`

`FOR THE PURPOSES OF INFORMATION ONLY
`
`Codes used to identify States party to the PCT on the front pages of pamphlets publishing international applications under the PCT.
`
`AL
`AM
`AT
`AU
`AZ
`BA
`BB
`BE
`BF
`BG
`BJ
`BR
`BY
`CA
`CF
`CG
`CH
`CI
`CM
`CN
`cu
`CZ
`DE
`DK
`EE
`
`Albania
`Annenia
`Austria
`Australia
`Azerbaijan
`Bosnia and Herzegovina
`Barbados
`Belgium
`Burkina Faso
`Bulgaria
`Benin
`Brazil
`Belarus
`Canada
`Central African Republic
`Congo
`Switzerland
`Cllte d'Ivoire
`Cameroon
`China
`Cuba
`Czech Republic
`Gennany
`Denmark
`Estonia
`
`ES
`FI
`FR
`GA
`GB
`GE
`GH
`GN
`GR
`HU
`IE
`IL
`IS
`IT
`JP
`KE
`KG
`KP
`
`KR
`KZ
`LC
`LI
`LK
`LR
`
`Spain
`Finland
`France
`Gabon
`United Kingdom
`Georgia
`Ghana
`Guinea
`Greece
`Hungary
`Ireland
`Israel
`Iceland
`Italy
`Japan
`Kenya
`Kyrgyzstan
`Democratic People's
`Republic of Korea
`Republic of Korea
`Kazakstan
`Saint Lucia
`Liechtenstein
`Sri Lanka
`Liberia
`
`LS
`LT
`LU
`LV
`MC
`MD
`MG
`MK
`
`ML
`MN
`MR
`MW
`MX
`NE
`NL
`NO
`NZ
`PL
`PT
`RO
`RU
`SD
`SE
`SG
`
`Lesotho
`Lithuania
`Luxembourg
`Latvia
`Monaco
`Republic of Moldova
`Madagascar
`The former Yugoslav
`Republic of Macedonia
`Mali
`Mongolia
`Mauritania
`Malawi
`Mexico
`Niger
`Netherlands
`Norway
`New Zealand
`Poland
`Portugal
`Romania
`Russian Federation
`Sudan
`Sweden
`Singapore
`
`SI
`SK
`SN
`sz
`TD
`TG
`TJ
`TM
`TR
`TT
`VA
`UG
`us
`uz
`VN
`YU
`zw
`
`Slovenia
`Slovakia
`Senegal
`Swaziland
`Chad
`Togo
`Tajikistan
`Turkmenistan
`Turkey
`Trinidad and Tobago
`Ukraine
`Uganda
`United States of America
`Uzbekistan
`Viet Nam
`Yugoslavia
`Zimbabwe
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
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`WO 99/41682
`
`PCT /US99/02970
`
`PATIENT DATA ACQUISITION UNIT AND DATA SUPPORT SYSTEM
`
`5
`
`RELATED APPLICATION
`
`This application claims priority to U.S. Provisional Application No.
`
`60/075,002, filed February 17, 1998, entitled "Data Collection Unit for Medical
`
`Practitioners" and to U.S. Provisional Application No. 60/093,128 filed July 16, 1998,
`
`10
`
`entitled "Patent Data Acquisition and Support System for Nurses."
`
`FIELD OF THE INVENTION
`
`The present invention is directed to the collection of patient data, and more
`
`particularly to a patient data acquisition unit and data support system.
`
`15
`
`BACKGROUND OF THE INVENTION
`
`There is an ever increasing need to automate the collection of patient data in
`
`the health care industry. This is true whether the data is collected from patients in
`
`hospitals or patients under home health care. Home health care, however, is a
`
`20
`
`growing industry where automation has not occurred as rapidly as needed.
`
`Services being provided in the patients' home range from monitoring patient
`
`conditions during recovery from hospital care to continuous monitoring by an in(cid:173)
`
`home nurse or aide. Patient data collection is necessary to monitor long term trends in
`
`patient status as well as to facilitate the practice of physicians and nursing staff. It is
`
`25
`
`also useful for billing purposes.
