WO2011028261A2 - Portable medical record storage device with wireless communication capability - Google Patents

Portable medical record storage device with wireless communication capability Download PDF

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Publication number
WO2011028261A2
WO2011028261A2 PCT/US2010/002354 US2010002354W WO2011028261A2 WO 2011028261 A2 WO2011028261 A2 WO 2011028261A2 US 2010002354 W US2010002354 W US 2010002354W WO 2011028261 A2 WO2011028261 A2 WO 2011028261A2
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WO
WIPO (PCT)
Prior art keywords
device
recognition
medical
information
medical record
Prior art date
Application number
PCT/US2010/002354
Other languages
French (fr)
Other versions
WO2011028261A3 (en
WO2011028261A8 (en
Inventor
Steven C. Quay
Shu-Chih Chen Quay
Jeremy J. Thompson
Original Assignee
Ensisheim Partners, Llc
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Publication date
Priority to US23766409P priority Critical
Priority to US61/237,664 priority
Application filed by Ensisheim Partners, Llc filed Critical Ensisheim Partners, Llc
Publication of WO2011028261A2 publication Critical patent/WO2011028261A2/en
Publication of WO2011028261A3 publication Critical patent/WO2011028261A3/en
Publication of WO2011028261A8 publication Critical patent/WO2011028261A8/en

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Classifications

    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W12/00Security arrangements, e.g. access security or fraud detection; Authentication, e.g. verifying user identity or authorisation; Protecting privacy or anonymity ; Protecting confidentiality; Key management; Integrity; Mobile application security; Using identity modules; Secure pairing of devices; Context aware security; Lawful interception
    • H04W12/02Protecting privacy or anonymity, e.g. protecting personally identifiable information [PII]
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F19/00Digital computing or data processing equipment or methods, specially adapted for specific applications
    • G06F19/30Medical informatics, i.e. computer-based analysis or dissemination of patient or disease data
    • G06F19/34Computer-assisted medical diagnosis or treatment, e.g. computerised prescription or delivery of medication or diets, computerised local control of medical devices, medical expert systems or telemedicine
    • G06F19/3418Telemedicine, e.g. remote diagnosis, remote control of instruments or remote monitoring of patient carried devices
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/30Authentication, i.e. establishing the identity or authorisation of security principals
    • G06F21/31User authentication
    • G06F21/32User authentication using biometric data, e.g. fingerprints, iris scans or voiceprints
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/60Protecting data
    • G06F21/62Protecting access to data via a platform, e.g. using keys or access control rules
    • G06F21/6218Protecting access to data via a platform, e.g. using keys or access control rules to a system of files or objects, e.g. local or distributed file system or database
    • G06F21/6245Protecting personal data, e.g. for financial or medical purposes
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F21/00Security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F21/70Protecting specific internal or peripheral components, in which the protection of a component leads to protection of the entire computer
    • G06F21/78Protecting specific internal or peripheral components, in which the protection of a component leads to protection of the entire computer to assure secure storage of data
    • G06F21/79Protecting specific internal or peripheral components, in which the protection of a component leads to protection of the entire computer to assure secure storage of data in semiconductor storage media, e.g. directly-addressable memories
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/10Office automation, e.g. computer aided management of electronic mail or groupware; Time management, e.g. calendars, reminders, meetings or time accounting
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06QDATA PROCESSING SYSTEMS OR METHODS, SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL, SUPERVISORY OR FORECASTING PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q50/00Systems or methods specially adapted for specific business sectors, e.g. utilities or tourism
    • G06Q50/10Services
    • G06Q50/22Social work
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • G16H10/65ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W4/00Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/02Services making use of location information
    • H04W4/029Location-based management or tracking services
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W4/00Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/90Services for handling of emergency or hazardous situations, e.g. earthquake and tsunami warning systems [ETWS]
    • GPHYSICS
    • G06COMPUTING; CALCULATING; COUNTING
    • G06FELECTRIC DIGITAL DATA PROCESSING
    • G06F2221/00Indexing scheme relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F2221/21Indexing scheme relating to G06F21/00 and subgroups addressing additional information or applications relating to security arrangements for protecting computers, components thereof, programs or data against unauthorised activity
    • G06F2221/2111Location-sensitive, e.g. geographical location, GPS
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H10/00ICT specially adapted for the handling or processing of patient-related medical or healthcare data
    • G16H10/60ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L63/00Network architectures or network communication protocols for network security
    • H04L63/08Network architectures or network communication protocols for network security for supporting authentication of entities communicating through a packet data network
    • H04L63/0861Network architectures or network communication protocols for network security for supporting authentication of entities communicating through a packet data network using biometrical features, e.g. fingerprint, retina-scan
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W4/00Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/12Messaging; Mailboxes; Announcements
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W4/00Services specially adapted for wireless communication networks; Facilities therefor
    • H04W4/80Services using short range communication, e.g. near-field communication [NFC], radio-frequency identification [RFID] or low energy communication
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W88/00Devices specially adapted for wireless communication networks, e.g. terminals, base stations or access point devices
    • H04W88/02Terminal devices

Abstract

A portable, secure medical record storage and management device is provided together with systems and methods for inputting, managing and updating the records contained in such a device. Additionally provided are mobile devices which can provide assistance and relay information in emergency situations. Access to the contents of medical record storage and management device is controlled using biometric sensors as well as other authentication means.

Description

Portable Medical Record Storage Device With Wireless Communication Capability

Related Applications

[0001] This application claims the benefit of priority from United States Provisional patent application Serial No. 61/237,664, filed August 27, 2009, of which the priority disclosure for each is incorporated herein by reference in its entirety.

Technical Field

[0002] The present invention is related to the field of secure information storage and management devices. More particularly, the invention relates to portable devices for secure storage and management of medical data.

Background

[0003] The growing complexity of medical care and the increasing number of professionals involved presents ever-increasing challenges to the delivery of coherent and consistent care. Medical records are key instruments that assist health care providers in delivering coherent and consistent care to patients and can include a wide variety of data, for example, physical examination notes, histories of illness or disease, surgical histories, operation reports, obstetric histories, medication status and history, medical allergies, family histories, social, education, employment, and behavioral data (e.g., alcohol and tobacco use, sexual habits, diet, exercise), immunization histories, growth and developmental data, and other clinical data, such as laboratory test results and diagnostic data, charts, and images (e.g., x-rays, CT scans, electrocardiograms, echocardiography reports, and the like.)

[0004] Access to these and other medical data in a current, comprehensive patient record is important for making medical diagnoses and providing successful patient care. However, most patients do not have access to their complete medical records, and records are frequently maintained in multiple sites by multiple care providers so that no one actually has access to a patient's complete file or even the relevant portions of a patient's file.

[0005] Most medical records are stored at individual doctors' offices or clinics, and patients seldom obtain and maintain copies of their own medical records. As is frequently the case, patients may be provided care at numerous independent facilities, for example in a doctor's office, at a clinic, in a hospital, in a rehabilitation facility, in a board-and-care facility, in an assisted living facility, or in a nursing home. Each facility is likely to keep distinct medical records pertinent to a patient's continuity of care. Practitioners may not know of or may not have up-to-date, accurate information about the care provided or recommended by other practitioners and at other facilities. Patients themselves are frequently unable to bridge the information gap between different facilities and providers because patients seldom fully comprehend the nature and details of their care and, as noted above, typically do not maintain their own comprehensive medical histories.

