and NM may include all of the components uotmally used in connection with a computer, such as a central processing unit (CPU),. memory tog, RAM mid internal hard drives) for storing, data 120 and 121 and instructions 1‘30 and 13] leg. at web browser for displaying es in HTML and a portable document format (PD?) reader), on electronic y l ll) and 115 (cg, a r having a screen. a small LCD screen. or any other electrical device that is operable to display information), and user input. lot) and 1:31 (ewg a mouse, keyboard, touch screen, audfor microphone). {0167] The memory 112 may be internal to diagnostic device 101 which may be ucces sect by connecting an USE data cable to a. separate computer. Accordingly. the term. “medical. device” in such a case may be interpreted broadly to include a personal computer, such as a desktop or ile computer, which contains usage dutut including diagnostic data. 1 ll ted from a medical . such as u home sleep testing device. in addition. While Fig. ‘2 illustrates server 201 and computeru 101-104 2014/050268 as being connected via a network 150, each two or more s Within system. 1.06 may be connected via a separate network or Via the Internet. {0168] in one example, any one of the ECG server 250 and its ated ECU database 1233, the Comm server 240 and its associated Comm database 231 and the CAL server 260 and its ated CAL database 232 may reside on a device at. a location that is remote from the. remaining servers. In addition, at least two of these servers, such as the Comm server 240, Comm database 231, CAL server ”260, and CAL database 232', may exist on a single device. 46 EXAMPLE S {0169] In order for a patient to undergo a test, the patient may need to he issued with a diagnostic order by the patient‘s treating physician. The patient is referred to a sleep test where the patient may be issued a diagnostic device 101 for sleep testing.

The diagnoatie device 101 may eoiieet any one of the thitowing types of data Poiysomnography (PEG) data? polygraphy data, oximen‘y data pneumatic or Respiratory ance Plethysmography (RIP)-based respiratory effort data, respiratory flow data, audio signal data, body position data etc. {01?0] The patient’s record is first created, during the stic stage, when the patient is approved for g a diagnostic test. The. patient’s record may comprise any data that is associated. with the patient or with the patient’s ion, such as the patient’s personal details (name, gender, age, address, contact details etc), symptoms, treating physician, insurance provider; type of insurance cover etc. From diagnostic er‘s computer 104, where the patient’s record is created, it is transfen‘ed to the ECO database of server 20]. It should be appreciated that computer 104 may not be a personal eomputen but. an administration computer used at the diagnostic provider clinie As such, this computer may be operated, at least partially, not by the specific diagnostie physician responsible for the testing and sis of the respective patient. but by a data administrator on the site. For example, it can, be envisaged that such an administrator may be sible for creating the patient’s record, {0171] During the actuai test, the diagnoatie device collects diagnostic data indicating any respiratory condition that the patient may have, as well as other information, such as the type and model of the diagnostic device; the patient’s details? including these of the ing diagnostic physieinni time and dates of usage etc. {0172] During the actual test, the diagnestic device saves the diagnostic test data 111 in memory 112,. A 11am of system 100, such as a user of stic provider computer 104, may have a remote access to the merncry 112 of the medical diagnestie device 101. Alternatively, user of diagnostic prdvider computer 184 may extract, the portehie memory card of device 101 and download the data to computer .104. An addition, one can connect the device 101, eg. via a USB cable, to the diagnostic provider computer 1041- to access the device memory 112.. A web r 1131 en the diagucstic provider cemputer 104 may then he used to contact. server 2131. and upiead stic data 111 to (me or more of the databases 2'31. 2.32, 233 and 235.

