NZ757760B2 - 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 D ART 1.2.1 Human Respiratory System and its Disorders {0063] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways 017a patient. {0003] The airways include a series of branching tubes, which becmne narrower, 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 eventually into terminal hmnehioies. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions; of the airways lead to the respiramry iolesq and eventually to the alveeli. The alveolated region of the lung is where the gas exchange takes place, and is ed to as the respiratory mne. See “Reepiratox‘y Physiology”, by John B. West, Lippincott Williams 85 s, 9th edition hed 2011. {0004] A range of respiratory disorders exist. Some examples of respiratory ers e: Ohetruetive Sleep Apnea (GSA), Clieyne Stokes Respiration (CSR), Obesity llyperventilation Syntlreme (OHS), Chronic Obetructive Pulmonary Disease (COPD), Neuromuseular 'Diseaee (NMD) or ehest wall dimmers. {0005] Otherwise healthy individuals may take advantage of systems and devices. to prevent respiratory diserders from arising. 1.2.2 Diagnosis and Therapy {0006] Patients’ interaction with the health system generally comprises two main stages or phases w a diagnostic stage and a treatment (also referred to as -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 s, or assisting practitioners referred to as clinicians. Instead of conducting a. sleep test in a sleep lap or sleep clinic, a diagnostic providers increasingly use portable take home testing devices to se ts with sleep disorder ing. Once the patient is diagnosed, they may he put on a suitable fhfi‘l‘flpy. {0008] The application of the respiratory y defines the therapy stage, during which the patient is d for the purpose of managing the patient’s condition and/or ameliorating its symptoms. The services to supply the CPAP devices used for such therapy and monitor the progreas of the patienfs therapy may be provided by a therapy provider organisation, such as a Home Medical Equipment (HME) company.

A therapy provider from the therapy provider company such as a therapy ian, may configure the device. as per directions from the prescription, and put, the patient on a program to monitor their ongoing adherence to y 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 ve airway pressure ("CPAP") device, for home respiratory therapy that, is prescribed to e at a particular pressure. The therapy provider for this patient will provide the device and set the required pressure and other settings. atively, 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 selection of a treatment. mask, humidifier, its 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 therapy data from the patient therapy sessions. if the patient’s therapy progress is unsatisfactory or there are other problems with the therapy, the therapy er may refer the patient. hack to the diagnostic provider for review and modification. to the therapy. {0010] Insrrrance companies. or other assessing or rsing 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 patient was appropriately diagnosed, a diagnostic er 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 sis 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 l. condition successfully proceeds to and remains on the therapy for which they are prescribed. This process can be inefficient and time consuming, with very poor patient hiiity during the transfer of the patient between the. diagnostic and therapy provider. The er may he inconvenient and disruptiv :, because multiple records of the patient (eg. one during the diagnostic stage patient management. and another one during the y 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 nrnents. 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 s {0013] A therapy system may comprise a Respiratory Pressure Therapy Device {RPT device), an. air t, a humidifier. a patient i'ntettaee. and data management. 1.2.4 Patient ace {0012] A patient interface may be used to ace respiratory equipment to its user, for example by providing a flow of breathahie gas. The flow of breathable gas may be provided 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 therapy to be applied the patient ace 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 t interface may not include a seal Sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of nbnut 'LZO, {0013] The design of a patient interface ts a number of challenges. The face has. a complex threewdimensional shape. The size and shape of noses varies considerably n individuals. Since the head includes" bone. cartilage and soft tissue. different regions of the face renpond 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 undesirable, costly, poorly fitting. difficult to use and uncomfortable ally when won} for long periods 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 ation. but nevertheless be undesirably uncomfortable 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 ersi provided patients comply with therapy. 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 ult to clean (eg. difficult to assemble or dieassemble). patients may not. clean their mask and this may . on patient compliance. {0016] While a mask for other ations (6.3;. aviators) may not. be suitable for use in treating sleep disordered ing. 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 Seal-forming portion {0018] Patient interfaces may include a seal—forming portion. Since it. is in direct contact with the patient’s face. the shape and configuration of the orming n can have a direct impact the effectiveness and comfort of the t. interface. {0019] A patient interface may be partly characterised aecerding to the design intent of where the seal—ferming n 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 respective left. and right hares. In one fame of patient. interface, a seal—ferming n 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. seal—forming poflion may comprise a, single element that sun‘ounds both name and a mouth region in use. These different types of patient aces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal s, nasal puffs and ore—nasal masks. {0020] A sealdi‘n‘riiiiig portion that. may be effective in one region of a patient’s face may be. in appropriate in another 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 riate 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 s mound the periphery of the patient interface and is intended to 581211 against the user's face when force is applied tn the patient ace with the seat-forming portion in nting engagement with the user‘s face. The neahi‘orming portion may include an air or. fluid filled cushion, 0r a moulded or formed surface of a resilient seal t made of an elastomer 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 material so positioned about the ery of the mask so as to provide a. caling 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 required to effect a seal, or the mask may leak. Furthermore, if the shape of the wallowing portion 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 seal—forming 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 t ‘aee seal—forming portion technologies are. disclosed in the following patent ations, assigned 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 Puritan t. Another naaal pillow, or nasal puff is the subject of US Patent 4,782,832 (Triniblc et 31.), ed to Puritan—B ennett Corporation. {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 pillowa mash SWIFT FX nasal pillows mask and Y full— face mask. The following patent applications, assigned to ResMcd Limited, be nasal. pillows masks: International Patent Application VVOZUEMIURJ’YS (describing annonga‘t other things; s of ResMcd SWIFT natal pillows), US Patent Application 2.0091(ltl44808 (describing amongst other things; aspects of ed SWIFT LT nasal pillows); International Patent Applications W0 2.005X063,328 and W0 20061130903 (describing t other things aspects of ResMed LIBERTY full-face mask): International Patent Application WC) 2009/052560 (describing amongst other things aspects. of Rest/led SWIFT FX nasal pillows). 1.2.4.2 oning 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 in it in g relation with the riate portion of the face. {0030] Cine technique is the use of vee. See for example U5 Patent publication US EMU/0000534. [003i] Another technique is the use of one or more straps and stabilising 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 treating Sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed. r 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 ve and nominvaaiue new ent ventilation for a range of patients for treating a number of conditions such as but not limited to NMD.‘ ()HS and COPD. RPT devices have also been known as flow tors.