[0006] Whenever a health care provider lacks complete, up-to-date and accurate medical records, patient care may be sub-optimal. In more serious cases,

inappropriate drugs or treatments may be prescribed. Diagnostic tests may be needlessly repeated, increasing costs and risks. Additionally, necessary preventive measures may not be taken because subsequent providers may assume prior caregivers have already addressed the subject.

[0007] In order to assemble a complete medical history, a patient or new caregiver must trace prior health care facilities and providers and request the transfer of patient records. In many instances, patient records become part of a paper file but not an electronic file so even if they are present in the office of a provider, a complete record may not be readily accessible or transferable. Some facilities only transfer their own records, so records from other facilities, though part of a patient's original file, may not be transferred to the next care provider. After a certain length of time, original records may be destroyed so that even if a patient goes back to an original care provider, the only place the records may exist is as copies in a later doctor's file. Additionally, if a patient is sent to a specialist, the records, if any, received by the specialist are usually incomplete.

[0008] Even more urgent problems relating to medical record storage and

management arise in the context of emergency situations. In such situations, health care decisions must be made rapidly, and there may be little or no time to access available medical records. When no medical records are available in a timely fashion, emergency health care providers must rely on patients themselves to provide critical care information, such as medication allergies, prior or current illness information, current medication data, etc. In some circumstances, the patient may be unable to provide such information. For example, each year in the U.S., over one million patients arrive at emergency departments unconscious. In cases where a patient in an emergency care situation is unconscious or otherwise incapacitated and unable to provide health information, there may be no access to critical medical data and the provider must rely purely on observation and/or generic protocols to guide emergency health care decisions. Many individuals with serious conditions wear medic alert bracelets, but such devices provide limited information by nature and may be overlooked in a rush to provide care.

[0009] A portable, complete and accurate set of patient medical records, or relevant portions of patient records (such as a Continuity of Care Document (CCD) or Continuity of Care Record (CCR)), would enable medical care providers and facilities to deliver better and more comprehensive care to individuals, increasing safety and efficiency, reducing errors, and decreasing costs. However, with increased portability, there is an attendant concern regarding security of patient medical information. There is therefore an unmet need for a secure, portable means for transferring, storing, accessing and updating individual healthcare information.

[0010] In addition to the foregoing problems and needs, under various circumstances, including emergency patient care in the field, medical records must be accessible to third parties, such as emergency care providers, in a secure fashion. Patients may not be able to assist in medical record retrieval under such circumstances, in which case secure access to the subject records may be impossible using current medical record storage and management device technologies. Therefore, there is a further need for medical record storage and management device tools that will allow third party access to patient medical records in the case of patients who are rendered unable to access the subject records, and/or to provide security access input on their own. A related need exists for tools that will allow patients to summon emergency assistance in the field, whereby upon arrival of the emergency provider the provider can access critical patient medical data that is securely stored and maintained with the patient. There is also a need for patients to be able to summon medical assistance quickly, optionally with the same device that stores and manages patient medical information. Summary of Exemplary Embodiments of the Invention

[0011] To solve these problems and others, the present invention provides a medical record storage and management device to which access is controlled by one or more levels of biometric authentication, alone or in combination with other methods of authentication and systems for creating, using and updating such a device. The present invention further provides means for overriding the biometric authentication to some or all of the records in emergency situations and a means for summoning assistance if required.

[0012] The medical record storage and management device may include some or all of a patient's medical records. In some embodiments, the device may include summaries of a patient's medical records. In other embodiments, the device may include a treatment plan currently in place for a patient. The device may optionally or additionally include documents such as advance medical directives, living wills or durable powers of attorney.

[0013] A further benefit of the invention is that it is a portable device that can be carried or worn by the user. In some embodiments it may be sized and dimensioned to fit in a pocket, to be handheld, or to be worn by the user. The data stored by the device may be static, in that it may not be altered, or fluid, in that the records can be updated each time a patient visits a healthcare provider or medical facility. In some embodiments, the medical record storage and management device may be updated through a central server that compiles information from a variety of sources including health care providers.

[0014] There may be templates for patient-entered information as well as for information to be entered by health care providers. The device may allow a care provider or facility to upload information to the provider's system as well as record information to the device. In some embodiments, the patient may specify the amount or type of data that may be transferred. In some embodiments, new data is added sequentially to an existing record. In other embodiments, the device may integrate new material into existing records and/ or generate current summaries based on new data received. In some embodiments the device contains complete medical records. In other embodiments, the device contains the most recent medical records. In yet another embodiment, the device may contain a summary of information that would be relevant in an emergency

[0015] In one embodiment, the medical record storage and management device also stores data from diagnoses that can be matched with patient symptoms, personal history, or family history. In other embodiments, upon receiving updated prescription information, the medical record storage and management device can signal a warning of possible allergic reactions or negative drug interactions based on prior information and existing prescriptions stored in the device. In another embodiment, the device may transmit monitoring information to a care facility and receive a diagnosis in return.

[0016] Some or all of the information on the medical record storage and management device may be encrypted or otherwise secured, for example requiring biometric authentication in order to unlock the device or portion of the device containing medical records or to un-encrypt the data on the device relating to medical records. In some embodiments, certain basic information that may be needed by emergency medical personnel may be available without biometric authentication, for example, emergency contact information, blood type, current medications, drug allergies, and insurance information may be part of the readily available data. In other

embodiments, information available without biometric authentication may include the type of information generally seen on medic alert bracelets. In further embodiments, the device may contain a pre-recorded health summary message. Such a message may be in an audio or visual format and may initiate automatically upon activation of the emergency system, may be accessed by a user of the device, may be accessed by health care personnel, or may be sent to emergency service providers.

[0017] There may be one or more levels of encryption or one or more levels of authorization or requirements for authentication for different types of medical records. In some embodiments, care providers may verify the ownership of the records on the medical care storage and management device through a patient verification system. Such a system may include a comparison of a facial image of the patient in the data of the medical record storage and management device with the individual being treated as well as other types of verification including personal information such as birthdates and social security numbers. In other embodiments, verification may occur through the use of a biometric sensor. In yet further embodiments, verification may occur through a combination of a biometric sensor and other forms of patient verification. In one embodiment, security of one or more levels of data may be overridden by emergency services personnel. The types of encryption or authorization and authentication and the levels of encryption or authorization and authentication may be standardized throughout the device or may vary depending on the sensitivity of the information. In some embodiments, the encryption and other means for securing the data meets FIPS (Federal Information Processing Standards) and HIPA (Health Insurance Portability and Accountability Act of 1996) standards.

[0018] The medical record storage and management device may be any form of portable or mobile mass storage device such as a Smart Card, compact flash ("CF") card, secure digital ("SD") card, mini SD card, micro SD card, multi-media ("MMC") card, and memory stick, portable flash memory based universal serial bus ("USB") drives with collapsible or rigid jacks, a micro drive, a Magnetic Random Access Memory (MRAM), a Ferroelectric Random Access Memory (FRAM), a Static Random Access Memory (SRAM) or the like or any combination thereof. The memory is a non-volatile memory. It is possible that various external circuitries, including power supply circuitry, clock circuitry, storage interface circuitry and USB communication circuitry, are involved in the design depending on the chip being used. The device may be in any shape useful, for example, in some embodiments, the device would be manufactured so that it could be worn, for example as jewelry, watches, key chains, wrist bands, etc. In other embodiments, the device may be in the shape of a chip, card, micro drive or memory stick. Generally, the device weighs between about 10 to about 900g, preferably about 20 to about 700g, about 30 to about 150g, 20 to about 80g, between about 40 to about 50g or about 50 to about 60g. The device may be any size useful, preferably from about 0.75 inches to about 10 inches long, about 1 inch to about 5 inches long, about 1 inch to about 4 inches long, about 1.5 inches to about 3 inches long, about 1 to about 2 and a half inches long.