The diagntistic date 111 previded to server 201 frem diagnostic device 101 may be stored in. 21 CAL database 2325 which may fy the type of patient device from which it. came. Fer example, each diagnostic device 101 may be assigned a device 11), which is previded tn server 201 along with the diagnostic date. The diagnostic data may then be stored by server 201 in a database that uses the device 1]) to associate the receii." ed data with. the appropriate patient diagnostic: device 101. The usage data from therapy device 105 may be processed in a, similar manner. {0174] In some instances: a patient is ed to use a medical diagnostic device fer a set duratidn and exhibit, certain clinical ms in order to be eligible to qualify for therapy of the ti's sleep disnrder breathing. For example, a patient who has been ordered a heme sleep test may be required to use the diagnostic device for at least four hours and t an Apnea—Hypopnen Index (AHI) of greater than 5 in order for a physician to write a prescription for CPA]? therapy. The prescription (also referred to as prescription data. or prescriptien information) may be saved in the HST se 235'). System 10G may he used to track r the patient. has been compliant in using the diagnostic device and may assist a physician in making a diagnosis. {0175] Once- the patient is tested; a. diagnosis may he issued by the sleep provider and may be based on the diagnostic infnmratien produced by system 100, and more specificaliy by the testingfdiagnostic device it) .1. Depending. en the patientris diagnosis, :1 diagnostic provider, and more specifically a diagnostic physician, may issue a prescription for therapy. The diagnostic er may input his or her clinica‘t interpretation of diagnostic data into the ts record. In addition, the. ECO database may contain a list of clinical. options for a number of therapy devices 105 which the dingncstic physician may assign in a patient as they see appropriate. In assigning these devices, ECU server 250 may select the nppreprinte pie—set of settings from the ECO database and then allow the diagnostic provider to input the clinical values into the appropriate fields. The data crn‘respont‘ling tn the patient and device type may then be stored on server 20] . such as in the ECG database 233. {0176] In some cases. the testing compliance criteria is y defined by the reimbursing ity and may he set in the system 100 by a. user, such as the sleep physician or clinician in the diagnostic site (in user of diagnostic computer HM). For example, usage data from diagnostic device 101 may demonstrate that. a. patient was tested for at. least 4 hours and had an Obstructive Sleep Apnea with an AHE of '20, and therefore may be a candidate fer CPAP y. A qualified fheeithcere professional, such as a sleep physician, may use ccntpnter 1.04 to write a prescription within a web browser 1‘31 for therapy for a CPA? device at a, pres sure of 14CDIH2Q stic computer 104 may transmit the prescription data to server 201, wherein it will be stored in a database, such as in. the ECU database 233, to become a part of the patient’s recnrd.

Patients prescribed for therapy will need to ripen new records with their diagnostic prtwidcr, eg. on diagnostic cnmputcr 1.04. Instead, the ed system chews access to their record: including any usage and settings (latter, to a therapy provider computer 102 so that the patients can be supplied and set up with a y device. For e the patient diagnosed with Obstructive Steep Apnea wit] need to have their patient information and prescription sent to an assigned therapy er who can supply them with a CPAP device. System 100 may be used to facilitate the assignment, accesa and transfer of data from the diagnostic provider to a trusted therapy er. Instead cf creating a new patient record, the patient’s reccrd may be electronically transferred. Furthermore instead cf erring the patient record, the system may allow the therapy provider to access the present t record, as created and updated during the. diagnostic stage. Depending on the ement, the therapy (a: U] provider may he allowed access either to the entire patient record. or only to some of the patient identification data. diagnostic data. diagnostic report. therapy prescription and initial device setting data. Also. the access to the respective data may be open access with full. functionality. or only limited access. Such a limited access. for example. may involve the capability to View and/or download the diagnostic data, but not to modify it. {0178] The therapy provider may he allowed to modify the access of the diagnostic provider: For example, after the record is made accessible to the therapy pmvider. the therapy provider may allow continuous access by the diagnostic er to the patient’s record. Depending on the arrangement, the diagnostic provider may be allowed access either to the entire patient record. or only to some of the t data, such as the patienfs identification data. diagnostic date, but not to the patient’s therapy data. Also. the access to the respective data may he open access with full functionality, or only limited access. Such, a limited access, for example, may involve the capability to View andjor download the therapy data, but not to modify it. {0179] Thus. once the electronic patient record is created, medical practitioners associated with either the diagnostic stage or the y stage may he provided various level of access to the electronic patient record during both the diagnostic stage and the y stage. {0180] A health care professional at, a diagnostic provider location, may monitor the status of their patient’ 5 diagnostics data and formed their prescription to a therapy provider by contacting server 201 Via. a website accessed on diagnostic computer 104.