Kit 33] The ResMed EliséeTM 150 ventilator and Flesh/ted V5 111"“ ventilator may provide support for invasive and noninvasive dependent ventilation 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 s 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 ller. A blower may include a Servo—controlled melon a voiute and an impeller. In some cases a brake for the motor may be implemented 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 e a lower ’pI‘ESSUYG condition in time for synchronization with expiration despite the inertia. in some cases the re generator may also include a valve capable of dischm‘ging generated air to atmosphere as a means for altering the pressure delivered to the t 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 transducer or the like. The controller may include data storage capacity with or t integrated data retrieval and display functions. {0036] Table of noise output levels of prior devices (one specimen only, measured 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 e II 2005 S8 Escape. I] with H4i Humidifier S9 AutoSct 39 AutoSet with H51 Humidifier 1.2.6 Humidifier {0037] Delivery of a flow of breathable gas without humidificatlon may cause drying of s. Medical fiers are used to increase humidity andlor temperature of the flow of breathable gas in relation to ambient air when required: typically where the t. may be aaleep or renting leg. at a hospital). As a result, a medical fier is preferably small for bedaide placement, and it is preferably configured to only humidify andfor heat the flow of able 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 ed in h}; the t, however 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 generator or RPT device and the patient ace 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 comfortable 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 t, is integrated with or configured to be coupled to the nt respiratory apparatus. While known passive humidifiers can provide some relief, generally a heated humidifier may be used to provide sufficient ty 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 (1111), a g 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 circuit 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 devices respectively.

