Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 1 of 307
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`IZI The term oi this patent shall
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 3 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 3 of 307
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`SERIAL NUMBER
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`09/ 38,270
`‘ PPLICANTS
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`FILING DATE
`12/15/2000
`RULE
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`' RogerJ. Quy, MIII Valley, CA;
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`Page 1 0’
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`5038 Saretoga Avenue
`San Diego ,CA 92107
`ITLE
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`Method and apparatus for health and disease management combining patient data monitoring with wireless
`internet connectlvi
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`FILING FEE
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 4 of 307
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`CONTENTS
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`Date Received
`Date Received
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`or
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`Date Mailed
`Date Mailed
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`1. Application
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 5 of 307
`Case i=19'cv'11586'FDS D°°“me”t lllfllflllllllliflllflllllliflllflllllflllhllllllllllllfll’llllllll
`
`USOO6602191B2
`
`(12) United States Patent
`(10) Patent N0.:
`US 6,602,191 B2
`
`Quy
`(45) Date of Patent:
`Aug. 5, 2003
`
`(54) METHOD AND APPARATUS FOR HEALTH
`AND DISEASE MANAGEMENT COMBINING
`PATIENT DATA MONITORING WITH
`WIRELESS IN FERN E'l LONNELI [VITY
`.
`W
`Il‘lVCl’ltOl‘I Roger J. Qlly, IVIIII Valley, CA (US)
`
`(75)
`
`(73) Assignee: Q-tec Systems LLP, \Vilmington, DE
`(US)
`
`( * ) Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U S C 154(b) by 199 days
`'
`'
`‘
`‘
`
`(2]) Appl. No; 09/738,270
`
`$8
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`FOREIGN PATENT DOCUMENTS
`a
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`$8 330:3?
`15:3;
`OW 97/255737
`8/1997
`“’0 98/24358
`6/1998
`“/0 98/38909
`9/1998
`WO 99/04687
`2/1999
`wo 99/148232
`3/1999
`\VO 99/41682
`8/1999
`“’0 99/44494
`9/1999
`W0 99/46718
`9/1999
`W0 00436900
`6/2000
`\VO 00/40145
`7/2000
`W0 0054205
`9.2000
`WO 00/54206
`9/2000
`W0 00/621562
`10/2000
`
`(22) Filed:
`
`Dec. 15,2000
`,
`,
`.
`.
`.
`_
`Prior Publication Data
`US 2001/0047125 A1 Nov. 29, 2001
`
`(65)
`
`(60)
`
`Related U.S.Application Data
`Provisional application No. 60/172,486, filed on Dec. 17,
`1999’
`Int. Cl.7 .................................................. A61B 5/00
`(51)
`(52) U.S. C].
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`_
`128/923
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`600/345, 365, 481, 483, 485, 509, 529;
`607/27, 30, 31, 32, 60; 128/902, 903, 904,
`905) 920, 923) 924; 709/204, 205’ 230,
`238 245 246' 705/2 3. 707/6
`’
`’
`’
`'
`i
`’
`'
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`Primary Examiner—Willis R. Wolfe
`(74) Attnrngy; Age”): (yr Firjn—Niark D Wieczorek
`(57)
`ABSTRACT
`
`A method and apparatus for a Wireless health monitoring
`system for interactively monitoring a disease or health
`condition of a patient by connecting an internet—enabled
`Wireless web device ("W WD”)
`to a health monitoring
`device which may be a medical device or other health related
`device. The WWD may be connected to the health moni-
`toring device directly by a Wired connection to a generic
`input/output port of the WWD or wirelessly connected to the
`health monitoring device, such as via an infrared or radio
`frequency connection. The health related data is transmitted
`from the WWD to a server I] sing standard internet protocols.
`The server calculates a response using a software program
`While providing for review bt a physician or health special-
`ist, The user may interact With the server, for example, the
`server transmits a response to the WWI) and the user may
`answer the response or provide other information.
`
`(List continued on next page.)
`
`105 Claims, 8 Drawing Sheets
`
`
`
`PNA-FBOOOG871
`
`