`
`Up until recently, all data collection has been accomplished through the use of
`
`paper medical forms which are manually filled out during or after the visit by the
`
`visiting nurse or aide. There has been an effort made to improve the accuracy and
`
`legibility of the patient data. Personal laptop computers are being considered as a data
`
`30
`
`collection tool. However, personal laptop computers are still fairly expensive and too
`
`large for light and portable applications. In addition, many patients find them
`
`intimidating and obtrusive.
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`2
`What is needed is a system by which a small inexpensive electronic data
`
`collection tool can be used in the field to help automate data collection of patient
`
`status.
`
`5
`
`SUMMARY OF THE INVENTION
`
`Briefly, the present invention is directed to a system for collecting health data
`
`from patients. The system comprises mobile computing devices which can be
`
`connected to one or more supporting computing devices to achieve the exchange of
`
`information between them. In its simplest configuration, the system consists of at
`
`IO
`
`least one personal digital assistant (PDA) unit that interfaces with at least one
`
`application server processor. The PDA is a mobile processor containing a program
`
`for acquiring data from patients using a suite of sensors, audible input, and/or manual
`
`input. The application server is used to transmit visit schedules to the PDA, recover
`
`patient data from the PDA following visits, and to store patient health data obtained
`
`15
`
`from the PDAs. This minimum system will usually be expanded by adding additional
`
`database and communication servers in a networked architecture to support a plurality
`
`of PDAs.
`
`The PDA unit comprises a processor and a memory and stores a software
`
`program which is executed by the processor to facilitate patient data entry in
`
`20
`
`accordance with a predetermined medical form. The PDA unit is capable of
`
`connecting to the application server via direct connection or through a modem. The
`
`application server transmits data representing the predetermined medical forms to the
`
`PDA unit and receives from the PDA unit data representing populated medical forms.
`
`These data are typically processed further in preparation for their transmission to a
`
`25
`
`larger patient records database.
`
`In addition, the present invention is directed to the combination of a PDA and
`
`a sensor interface that connects with one or more patient data sensors for collecting
`
`health status information from the patient and automatically populating the medical
`
`forms in the personal digital assistant with the acquired data.
`
`30
`
`Other objects and advantages of the present invention will become more
`
`readily apparent when reference is made to the following description taken in
`
`conjunction with the accompanying drawings.
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
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`WO 99/41682
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`PCT/US99/02970
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`3
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Figure 1 is a block diagram of a system for collecting patient data according to
`
`the present invention.
`
`5
`
`Figure 2 is a block diagram of a personal digital assistant unit and a sensor
`
`interface according to one embodiment of the present invention.
`
`Figure 3 is a block diagram of one embodiment the sensor interface.
`
`Figure 4 is a flow chart showing the general operation of the system according
`
`to the present invention.
`
`Io
`
`Figure 5 is a flow chart showing the method by which patient data information
`
`is collected by a personal digital assistant unit according to the present invention.
`
`Figures 6-15 are sample screens displayed on the personal digital assistant unit
`
`to prompt attending personnel to enter data to be populated into a medical form.
`
`15
`
`DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT
`
`Referring first to Figure 1, the patient data acquisition or collection system
`
`according to the present invention is shown generally at reference numeral 10. The
`
`system 10 comprises one or more mobile computing devices, such as personal digital
`
`assistants (PD As) 20, and an application server 30. Connection of the application
`
`20
`
`server 30 through a network 60 with other computer resources such as a
`
`communication server 50 and/or a database server 80 are typical approaches to
`
`expanding the system to handle a larger number of patients. The functions of the
`
`application server 30 and the database server 80 may reside in the same physical
`
`machine, or they may be distributed (as shown in Figure 1) as appropriate to the
`
`25
`
`processing load anticipated for the system 10. The database server 80 organizes and
`
`maintains the collected patient medical information.
`
`The PDA 20 is a well known piece of hardware that is capable of performing a
`
`variety of tasks. For example, the PDA 20 is PalmPilot™ PDA sold by 3Com
`
`Corporation, or a MobilePro™ PDA, sold by NEC. The PDA 20 receives software
`
`30
`
`application functionalities from the application server 30. Other similar mobile
`
`computing devices are also suitable for use in accordance with the present invention.
