Digital Healthcare – Richard S. Dick, Verisma Systems Inc
Abstract for “Managing data in compliance to regulated privacy, security and electronic transaction standards
“Systems and methods to manage data in compliance with electronic transaction, privacy, and security standards. The present invention is implemented in conjunction with one or more computers that are used in a system for managing data in accordance with regulated privacy and security standards. One implementation provides a single point for both internal and external requests and a single exit point for information transmissions. The transmissions can include patient information and legitimate patient-approved requests. The present invention also allows for the de-identification and sale of selectively used or sold information. De-identification prevents identification of patients with medical information. This allows the information to be used while maintaining professional confidentiality. The present invention also allows for fully digital authorizations and consents to retrieve external data sources.
Background for “Managing data in compliance to regulated privacy, security and electronic transaction standards
“1. “1.
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“2. “2.
Information management is an integral part of business practice. Information is collected from patients, physicians, research, training, underwriting insurance policies, and other sources. Patients, doctors, medial service providers, as well as other business entities, have found the medical information to be very beneficial. Insurance companies that offer life, health, disability income and long term care often require medical information to determine eligibility. Analyzing medical information usually involves reviewing medical records such as the statement of an attending physician. This is a reliable record because it contains analysis and conclusions by licensed medical professionals. The medical records can also be used to determine the risk posed by an individual for a policy and to determine causation and other issues that are relevant to insurance claim adjustment.
“Medical records are currently generally accessible, but they are difficult to access due to the confidential nature. The medical records are protected by professional standards and enacted legislation that requires consent from the patient before any disclosures of medical record information. The majority of medical records information is contained in paper documents that are kept in the offices of medical service providers. This restricts information sharing.
Some medical providers have begun to convert paper records to electronic records in order to save space and avoid the cost of filling up offices with large volumes of records. The electronic records are often isolated from external sources, just like their paper counterparts.
Requesting information from a medical data repository such as a doctor’s office can sometimes lead to a delay. This is due to the delay in receiving information from a medical information repository. The delay in underwriting policies can cause applicants to lose their interest and result in a loss of business for the insurer.
Some requesters use agents to travel to various medical offices in order to retrieve medical records manually. This helps to reduce delays. This may speed up the process, but it can also be costly and does not resolve the issue of whether or not the record retrieved is complete. Even if the location and existence of a record is known, their relevance will not be known until it is retrieved and reviewed.
Access to medical records is a requirement for emergency medical technicians and health care providers. In situations where paper records are not available, emergency medical technicians and health care providers are often required to make decisions about the care of patients. Inability to use traditional methods to provide information about medical records to emergency medical technicians and health care providers increases the chance of incorrect treatment and medical malpractice.
“The Health Insurance Portability and Accountability Act, (HIPAA) creates additional complications in the provision of medical information to a specific requestor. It mandates regulations that regulate privacy, security, and electronic transaction standards for health information. Major changes are required in the way that health care organizations manage all aspects of medical information management. This includes reimbursements, coding and security. Every department that provides or pays health care has a profound impact from the regulations.
HIPAA, for example, requires that patients be able to view all information the medical entity may have about them. Patients should also be able to comment or make annotations to any information the entity has given. Patients may also request corrections. The entity must allow patient-driven editing comments. capability. The medical entity is not required to make any actual corrections. They are required to note that the patient has made suggestions or registered comments to their records.”
Many medical entities may view such requirements as a serious problem. For others, however, it may be a great opportunity for the entity (e.g. It can be used by a physician, or other medical professionals who might have crucial clinical information such as a prescription record, to verify and publish that the patient has actually reviewed and verified the accuracy and completeness their personal information. A patient-verified history is very helpful to an emergency physician who is treating the patient.
“Accordingly, this would be an improvement of the art to allow affected entities to conform to the regulations that have been adopted, and to facilitate information exchange and management without breaching professional relationships or duties of confidentiality.”
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“The present invention is implemented in conjunction with one or more computers that are used in a system for managing data in compliance to regulated privacy, security and electronic transaction standards. One implementation includes an entry point for both internal and external requests and/or an exit point for information transmissions. The transmissions may include patient information and legitimate patient-approved requests. The present invention also allows for the de-identification and sale of selective information. De-identification prevents identification of patients with medical information. This allows the information to be used while maintaining professional confidentiality. The present invention also allows for fully digital authorizations and consents to retrieve external data sources.
The methods and processes of this invention have been particularly helpful in managing medical information. However, those who are skilled in the art will recognize that they can be used in many different applications and areas of manufacture to manage information such as financial information and academic information.