`

`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 6 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 6 of 307
`
`US 6,602,191 B2
`
`Page 2
`
`“Wired for Wellness”; LifeChart.con1; http://wwwlifecharh
`.com; 2 pages; Nov. 24, 2000.
`“About Data Critical Corporation”; Yahoo—Data Critical to
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`palowireless.com—bluetooth
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`torial.aso; 4 pages; Nov. 28, 2000.
`“Bluetooth Profiles”; palowirelesscom777777bluetooth resource
`center; http://www.palowireless.com/infotooth/tutorial/pro—
`filesasp; 4 pages; Nov. 28, 2000.
`Nick Hunt; “Bluetooth Vesus 802.11”; TDK Systems; http://
`www.cellular.co.za/bluetooth versus 802.htrn; 4 pages; Nov.
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`“Bluetooth vs. Airport (802.1] Network)”; palowireless—
`.com—bluetooth resource center; http://www.palowireless-
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`mas Weisel Partners (Merchant Banking); 5 pages; Nov. 29,
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`Ashlee Vance; “Ericsson and Intel make Bluetooth pact”;
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`.
`.
`.
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`
`

`

`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 7 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 7 of 307
`
`US. Patent
`
`Aug. 5,2003
`
`Sheet 1 0f 8
`
`US 6,602,191 B2
`
`INTERNET
`
`____________________________________________________________________
`
` WIRED
`
`______________________________________________________________________
`
`FIG.1
`
`
`
`PNA-F80006873
`
`