{DOM} (lather humidifiers may also he used such as a bubble or diffuser humidifier, a jet humidifier or a g fier. In a bubble or diffuser humidifier the ' z ' is ted below the surface 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 portion of the air flow path to allow evaporation of the water in the absorbing 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 ion. The ResMed HumiCaiel'M D900 humidifier may be used with a range of invasive and non-invasive ventilators. 2 BRIEF SUMMARY OF THE TECHNOLOGY {0043] The present teehnnlngy relates tn the sis and treatment 01“ sleep disorder breathing patients and related respiratory icieneies. Currently the stic stage and the therapy stage of patient management are snmewhal nected. and incoherent. What is needed, is an integrated electrnnic system which links the diagnostic provider and y provider to the same patient database. and allows for easy generation, management, and er of a t’s diagnostic. information directly in the prescribed flow generator (which will also be ed to in herein as a therapy device). {0044] The present technology therefnre relates to a. method and system for an integrated processing and management nf the patient data during the diagnostic and therapy stages. in particular, the described system, provides diagnostic 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 technology a server enntains memory ured 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 diagnostic data from the device contains a predetennined duration of 2014/050268 recording information and conforms to acceptable clinical ranges. Therapy compliance may be "based on whether 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 processor in also configured to receive a request from the diagnostic provider or health providers for the diagnostic stage. as well as a. compliance status for one or more of the patients using medical devices, and to transfer access to those ts from one er to another. {0048] In accordance with another aspect of the technology, a medical device can either be u Diagnmtic l-Iotne Sleep g Device or a Therapy Device (eg. a Flow Generator) used for respiratory therapy. In. addition, the memory of the server may be further configured to Store device identifiers, e.g., a unique ID number, wherein the medical device data for each of the plurality of medical device users includes a device identifien which may be a unique device fier, and wherein 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 l device diagnostic data from at least one of the plurality of medical device user-st based on a user determined change in analysis parameterg. {0050] In r aspect, a clinical diagnostic summary report may he. provided, the report being of a fomiet that allows an aeseseing entity to accept the report as verification of sis, For example. the report may n summary statistics from the diagnostic test date, a. ian’s retation. 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 y provider 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), pressure settings for the device and an, electronic signature. This document may he used by a y Provider to legally supply the patient with the listed therapy items. {0052] in another aspect of the technology, diagnontie and ance indications are generated and displayed as selectable icons on the screen QE 3. user. {0053] In another aspect, a compliance report may he provided. The report may be of a format that allows an ing entity to accept the report as verification 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 zations within the system and send the selected patients" diagnostic information to the ed organization. A user Within the therapy provider will then receive. a notification of the availability of stic information for each of the one or more n‘misfened medical 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 sing during sis and therapy of sleep disorder breathing may be performed. The method may include ting, 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, diagnoeticsrelated data in the electronic patient record; providing by the one or more computing devices, a diagnostic medical practitioner with access to the electronic patient record; during a therapy stage of the patient, providing, by the one or more computing s, a treating medical 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 another aspect, the method may include g at. least one of reports and prescriptions, generated during either the diagnostic stage or the y stage. in the electronic patient record. When the diagnostic stage is at an end? the treating medical tioner is notified and provided access to at least one of diagnostic data and prescription, data of the patient. y settings from a therapy prescription may be retrieved from the electronic patient record and used to automatically configure a y device for the t. The automatic configuration may be effected by way of a network connection or a memory card. in addition, the data e, processing, and access during the stic stage and the therapy stage are med on a single software platform and on a single physical system of servers. {0057] Once the electronic patient record is created, medical, practitioners ated with either the diagnostic stage or the therapy stage may he provided 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 device, the therapy medical device being a flow generator for respiratory y. {0058] in accordance with another aspect, a disclosed method may include receiving, by one or more computing 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 computing devices, r to process 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 ting, 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 transmitting by the one or more ing devices, a therapy settings to a therapy device associated with the sis report. {0059] In accordance with another aspect, receiving 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 atory therapy. {0060] A ted diagnostic report may contain statistical, indications which assist diagnosis and provide an area where a healthcare professional may input their 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 e assigning a y provider to a patient that is ready for therapy; transferring diagnostic information for the patient 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 tus 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; associate the received inedi :al device data with at corresponding patient records; determine whether received medical device data is diagnostic or usage data; update the patient records in accordance with the determination of r the received l device data is diagnostic or usage data; store a list of y providers within a system of therapy providers; receive a request: 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; receive a t generated by a al uner; and transmit, in respon se to the request, a diagnostic report. sing the summary statistics. l0063] The processors may also be configured to store a list of medical devices and ntcessory items; receive a request to display the list by a, clinical user; receive clinical settings ation generated by the clinical user; receive text generated by the clinical user; transmit a prescription for therapy report displaying a ed item manifest and clinical settings; securely allow access to diagnostic and prescription data of a patient record by the selected therapy provider; cally update the. therapy er" 5 ble patient list with at least one patient record; display the additional t record in the patient list; securely display patient information, diagnostic reports and prescription for therapy reports as ed by a therapy provider user; receive a request to assign a patient with n therapy device ID that 2014/050268 canesponds to the prescription; and autmnaticnlly tran slur clinical satl‘ings information into the niemnry from the prescriptiun. 3 BRIEF DESCRIPTION OF THE DRAWINGS {0064] The pressnt tuchnology is rated by way of example, and not by way of limitation, in the figures of the anying drawings, in which liks ams numerals refer to similar elements including: 3.1 THERAPY S {0065] Fig. 1A slinws a system in mammalian with the present. 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 humidified 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 ve 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 patient 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. patient 1000. 3,2 Y 3.2.1 atory system {0068] Fig. 2A shows an ovci'vicw of a human respiratory system ing. tlu: nasal and oral cavities, the larynx. vocal folds, oesophagus, Hashes, bronchus. lung, alveular sacs, heart and disphrsgm. {0069] Fig. EB shows a vinw of a human upsr airway including lht': nasal cavity, nasal E30116, latsrnl nasal cartilaga granter slur cartilage, nnstril, lip or, lip inferior, larynx, lurid palate, soft palate, 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 superior. upper ve‘i‘millien, lower vermillion. lip inferitrr. mouth width. endocanthien. a nasal ala, namlabiel 31110113 and tm. 3,3 PATIENT INTERFACE Fig. 3:1 ehewe an e 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 present logy. {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. m of the electrical components of a RPT device in accordance 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 wavefemi of a persen while sleeping. the herizmitsrl axis is time and the al axis l8 respiratory flew. While the parameter vaiues may vary, a l breath may 131th: the fellewing approximate values: 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 . T‘tet, is about 4s. The person typically breathes at a rate of about. 15 breaths per minute (BPM). with Ventilatieni 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 MENT {0077] Fig. 7 shows a system 100 that. may be used in diagnosing 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 ED DESCRIPTION OF EXAMPLES OF- THE TECHNOLOGY {0079] Before the present technology is described in further detail,_ it is to be tood that the technology is: not limited to the ular exmnples described herein, which may vary. It is also to be tood that the terminology used in this eure is; for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting. 4.1 THERAPY S {0080] In one form. the present. system composes an apparatus for treating a respiratory disorder. The apparatus may comprise a. flow generator or blower for supplying pressurised respiratory gas, such as air, to the patient 1000 Via an air delivery tube leading to a patient interface 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 airways 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. 4.3. PATIENT INTERFACE 3000 {0083] A nen~=invasive patient interface 3.000 in aeeerdnnee with one aspect 0f the present legy comprises the fellewing funetitmnl s: 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 provided by one er more physical. enmpnnents. In some forms, ene physical component. may preside ene (11' more funetienel aspects. In use the seal—forming structure 3100 is arranged. tn nd an ce to the airways of the t so as tn facilitate 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 {0085] A 0nning stmettn‘e 3100 in accordance with the present technology may be constructed fmm a soft. flexible, resilient material Such as ne. {0086] In nne farm, the sealafm‘ming structure 3l0i) comprises a sealing flange and a suppen flange. Preferably the sealing flange eemnrises a relatively thin member with a thieknese Of less than about 1mm, fer e nbeut (3.25111111 to about 0415111111, that. extends around the perimeter 3310 of the plenum Chamber 3200.