These and other features and benefits of the invention will be described or made more clear in the following description and the appended claims. You can realize and obtain the features and benefits of the invention by using the combinations and instruments specifically mentioned in the appended claims. The features and benefits of the invention can also be learned through the practice of it or from the description as described hereinafter.
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“Embodiments according to the present invention are performed in conjunction with one or more computers that are used in a system for managing data in accordance with electronic transaction, privacy, and security standards. One embodiment of the system has a single point for entry for external and/or intra-related requests and/or an exit point for information transmissions. The transmissions may include patient information that is individually identifiable to legitimate patient-approved request. The present invention also includes fully digital authorizations, consents, and permissions for retrieval of external data sources.
The present invention allows for the selective use and/or sale of information. De-identification prevents identification of patients that correspond to medical information. This allows the information to be used while maintaining professional confidentiality.
“The disclosures of the present invention are grouped under two subheadings:?Exemplary operating environment? The other subheading is Managing Data in Compliance With Regulation Standards. These subheadings are used for informational purposes only.
“Exemplary Operating Environment.”
“FIG. “FIG. The invention can be used in many configurations of computing devices, including a networked one.
“Embodiments” of the present invention include one or more computer-readable media. Each medium can be configured to contain data or computer executable directions for manipulating data. Computer executable instructions can include data structures, objects and programs, routines or other modules that can be accessed by a processor system. They may either be associated with a general purpose computer that can perform many different functions, or one that is limited to a specific function. Computer executable instructions are program code that instruct the processor to execute a specific function or group. A particular sequence of executable instructions can be used as an example of the corresponding actions that could be used to implement these steps. Computer-readable media can include random-access memory, (?RAM?) ), read-only memories (?ROM) ), read-only memory (??ROM? ), erasable, programmable read only memory (?EPROM) ), Electrically eraseable programmable read only memory (?EEPROM) ), compact disk read only memory (?CDROM? ), compact disk read-only memory (?CD-ROM) or any other device, component, or device that can provide data or executable directions that may be accessed via a processing system.
“With reference to FIG. 1. A representative system for implementing this invention includes computer device 10. This computer device can be general-purpose, or special-purpose. Computer device 10 could be, for example, a personal computer or a notebook computer. Or any other handheld device, such as a laptop, a desktop computer, a mainframe or a supercomputer. A multi-processor system, network computer, processor-based consumer electronic devices, or the like.
“Computer device 10, which includes system bus 12, may be used to connect different components and allow data to be exchanged between them. One of many bus structures that system bus 12 can include is a memory bus, memory controller, peripheral bus, or local bus that makes use of any one of the various bus architectures. The typical components that are connected to system bus 12 include memory 16 and processing system 14. Other components could include input interfaces 20 and 22 for mass storage devices 18, as well as network interfaces 24. Each of these will be discussed later.
“Processing System 14” includes one or more processors. This could include a central processor or one or more processors that are specifically designed to execute a specific function or task. Processing system 14 executes instructions from computer-readable media such as memory 16, magnetic hard drives, removable magnetic disks, magnetic cassettes, optical disks, and communication connections. These can also be considered computer readable media.
“Memory 16” may include one or more computer-readable media that can be configured to contain or include data or instructions for manipulating it. It may be accessed through processing system 14 via system bus 12. For example, Memory 16 could include ROM 28 used to store data permanently and/or RAM 30 used to temporarily store data. ROM 28 could include a basic input/output (?BIOS?) One or more routines used to establish communication such as when the computer is first started up. RAM 30 could include one or several program modules such as operating systems, applications programs and/or data.
“One or more mass-storage device interfaces 18 can be used to connect one, or more mass-storage devices 26, to the system bus 12. Computer device 10 may include or be connected to mass storage devices 26, which allow it to store large amounts of data. One or more mass storage devices 26 can be removed from computer device 10. Some examples of mass storage devices are hard disk drives (magnetic disk drives), tape drives (tape drives), and optical disk drive(s). A mass storage device 26 can read and/or write from a magnetic hard drive, removable magnetic disk or magnetic cassette. It may also be able to access an optical disk or other computer-readable media. Mass storage devices 26 along with their computer-readable media can store nonvolatile data and/or executable instruction. These instructions may contain one or more program module, such as an operating system, one, two or more applications programs, other modules, or data. These executable instructions can be used to implement steps of the methods described herein.