Information transfer may occur using a card reader, USB connection, using Bluetooth, wirelessly or by any other means generally used to transfer data. In some

embodiments, some information may be sent wirelessly while the transfer of other information may require a direct connection. Wireless transmission may occur by any means generally used to send information such as, but not limited to, radio signals, infrared signals, VHF signals, UHF signals, satellite signals, cellular signals, laser light, visible light, acoustic energy or radiowave signals and the like. In some embodiments, the medical record storage and management device may be

incorporated into a larger portable or mobile device, for example, a cell phone, an

MP3 player, a smart phone, a handheld computer, a personal digital assistant (PDA), a computer tablet, or other similar device. Smartphones offer computing environments that are similar to that provided by a personal computer. They can effectively provide a complete operating system as a standardized interface and platform for application developers.

[0019] Mobile computing devices such as smart phones, typically include at least some form of readable media. Readable media can be any available media that can be accessed by the mobile device including computer storage media and communication media. Computer storage media includes, but is not limited to, volatile, non-volatile, removable, non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules, plug-ins or other data. Such storage media includes RAM, ROM, EEPROM, flash meory, or other memory technology, CD-ROM, DVD, or other optical storage, magnetic cassettes, magnetic tape, magnetic disk storage or other magenetic storage devices, or any other medium which can be used to store the deired information and which can be accessed by the mobile device such as a smartphone. Exemplary smartphones run operating systems including, but not limited to, Google Android, RIM Blackberry, Microsoft Windows Mobile, Palm, Linux, Symbian and/or Apple iPhone, iPad Operating System (OS). Descriptions of smart phones may be found, for example in U.S. Patent No. 7,571,393 incorporated herein by reference in its entirety. In some embodiments, the medical record storage and management device may be installed as an application or plug-in on a smart phone or other PDA, including, but not limited to, devices such as Google Android, RIM Blackberry, Microsoft Windows Mobile, Palm, Linux, Symbian and/or Apple iPhone, iPad Operating System (OS) compatible device, turning the smartphone or other PDA into a medical record storage and management device. In some embodiments, a portion of the memory in such devices is dedicated to medical record storage. Such devices can transfer records by any means generally used including wirelessly, via a Bluetooth protocol, via the Internet, using a USB connection or other data transfer protocol. In some embodiments, the device will wirelessly synchronize the personal medical record from one or multiple online services and information aggregators such as Google Health, Microsoft Health Vault, or any other eCCR compatible personal medical record services.

[0020] The medical record storage and management device may also include a wireless transmitter capable of sending a signal. For example, the medical record storage and management device may include an emergency function that includes a medical alert system. A medical alert system is a personal emergency response system designed to reduce complications associated with a health-related

emergencies. Such an alert system may be accessed by any means commonly used. In some embodiments, the emergency function may be activated by a single push button or other operation that initiates the medical alert system to contact emergency services, a monitoring service or any other contacts the user wishes to include. For example, activation of the emergency function initiating the medical alert system may send a signal to 911 or other emergency service number and the user's emergency contact person, or may contact the nearest hospital. The medical alert system may contact one, two, three, four, five, six, seven or more contacts. For example, in the case of an elderly person, the single push button or other operation contacts 911, the person's spouse, the person's doctor and/or the assisted living facility where the person resides in any order chosen by the user or simultaneously. In a further embodiment, activation of the emergency procedure may provide the option of sending a signal.

[0021] Activation of the emergency function of the medical record storage and management device may occur by any means generally used. A trigger may be mechanical, audio or electronic such as on a touch screen. Exemplary triggers include, but are not limited to, a panic button on the device, voice activation, a particular keying sequence, a touch screen button, a toggle, a slide, a strong impact sensor (e.g., for use in automatically transmitting a request in the event of a high- impact collision), a heat sensor (e.g., for use in automatically requesting emergency services in the event of a fire), a medical sensor (e.g., for automatically triggering a request for emergency services upon the detection of the cessation of a heart beat or other physical or medical condition).

[0022] In some embodiments, activation of the emergency function on the portable medical record storage and management device may require a sequence of events, i.e. pushing a panic button one or more times within a particular length of time, such as, for example, three times within five seconds. In another embodiment, the emergency function may be activated by holding a button on the medical record storage and management device for a particular length of time, for example, 2, 3, 4, 5, 6, or more seconds. In a further embodiment, the emergency function may be activated by moving a slide across a screen or shaking the device for a particular length of time.

[0023] When the medical alert system is initiated and a signal is to be sent, the signal may be sent by any means generally used to convey a signal to a third party. For example, the information may be sent by radio signal, infrared signal, a VHF signal, a UHF signal, a satellite signal, a cellular signal, laser light, visible light, acoustic energy, microwave signal, or a radiowave signal or other wireless means of conveying information. In some instances, for example, when the medical record storage and management device is incorporated in a cellular phone, the device may automatically place a phone call to the appropriate service, for example, 911, a monitoring company (which can then contact 911), the medical record storage and management device owner's physician, or a friend or family member. In other embodiments, the device may send a message such as a text message, email, post to an appropriate website, or by any other means of communication generally available on such devices to send information to a third party.

[0024] In some embodiments, activation of the emergency function initiating the alert system may trigger a pre-recorded message. Such a message may be played by or displayed on the medical record storage and management device and/or sent to the emergency services provider or monitoring service. Such a message may include, for example, identification information, a health summary and/or additional information such as an emergency contact, the name of the individual's doctor, the location of medical records, actual medical records or a portion thereof or any other such information. In some embodiments such information is fixed, in other embodiments, the user may record new information. The pre-recorded message may be in any format applicable. For example, it may be a voice message, a text message, a prewritten email message, an automatic posting, or any other applicable format. In some embodiments, the medical record storage and management device may send a code to emergency services providing access to the individual's medical records. Such a code may provide access to the portable medical record storage and management device or to a source for the individual's medical records such as, for example, a website or other readily accessible storage location. In other embodiments, the device may inform the emergency medical personnel where a code may be obtained. For example, a code may be written on an i.d. or medic alert bracelet, or contained in the person's wallet, or otherwise secreted on the individual, or obtained by calling a particular phone number or providing certain identifying information.

[0025] In one embodiment, the medical record storage and management device may also include a tracker, for example a GPS locator or other similar locating device. In such embodiment, the GPS coordinates for the location of the device will be relayed via text to speech, just text, speech, or both. In some embodiments the activation of an alert may send out SMS messages, emails, or updates to Twitter or other social networking websites. In some embodiments the activation of an alert may also send out a hyperlink to access the full personal medical record securely online. In some embodiments, the location of the device will be sent automatically upon activation of the emergency signal. In other embodiments, the user may choose to send their location when they activate the emergency signal. In other embodiments, the device may be located using cell tower triangulation.