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`IPR2020-00828
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`4
`Depending on the make and model of the PDA 20, it interfaces with the
`
`application server 30 through a cradle interface 40, by telephonic connection via an
`
`internal or external modem (not shown) over a telephone network 70, or via a standard
`
`serial interface cable (not shown). These interfaces are well known in the art and
`
`5
`
`therefore are not shown or described herein. The software applications that manage
`
`the downloading of new applications or new data to the PDA 20 reside in application
`
`server 30. As is known in the art, new software applications or new data are installed
`
`in the PDA 20 when the PDA 20 is connected to the application server 30 and a
`
`"synchronization" operation is initiated. Similarly, data collected and stored in the
`
`10
`
`PDA 20 are downloaded to the application server 30 during a "synchronization"
`
`operation. Some PDAs 20 have the capability to support certain downloading
`
`functions whereby only specific data can be designated for exchange between the
`
`PDA 20 and the application server 30.
`
`Some PDAs 20 have built in keyboards, while others, such as the PalmPilot™
`
`15
`
`PDA have a graphical user interface which includes handwriting or speech recognition
`
`software to facilitate manual or voice data entry, respectfully. In addition, the PDA
`
`20 has a display (not shown) that can present information in black-white or color.
`
`Text may be entered by writing directly onto a digitizer tablet that overlies the display
`
`or which may be separate from it. In accordance with the present invention, the
`
`20
`
`functionality of the PDA 20 is refocused from its use as a personal contact
`
`manager/scheduler to the specific needs of the health care industry.
`
`The application server 30 is a computer that stores (in an internal memory or
`
`hard disk) data representing one or more predetermined medical forms to be populated
`
`with information from a plurality of patients. These forms may be changed from
`
`25
`
`time-to-time. For example, a typical medical form may be one of the Outcome and
`
`Assessment Information Set (OASIS) forms or what is commonly referred to as
`
`Nurses Notes, from a patient visit. Information that is collected by the one or more
`
`PD As 20 is ultimately stored in one or more databases which themselves, may reside
`
`on other dedicated computers.
`
`30
`
`The network 60 may be any standard computer network known in the art, such
`
`as an Ethernet™ network for use internally by a hospital or home health care business.
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`5
`Moreover, the network 60 could encompass data networks external to business, such
`
`as the Internet/World Wide Web.
`
`Turning to Figure 2, a PDA 20 is shown together with a sensor interface/signal
`
`processor device 100 according to an alternative embodiment of the present invention.
`
`5
`
`The sensor interface 100 connects to one or more patient data sensors 110 attached in,
`
`on or about the patient. Examples of sensors to which the sensor interface attaches are
`
`a temperature sensor, pulse/blood pressure sensor, blood glucose sensor, electronic
`
`scale, respiration monitor, etc. It is envisioned that as technologies develop, the
`
`sensor interface 100 may read data from microscopic in-body sensors in which a
`
`10
`
`variety of medical information is derived from very small samples of a patient's
`
`biological fluids or tissues, or indirectly from other physical phenomena associated
`
`with the patient's body. The sensor interface 100 affords the ability to automatically
`
`read patient data sensors rather than requiring that the data be manually entered into
`
`the PDA 20.
`
`15
`
`An electrical block diagram for the sensor interface 100 is shown in Figure 3.
`
`Generally, the sensor interface 100 includes the ability to convert an analog output
`
`signal from a sensor to a digital signal suitable for storage by the PDA 20. For
`
`example, typical temperature sensors and blood pressure/pulse sensors may provide
`
`an analog output signal, while other sensors may provide a digital output. For those
`
`20
`
`sensors that generate an analog output, one or several analog signal processor circuits
`
`120 are provided to condition the analog output. An analog-to-digital converter
`
`(ADC) 130 converts the conditioned analog output to a digital signal. A digital data
`
`processor 140 connected to the ADC 130 processes the digital signal(s) representing
`
`the analog sensor output and organizes the information into a suitable data packet to
`
`25
`
`be uploaded into a host device from the PDA 20. The sensor interface 100 may be
`
`powered by the PDA 20, or by an internal battery power conditioning supply 150.