Suppt‘n‘t flange may be lelntively thicker than the sealing flange. The support flange is disposed between the sealing flange and the marginal edge elf the plenum chamber 3200., and extends at least part of the way around the perimeter 3210. The support flange is. UT includes a. spring—like element and ons 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 arranged 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 logy 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 on, 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 tate a. universal. joint structure that is acconunodating of relative nt— both displacement and angular— of the frustc— cone and the structure to which the nasal pillow is connected. For example, the HUSH)“ cone may he axially displaced towarde the Structure to which the stall; is ted. {0089] In one form the vasive 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 patients 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 eontact 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 Chamber 3200.. {0092] In one form, the plenum chamber 3200 may surround and/or be in fluid ication 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 surround audios? he in fluid communication 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 r 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 on in nee by the positioning and stabilieing Structure 3300. 4.4 RPT DEVICE 4000 {0094] An example RPT device 4000 that may be suitable for implementing aspects of the present: logy 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 housing 4010, preferably formed in two parts, an upper n 4012 of the external housing 4010, and a lower portion 4014 of the external homing 40,10. In alternative forms, the al housing 4010 may include one or more panelts) 4Ql 5. Preferably the EFT device 4000 comprises a Chassis 40,16 that supports one or more internal. components of the RPT device 4000. In one form a tic: block 4020 is supported by, or formed as. part of the s; 4016. The RPT device 4000 may include a handle 4018i {0095] The pneumatic path of the RPT device 4000 preferably ses 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 sensors 4272 and pressure sensors 4274 are included in the pneumatic path, {0096] The preferred pneumatic block 4020 comprises 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 ller 4240 andinr any of the controllers previously described, a pressure device 4140* one or more tion circuits 4250, memory 4260, transducers (also referred to as sensors) 4270, data communication interface 428.0 and one or more output devices 4290. Electrical erm‘tponenta 4300 may be mounted on, a single d 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 modules, preferably including a pro—processing module, a therapy engine module. a pressure control module, anti further preferably a fault ion 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 specification. 4.4.1 RPT device mechanical & pneumatic eomnonents 4100 4.4.1.1 Air filtert‘s) 4110 A RPT device in accordance with one form of the t technology may include on air filter 41 .10, or a plurality 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 located between an outlet of the tic block 4020 and a patient interface 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 upstream of a blower 4142. See Fig. 4B. {0103] In one fonn of. the present technology an outlet r 4124 is d 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 nd '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 ers housed in a . 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 ucefls) 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 pneumatic 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 am of the air circuit 4170.

The one or more transdueers 4270 are constructed and an‘anged to measure properties of the air at that point: in the pneumatic path. {0108] In one form of the present technology, one or more transducera 427i) are d proximate to the patient. interface 300G. 4.4.1.5 Anti-spill back valve 416“ [010,9] In one form of the t technology, on anti—spill book value is located between the humidifier 5000 and the pneumatic block 4020. The antiatspill. hack valve is construoted and ed 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. patient. interface 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 red am of the pneumatic block 4020.