One or more input interfaces 20 can be used to allow a user to input data and/or instructions to a computer device 10 via one or more corresponding inputting devices 32. You can use a keyboard or alternative input devices such as a trackball, light pen and stylus to point at the computer. Examples of input interfaces 20 may also be used to connect input devices 32 and 12 to the system bus 12. These include a serial port or parallel port, as well as a game port or universal serial bus (?USB). ), a firewire, (IEEE 1394), and another interface.
One or more output interfaces 22 can be used to connect one or several corresponding output devices 34 on the system bus 12. A monitor, display screen, speaker, printer and other output devices are some examples. One particular output device 34 can be connected to or peripheral to another computer device 10. A video adapter, an adapter for audio, or a parallel port are examples of possible output interfaces.
“One or more network interfaces 24 allow computer device 10 to exchange data with one another local or remote computer device, illustrated as computer units 36 via a network 38 which may include hardwired or wireless links. A network adapter is a device that connects to a local network (?LAN?) as an example of a network interface. or a modem or wireless link to connect to a wide-area network (?WAN?) The Internet is an example of a network interface 24. The network interface 24 can be integrated with or peripheral to a computer device 10. Accessible program modules and portions of them may be stored in remote memory storage devices in a networked environment. In a networked environment computer device 10 can participate in a distributed computing environment where tasks or functions are performed by a number of computer devices.
“While the invention can be used in networked computing environments that support many different types of computer systems configurations, those who are skilled in the art will recognize that it may also be practiced in such environments. FIG. 2. This is an embodiment of the invention in a networked environment with clients connected to a server through a network. FIG. 2 illustrates an embodiment that includes two clients connected to the network. Other embodiments include one client connected to a server via a network. FIG. 2. illustrates an embodiment with two clients connected via a network. Other embodiments may include one client or multiple clients connected to a single network. The embodiments of the present invention also include many clients connected to the network. This is where the network is a large area network such as the Internet.
“In FIG. 2 clients 50 and 60 exchange information via network 70 with information retrieval software 40. Information exchanges can be described as a request by a client for information to the information retrieval network. These requests can be made in electronic data. The network interfaces 42-52 and 62 allow the exchange of information between clients fifty and sixty and the information retrieval system forty, which includes servers 44, 46, and storage devices 46. Servers 44 respond to clients 50-60 with information requests. The stored information is kept at storage device(s). 46. Once the requested information has been selected, system 40 preserves the report and transmits a copy to the requestor as a response. As will be discussed further below.
“Managing Data in Compliance With Regulation Standards”
“As mentioned above, embodiments according to the present invention are in association with one or several computer devices that are used as part of a system to manage data in accordance with regulated privacy and security standards. Particularly, embodiments include a single point for entry for external and/or inner requests and/or one point for exit for information transmissions.
“With reference to FIG. 3 illustrates a representative system that allows a requestor to interface with a gatekeeper 90 to select information from one or several sources within an information repository 100. Any person or entity who wishes to receive information is called requestor 80. These requesters could be insurance companies, research organizations, patients, or care providers.
“Enabling the patient to view their personal information”
“For instance, a requester 80 might request specific information from a covered medical entity. This capability is provided by the enterprise via retrieval request or processing procedures that are made available to the requestor (e.g. An insurance underwriter who has the patient’s signed authorization. Patients can request a copy at any time of all their patient-specific information. The entity will respond by promptly sending the requested information.
The illustrated embodiment includes information/data sources from a variety of locations, including those that are located remotely. The data sources illustrated include the enterprise clinical data repository (104a), pathology laboratory system(s), 104b, in-patient pharmacie system(s), 104c, clinical laboratory systems(s), 104d), enterprise master person index (104f), and other data source(s). When information is requested, data is selected from one or more data sources using an interface engine (102). This interfaces with gatekeeper 90 to produce a response to requester 80.
“As shown, the gatekeeper system 90 provides one point of entry for all requests. Requests can come from internal or external requesters. Anyone authorized can enter requests through one point of entry. One embodiment of the system allows the point-of-entry to receive fully digital authorizations and consents for retrieval form external sources. This allows the entry point access to diverse data feeds from outside sources to improve patient safety.
“As we will discuss below, the processing that an enterprise does to respond to requests includes processing an authenticated request to obtain a copy of a patient’s specific record. Flags are used to facilitate processing in embodiments of the invention. For example, a flag is set for the output of all retrieval functions to be in a desired format so that the entity may easily print the information/documents or electronically transmit them to the requestor in a format that is useful to the requestor. An index of gatekeeper systems 90 and the specific record in the gatekeeper archive 90 indicate that the request is patient-driven. The flag is placed in the index gatekeeper system 90, and in the specific record of the audit trail archive at gatekeeper system90 that the patient has not yet commented on the information.