`
`The sensor interface 100 connects to the PDA 20 by a standard cable, such as an RS-
`
`232 digital serial interface cable. The sensor interface 100 connects to the sensors
`
`110 either by hardwire connection or by a wireless link via antenna 112. If a wireless
`
`30
`
`link is employed the sensor interface 100 and sensors 110 would include suitable
`
`transmission and reception circuitry 160.
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`6
`Reference is now made to Figure 4, in conjunction with Figures 1-3, for a
`
`description of the operation of the PDA 20 and the patient data acquisition system 10
`
`in general. In Figure 4, the application server 30 is referred to as the "MediFORM
`
`Application Processor." In step 300, patient schedules are entered into the application
`
`s
`
`server 30 either manually or through a network accessible external computer that
`
`contains and updates patient schedule information. Next, in step 310, the application
`
`server 30 allocates attending personnel (nurses, nurse/aides, doctors, etc.) in
`
`accordance with the patient visitation schedule. Then, in step 320, the data
`
`representing the medical form(s) is downloaded from the application server 30 to
`
`10
`
`PDAs 20 via the cradle interface 40, telephone network 70, etc. Typically, these data
`
`are used to generate one or more forms which are presented on the PDA 20 display to
`
`guide the user through the data collection process.
`
`In step 330, the user of the PDA 20 enters the data (either manually,
`
`electronically or audibly) into the PDA 20 at the patient site. This process will be
`
`15
`
`described in greater detail hereinafter in conjunction with Figure 5. The information
`
`that is downloaded to a PDA 20 may include instructions for the nurse or aide to
`
`collect data from a plurality of specified patients.
`
`Once all of the data from a patient or patients are collected, in step 340, the
`
`PDA is coupled to the application server 30 to upload data representing the populated
`
`20
`
`medical forms. Alternatively, the data may be uploaded via telephone network 70.
`
`The data are uploaded from the PDA 20 to the application server 30 where it is
`
`processed in step 350 and formatted for storage in a database. The processing
`
`described in this step may be as simple as converging data from several reports into a
`
`permanent patient record or may involve the conversion from one database format to
`
`25
`
`another in order to interface with the existing databases of a healthcare provider.
`
`Finally, in step 360 the data, now properly formatted representing the
`
`populated medical forms, are transferred to the database server 80 for storage.
`
`Turning now to Figure 5, the manner in which the patient data are collected
`
`and entered into the PDA 20 (step 330 of Figure 4) will be described. If the PDA 20
`
`30
`
`supports only manual data entry in step 332, then in step 334, the user enters data into
`
`the PDA through standard PDA user interfaces (keyboard, handwriting or speech
`
`recognition, etc.). On the other hand, if the PDA 20 is augmented to support
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`7
`electronic and automatic data collection and entry via sensor interface 100, then in
`
`step 336, the sensor interface 100 is connected to the patient data sensors 110. Then,
`
`by initiating a procedure on the PDA 20, the sensor interface 100 triggers activation of
`
`the various patient sensors (if necessary) to obtain a reading of the related
`
`5
`
`information, such as blood pressure/pulse rate, temperature, etc. Once the patient data
`
`sensors 110 make the information available, the sensor interface I 00 reads the
`
`information from them, converts and/or processes the information as appropriate and
`
`uploads the information to the PDA 20. The PDA 20 receives the information and
`
`automatically populates the medical form for the patient.
`
`10
`
`Reference is now made to Figures 6-15 in which examples of the screens
`
`displayed on a typical PDA 20 are shown. Each screen includes icons or graphical
`
`button elements that can be selected by the user (with a stylus or some other means) to
`
`move to another screen containing additional information or data entry prompts.
`
`Figure 6 illustrates an initial screen having two buttons: VISIT REPORT and
`
`15
`
`VITAL STATISTICS. When the VISIT REPORT button is selected, the screen
`
`shown in Figure 7 is displayed. The screen in Figure 7 includes prompts to enter
`
`basic information about the particular patient and patient site being visited. This
`
`information is self explanatory. When all of this information is entered, the user
`
`selects the DONE button.