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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 8 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 8 of 307
`
`US. Patent
`
`Aug. 5, 2003
`
`Sheet 2 0f 8
`
`US 6,602,191 B2
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 9 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 9 of 307
`
`US. Patent
`
`Aug. 5,2003
`
`Sheet 3 0f 8
`
`US 6,602,191 B2
`
`SERVER 1s
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 10 of 307
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 12 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 12 of 307
`
`US. Patent
`
`Aug. 5, 2003
`
`Sheet 6 of 8
`
`US 6,602,191 B2
`
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 13 of 307
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 14 of 307
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`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 15 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 15 of 307
`
`US 6,602,191 B2
`
`1
`METHOD AND APPARATUS FOR HEALTH
`AND DISEASE MANAGEMENT COMBINING
`PATIENT DATA MONITORING WITH
`WIRELESS INTERNET CONNECTIVITY
`
`CROSS-REFERENCE T0 RELATED
`APPLICATIONS
`
`This application is a conversion of U.S. Provisional Patent
`Application Ser. No. 60/172,486 filed Dec. 17, 1999, entitled
`“Method and Apparatus for Health and Disease Manage—
`ment Combining Patient Data Monitoring with Wireless
`Internet Connectivity”.
`
`10
`
`REFERENCE TO GOVERNMENTAL SUPPORT
`
`(none)
`REFERENCE TO MICROFICHE APPENDIX
`
`(none)
`
`FIELD OF THE INVENTION
`
`invention relates to monitoring of living
`The present
`subjects, and more particularly to health—monitoring of
`persons where measured or input health data is communi-
`cated by a wireless device to and from a software application
`running on an internet—connected server and where the same
`may be studied and processed by the software application, a
`health professional, or the subject.
`
`BACKGROUND OF THE INVENTION
`
`Several attempts have been made in the past to achieve
`etficient interactive communication of medical or health
`information between a subject or patient and a reviewer or
`provider of that information. In particular, communication
`of consumer physiological information has been a subject of
`such attempts. It is noted that in this regard the “reviewer or
`provider of medical or' health information” is understood to
`include not only a physician but also a software application
`or algorithm that may analyze the information.
`Medical or health information has been made available on
`a CD—ROM accessible by a home computer system. This
`passive approach had certain disadvantages. First, although
`the personal computer is prevalent is the United States, it is
`generally too expensive for a consumer physiological moni-
`toring system and there are many people who find it too
`complicated to set up and use for that purpose. High-risk,
`chronically ill patients, responsible for more than half of
`health care costs in the. United States and forming the fastest
`growing segment of those requiring health care, are indeed
`the most likely not to be. able to afford or use a system built
`around a personal computer. In addition, such systems are
`limited in their interactivity to the information stored on the
`CD.
`
`Previous patents by the Inventor addressed both of these
`disadvantages, as well as the need to reduce health care costs
`through providing educational health care information and
`interactive physiological monitoring in the home environ-
`ment by means of a user-friendly, interactive system (see,
`e.g., U.S. Pat. Nos. 5,601,435, 6,144,837, and continuations
`thereof).
`These previous patents were based on a video game
`console, or a multimedia player using a conventional tele—
`vision screen as the display device to achieve a system
`which is simpler to use than systems based on a personal
`computer. An initial embodiment of the previous patents
`
`7
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`2
`utilized a compact disc to provide interactive information for
`disease management.
`Even with the advantages provided, these systems limited
`the user to location in which the device was located. Even
`where devices are portable. as in the case of a laptop
`computer with a modem, an ordinary POTS phone line must
`be found and used. Where the user’s computer employs a
`broadband connection, such as DSL or satellite, the choices
`of location are even more limited.
`
`Attempts have been made to remedy this deficiency. For
`example, many telemetry systems allow a “wireless” dis-
`tance to be placed between a health measuring unit and a
`remote monitoring system. However, such systems are lim-
`ited in their range.
`Other systems have used cellular telephone technology to
`increase the wireless health monitoring range. However,
`these systems have several deficiencies, such as requiring
`significant modification of the mobile phone. For example,
`US. Pat. No. 5,772,586, issued Jun. 30, 1998 to Heinonon
`et al., discloses a method for monitoring the health of a
`patient. This system uses a specialized connection between
`the patient health measuring unit and the cellular phone,
`however. The patient health measuring unit is located in the
`battery space of the mobile phone and is connected to a
`COIIIITIUHICfllell bus of the mobile phone. Other systems
`have been proposed, but these suffer from similar deficien-
`cies in that they are not designed to be used with “off—the-
`shelf” wireless devices or health measuring equipment.
`The deployment of the above systems also currently lacks
`employment of full back—end server functionality with
`which to provide a wide range of interactive communication
`with the patient. Instead, such systems, if internet—enabled,
`are often limited to mere one-way non—interactive data
`transfer via a modern. While some systems are more
`enhanced, including that disclosed in US. Pat. No. 5,357,
`427, issued Oct. 18, 1994 to Langcn, ct al., and entitled
`“Remote Monitoring of High—Risk Patients using Artificial
`Intelligence", these systems are limited by the wired tele-
`communications infrastructure.
`
`SUMMARY OF THE INVENTION
`
`Embodiments of the present invention overcome one or
`more of the disadvantages of the prior art by providing a
`full-feature health-monitoring system that may wirelessly
`connect to a back-end server application via the internet. The
`invention allows wireless access to and from a wide variety
`ofpresent medical or health—related instruments and devices,
`while maintaining the capability of connecting to future such
`devices.
`
`In particular, the invention may be embodied in several
`systems. Two complementary such systems are described
`herein, although extensions to other such systems can be
`envisioned. First, an embodiment of the invention may be
`employed to manage the disease state or condition of a
`patient. In this embodiment, the patient may employ a health
`monitoring device (“HMD”), in particular a medical device,
`and a Wireless connection provides data from the medical
`device for processing via the internet including a review by
`a physician or other health care professional if required.
`In the second embodiment, a health or lifestyle manage—
`ment plan may be implemented. Various health parameters,
`such as those relating to nutrition or exercise, may be
`entered into a health monitoring device, in this instance
`terrned an “exercise machine”, and the same may be wireless
`communicated to a server. An application may process and
`store the health parameters, and a health specialist may
`optionally review the same.
`
`PNA-FBOOOG881
`
`