“Other processing” includes the creation of a cover page with specific information and instructions to the patient describing their rights under a particular regulation or law. A record is assigned an internal reference number so that future referencing can be done quickly. For information transmission via facsimile, a dedicated FAX number is used. This includes the actual cover sheet used to send back comments. The patient is notified in writing and the output is sent to him in a secure way.
“As such, gatekeeper system 90 receives requests and the information is retrieved from one or more data sources. This includes system 90 locally. The report will provide the requested information to requestors as a report. As we’ll discuss below.
“Embodiments” of the invention include the ability for patients to comment on particular information. Patients can send comments to the gatekeeper system in a variety of formats, including via facsimile or standard courier mail. A specific fax number can be assigned to requestor information if it is sent via facsimile. In one embodiment, it’s a fax modem set to receive facsimiles only. The comments are therefore received at a particular location to ensure that they won’t be lost.
“When a patient responds (e.g. “When a response (e.g., comment) is received by a patient the mechanisms for attaching all comments as though they were attached files to an original request/response are invoked. This audit trail will be discussed later. Facsimile stores can receive information. The images of patient responses are stamped with the appropriate date and time. All flags and mechanisms that allow tracking of all communications with patients are enabled in one embodiment.
“Embodiments” of the invention include the management of comments received by requestors such as patients. Patients may respond in a variety of ways, and there are mechanisms that can address and handle each one. One embodiment allows the entity to support the patient in all aspects of their interactions, as required by the regulations. One example is setting a flag to indicate the patient has answered with the status set for the verification of completeness and/or accurate of the information, providing minor comments, providing substantial comments, adding to records, or making requests to modify the information.
“As illustrate in FIG. 3. Once the requested information has been obtained, it is to be given to the requestor. A single point of exit is provided by gatekeeper 90 for the transmission individually identifiable patient data. This is done in response to legitimate patient requests. This single point of exit allows for a potential revenue stream through completely de-identified, certified data. De-identified data can then be sold to select buyers such as researchers, pharmaceutical companies, and insurance companies. One embodiment of the provided information is encrypted. If the information cannot be de-identified the patient’s individually identifiable data is sent to patient-approved, legitimate requests.
“In accordance to the invention, all information that is released to a requestor goes through a gatekeeper system. The information is not directly provided to the requester from any of the data sources. Instead, the information is sent through the gatekeeper system to be provided as a report to the requestor.
“Embodiments” of the invention include source data systems that are protected from physical and electronic intrusion. To control physical and electronically accessible information, organizations use a combination biometric and digital signature technology.
“As stated above, all requests for data received electronically from requestor 80 are entered into the gatekeeper system to be processed. All requests, regardless of origin, are included in this system. Requests received by facsimile with a signed authorization are also scanned into the gatekeeper software. These documents are compressed and digitized images, which are linked to the information being retrieved. Both are kept in an audit trail maintained by gatekeeper 90.
“Since system 90 is the exclusive mechanism for receiving incoming requests for information, it consolidates all facets of the requesting process, including validation, verification, and authentication of not only the requests but also the accompanying patient-signed authorization/consent. System 90 provides the ability to authenticate electronic requests from any industry, such as the insurance industry, and all legitimate, patient-authorized requestors including patients. The system allows patients to submit requests to the enterprise to retrieve, review and comment on data they have on file. The system removes the need for data sources to directly provide information to requesters and in compliance with established regulations.
“Refer to FIG. “With reference now to FIG. 4, a representative system according to the present invention is shown that allows a requestor 110 interface with a clearinghouse 120. This provides the single point for entry and exit. Clearinghouse 120 is composed of one or more servers 122, one or two storage devices 124 and is connected to a variety 140 medical centers (e.g. hospitals, clinics and laboratories). Each medical center 140 has a gatekeeper system 142. FIG. FIG. 4. Each gatekeeper system 142 provides information to clearinghouse 120. In response to a request, 110 receives a report. To meet the regulation-imposed time limit, the report’s information is archived for 6 years.
“With reference to FIG. 5 illustrates a flowchart that shows how to create, archive and transmit a patient-specific reports. FIG. FIG. 5 shows the execution of step 150. This is where an authenticated request is received. Decision block 152 determines whether the request has been authorized by the patient. Execution proceeds to step 54 if the patient has not authorized the request. The patient authorization then goes to step 56. Alternativly, execution can proceed directly to step 56 if the decision block 152 determines that the patient has authorized the request.