WO 48857 {0113] In one form of the present logy, mental. oxygen 4181) is red 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 components 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 t 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 electrical 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 actuator, 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 logy, a RPT device 4000 includes one or more input s 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 operation of the components of the RPT device such as the vent arrangement. The buttons, switches or dials may be physical devices, or software devices accessible via a. touch screen. The buttons, Switches or dials may, in one form, be physically connected to the external housing 4010, or may in another form, he in wireless communication with a receiver that is in electrical, connection to the central controller 4230. {(11 18] In one thou the input device 4220 may be constructed and arranged to allow a permit to select a value r a. menu option, 4.4.2.3 Central controller 4230 {0119] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit configured to receive input. signalts) from the input device 4220, and to e output l(n) to the output device 4290 and I or the therapy device controller 4240. {0120] In One form, the central controller 42.30 is an application-specific integrated circuit. In, r form, the central controller 4230 compriSes discrete electronic 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- processor.

A processor of a central ller 423G suitable to control a RPT device 4000 in ance with another form of the present technology includes a proceseor based on ARM ~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 n 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, manufactured by TEXAS INSTRUMENTS, may be used. {0125] The processor is configured to receive input signalts) from one or more ucers 4270, and one or more input s 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 interface 4280 and fier controller 52.50. {0127] In some forms of the preeent technology the processor of the central controller 4230. or multiple such processors, is configured to implement the one or more methodologies described herein such as the one or more algorithms 4300 expressed .as computer ms stored in a non-transitory computer readable storage medium such as memory 4260. In some cases, as usly 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 purpose of performing any of the ologies described herein without. directly controlling delivery of a respiratory therapy. For e, such 21 processor may perform any of the ologies described herein for purport-:5 of determining control settings for a ator or other respiratory related events by analysis of stored data such as from any of the sensors described herein. Similarly, such 21 processor may perform any of the methodologies described herein for purposes controlling operation 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 ller 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 logy, therapy device controller 42,40 is a ted. motor control ated circuit. For example. in one form a MC33035 broshlcss DC motor controller, manufactured by I is used, 4.4.2.6 Protection circuits 425i} {013l] Preferably a RPT device 4000 in accordance with the present technology comprises one or more protection circuits 4250. {0132] One form of P‘rotection circuit 4250 in accordance with the Present technology is an electrical protection circuit.

One four: of protection circuit 4250 in accordance with the present technology is a temperature or pressure safety circuit. 2014/050268 4.4.2.7 Memory 4260 {0134] In accordance with one term. of the present technology the EFT device 4000 es memory 4260, preferably non—volatile memory. In some forms, memory 4260 may include battery powered static RAM. In 6 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 Digital {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 er m instructiens expressing the one 01‘ mere methodologies described herein. such as the one or mere ulgerithms 4300. 4.4.2.8 Transducers 4270 {0138] Transducere 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 Doppler 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 transducer {item SENSIRIION, The ential pressure transducer is in fluid communication with the pneumatic t. with one of each of the pressure ucers etinnected to respective first. and second points in a flew restricting element. {0140] In use? a signal represent.ng total flow Qt fI'Gfl'l the flew senser 4272. is received by the processor. 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 HONEYWELL- ASDX series. An ative suitable re transducer is a sensor frem the NPA Series from L ELECTRIC. {0142] In Use, a Signal item the re transducer 42?4 is, received by the central controller preeeeser. In ene tonne the Signal from the pressure ucer 4274 is filtered prier in being received by the central centreller 423i}. 4.42.8.3 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 eentrelier 4240‘ Meter speed may, for example, be ted by a speed sensor £1276, such as a Hall effect 4.4.2.!) Data communication interface 4230 In one preferred form of the present, technology, a data communication interface 4280 is provided, and is connected to central controller processor. Date communication interface 4280 is preferably table to remete external communication, network, 4282. Data cennnunicatien interface 42.80- is preferably connectable to local external nieation network 4284. Preferably remete external communication network 4282 i3 cennectable to remote external device 4286. ahly lace} external cemmunicatien network 4284 is eennectable 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 communication 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 r of networked computers. in one form, remote external device 4286 may he virtual computers: rather than physical computers. In, either case: such remote external device 4286 may be accessible to an riately authorised person such as a clinician. {0149] Preferably local external device 4288 is a personal computer, mobile phone, tablet or remote l. 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) y. 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 y those charactera, symbola, or images. 4.4.2.102 Display 4294 {0152] A display 42.94 is configured to Visually display Characters, s, or images in response to ds 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 s indicating whether the eight respective segments are to be activated to display a pa'mieular character or symbol. 4.5 COMMUNICATION AND DATA MANAGEMENT SYSTEM {0153] Fig. 7 depicts an e- 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 ed above, patient l 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 patients; sileepq'eiated ing disorder. The diagnostic device till and therapy device 105 may each include the EFT device 4000, humidifier 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 received 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 diagnostic data, the system may be configured to process the diagnostic data and to generate a diagnostic report andlor a prescription based on ermined analysis criteria. The system may be further ermfigured to y the diagnostic report andlor the prescription to a stic provider for review and to enable an electronic transfer of a diagnosis report or a y prescriptiotn based on the diagnostic data, to a therapy er, {0154] . 100 has the ability to seamlessly transfer a patient’s health information (including demographic and medical data) directly from diagnosis through to patient therapy within the same system within a single patient record. To facilitate this workflow, system 100 may have the following, functional features: {0'1 9.2; 5] The ability to upload and analyse therapy ment 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 l. in avoiding formatting problems when transitioning between different software applications. {0156] The ability to share the patient’s diagnostic record with therapy management users, thus ng them to save a patieri‘t’s therapy and compliance data directly to the common patient record having the patient’s stic report and prescription data. {0157] Th 2. ability of therapy provider to access the diagnostic data, as well as therapy settings infomiation from the initial prescription. data, as saved in the patients record, or even. for the therapy device to be automatically configured via a cable connection, wireless tion, or a memory card, by acceseing this record. {0158] As the patient uses medical stic device .101. diagnostic date lli may he recorded on a. Storage medium, 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, ing a1emriputer—readabie medium, or other medium that stores date that may be read with the aid of an onic device, such as a 'hnrd~drive, memory card, ROM, RAM. DVD or other optical disks, as well as other write-capable and read-only es. {0159] Server 20] ineludee a processor 210 and a memory 220 for storing data 230 and. ctions 234. Memory .220 stores information accessible by proeessor 210, ineiuding instructions 234 that may be executed or otherwise used by the processor 21. The mommy 220 may be of any non—transitory type capable of storing 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 nly memories. Systems and methods may include different combinations of the foregoing, whereby different portions of the instructions and data are stored on difiierent types of media. {0160] The instructions 2'34 may be any set of instructions to be executed directly {Such 213 machine code) or indirectly touch as scripts) by the processor. For e, the instructions may be stored as computer code on. the computer—readable medium.