`

`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 16 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 16 of 307
`
`US 6,602,191 B2
`
`3
`Wireless internet connectivity has many advantages. For
`example, in the first embodiment, a diabetic could connect
`a blood glucose meter to an intemet-enabled wireless web
`device (“WWD”) away from home and download data to a
`Diabetes Management Company’s server and, in response,
`receive guidance displayed on the screen (or by voice) about
`choices for the next meal.
`
`Alternatively, in the second embodiment, a person inter-
`ested in tracking an exercise program may take the WD to
`the local health club and attach the same to an exercise
`machine, send data output from various exercise machines
`over the Internet, and receive a personalized response from
`the server of a company specializing in Health & Lifestyle
`Management. The individual may input caloric content of
`foods eaten, and may further input caloric content of exer—
`cise performed. In this way, e.g., a person in a weight—loss
`program may see in great detail whether they are expending
`more calories in the form of exercise than the same indi~
`vidual is consuming in the form of food.
`the
`In general, in the health management embodiment,
`system may be employed to monitor the physiologic status
`of a healthy subject while eating, exercising, or performing
`other activities. For clarity, such devices are termed herein
`“exercise machines”. These may include an electronic body
`weight scale, a body fat gauge, biofeedback devices, phys-
`iotherapy or chiropractic equipment, blood pressure
`recorders, or the like, or any type of exercise machine or
`monitor, including a heart rate monitor, treadmill, rowing
`machine, stepper, or the like.
`In more detail, the present invention provides a method
`and system for assisting patients to manage a disease or
`maintain healthy lifestyle by collecting health-related data
`and providing information in response to those data by
`means of a WWD designed to display interactive informa-
`tion through a connection to the 1ntemet. The present
`invention may be connected to various HMDs, both medical
`and exercise-related in nature, and may communicate infor-
`mation via a wireless connection such as a wireless Internet
`connection.
`
`A major advantage of embodiments of the invention is
`that the same frees the patient from the constraints of wired
`systems. The same allows users with consumer “off-the-
`shelf” wireless devices to significantly extend the range of
`connectivity over that of wired computer, television, or even
`wireless telemetry systems.
`In a first embodiment of the present invention, the WWD
`is a web-enabled cellular phoue. Here it is noted that the
`term “web” or “internet” are used interchangeably to refer to
`the intemet in general. In a second embodiment, the WD
`is a palm, handheld, or laptop computer, or a PDA, equipped
`with a wireless modem. In a third embodiment, the WWD
`may he a hybrid device that combines the functions of a
`computer, PDA and telephone.
`An adaptor is used if necessary to convert the output
`signal of the medical monitoring device to a suitable input
`signal for the WW'D. The adaptor allows connection of the
`WWD to a medical device, exercise machine or other variety
`of health care equipment, and the connection may be made
`Via several techniques. As for wired techniques, a standard
`parallel bus or serial cable may be used if the input/output
`ports between the HMD and the WWD are appropriate.
`Otherwise, a suitable separate adaptor may be employed.
`The connection may also be an input such as a disk drive
`or other media input for input of data, a USB port or phone
`jack or other such wired input, again employing an adaptor
`if required.
`
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`As for wireless techniques, infrared (IR), microwaves,
`radio frequency (RF), e.g., Bluetooth® or 802.11 protocols,
`optical
`techniques including lasers, and other such tech—
`niques may be used. The patient or subject may also input
`data manually, such as by a stylus, keypad, synchronization
`from a PC, or by various other techniques discussed below.
`A major advantage of the invention is that by use of an
`optional adaptor, the system is compatible with current and
`prior I’lMI)s as well as maintaining a capability of adapting
`to future such systems.
`Other advantages of the invention may include one or
`more of the following. An embodiment of the invention may
`be used when a patient is traveling or otherwise away from
`their “wired” means of communication. The invention
`allows wireless health-monitoring to the level of accuracy
`previously achieved only by desktop so-called “wired”
`computer systems. The invention is protocolvindependent.
`The interaction between a WWD and a back-end server
`may provide a major additional advantage in certain
`embodiments of the invention. In particular, the relatively
`small amount of memory currently provided on a WWD as
`compared to a back—end server severely limits the function—
`ality of applications running on the WWD, especially in
`terms of computing capacity, processing power, and user
`interface. By providing significant application functionality
`on the back—end, less memory and processing capabilities
`become necessary on the WWD (i.e., on the “front-end”).
`Thus, memory may be used in the WD for an enhanced
`user interface or for other purposes, according to the user
`requirements.
`In a method according to an embodiment of the invention,
`the patient connects to a specific 1ntemet site and a software
`program, resident on a remote server located on the Internet,
`downloads an interactive user interface for that patient and
`an application for the measurement of the physiological
`data. The software may also be downloaded to the WWD
`from a personal computer via a synchronization operation in
`known fashion. The software provides a personalized dis—
`play for the user and configures the WWD to control and
`monitor devices connected via a generic input/output port to
`the WD. The software may be designed to suit
`the
`constraints of the small display screens of WWDs. The
`software, as well as inputs from the patient or other inputs,
`can control the manner, content, and display of information
`presented to the patient, and measured or input data can be
`stored for review by a health care provider or by a software
`algorithm or application. The algorithm may be of varying
`complexity, from a simple program that merely acknowl-
`edges receipt of information to an artificial
`intelligence
`algorithm, such as an expert system, collaborative filtering
`system, rules based system, case-based reasoning system, or
`other such artificial intelligence application.
`Further information may be provided to or from the
`patient, including information entered manually. The patient
`may input this information via a personal computer, which
`then may download the input information to the WD via
`a synchronization operation using standard protocols, such
`as those for Palm PDA devices.
`
`The user may also input supplemental information via a
`PC connected independently to the server via the internet.
`Such supplemental information may include data that
`is
`difficult or inconvenient to input on the WWD. In this way,
`the patient may be afforded a more convenient environment
`in which to manipulate data to supplement the data input to
`the WWD. The deployment of voice processing technology
`may be used to enable an even more convenient user
`interface: i.e., one to which patients can talk.
`
`PNA-F80006882
`
`