For example, the healthcare professional may access patient data via webpage 800 tthe ‘dashboard‘) shown in Fig. 8. Webpage 800 may contain a list of active ts who are cunfently ding h home sleep testing. including status- indicators that indicate the status of the patients stic tests. The variOus icons indicate the different status of the patient. For example — the bed-like icons indicate that the patient. is stiil in testing phase. The physician profiledike icon indicates that the patient. has moved to the stic report phase. ent colour. for example. may he used to, te whether the report has or has not being iswed yet. rly, the Rat icon indicates that the pa‘tient’s diagnostic report is ready and the patient has moved to the iption stage. Again, different colour may he used to indicate whether the prescription has or has not being issued yet. Finally, icon 87] may indicate that the patient is in the nt record lining finalised" phase. {0181] As shown in Fig. 9: the patient Noemy Berber has completed her testing, diagnostic report and prescriptions stages. The ieen Rn indicates that Noemy’s diagnostic report and prescription are ready. As indicated by status tnr 87; the pntient’s record has one. even the finai cheeks and is now ready to be sent.

Such final. checks may involve verification of the patient’s name, phone number and nce previder details. {0182] Once a diagnostic provider associated with diagnostic computer 104 has ined that the t needs to go onto therapy the diagnostic er may elicit on. the icon 87]. As shown in Fig. 9,. pop—up window 973 may appear when icon 871 is selected. Pop—up window 973 may then be used to send patient information to a selected y provider that is to he as sociated with the therapy of the patient. The diagnostic provider may select a. particular therapy prnvider from it list of therapy providers using drop-down menu 974. For that purpose the diagnestie provider computer 104 may send a transmission to the ECG server requesting data for a‘rniinble y providers within. the system of therapy providers. ECO server will then provide data responsive to the t; which will populate menu 974 within the web hrewser 131. By clicking on send hutten 976 the healtheare sional can instantly confirm their Choice and initiate a cnniniand to, the ECU server to transfer ownership of the patient record to the therapy provider nominated in menu 974.

Clicking on send button 976 transfers ownership of the patient: to the thernpy provider and changes the status of the patient within the dashboard tn "Resuits Sent." in this way, heuitheare pi‘t‘ifessionnls may quickly and easily transfer their patients directly into the therapy provider’s in‘hox without having to manually transfer paper reenrde viz-1 fax, mail, or via the patient In some instances. ECO server 250 may automatically previde thempy provider coniputer .102, by way of. web browser (eg. timis 130) and via the network 150. with the usage and therapy settings data required to set. up a; patient on therapy device 105 as threaten by the diagnostic provider physician‘s prescription. For example a therapy previder may he notified by the ECG server 250 when a diagnosis and prescription for therapy has been created on the server by n diagnostics provider and assigned to them. This allows the therapy er to be immediately informed of a. patient’s transfer into their care and ensuree that a patient is supplied with the correct therapy device having the ed therapeutic settings... The settings data. can be tically transferred directly to therapy device 105, each as via an internet connection, or manually inputted via an SD card or the therapy device’s. interface. {0184] A therapy provider may be automatically alerted that a patient has been referred to them by messaging service, such as Email or SMS messaging, or by contacting therapy provider computer 192 via server 201. For example, the y provider or an strator at the therapy provider” 3 office may aceea 3 th ‘ transferred patient information described above via wehpage 900 shown in Fig. 10.