[0026] In some embodiments, the medical record storage and management device may also include a bodily function monitor. Such a monitor may monitor functions such as respiration, heart rate, blood pressure, blood sugar, body temperature or any other type of bodily function generally monitored by such passive devices. In some embodiments, the medical record storage and management device may record and/or transmit transmissions from implanted or surface sensors, for example, a pacemaker or electrode on the skin. Monitoring information may be transmitted with an emergency signal or may be accessed by emergency personnel at the scene. In some embodiments, the real time medical data may be transmitted wirelessly to an online medical records server.

[0027] In a further embodiment, activation of the emergency function may trigger an audible alarm. Such an alarm may be simply a noise, or a message that may be repeated requesting assistance.

[0028] Access to the information on the medical record storage and management device may be granted by verification of one or more levels of biometric

identification alone or in combination with other types of authentication such as, for example, authorization/access code, personal identification number (PIN), digital certificate, and/or other identification indicia. In some embodiments, a biometric sensor is incorporated into the medical record storage and management device. In other embodiments, the biometric sensor may be associated with the medical record storage and management device. In further embodiments, the biometric sensor may be separate from the medical record storage and management device. The biometric sensor may authenticate a user using voice recognition, fingerprints, handprints, blood vessel patterns, DNA tests, retinal or iris scan, and face recognition or a combination thereof. In some embodiments, biometric sensors may be attached, plugged into, or otherwise connected to the medical record storage and management device. In some embodiments the medical record storage and management device may include a camera for use in facial recognition.

[0029] In some embodiments, verification of the user may allow activation of the medical record storage and management device. In other embodiments, verification of the. user may decrypt the information on the medical record storage and management device. In yet another embodiment, verification may do both. Different means of authentication or verification may be used to access different types or levels of information on the medical record storage and management device. For example, psychological and counseling service records or drug treatment records may be stored separately from general medical records and may require additional biometric or other authentication in order to be accessed. Verification of the user at one or more stages of accessing and or recording of information on the medical record storage and management device may use the same or different means of authentication.

Authentication may be performed by the medical record storage and management device itself, i.e. through an embedded scanner, or by inputting data into a host device such as a computer, mobile phone, personal digital assistant, or whatever electronic device is used by the care provider to access the medical record storage and management device. Different levels of authentication may also be used to determine what if any data may be transferred to a service provider's system. In some embodiments, after authentication, the personal medical record may be transferred to a doctor or service provider's system either wirelessly or via Bluetooth by bumping their device against a compatible device running the same software. In other embodiments, the personal medical record may be shared with anyone via email and secured with an online passcode or other encryption method including biometric identification of the person accessing a patient's medical records. In some embodiments, there may be an override to the biometric sensor, for example a code that can be entered by emergency personnel. Such a code may be carried on the individual, for example on an i.d. bracelet, or obtainable by contacting a particular service, or sending a message to the service provider for the portable medical record storage and management device, available to all hospitals or medical service providers, or by any other means generally available. In other embodiments, certain information may become accessible if an emergency signal is sent, such as a health care summary and/or list of current medications. [0030] In some embodiments, the medical record storage and management device can be updated through a network from a home computer or other personal computing device. For example, a care facility may provide access to a patient record through the Internet. Updates to a patient's charts, test results, responses to email questions or other information may be transferred to the medical record storage and management device connected to the electronic device the patient is using remotely In other embodiments, the medical record may be updated wirelessly from various online personal medical record providers, such as the provider of the medical record storage device, or a service provider for the medical record storage device, Google Health or Microsoft Health Vault.

[0031] The foregoing objects and additional objects, features, aspects and advantages of the present invention are further exemplified and described in the following detailed description. Brief Description of the Drawings

[0032] Figure 1 is a perspective view of an embodiment of a medical record storage and management device of the present invention.

[0033] Figure 2 is a perspective view of an embodiment of a medical record storage and management device of the present invention.

[0034] Figure 3 is a perspective view of an embodiment of a medical record storage and management device of the present invention.

[0035] Figure 4 is a perspective view of an embodiment of a medical record storage and management device of the present invention.

[0036] Figure 5 is an embodiment of a system for accessing information on a medical record storage and management device of the present invention.

[0037] Figure 6 is an embodiment of a system for accessing information on a medical record storage and management device of the present invention.

[0038] Figure 7 is an embodiment of a system for accessing information on a medical record storage and management device of the present invention.

[0039] Figure 8 is an embodiment of a system for sending an alert using a medical record storage and management device of the present invention.

[0040] Figure 9 is a perspective view of an embodiment of a medical record storage and management device of the present invention. [0041] Figure 10 is an embodiment of a system for accessing information on a medical record storage and management device of the present invention.

[0042] Figure 11 is a view of an embodiment of a display on a medical record storage and management device of the present invention.

[0043] Figure 12 is a view of an embodiment of a display on a medical record storage and mangement device of the present invention.

[0044] Figure 13 is a method of accessing information in an embodiment of the medical record storage and management device of the present invention.

[0045] Figure 14 is a method of accessing and updating information in an

embodiment of the medical record storage and management device of the present invention.

[0046] Fig. 15 is a method of transferring medical records according to an embodiment of the invention.

[0047] Figure 16 is a view of an embodiment of an environment for the operation of a medical record storage and management device of the present invention.

Detailed Description of Exemplary Embodiments of the Invention

[0048] Embodiments herein describe a mobile or portable medical record storage and management device, systems and methods for inputting, managing and updating the records contained in such a device, mobile or portable devices which can run applications capable of securely storing and managing medical records, and devices which are capable of assisting the user and conveying information to the relevant parties in an emergency situation. The systems and methods described herein may be contained in a single mobile or portable device or may be part of a network of the same or different types of devices.

[0049] With reference to FIG. 1 a medical record storage and management device 100 is shown and displayed. This device 100 is composed of flash memory (not shown) which stores medical records, integrated with a universal serial bus ("USB") male type connecter 10 at one end and a biometric sensor 12. The flash memory consists of a small printed circuit board mounted with at least one processor or microcontroller, power circuitry, random access memory and a small number of surface integrated circuits. In some embodiments, the power circuitry derives power via the USB connector interface insertion into the USB port on a host computer. The device 100 has at least 100 to 500 MB of storage capacity and may have about 1 to about 50GB, about 1 to about 20GB, about 1GB, about 2GB, about 4GB or about 8GB or more of storage capacity. The casing 14 of the medical record storage and management device is fabricated from high-impact plastic or other durable material. In some embodiments, the casing may be impact resistant, tamper proof, electron shielded, electromagnetic pulse shielded or otherwise protected. The device may also include lockout or self-destruct capabilities where the information in the memory is rendered inaccessible or destroyed if repeated attempts at authentication fail. There may also be a plurality of light emitting diodes or other visual indicator cues such as those shown at 15 and 16 which indicate such information as whether the medical record storage and management device 100 is powered, whether biometric data had been entered and/or authenticated, if data is being transmitted or received or any other indication that would be useful in such circumstances.

[0050] In some embodiments, the medical record storage and management device 100 may include one or more "panic" or medical alert button(s) 18 which will activate an emergency function and transmit a signal to a bystander, emergency services responder, other care provider or coordinating individual or service. In some embodiments, the signal may contain emergency medical information regarding the owner of the medical record storage and management device. In a preferred embodiment, the device 100 is capable of wirelessly transmitting an emergency alert signal activated by a subject wearing or carrying the device. The emergency signal transmission may be actively or passively triggered as described herein. In these embodiments of the invention, the device is portable and sized and dimensioned to be easily worn or carried by the user, for example in comparable size and dimension to standard flash drives or memory stick.