`

`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 17 of 307
`Case 1:19-cv-11586-FDS Document 168-12 Filed 03/31/21 Page 17 of 307
`
`US 6,602,191 B2
`
`5
`In all of these respects, the portable aspect of the WD
`is important:
`to wit, the user may conveniently carry the
`WWD on their person wherever they may go, allowing data
`entry at the time needed.
`Other aspects, features, and advantages will be apparent
`from the summary above, as well as from the description
`that follows, including the figures and the claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 illustrates a general embodiment of a wireless
`health-monitoring system according to the present inven-
`tion;
`FIG. 2 illustrates an embodiment of a wireless health-
`monitoring apparatus according to the present invention,
`showing the system of FIG. 1 up to a point of a wireless
`antenna;
`FIG. 3 illustrates an embodiment of a back end of a
`health-monitoring system according to the present inven-
`tion;
`
`FIG. 4 illustrates a data flow diagram according to an
`embodiment of the present invention;
`FIG. 5 illustrates an embodiment of a method of use for
`
`a wireless application and a server application according to
`the present invention, in which the same is implemented for
`disease and patient management,
`FIG. 6 illustrates an embodiment of a method of use for
`a wireless application and a server application according to
`the present invention, in which the same is implemented for
`health management;
`FIG. 7 illustrates an embodiment of a wired connection
`between a HMD and a W'WD, also showing an optional
`adaptor; and
`FIG. 8 illustrates an embodiment of a wireless connection
`between a IIMD and a WWD, also showing an optional
`adaptor.
`
`DETAILED DESCRIPTION OF THE
`PREFERRED EMBODIMENTS
`
`Various acronyms are used for clarity herein. Definitions
`are given below.
`The term “HMD” may encompass not only devices with
`physiologic sensors but also devices with a keypad,
`keyboard, mouse, pointer, pressure sensor, or other such
`inputs that the patient or user may employ to perform data
`entry of the desired parameters. In general, HMDs include
`some means for determining a health parameter.
`In a disease management embodiment, an HMD may be
`a blood glucose monitor, a blood pressure monitor, an
`ambulatory ECG recorder, a respiratory monitor, a tempera-
`ture or heart rate monitor, and so on.
`In a healthy lifestyle management embodiment, an IIMD
`may be an exercise machine, including treadmills, rowers,
`steppers, exercise cycles, or other aerobic or anaerobic
`exercisers, or a monitor, include monitors for temperature,
`heart rate, blood pressure, amount of work or rate of work
`performed, etc.
`The term “subject” as used herein primarily indicates a
`human subject. The same may be a medical patient under
`physician care, a person interested in maintaining health via
`accurate recording of nutrition and exercise, and so on. The
`term “user” is generally used to refer to the user of the
`device, which may be synonymous with the subject or may
`alternatively be a caregiver of the subject, etc. The term
`“patient” is used, in addition to a person under the care of a
`
`10
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