W’ehpage 900 may contain various data items, such as patient names 970: referring diagnostic providers 982,. contact: details 933, diagnostic and prescription. information 984, insurer data. 986. an acceptance Status 987,. or any other patient information of intereat. A y provider may use wehpage 900 to accept or reject a t. referral. For e, the therapy provider may select a patient having an ”accept/reject” Status, and then deaignate the patients referral as either "accepted" or "rejected" Once the therapy provider has accepted the d patient, the therapy provider computer 102 may send a transmission to the ECG server ting additional patient health intonnatilon from the ECU database for the relevant patient ID. ECO server will then provide patient. demographi : and therapy gs data responsive to the request... which once available will be used to fire—populate data. fields required for a Setup of the new t with a therapy device. Thus, the system is configured to dynamically update the therapy provider‘s available patient list the record of the new patient, as well as to start displaying the additional. patient. record in the patient list of the therapy provider. For example, Fig. 11 shows webpage 910 in which the patient Noemy Harbor may be automatically assigned various therapy devices in accordance with her prescription. The care sional. may alter the aasigned devices or identify onal therapy devices or components infield 1102. and have those devices or components assigned to the patient by selecting the Add icon l .164. {0185] As shown in Fig. it), Noenty Barber’s patient. record details are now visible to the administrative staff using therapy provider computer 1(i2. After contacting the patient. such an by the website. email, or phone, the administrator may schedule .a time for a therapy provider to meet with the t. For example. the administrator may click on Accept and use dialogue box. 985 to assign the patient to a clinical user and transfer the new patient into the y provider” s work queue. The therapy provider’s work queue is Shown in Fig. 12 as webpage 9:20. The work queue wehpnge may Show compliance icons 1202 and pliance icons 1204 to indicate whether a patient. is currently ant with his or her prescribed therapy. The work queue may also indicate the last time the compliance data was updated, as Welt as Statietics regarding the patients usage of the therapy device. The work queue of webpage 920 may be securely accessed by a .ian,. an administrator, or both.