[0051] In an alternate embodiment, as shown in FIG. 2, a medical record storage and management device 200 is shown. This device 200 is composed of flash memory (not shown) which stores medical records integrated with a universal serial bus ("USB") male type connecter 20 at one end. The device 200 has at least 500 MB of storage capacity and may have about 1 to about 20GB, about 1GB, about 2GB, about 4GB, about 8 GB, about 10 GBor more of storage capacity. The component 22 containing the flash memory is connected to a second component 24 which contains a biometric sensor such as a fingerprint scanner 26. The casing 28 of the medical record information storage and management device is fabricated from high-impact plastic or other durable material. In some embodiments, the casing may be impact resistant, tamper proof, electron shielded, electromagnetic pulse shielded or otherwise protected The casing may also include a "panic" or medical alert button 29 which will wirelessly transmit a signal to an emergency services responder or other coordinating service.

[0052] With reference to FIG. 3 a medical record storage and management device 300 is shown and displayed. This device 300 is composed of flash memory (not shown) which stores medical records integrated with a universal serial bus ("USB") male type connecter 30 at one end. The flash memory consists of a small printed circuit board mounted with at least one processor or microcontroller, power circuitry, random access memory and a small number of surface integrated circuits. In some embodiments, the power circuitry derives power via the USB connector interface insertion into the USB port on a host computer. The device 300 has at least 500 MB of storage capacity and may have about 1 to about 50GB, about 1GB, about 2GB, about 4GB or about 8GB or more of storage capacity. The casing 34 of the medical record storage and management device is fabricated from high-impact plastic or other durable material. In some embodiments, the casing may be impact resistant, tamper proof, electron shielded, electromagnetic pulse shielded or otherwise protected. The device may also include lockout or self-destruct capabilities where the information in the memory is rendered inaccessible or destroyed if repeated attempts at

authentication fail. There may also be a plurality of light emitting diodes or other visual indicator cues such as those shown at 35 and 36 which indicate such things as whether the medical record storage and management device 300 is powered, whether biometric data had been entered and/or authenticated, if data is being transmitted or received or any other indication that would be useful in such circumstances. In some embodiments, the device 300 may include a "panic" or medical alert button 38 which will wirelessly transmit a signal to an emergency services responder or other coordinating service. In some embodiments, activation of the emergency function may further transmit emergency medical information regarding the owner of the medical record and storage device. In a preferred embodiment, the device 300 is sized similarly to standard flash drives or memory sticks.

[0053] The medical record storage and management device may also be provided in the form of a smart card 400 or like device as shown in reference to FIG. 4. A smart card usually consists of a plastic part and another metallic part where the contacts of the card are located, such contacts being internally connected to an integrated circuit. The smart card 400 is composed of a microchip 40 and a biometric sensor such as a fingerprint scanner 42.

[0054] Medical record storage and management device devices as described above with reference to Figs. 1-4 may also include lock-down or self-destruct capabilities where the information in the memory is rendered inaccessible or destroyed if repeated attempts at authentication fail. There may also be a plurality of light emitting diodes or other visual indicator cues which indicate such things as whether the medical record storage and management device is powered, whether biometric data had been entered and/or authenticated, if data is being transmitted or received or any other indication that would be useful in such circumstances.

[0055] Medical information can be updated onto the exemplary devices shown in FIGS. 1-4 by connecting the medical record storage and management device to an electronic device as shown in FIGS. 5, 6, and 7. The device 52 may be plugged directly into a computer 50 of system 500 through a USB port such as that shown in FIG. 5. Alternatively, the device 64 may be inserted into a system 600 through a reader 62 attached to a computer 60 as shown in FIG 6, or a signal may be sent wirelessly to a system 700 by device 74 as shown in FIG. 7. The identity of the patient is authenticated using the embedded biometric scanner such as that shown at 12, 26 and 42 at or through a biometric scanner 72 attached to the care provider's electronic device. Once access to the medical record storage and management device is granted, there may be one or more additional authentication or verification steps. For example, the opening screen of the data on the medical record storage and management device may include a photograph of the patient for verification purposes, e.g., for an emergency responder to quickly and reliably confirm that the data stored on the device corresponds to the medical records of the individual wearing or carrying the device. Alternatively, the device may include other information, or questions that must be answered regarding the patient before access to the medical records is granted, and/or for a third party to confirm that the stored medical data pertains to the individual presenting with the device. In some embodiments, care facilities may have passwords that permit access to all or some of the data on the medical record storage and management device. Medical information is then transferred from the computer or other electronic device as shown in FIGS. 5-7 onto the medical record information storage and management device such as that shown in Figures 1-4 or vice versa. In one embodiment, information is stored in a set format. In other embodiments, the input of medical information is dynamic. In some embodiments, authentication may be required prior to removal of the medical record storage and management device from the computing device.

[00056] FIG. 8 illustrates an exemplary emergency services provider system 800, including a customer carrying a medical record storage and management device 802; a wireless communications network, including a wireless transceiver tower 806; a monitoring center 808; and emergency service providers 810.

[00057] A signal is sent from the medical record storage and management device 802 upon activation by the customer, to tower 806. The request is sent to an appropriate monitoring center 808 or directly to an emergency service provider 810. The monitoring center 808 may be a paid provider or a public service such as a 911 call center. In some embodiments, the medical record storage and management device 802 may include a GPS tracker. In other embodiments, the location of the customer may be determined by the transmission tower triangulation using transmission tower 806.

[0056] A signal is sent from the medical record storage and management device 802 to tower 806. The request is sent to an appropriate security monitoring center 808 or directly to an emergency service provider 810. The security monitoring center 808 may be a paid provider or a public service such as a 911 call center. In some embodiments, the medical record storage and management device 802 may include a GPS tracker. In other embodiments, the location of the customer may be determined by the transmission tower 806.

[0057] In some embodiments, the medical record storage and management device may additionally send information regarding the owner of the medical record storage and transmission device such as identification, emergency contact information, recent medical history, chronic conditions, blood type, drug allergies, current medications and any other information that would be useful in an emergency situation.

[0058] In some embodiments, the medical record storage and management device may also monitor bodily functions such as blood pressure, respiration, blood sugar, heart rate and body temperature. Such information may be conveyed to the responding emergency technician for use in treatment in combination with the medical records or may be transmitted with the medical records to a nearby care facility for evaluation by a care provider such as a physician. Care instructions may be transmitted directly back to the device, or sent to the emergency responder. In other embodiments, data can be transferred to a laptop computer or other device in an emergency vehicle during transfer to a care facility.

[0059] With reference to Fig. 9, a cell phone 900 which can be used as a medical record storage and management device is displayed. The cell phone 900 has a display 910, and a telephone keypad 920. The cell phone 900 may be a smart phone, PDA, or similar device or a traditional cell phone. In some embodiments, the cell phone 900 may include a locating device such as a GPS locator. In some embodiments, the cell phone 900 is further equipped with one or more USB or similar ports 930. In this embodiment, the USB port is shown at one end of the cell phone. However, it can be located in any location that is convenient, for example on either side of the cell phone, the front, the back or the top of the cell phone. The port 930 allows the cell phone to be connected to a number of other devices including, but not limited to, an external drive, a printer, a computer, another handheld device, or any other device that is capable of connecting through a USB or similar port. In other embodiments, the cell phone 910 may transmit and receive information wirelessly such as through an internet connection, Bluetooth, wifi or other wireless protocol. The cell phone 910 also contains at least one biometric sensor 940 which may be a fingerprint reader, voice recognition sensor, blood vessel pattern reader, DNA reader, retinal reader, iris reader, face recognition system or the like. In some embodiments, the biometric sensor may be a camera with facial recognition technology.