`
`20
`
`When the VITAL STATISTICS button is selected, the screen shown in Figure
`
`8 is displayed. The VITAL STATISTICS screen includes data entry prompts for
`
`entering temperature, pulse rate, respiration, blood pressure, weight, and last bowel
`
`movement. All of this information may be entered manually, or as explained above,
`
`it may be entered electronically via the sensor interface 100. Another set of screens
`
`25
`
`may be displayed to enter a variety of patient care information. These screens are
`
`shown in Figures 9-14, and are self-explanatory. The screens shown in Figures 9-14
`
`are exemplary and in no way limit the expansion of these concepts to include other
`
`patient related information.
`
`The last screen shown in Figure 15 is a general entry screen where general
`
`30
`
`comments can be entered by the attending personnel into the PDA 20 using the PDA's
`
`text and speech recognition capabilities.
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`PCT/US99/02970
`
`8
`In summary, the present invention is directed to a method of acquiring health
`
`data from patients comprising steps of: generating information representing a medical
`
`form to be populated with patient data collected from a plurality of patients; storing
`
`the information representing the medical form in a mobile computing device, such as
`
`5
`
`portable digital assistant (PDA) unit; collecting patient health data from patients,
`
`inputting the patient health data into the PDA, and populating a medical form in the
`
`PDA unit with patient health data collected for each patient; and uploading data
`
`representing populated medical forms from the PDA unit to a database for storage
`
`therein. The information representing the medical form may initially reside on an
`
`10
`
`application server, and the PDA unit receives the information over a communication
`
`network during a "synchronization" procedure or other dedicated downloading
`
`procedure.
`
`Similarly, the present invention is directed to a system for collecting patient
`
`data from patients, comprising: a network supporting communication and exchange of
`
`15
`
`information between devices connected thereto; an application server connected to the
`
`network that stores data representing a predetermined medical form to be populated
`
`with information collected from patients and for storage in a database; and at least one
`
`mobile computing device, such as a personal digital assistant (PDA) unit, comprising
`
`a processor and a memory, the memory of the PDA unit storing a software program
`
`20
`
`and information representing the predetermined medical form received from the
`
`application server, the processor of the PDA unit executing the software program to
`
`populate the predetermined medical form with patient health data received as input to
`
`the PDA unit.
`
`Finally, the present invention also is directed to the combination of a mobile
`
`25
`
`computing device, such as a personal digital assistant (PDA) unit, and a sensor
`
`interface. The PDA unit comprises a processor and a memory, the memory of the
`
`PDA unit storing a software program and information representing a predetermined
`
`medical form received from the application server, the processor of the PDA unit
`
`executing the software program to populate the predetermined medical form with
`
`30
`
`patient health data received as input to the PDA unit. The sensor interface receives
`
`the patient health data from one or more sensors attached to, implanted in or which
`
`otherwise derive information from the patient's body, wherein the PDA unit receives
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`
`9
`the patient health data from the sensor interface and automatically populates the
`
`medical form in the PDA unit with the patient health data.
`
`The foregoing description is intended by way of example only and is not
`
`intended to limit the present invention in any way except as set forth in the following
`
`5
`
`claims.
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`IPR2020-00828
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`WO 99/41682
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`10
`
`What is claimed is:
`
`1.
`
`A system for collecting patient data from patients, comprising:
`
`a network supporting communication and exchange of information between
`
`devices connected thereto;
`
`an application server connected to the network that stores data representing a
`
`predetermined medical form to be populated with information collected from patients
`
`and for storage in a database; and
`
`at least one mobile computing device comprising a processor and a memory,
`
`the memory of the mobile computing device storing a software program and
`
`information representing the predetermined medical form received from the
`
`application server, the processor of the mobile computing device executing the
`
`software program to populate the predetermined medical form with patient health data
`
`received as input to the mobile computing device.
`
`2.
`
`The system of claim 1, and further comprising a sensor interface that
`
`electrically connects to one or more patient data sensors for collecting patient data
`
`from the patient data sensors and automatically populating the medical forms in the
`
`mobile computing device with patient data sensor information.
`
`3.
`
`The system of claim 1, and further comprising a database server
`
`connected to the network that supports and maintains the database of collected
`
`information.
`
`4.