Secure access may include some form of' protection to t unauthorized individuals from access patient data. F01“ example. Server 201 of Fig. 7 may require a password before transmitting patient. data. Server 20} may also encrypt: the transmitted data so as to t unauthorized devices from ying the data. {0186] A healthcare professional may also assign and configure Noemy Heather’s therapy device via webpage 920 shown in Fig. 12, and set her up for ongoing, monitoring by clicking on her name and opening the patient record shown in Fig. 13 as e 9‘30. As seen on wehpage 930 within the t record section, the patient information required to set up a patient for g monitoring may be already pro-populated from the ECO database 233 with any patient data. available from the diagnostic provider including patient demographics, insurance information and device therapy settinge. As described above, a. prescribed CPAP therapy device with a. humidificntion unit is may be automatically aSsigned to the patient. In this way, healthcnre professionals may y and easily set up patients on therapy without having to re—enter the patient: data manually from paper prescriptions as well as reducing the percentage of patient who fail to present at the therapy provider for therapy. All y note-s, prescriptions, and diagnostic reports may be viewed within the notes section of the patient record as shown in webpage £140 of Fig. 14. {0.1 $7] Returning to Fig. 7, a therapy healthcnre pretensional who accesses eerver ]. Via therapy provider computer 1‘32 may provide diagnostic; and compliance summary reports. which. bewe been generated by server 201, to the respective assessing entities. This can be performed, by transmitting the diagnostic and/or compliance s from. therapy prttwider computer 102 to an external party, such as the reimbursing entity computer 163, via k 150. The diagnostic andfor compliance reports may be transmitted in any number of ways. including as part of an Email transmis sinn. Alternatively, the cliagnnstic andfor compliance reports may be saved either at therapy provider computer 102 or server 201 and the assessing entity may send, via the reimbursing entity computer KB, a request for diagnostic andjor compliance reports to either computer 102 or sewer 201. {0188] Fig. 15 provides a schematic representation for the system and methods described above. As seen, in Fig. 15? a single patient record may he created, saved to a single data platform! updated and acces and by using a single settwarc system, less of whether the t is the diagnostic or the therapy stage of the patient management. In addition, the data platform may reside on multiple remote servers or en a. single physical system of servers so as to allow for integrated electronic management of data relating to both the diagnnstic stage and therapy stage. Medical practitioners from both the diagnostic management stage and the therapy management stage may be provided access to this record and can save and access relevant data associated with at least one of general patient data, diagnostic data, device usage data, compliance data, device parameters, diagnostic report, device prescription etc. This s the time and effort involved in creating multiple s, as well as minimises the likelihood of errors The described system has the following features: The capability to download to, upload from. View anti analyse diagnostic data within the same software management: tools and, in, some cases, physical set of servers as the therapy ment; stage data. This makes it much more convenient for both the diagnostic providers and the y ers, as they have a single point of access to the patient’s data and do not need to use two different data platforms, have two different passwords etc. Here the term data platform is used broadly in relation to at least one of the re setup and the used software. The service previtlers front the reimbursement entity 1633 also need to access both the diagnostic and the therapy data {if the patient to evaluate whether the patient is compliant with the prescribed diagnostic or therapy ements. Thus, they also benefit from the single password, the single point of entry and the use of a single data platform used for accessing both types of data. {0190] The capability to upload diagnostic data, diagnostic reports, prescription ation. as well as a therapy device usage and compliance data, directly into the original patient’s therapy record d mid populated in the. stics data management stage. {0193] The capability to send device settings data from, a prescription issued by a sleep physician directly to the diagnostic patient reenrd, where it can be accessed and downloaded by the therapy provider without the need of manual rewriting or electronic recreating of the record. This contrasts with the current practice of the patient having to ally take their prescription to the therapy provider or, at best. the diagnostic provider faxing or otherwise transfening the prescription to the therapy provider who then has to read the prescription and manually input the settings into the device. The proposed system allnws the diagnostic provider to save the iption in the patient record from where it is directly accessed by the y provider. Those settings can also he automatically downloaded to a card or sent. wirelessly to the device upon device setup. 4.7 OTHER REMARKS {0192] Unless defined otherwise, all cal and scientific terms used herein have the same meaning as connnonly understood by one of ry skill in the art. to which this. technology belongs. Although any methods and materials r or equivalent to those described herein can also he used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein. {0193] It must be noted that: as used herein and in the ed claims, the singular forms “a", "an"; and "the“ include their plural equivalents. unless the context clearly dictates otherwise. {0194] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter t‘nnnd throughout the disclosure er the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations. {0195] Althnugh the tachuology herein has baan bed with Tefercnca to particular examples. it. is to be tood that thcsc examples 2m: merely illustrative of the principles and applications of the logy. in some ces, the terminolagy and symbols may imply spacific details that, are not required to practice the. logy. For exztmplts, although. the temm H first" and "second" may be used, unless atheiwise Specified. thay are not intended tn indicate any order but may be utilised to distinguish between distinct elements. Fuithermore, althOugh process steps in the methodologies may be descrihad 01' illustrated in. an t‘fl‘dfil‘, such an t‘n‘dering is not required. Those skilled in the. art: will remgnize that such ordering may be modified andmr aspects thareof may be: conducthd concurrently or Even synchronously. {0196] It is therefore to be understand that numerous mfldifications may ht: made: to the illuStrative. embodiments, and that other arrangements may be devised without departing from the spirit and Scope 0f the technology.

Claims (16)

1. A method for patient data processing during diagnosis and therapy of sleep disorder breathing, the method comprising: generating, by one or more computing devices, an electronic t record for a patient; during a diagnostic stage of the patient, storing, by the one or more computing devices, diagnostic data from a diagnostic device in the electronic patient record; providing, by the one or more computing devices, a diagnostic provider with access to the electronic patient record, wherein the providing the diagnostic provider with access to the electronic patient record comprises providing a user interface that presents: (a) a plurality of patient status icons presenting a plurality of different sequential phases of a t status along the diagnostic stage, and (b) a selector for selecting a therapy provider from a plurality of therapy provider ions, the selector being made selectable upon activation of a completion icon of the plurality of patient status icons, the tion icon presented by the user interface if a portion of the diagnostic stage is te, wherein the selector enables an electronic transfer of at least one of a diagnostic report and a therapy prescription to the y provider ed from the plurality of therapy provider selections; during a therapy stage of the patient, providing, by the one or more ing devices, a therapy provider with access to the electronic patient ; and updating, by the one or more computing devices, the electronic t record to include therapy data from a therapy device; wherein at least one of the one or more computing devices is configured to retrieve therapy settings from a y prescription of the electronic patient record and use the therapy settings to automatically configure a therapy device for the patient.