In that , the terms "instructions“ and "programs" may be used interehmigezibly herein. The instructions may be stored in object code format for direct proceseing by the pn'aeesoor, or in any other computer language including scripts or collections of ndent 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 ction 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 tors 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 server. {0162] The CAL server is responsible for communicating with Therapy s.

The CAL sewer’s enre responsibilities may include, nbtaining daily summary data for active patients; retrieving and ng therapy device settings; and converting raw y 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, presenting patient and device information within the user interface, and writing and managing t health irtation; and g applieatien related processes. {0164] The data 230 may be ved, 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 numbers, descriptive text... proprietary codese references to data stored in. other areas of the same memory or (lifterent es (“including other locations 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 database 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 tional processor, including commercially available proeeusors. Alternatively, the proceeuor muy be a dedicated device such as an ASIC or FPGA. Although Fig. 2. functionally illustrates the processor, 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 e references to a collection of processors or computers or es that may or may not ope “ate in el 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 ent's specific on. Thus server .201 may be referred to as both a System and an apparatus. {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 wehpuges in HTML and a le document format (PD?) reader), on electronic display l ll) and 115 (cg, a r having a screen. a small LCD touch-screen. or any other ical 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 riitihile computer, which ns usage dutut including diagnostic data. 1 ll collected from a medical device. such as u home sleep g device. in addition. While Fig. ‘2 illustrates server 201 and computeru 101-104 WO 48857 as being connected via a network 150, each two or more devices 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 associated ECU database 1233, the Comm server 240 and its ated Comm database 231 and the CAL server 260 and its associated 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 METHODS {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 ing types of data Poiysomnography (PEG) data? aphy data, oximen‘y data pneumatic or Respiratory Inductance smography (RIP)-based respiratory effort data, atory flow data, audio signal data, body position data etc. {01?0] The patient’s record is first created, during the diagnostic stage, when the patient is approved for running a diagnostic test. The. patient’s record may comprise any data that is associated. with the patient or with the patient’s condition, such as the patient’s personal details (name, , age, address, contact details etc), symptoms, ng ian, insurance provider; type of nce cover etc. From diagnostic provider‘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 tive patient. but by a data administrator on the site. For example, it can, be envisaged that such an administrator may be responsible 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 ation, such as the type and model of the diagnostic ; the patient’s details? including these of the referring diagnostic physieinni time and dates of usage etc. {0172] During the actual test, the diagnestic device saves the stic test data 111 in memory 112,. A 11am of system 100, such as a user of diagnostic 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 ie 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 browser 1131 en the diagucstic provider cemputer 104 may then he used to contact. server 2131. and upiead diagnestic 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 identify the type of patient device from which it. came. Fer example, each stic device 101 may be ed 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 y device 105 may be processed in a, similar manner. {0174] In some instances: a patient is required to use a medical diagnostic device fer a set duratidn and exhibit, certain clinical symptoms in order to be eligible to qualify for therapy of the ti's sleep disnrder ing. 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 exhibit an Apnea—Hypopnen Index (AHI) of greater than 5 in order for a physician to write a iption for CPA]? therapy. The prescription (also referred to as prescription data. or prescriptien information) may be saved in the HST database 235'). System 10G may he used to track whether 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. sis 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 ically a diagnostic physician, may issue a prescription for therapy. The diagnostic provider may input his or her a‘t interpretation of diagnostic data into the patients . In addition, the. ECO database may contain a list of clinical. s for a number of y 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 t 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 usually 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 stic 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 ctive Sleep Apnea with an AHE of '20, and therefore may be a candidate fer CPAP therapy. 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 Dingnnstic 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 stic cnmputcr 1.04. Instead, the proposed 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 therapy device. For example the patient diagnosed with Obstructive Steep Apnea wit] need to have their patient information and prescription sent to an ed therapy provider 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 er to a trusted therapy provider. Instead cf creating a new patient record, the patient’s reccrd may be electronically transferred. Furthermore instead cf transferring the patient record, the system may allow the therapy provider to access the present pntient record, as created and d during the. diagnostic stage. Depending on the arrangement, the therapy (a: U] provider may he d access either to the entire patient record. or only to some of the patient identification data. stic 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 d 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 e, after the record is made accessible to the therapy pmvider. the therapy er may allow continuous access by the diagnostic provider to the patient’s record. Depending on the arrangement, the stic provider may be allowed access either to the entire t record. or only to some of the patient 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 y 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 therapy stage may he provided various level of access to the electronic patient record during both the diagnostic stage and the therapy 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 e accessed on diagnostic computer 104.