“In step 56, the requested information was retrieved. Step 158 is where a report is assembled. At step 158, a report is assembled. At decision block 160, a decision is made about whether or not the report should be reviewed. Execution proceeds to step 162 if a review of a report is required. Then to step 164 if the review is included in a report. Execution proceeds to step 162. Or, execution can proceed directly to step 162 if it is decided at decision block 160 that the report is not up for review.
“At step 166, the report is encrypted, and at step168 the report’s archive is created in a storage device. Execution proceeds to decision block 170 to determine if the archive is complete. Execution returns to block 168 if the archive is not complete. This allows the report to be archived completely. Alternately, execution can continue to step 172 if the report’s archival is complete at decision block 170. A copy of the report will be sent to the authorized requester.
“FIG. “FIG. FIG. FIG. 6. Execution begins at step 180. This is where an authenticated request is received. Step 182 retrieves the requested information and step 184 deidentifies it. The report is then assembled at step 186. Execution proceeds to decision block 188, where it is decided whether or not to conduct a review. Execution proceeds to decision block 191 for the execution of the review. If not, execution proceeds to decision block 192. Or, execution can proceed directly to decision block 192 if it is decided at decision block 188 that no review should be performed.
“A decision block 192 is where the report assembled will be archived. If the decision block is 192 that the report should be archived, execution proceeds to step 194 to archive the report and then to decision block number 196. Alternativly, execution can be initiated directly at decision block 194 if the report is not to archived.
“A decision block 196 is where the decision is made about whether or not to encrypt a report that has been assembled. Execution proceeds to step 198 to encrypt the report, and then to step 200 if it is decided at decision block 194. Alternativly, execution can proceed directly to step 200 if the report cannot be encrypted. The report will then be transmitted to the requester.
“Refer to FIG. “With reference now to FIG. 7, a representative system allows a requestor select information from a public realm clearinghouse (214) and/or a member clearinghouse (216), wherein members can selectively update or modify their personal information. The member clearinghouse 216 receives information from information sources 218, which include personal information such as financial, academic, medical, and any other information that could be of use to the requester. To manage and monitor the information provided to the requester, the member clearinghouse is a single point for entry and exit.
“The embodiments of this invention include information management, as we have discussed. The present invention is a system and method for managing data in accordance with electronic transaction, privacy and security standards. You can incorporate the present invention in different forms without departing substantially from its essence or characteristics. These embodiments should be considered only as examples and not as restrictive. The appended claims indicate the scope of the invention and not the description. All modifications that fall within the scope of the claims’ meaning and range of equivalentity are to be included.
Summary for “Managing data in compliance to regulated privacy, security and electronic transaction standards
“1. “1.
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“2. “2.
Information management is an integral part of business practice. Information is collected from patients, physicians, research, training, underwriting insurance policies, and other sources. Patients, doctors, medial service providers, as well as other business entities, have found the medical information to be very beneficial. Insurance companies that offer life, health, disability income and long term care often require medical information to determine eligibility. Analyzing medical information usually involves reviewing medical records such as the statement of an attending physician. This is a reliable record because it contains analysis and conclusions by licensed medical professionals. The medical records can also be used to determine the risk posed by an individual for a policy and to determine causation and other issues that are relevant to insurance claim adjustment.
“Medical records are currently generally accessible, but they are difficult to access due to the confidential nature. The medical records are protected by professional standards and enacted legislation that requires consent from the patient before any disclosures of medical record information. The majority of medical records information is contained in paper documents that are kept in the offices of medical service providers. This restricts information sharing.
Some medical providers have begun to convert paper records to electronic records in order to save space and avoid the cost of filling up offices with large volumes of records. The electronic records are often isolated from external sources, just like their paper counterparts.
Requesting information from a medical data repository such as a doctor’s office can sometimes lead to a delay. This is due to the delay in receiving information from a medical information repository. The delay in underwriting policies can cause applicants to lose their interest and result in a loss of business for the insurer.
Some requesters use agents to travel to various medical offices in order to retrieve medical records manually. This helps to reduce delays. This may speed up the process, but it can also be costly and does not resolve the issue of whether or not the record retrieved is complete. Even if the location and existence of a record is known, their relevance will not be known until it is retrieved and reviewed.