`
`The system of claim 1, wherein the mobile computing device is a
`
`personal digital assistant (PDA) unit.
`
`5.
`
`A method for acquiring health data from patients comprising steps of:
`
`generating information representing a medical form to be populated with
`
`patient data collected from a plurality of patients;
`
`storing the information representing the medical form in a processor server;
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
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`11
`downloading the information representing the medical form to a portable
`
`digital assistant mobile computing device;
`
`collecting patient health data from patients, inputting the patient health data
`
`into the mobile computing device, and populating a medical form in the mobile
`
`computing device with patient health data collected for each patient; and
`
`uploading data representing populated medical forms from the mobile
`
`computing device to a database for storage therein.
`
`6.
`
`The method of claim 5, wherein the step of collecting patient data
`
`comprises manually or audibly entering patient data observed by an attending
`
`personnel into the mobile computing device.
`
`7.
`
`The method of claim 5, wherein the step of manually entering
`
`comprises displaying a plurality of screens each representing a subset of queries for
`
`types of patient data to be manually or audibly entered by the attending personnel.
`
`8.
`
`The method of claim 5, wherein the step of collecting comprises
`
`connecting a sensor interface to the mobile computing device and to one or more
`
`patient data sensors, electronically reading the patient data sensors, uploading patient
`
`data sensor information into the mobile computing device.
`
`9.
`
`The method of claim 8, and further comprising the step of
`
`automatically populating the medical form in the mobile computing device with data
`
`collected from the patient data sensors.
`
`10.
`
`In combination, a mobile computing device comprising a processor
`
`and a memory, the memory of the mobile computing device storing a software
`
`program and information representing a predetermined medical form received from
`
`the application server, the processor of the mobile computing device executing the
`
`software program to populate the predetermined medical form with patient health data
`
`received as input to the mobile computing device, and a sensor interface that receives
`
`patient health data from one or more sensors attached to, implanted in or which
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`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1019 Page 0013
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`WO 99/41682
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`PCT/US99/02970
`
`12
`otherwise derive information from the patient's body, wherein the mobile computing
`
`device receives the patient health data from the sensor interface and automatically
`
`populates a medical form stored in the mobile computing device with the patient
`
`health data.
`
`11.
`
`A method of acquiring health data from patients comprising steps of:
`
`generating information representing a medical form to be populated with
`
`patient data collected from a plurality of patients;
`
`storing the information representing the medical form in a portable digital
`
`assistant (PDA) unit;
`
`collecting patient health data from patients, inputting the patient health data
`
`into the PDA, and populating a medical form in the PDA unit with patient health data
`
`collected for each patient; and
`
`uploading data representing populated medical forms from the PDA unit to a
`
`database for storage therein.
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1019 Page 0014
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`WO 99/41682
`
`PCT /US99/02970
`
`4/10
`
`340
`
`r
`
`UPLOAD PDA DATA TO
`MEDIFORM APPLICATION
`PROCESSOR
`
`.....
`
`r
`
`,
`
`\..
`
`DATA CHECKING &:
`REFORMAmNG FOR
`IS DATABASE(S)
`
`UPLOAD POPULATED
`FORMS TO
`IS DATABASE{S)
`
`3 50
`
`3 60
`
`'I
`
`....
`
`..I
`
`300
`
`310
`
`320
`
`330
`
`"
`
`r
`
`"
`
`DOWNLOAD PATIENT
`VISIT SCHEDULES TO
`MEDIFORM APPLICATION
`PROCESSOR
`
`'
`ALLOCATE PATIENT
`SCHEDULES/SERVICES
`TO ATIENDING
`PERSONNEL
`
`DOWNLOAD FROMS
`FILE TO PDAs
`
`..
`
`"
`
`,I
`
`T
`
`\..
`
`T
`
`"
`
`SERVICES DELIVERY.
`FORMS DATA ENTRY AT
`PATIENT SITE
`
`'
`
`..
`
`\..
`
`FIG.4
`
`SUBSTITUTE SHEET (RULE 26)
`
`Fitbit, Inc. v. Philips North America LLC
`IPR2020-00828
`
`Fitbit, Inc. Ex. 1019 Page 0018
`
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