For e, the healthcare professional may access patient data via webpage 800 tthe ‘dashboard‘) shown in Fig. 8. Webpage 800 may n a list of active patients who are cunfently proceeding through 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 diagnostic report phase. ent colour. for e. may he used to, indicate whether the report has or has not being iswed yet. Similarly, the Rat icon indicates that the pa‘tient’s diagnostic report is ready and the patient has moved to the prescription 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 “patient 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 stic report and iption are ready. As indicated by status indicatnr 87; the pntient’s record has undergone. even the finai cheeks and is now ready to be sent.

Such final. checks may involve cation of the patient’s name, phone number and insurance previder details. {0182] Once a diagnostic provider associated with diagnostic computer 104 has determined that the patient needs to go onto therapy the diagnostic provider 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 stic 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 ting data for a‘rniinble therapy providers within. the system of therapy ers. ECO server will then provide data responsive to the request; which will populate menu 974 within the web hrewser 131. By clicking on send hutten 976 the healtheare professional can instantly confirm their Choice and initiate a cnniniand to, the ECU server to transfer ownership of the t record to the therapy provider nominated in menu 974.

Clicking on send button 976 transfers hip of the patient: to the thernpy er 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 tically previde thempy provider coniputer .102, by way of. web browser (eg. instmetimis 130) and via the k 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 d on the server by n diagnostics provider 2014/050268 and assigned to them. This allows the therapy provider 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 automatically transferred directly to therapy device 105, each as via an internet connection, or ly 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 therapy provider or an administrator at the therapy provider” 3 office may aceea 3 th ‘ transferred t 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, stic and prescription. information 984, insurer data. 986. an acceptance Status 987,. or any other patient information of intereat. A therapy 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 desired patient, the therapy provider computer 102 may send a transmission to the ECG server ting additional patient health atilon from the ECU database for the nt patient ID. ECO server will then provide patient. demographi : and therapy settings data responsive to the request... which once ble will be used to fire—populate data. fields required for a Setup of the new patient 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 t Noemy Harbor may be automatically assigned s y devices in accordance with her prescription. The healthcare professional. 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 ing 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 t. such an by the website. email, or phone, the administrator may schedule .a time for a therapy er to meet with the t. For e. 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 therapy 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 noncompliance icons 1204 to indicate whether a patient. is currently compliant 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 . The work queue of webpage 920 may be securely ed by a .ian,. an administrator, or both.