[0060] For example, as shown in Fig. 10, the cell phone 1030 may be attached through a connector 1020 to computer 1010. Alternatively, the cell phone may be attached directly to a USB port as shown in Fig. 5, or may send a signal wirelessly as shown in Fig. 7. In some embodiments, the cell phone 1030 may be connected to another cell phone, a smart phone, a PDA, or other handheld computing device.

[0061] With reference to Figure 11, an embodiment of a display on the the medical record storage and management device 1 100 is shown. Such a display may be on any type of portable device that has a screen, such as a smart phone or other PDA, including, but not limited to, devices which use Google Android, RIM Blackberry, Microsoft Windows Mobile, Palm, Linux, Symbian and/or Apple iPhone, iPad Operating System (OS) compatible devices. Upon activation of an emergency function, a screen 11 10 could be displayed showing emergency information 11 12. Such emergency information could contain for example, the name of the individual, one or more emergency contact numbers, as well as information commonly seen on a medic alert bracelet. In some embodiments there may be a means for playing or displaying a pre-recorded message 1113. Such a message may be audio or visual and may include information such as identifying information regarding the owner of the device, a summary of relevant medical information, a location for medical records, a request for assistance, allergies to medicines or any other information that would be relevant in identifying the owner and relaying emergency information, including medical information. In some embodiments, activation of the pre-recorded message may trigger a signal sent to an emergency contact, including 911 or a monitoring service. Such a signal may be sent to one or more emergency contacts, for example, emergency services, an emergency contact, the individual's doctor, the local hospital, a care-facility or other agency that may need to be contacted in case of an emergency. In other embodiments, there may be a second button 1114 to activate requesting emergency services. In some embodiments, there may be a button 1115 to be activated upon arrival at a hospital or other care facility. Such buttons may be on the phone 1100 or on a touch screen 1110 and may be activated by any means generally used. In some embodiments, the portable medical record storage and management device may provide information to a hospital or other care facility as shown in Fig. 12.

[0062] For example as seen in Fig. 12, the medical record storage and management device 1200, may have means for entry of identifying override information to provide access to medical records stored on the device, for example a place to enter additional information 1210 as shown on the screen 1201. Such a screen 1201 may be a passive screen or a touch screen. Access to the information on the medical record storage and management device may be granted by verification of one or more levels of biometric identification alone or in combination with other types of authentication such as, for example, authorization/access code, personal identification number (PIN), digital certificate, and/or other identification indicia. The biometric sensor may authenticate a user using voice recognition, fingerprints, handprints, blood vessel patterns, DNA tests, retinal or iris scan, and face recognition or a combination thereof. In some embodiments, the biometric sensor may be a camera capable of performing or being used in combination with a facial recognition protocol.

[0063] In some embodiments, verification of the user may allow activation of the medical record storage and management device. In other embodiments, verification of the user may decrypt the information on the medical record storage and

management device. In yet another embodiment, verification may do both. The means of authentication or verification used to access different types or levels of information on the medical record storage and management device may be the same or different. In some embodiments, as shown in Fig. 12, there may be an override to the biometric sensor, for example a code that can be entered by emergency personnel. Such a code may be carried on the individual, for example on an i.d. bracelet, obtainable by contacting a particular service, be known generally at care facilities, by sending a message to the service provider for the portable medical record storage and management device, or by any other means generally available. Entry of the override code may provide access to some or all of the medical records on the medical record storage and management device.

[0064] A method of accessing the information in the medical record storage and management device is depicted in Fig. 13. In Fig. 13, the emergency function or medical alert system of the medical record storage and management device is activated at 1310 initiating a medical alert system. The emergency function may be activated by any means feasible, including, mechanical, audio and electronic means such as, but not limited to, pushing a button; holding a button for a particular length of time, for example 1, 2, 3, 4, 5, or 6 seconds; the utterance of a particular phrase; a particular keying sequence; a toggle, a slide, a touch screen, a strong impact sensor (for example, for use in automatically transmitting a request in the event of a high- impact collision); a heat sensor (for example, for use in automatically requesting emergency services in the event of a fire); or a medical sensor (e.g., for automatically triggering a request for emergency services upon the detection of the cessation of a heart beat or other physical or medical condition). Once the emergency function 1310 is activated, the medical record storage and management device may activate a prerecorded message 1315 and display an Emergency Menu 1320. The pre-recorded message 1315 may be an audio or visual message. It may include a variety of information regarding the owner of the device such as their name, age, chronic or current medical conditions, medication allergies, or other information that would be important for a health service provider or bystander to know immediately.

[0065] For example, it may say something like "My name is Marcus Iver, I have a heart condition which causes me to black out" or a related message. It may contain as much or as little information as the user chooses. The Emergency Menu 1320 may additionally display the name of the owner of the device and additional information such as an emergency contact number, the name of someone to contact, a physician's name, allergies, chronic conditions or any other such information. The Emergency Menu 1320 may additionally provide options for receiving additional information and/or notifying emergency services such as 911 or an emergency contact. If no further action is taken once the Emergency Function 1310 is activated, the medical record storage and management device will send a signal to Emergency services 1340 requesting assistance. Such a signal may be sent by any means feasible. A signal 1340 may be sent if no further action is taken within a specific amount of time, for example 1, 2, 3, 4, 5, or more minutes or may be sent immediately upon activation of the Emergency Function. Once contact with Emergency services is established, the device may send an audio or visual message to Emergency Services 1350. The message 1350 may be the same or different than the message activated by triggering the Emergency Function 1310.

[0066] The Emergency Menu 1320 may provide a plurality of options to the user who may be the same or a different person than the person who activated the Emergency Function 1310. In one embodiment, the Emergency Menu 1320 may offer further actions that may be taken using the device. For example, an immediate response 1355 may be selected. Selection of an immediate response 1355 sends a signal to