2. The method of claim 1, n the method further comprises storing reports and prescriptions, generated during either the diagnostic stage or the therapy stage, in the electronic patient record.

3. The method of claim 1 or claim 2, wherein the method further comprises, when the diagnostic stage is at an end, electronically notifying the therapy provider of a new t, and providing the therapy provider with access to at least one of diagnostic data and prescription data of the patient.

4. The method of claim 1, wherein the automatic configuration is effected by way of a network connection or a memory card.

5. The method of any one of the preceding claims, wherein storing the electronic patient record during the diagnostic stage and updating the electronic patient record during the therapy stage are performed on a single data platform.

6. The method of any one of the preceding claims, wherein storing the electronic patient record during the diagnostic stage and updating the onic patient record during the therapy stage is performed on a single physical system of servers.

7. The method of any one of the preceding claims, wherein, once the electronic patient record is created, medical practitioners associated with either the stic stage or the therapy stage are ed access to the electronic patient record during both the diagnostic stage and the therapy stage.

8. The method of any one of the preceding , wherein the diagnostic stage comprises receiving data from a diagnostic device and the therapy stage comprises receiving data from a therapy device, the therapy device being a flow generator for respiratory therapy.

9. An onic system for integrated management of diagnostic and therapy data of a plurality of sleep disorder breathing patients: one or more es configured to store an electronic patient record comprising patient data; one or more processors in communication with the memory, the one or more processors configured to: receive and store diagnostic data from a diagnostic device in the electronic patient record and provide a stic provider with access to the onic patient record during a diagnostic stage of patient management; and receive and store therapy data from a therapy device in the electronic patient record and provide a therapy provider with access to the electronic patient record during a therapy stage of the patient management, wherein to provide the diagnostic provider with access to the electronic patient record, the electronic system is ured to provide a user interface that presents: (a) a plurality of patient status icons presenting a plurality of different sequential phases of a patient status along the stic stage, and (b) a selector for selecting a therapy provider from a plurality of therapy provider selections, the selector being made selectable upon tion of a completion icon of the plurality of t status icons, the completion icon ted by the user interface if a portion of the diagnostic stage is complete, wherein the selector enables an electronic transfer of at least one of a diagnostic report and a therapy prescription to the therapy provider selected from the ity of therapy provider selections; and wherein at least one of the one or more processors is configured to retrieve therapy settings from a therapy prescription of the electronic t record and use the therapy settings to automatically configure a patient’s y device.

10. The electronic system of claim 9, wherein at least one of the one or more processors are configured to store reports and prescriptions, generated during either the diagnostic stage or the therapy stage, in the electronic patient record.

11. The electronic system of claim 9 or claim 10, wherein when the diagnostic stage is at an end, at least one of the one or more processors is configured to enable sending of a notification to the therapy provider and provide access for the therapy provider to at least one of diagnostic, prescription and therapy data of the patient.

12. The electronic system of claim 9, wherein the automatic uration is effected by way of a network connection or a memory card.

13. The electronic system of any one of claims 9 to 12, n the electronic system is configured to operate on a single data platform during both the diagnostic stage and the therapy stage, and wherein at least one of the one or more sors is configured to e therapy data from the patient's therapy device during the therapy stage.

14. The electronic system of any one of claims 9 to 13, wherein the electronic system comprises one or more servers configured to process data from both the diagnostic stage and the therapy stage.

15. The electronic system of any one of claims 9 to 14, wherein, once the electronic patient record is created, at least one of the one or more processors is configured to provide a provider associated with either the diagnostic stage or the therapy stage, with access to the electronic patient record during the diagnostic stage and the therapy stage.

16. The electronic system of any one of claims 9 to 15, wherein the one or more processors is configured to process data from a diagnostic device, during the stic stage, and from a therapy , during the therapy stage, the therapy device being a flow generator used for respiratory therapy.