Secure access may include some form of' protection to prevent unauthorized duals from access patient data. F01“ example. Server 201 of Fig. 7 may require a password before transmitting patient. data. Server 20} may also t: the transmitted data so as to prevent unauthorized devices from displaying 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 wehpage 9‘30. As seen on wehpage 930 within the patient record section, the patient information required to set up a patient for ongoing monitoring may be y 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 ed to the patient. In this way, healthcnre professionals may quickly 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 t at the therapy provider for therapy. All therapy 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 y reports. which. bewe been generated by server 201, to the tive assessing entities. This can be performed, by transmitting the diagnostic and/or compliance reports from. therapy prttwider computer 102 to an external party, such as the reimbursing entity computer 163, via network 150. The diagnostic andfor compliance reports may be transmitted in any number of ways. including as part of an Email transmis sinn. Alternatively, the nstic 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 t 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, regardless of whether the patient 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 ng 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 l patient data, diagnostic data, device usage data, compliance data, device parameters, diagnostic report, device prescription etc. This reduces the time and effort ed in creating multiple records, as well as minimises the likelihood of errors The described system has the following features: The lity 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 y management; stage data. This makes it much more convenient for both the stic 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 hardware setup and the used software. The e 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 ibed diagnostic or therapy requirements. 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 lity to upload diagnostic data, diagnostic reports, prescription ation. as well as a therapy device usage and compliance data, ly into the original patient’s therapy record created mid populated in the. diagnostics data management stage. {0193] The capability to send device settings data from, a prescription issued by a sleep physician directly to the stic t 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 personally 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 er to save the prescription in the patient record from where it is directly accessed by the therapy 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 technical and scientific terms used herein have the same meaning as connnonly understood by one of ordinary skill in the art. to which this. technology belongs. Although any methods and materials similar or equivalent to those described herein can also he used in the practice or g of the present technology, a limited number of the exemplary methods and als are described herein. {0193] It must be noted that: as used herein and in the appended 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 ed description are ed 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 uing the scope of the claims or the claim limitations. {0195] Althnugh the logy herein has baan described with Tefercnca to particular examples. it. is to be tood that thcsc examples 2m: merely illustrative of the principles and applications of the technology. in some ces, the terminolagy and symbols may imply spacific details that, are not required to practice the. technology. For exztmplts, gh. the temm H first" and "second" may be used, unless ise 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 t departing from the spirit and Scope 0f the technology.

Claims (18)

1. A method for patient data processing during diagnosis and therapy of sleep disorder breathing, the method comprising: generating, by one or more ing devices, an electronic patient 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 er with a first level of access to the electronic t record; during a therapy stage of the patient, providing, by the one or more computing devices, a therapy er with a second level of access to the electronic patient record; updating, by the one or more computing devices, the electronic patient record to include therapy data from a therapy device, wherein the first level of access comprises enabling the diagnostic provider to view and/or download the y data and preventing the diagnostic provider from modifying the therapy data and the second level of access comprises enabling the therapy provider to view and/or download the stic data and preventing the therapy provider from modifying the stic data; transmitting, by the one or more computing devices, therapy settings to a therapy , the therapy settings associated with at least one of a diagnostic report and a therapy prescription.

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

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 patient, and providing the therapy provider with access to at least one of diagnostic data and prescription data of the patient.

4. The method of any one of the preceding claims, wherein therapy settings from the therapy prescription are retrieved from the electronic patient record and used to automatically configure the therapy device for the patient.

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

6. The method of any one of the preceding claims, wherein providing the first level of access to the electronic patient record further comprises providing access to a first subset of the electronic patient .

7. The method of any one of the preceding claims, wherein providing the second level of access to the electronic patient record further comprises providing access to a second subset of the onic patient record.

8. The method of any one of the preceding claims, wherein, once the electronic patient record is d, medical tioners associated with the diagnostic stage are provided with the first level of access to the electronic patient record and medical tioners associated with the therapy stage are provided with the second level of access to the electronic patient record during both the diagnostic stage and the therapy stage.

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

10. An electronic system for integrated management of diagnostic and therapy data of a ity of sleep disorder breathing patients: one or more memories ured to store an electronic patient record comprising t 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 diagnostic provider with a first level of access to the electronic patient record during a diagnostic stage of patient management; receive and store therapy data from a therapy device in the electronic patient record and provide a therapy provider with a second level of access to the electronic patient record during a therapy stage of the patient management, wherein the first level of access comprises enabling the diagnostic provider to view and/or download the y data and preventing the diagnostic provider from modifying the therapy data and the second level of access comprises ng the therapy provider to view and/or download the stic data and preventing the therapy provider from modifying the diagnostic data; and transmit therapy settings to a therapy device, the therapy settings associated with at least one of a diagnostic report and a therapy prescription.

11. The electronic system of claim 10, 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.

12. The electronic system of claim 10 or claim 11, wherein when the diagnostic stage is at an end, at least one of the one or more processors is ured 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.

13. The electronic system of any one of claims 10-12, wherein at least one of the one or more processors is ured to retrieve y settings from the y prescription of the electronic patient record and use it to automatically ure the therapy device for the t.

14. The electronic system of claim 13, n the automatic configuration is effected by way of a network connection or a memory card.

15. The electronic system of any one of claims 10-14, wherein providing the first level of access to the electronic patient record further comprises providing access to a first subset of the electronic patient record.

16. The electronic system of any one of claims 10-15, wherein the providing the second level of access to the electronic patient record further comprises providing access to a second subset of the electronic t .

17. The electronic system of any one of claims 10-16, wherein, once the electronic patient record is d, at least one of the one or more processors is configured to provide a provider associated with the diagnostic stage with the first level of access to the electronic patient record and to provide a provider ated with the therapy stage with the second level of access to the electronic patient record during both the diagnostic stage and the therapy stage.

18. The electronic system of any one of claims 10-17, wherein the at least one processor is configured to process data from the diagnostic device, during the diagnostic stage, and from the therapy device, during the therapy stage, the y device being a flow generator used for respiratory therapy.