Emergency services 1340 and/or another number selected by the owner of the medical record storage and management device. In one embodiment, Emergency services may be reached by calling 911 or whatever the local number is for Emergency services. Once contact is established with Emergency services, an audio or visual message may be sent to Emergency services 1350 containing the same or different information than the pre-recorded message activated at 1315. Such a message may contain the identity of the person in trouble, important medical information that an Emergency services provider would need to know, and/or the location of the medical record storage and management device. The location of the person may be GPS coordinates or other locator means, for example cell tower triangulation. In some embodiments the activation of an alert may send out SMS messages, emails, or updates to Twitter or other social networking websites. In other embodiments the activation of an alert may also send out a hyperlink to access the full personal medical record securely online. [0067] The Emergency Menu 1320 may also include an option to be used by a hospital staff member or medical personnel treating the owner of the medical record storage and management device. If the Hospital option 1345 is selected, authorization may be requested 1357. Such authorization may be biometric identification, authorization/access code, an override code, personal identification number (PIN), digital certificate, information received from the monitoring service, and/or other identification indicia or a combination thereof as described above. In some embodiments, activation of the emergency function may transmit a code to the nearest hospital. In other embodiments, there may be instructions for obtaining an authorization code to override the normal security features. If the authorization is unsuccessful, the process will end 1365. In some embodiments, the device may wipe the records if the authorization is unsuccessful. In other embodiments, the device may permit multiple attempts to access the information, such as two, three, four or more attempts after which it will erase the records. In yet another embodiment, it may initiate a lock down procedure rendering the information inaccessible if authorization fails. If the authorization is successful 1360, a menu of the available information will be displayed 1370. Such a menu may include emergency contact information, insurance information, and any of a variety of medical information including, but not limited to, recent practitioners, present medical conditions, current medications, medical history, hospitalizations, surgeries, blood tests, family history, injuries, accidents, disabilities, lifestyle information, family history, review of systems, work history, office visits. In some embodiment there may be a category of critical information such as a particular condition or information that would be important for an emergency services provider to know. The user selects the category of information of interest 1375 and the medical record storage and management device displays the requested information 1380. In some embodiments, different types of information may require different levels of authorization or access codes. For example, a list of drug allergies may be available to all medical personnel whereas psychiatric records may require further authorization. The contents of the Emergency menu 1320 may be fixed or customizable. In some embodiments, the pieces of the Emergency Menu are 1320 are composed of individual plug- ins which may be added or deleted according to the needs of the user. For example, means for altering the appearance of a home screen, such as that of the Emergency Menu 1320 are described for example in U.S. Patent Application No.11/402,130 incorporated by reference herein in its entirety. In another embodiment, the appearance and location of the Emergency Function

Activation mechanism could be similarly altered on the home page of the mobile medical record storage and management device.

[0068] Fig. 14 is a method of accessing and updating health records. A user logs on through a medical record storage and management device or through a website. The user is authenticated 1410 by any means feasible. Authentication may occur through biometric identification alone or in combination with other types of authentication such as, for example, authorization/access code, personal identification number (PIN), digital certificate, and/or other identification indicia. The biometric sensor may authenticate a user using voice recognition, fingerprints, handprints, blood vessel patterns, DNA tests, retinal or iris scan, and face recognition or a combination thereof. If the user is not authenticated, the session ends 1415. If the user is authenticated, a summary of the information currently in the record storage and management database is displayed. The user is asked if there is new information to add 1430. If there is no information to add, the medical record storage and management device is updated through a medical record storage and management database, i.e. it is synced. If there is new information to add, the user is asked to select the category of information to be added 1440. Categories of information may include any of a variety of topics. Such topics may be predefined or defined by the user. In some embodiments, information categories may include personal information such as name, gender, birthdate, marital status, spouse's name, emergency contact information, children's names and birthdates, address, contact information, and religion; insurance information; medical provider contact information; present medical conditions including, but not limited to current, chronic or recurring conditions; current medications; allergies; past medical history; hospitalizations; surgeries; test results; special procedures; family history; review of systems or other means for tracking symptoms and disease progression including neurological, vision, respiratory, otolaryngolical, cardiac, gastrointestrial, urinary, musculoskeletal, sexual organs, endocrine, blood and lymph systems, psychological, or general symptoms; social history and lifestyle; work history;

chronological list of recent office visits; or other similar categories. The user can add new information 1450 and is then queried as to whether there is additional

information to be added 1460. If there is additional information to be added, the user is directed to select the category of information to add 1440. If there is no more information to be added, the handheld medical record and storage management device may be synced and the new information integrated into the device or synced with a medical record storage and management database or central aggregator. In some embodiments, the syncing will be automatic. In other embodiments, the user may be asked if they would like to sync the device. Additionally, the user may determine how much or how little information is to be transferred to or maintained on the handheld device.

[0069) As shown in Fig. 15, the user may share some or all of the information in the medical record storage and management device. In one embodiment, the user may be authenticated 1510. Authentication may occur by any means, including but not limited to, biometric identification, authorization/access code, personal identification number (PIN), digital certificate, and/or other identification indicia or a combination thereof. The user may then select the information to be transferred 1520. Such information may be all or part of the records stored in either the medical record storage and management device or in a remote medical record storage and management database. The user then initiates a transfer 1530. Such a transfer may take place according to any means generally used to transfer such information including wirelessly or by a bump protocol and the receiver confirms receipt of the information 1540. In another embodiment, the user may generate a url or hyperlink containing the information they wish to transfer and such a url or hyperlink may be sent to the person to whom the user wishes to transfer the information.

[0070] Fig. 16 is a diagram showing an exemplary environment 1600 in which the medical record storage and management device may be used. The environment allows for the implementation of systems and methods by which medical records are inputted, received, managed and transferred or accessed by a client or healthcare provider. The environment further allows for the implementation of systems and methods by which medical records can be stored and managed. The environment 1600 includes one or a plurality of service providers 1610 including, but not limited to, insurance companies, healthcare providers, pharmacies, hospitals, or one or more information aggregators such as , for example, Microsoft Health Vault, or Google Health. The information from the service providers is consolidated into the format used by the portable medical record storage and management device 1640. The information may be accessed directly from the consolidator 1620, or through a web service layer 1650. The information is then available through a web browser 1630 or a portable medical record storage and management device 1640, including a smart phone, tablet computer, PDA, mobile phone or other information viewing device.

[0071] Although a few embodiments have been described in detail above, other modifications are possible. The systems and methods described herein may be implemented in any type of network familiar to those skilled in the art that can support voice and data communications using any of a variety of commercially available protocols including TCP/IP, SNA, IPX, AppleTalk; a local area network including, but not limited to, an Ethernet network, a token-ring network; a virtual network; the Internet; an intranet; an infra-red network; cellular voice network; or a wireless network including, but not limited to, wide area wireless networks such as TDMA, CDMA, W-CDMA, GSM, satellite-based, or EDGE networks; metro area networks such as WiMAX networks; local area networks such as WiFi networks; and any other wireless networks that can deliver voice, data, information, or other services over a large or small geographical area. Also, the logic flows depicted in the figures may not require the particular order shown, or sequential order, to achieve desirable results. Other steps may be provided, or steps may be eliminated, from the described flows; and other components may be added to, or removed from, the described systems. Other embodiments may be within the scope of the following claims. [0072] The above description of disclosed embodiments is provided to enable any person skilled in the art to make or use the invention. Various modifications to the embodiments will be readily apparent to those skilled in the art; the generic principals defined herein can be applied to other embodiments without departing from spirit or scope of the invention. Thus, the invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principals and novel features disclosed herein.

Claims

We claim:
1. A medical record storage and management device comprising:
a mass storage device;
a biometric sensor;
a wireless transmitter; and
wherein the medical record storage and management device is portable.
2. The device of claim 1, wherein the mass storage device is a USB flash drive.
3. The device of claim 1, wherein the medical record storage and management device is part of a cell phone.
4. The device of claim 2, wherein the USB flash drive weighs between 10 and 100g.
5. The device of claim 2, wherein the USB flash drive is between 1 inch and 5 inches long.
6. The device of claim 1, wherein the mass storage device is a Smart Card, compact flash card, secure digital card, mini SD card, micro SD card, multimedia card, memory stick, a micro drive, a Magnetic Random Access Memory, a Ferroelectric Random Access Memory, or a Static Random Access Memory.
7. The device of claim 1, wherein the medical record storage and management device is a smartphone or personal digital assistant.
8. The device of claim 1, further comprising a pre-recorded message.
9. The device of claim 8, wherein the pre-recorded comprises identification information and medical history.
10. The device of claim 1, wherein the biometric sensor is capable of voice
recognition, handprint recognition, blood vessel pattern recognition, fingerprint recognition, DNA recognition, retinal recognition, iris recognition, or face recognition.
11. The device of claim 1, further comprising a patient verification system.
12. The device of claim 1 1, wherein the patient verification system comprises a facial image in the medical record storage and management device.
13. The device of claim 1, further comprising an audible alarm.
14. The device of claim 1, further comprising a locator system.
15. The device of claim 14, wherein the locator system is a GPS locator.
16. The device of claim 1, wherein the wireless transmitter is capable of sending a radio signal, an infrared signal, a VHF signal, a UHF signal, a satellite signal, laser light, visible light, acoustic energy, a cellular signal, or radiowave signal.
17. The device of claim 1, further comprising an emergency button.
18. The device of claim 17, wherein the wireless transmitter is capable of sending a signal when an emergency button is depressed.
19. The device of claim 1, wherein the wireless transmitter is capable of sending a signal when a strong impact is detected, if a heat sensor reaches a threshold temperature, or upon detection of a change in the physical state of the wearer.
20. The device of claim 18, wherein the signal sent by the wireless transmitter is sent to an emergency services provider.
21. The device of claim 18, wherein the signal sent by the wireless transmitter is sent to a monitoring service.
22. The device of claim 1, wherein the device further comprises at least one bodily function monitor.
23. The device of claim 22, wherein the bodily function monitor monitors
respiration, heart rate, blood pressure, blood sugar, or body temperature.
24. A method of securely storing and managing medical records in a portable device comprising:
providing a medical record storage device to be carried or worn by a patient; authenticating the holder of the device; and
transferring medical records to the device;
wherein the transferred medical records can integrate into medical records already on the device.
25. The method of claim 24, wherein authenticating the holder of the device
comprises using a biometric sensor.
26. The method of claim 25, wherein the biometric sensor is capable of voice recognition, fingerprint recognition, handprint recognition, blood vessel pattern recognition, DNA recognition, retinal recognition, iris recognition, or face recognition.
27. The method of claim 24, further comprising allowing access to the medical records by emergency personnel.
28. A method of using securely stored medical records in a portable device
comprising: providing a medical record storage device to be worn or carried by a patient; authenticating the identity of the patient whose medical records are on the device;
securely accessing the records on the device;
accessing monitoring information in the device;
and treating the patient based on the monitoring and medical record information contained in the device.
29. The method of claim 28, wherein the identity of the patient is authenticated using a biometric sensor.
30. The method of claim 29, wherein the biometric sensor is capable of voice recognition, fingerprint recognition, handprint recognition, blood vessel pattern recognition, DNA recognition, retinal recognition, iris recognition, or face recognition.
31. The method of claim 28, wherein the monitoring information is transmitted to a care facility and treatment instructions are transmitted back to the portable device.
32. A system for providing medical records to a mobile device, the system
comprising:
an interface that receives input from the mobile device;
a biometric sensor for verifying the user of the mobile device;
an automated information gatherer that, in response to the received input compiles records from the user and medical service providers;
a means for reformatting the obtained records;
an interface that displays the compiled records on the mobile device.
33. The system of claim 32, wherein the mobile device is a cellular telephone, a smartphone, a wireless-enabled personal digital assistant, or a mobile device that receives content from the Internet.
34. The system of claim 32, wherein the system further comprises a means for locating the mobile device.
35. The system of claim 32, wherein the means for locating the mobile device comprises the use of a global positioning system.
36. The system of claim 32, wherein the system further comprises a means for contacting an emergency services provider.
37. A mobile device capable of running an operating system, wherein the mobile device comprises: one or more files containing electronic medical records;
a biometric sensor;
a means for contacting another device;
a means for displaying or communicating a pre-recorded message; and a locating system.
38. The mobile device of claim 37, wherein the mobile device is a cellular
telephone, a smartphone, a wireless-enabled personal digital assistant, or a mobile device that receives content from the Internet.
39. The mobile device of claim 37, wherein the biometric sensor is capable of voice recognition, handprint recognition, blood vessel pattern recognition,
DNA recognition, retinal recognition, iris recognition, or face recognition.
40. The mobile device of claim 37, wherein the device further comprises a camera with face recognition capability.
41. The mobile device of claim 37, wherein the medical records are stored in a secure format.
42. The mobile device of claim 37, wherein the locating system is a global
positioning system (GPS).
43. The mobile device of claim 37, wherein the mobile device can transmit its location to another device.
44. The mobile device of claim 37, wherein the other device is a device used by Emergency services personnel.
45. The mobile device of claim 37, wherein the pre-recorded message is an audio message.
46. The mobile device of claim 37, wherein the pre-recorded message is a visual message.
47. The mobile device of claim 37, wherein the pre-recorded message contains emergency medical information regarding a user of the device.
48. The mobile device of claim 37, wherein the means for contacting another device is a single button.
49. The mobile device of claim 37, wherein the operating system is Google
Android, RIM Blackberry, Microsoft Windows Mobile, Palm, Linux, Symbian or Apple iPhone I Operating System (OS).
50. A method for securely storing medical and managing medical records adapted for use in a mobile device comprising: authenticating a user biometrically;
displaying a summary of medical information;
allowing a user to update medical information;
adding the medical information to a category of medical information; and updating the contents of the mobile device to include the new information.
51. The method of claim 50, wherein the biometric authentication is voice
recognition, handprint recognition, blood vessel pattern recognition, DNA recognition, retinal recognition, iris recognition, or face recognition.
52. The method of claim 50, wherein if the user is not authenticated, the mobile device erases the medical records.
53. The method of claim 50, wherein the medical records are updated on a
computer.
54. The method of claim 50, wherein the contents of the mobile device are
updated wirelessly.
55. The method of claim 50, wherein the contents of the mobile device are
updated via the Internet.
56. A medical record storage and management application for use in a smartphone having an operating system capable of executing the application comprising: one or more files containing electronic medical records stored in a secure format;
a biometric authorization protocol;
a means for updating the electronic medical records;
a means for viewing the electronic medical records.
57. The smartphone of claim 56, wherein the operating system is Google
Android, RIM Blackberry, Microsoft Windows Mobile, Palm, Linux, Symbian or Apple iPhone I Operating System (OS).
58. The smartphone of claim 56, wherein the biometric authorization protocol comprises voice recognition, handprint recognition, blood vessel pattern recognition, DNA recognition, retinal recognition, iris recognition, or face recognition.
59. The smartphone of claim 58, wherein the biometric authorization protocol comprises face recognition.
60. The smartphone of claim 59, where in the face recognition is performed by a camera in the smartphone.
61. The medical record storage and management application of claim 56, wherein the application further comprises a protocol for contacting an emergency services provider.
62. The medical record storage and management application of claim 56, wherein the application further comprises a pre-recorded file containing personal identification and medical information regarding the user of the device.
63. The medical record storage and management application of claim 62, wherein the pre-recorded file is accessible by emergency services personnel.
64. The medical record storage and management application of claim 56, wherein the application further conveys location information to emergency services personnel.
65. The medical record storage and management application of claim 64, wherein . the location information is obtained using a global positioning system.
66. The medical record storage and management application of claim 64, wherein the location information is obtained using cell tower triangulation.
PCT/US2010/002354 2009-08-27 2010-08-27 Portable medical record storage device with wireless communication capability WO2011028261A2 (en)

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