Access to medical records is a requirement for emergency medical technicians and health care providers. In situations where paper records are not available, emergency medical technicians and health care providers are often required to make decisions about the care of patients. Inability to use traditional methods to provide information about medical records to emergency medical technicians and health care providers increases the chance of incorrect treatment and medical malpractice.
“The Health Insurance Portability and Accountability Act, (HIPAA) creates additional complications in the provision of medical information to a specific requestor. It mandates regulations that regulate privacy, security, and electronic transaction standards for health information. Major changes are required in the way that health care organizations manage all aspects of medical information management. This includes reimbursements, coding and security. Every department that provides or pays health care has a profound impact from the regulations.
HIPAA, for example, requires that patients be able to view all information the medical entity may have about them. Patients should also be able to comment or make annotations to any information the entity has given. Patients may also request corrections. The entity must allow patient-driven editing comments. capability. The medical entity is not required to make any actual corrections. They are required to note that the patient has made suggestions or registered comments to their records.”
Many medical entities may view such requirements as a serious problem. For others, however, it may be a great opportunity for the entity (e.g. It can be used by a physician, or other medical professionals who might have crucial clinical information such as a prescription record, to verify and publish that the patient has actually reviewed and verified the accuracy and completeness their personal information. A patient-verified history is very helpful to an emergency physician who is treating the patient.
“Accordingly, this would be an improvement of the art to allow affected entities to conform to the regulations that have been adopted, and to facilitate information exchange and management without breaching professional relationships or duties of confidentiality.”
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“The present invention is implemented in conjunction with one or more computers that are used in a system for managing data in compliance to regulated privacy, security and electronic transaction standards. One implementation includes an entry point for both internal and external requests and/or an exit point for information transmissions. The transmissions may include patient information and legitimate patient-approved requests. The present invention also allows for the de-identification and sale of selective information. De-identification prevents identification of patients with medical information. This allows the information to be used while maintaining professional confidentiality. The present invention also allows for fully digital authorizations and consents to retrieve external data sources.
The methods and processes of this invention have been particularly helpful in managing medical information. However, those who are skilled in the art will recognize that they can be used in many different applications and areas of manufacture to manage information such as financial information and academic information.
These and other features and benefits of the invention will be described or made more clear in the following description and the appended claims. You can realize and obtain the features and benefits of the invention by using the combinations and instruments specifically mentioned in the appended claims. The features and benefits of the invention can also be learned through the practice of it or from the description as described hereinafter.
“The invention concerns information management. The present invention is a system and method for managing data in accordance with electronic transaction, privacy, security and security standards.
“Embodiments according to the present invention are performed in conjunction with one or more computers that are used in a system for managing data in accordance with electronic transaction, privacy, and security standards. One embodiment of the system has a single point for entry for external and/or intra-related requests and/or an exit point for information transmissions. The transmissions may include patient information that is individually identifiable to legitimate patient-approved request. The present invention also includes fully digital authorizations, consents, and permissions for retrieval of external data sources.
The present invention allows for the selective use and/or sale of information. De-identification prevents identification of patients that correspond to medical information. This allows the information to be used while maintaining professional confidentiality.
“The disclosures of the present invention are grouped under two subheadings:?Exemplary operating environment? The other subheading is Managing Data in Compliance With Regulation Standards. These subheadings are used for informational purposes only.
“Exemplary Operating Environment.”
“FIG. “FIG. The invention can be used in many configurations of computing devices, including a networked one.
“Embodiments” of the present invention include one or more computer-readable media. Each medium can be configured to contain data or computer executable directions for manipulating data. Computer executable instructions can include data structures, objects and programs, routines or other modules that can be accessed by a processor system. They may either be associated with a general purpose computer that can perform many different functions, or one that is limited to a specific function. Computer executable instructions are program code that instruct the processor to execute a specific function or group. A particular sequence of executable instructions can be used as an example of the corresponding actions that could be used to implement these steps. Computer-readable media can include random-access memory, (?RAM?) ), read-only memories (?ROM) ), read-only memory (??ROM? ), erasable, programmable read only memory (?EPROM) ), Electrically eraseable programmable read only memory (?EEPROM) ), compact disk read only memory (?CDROM? ), compact disk read-only memory (?CD-ROM) or any other device, component, or device that can provide data or executable directions that may be accessed via a processing system.
“With reference to FIG. 1. A representative system for implementing this invention includes computer device 10. This computer device can be general-purpose, or special-purpose. Computer device 10 could be, for example, a personal computer or a notebook computer. Or any other handheld device, such as a laptop, a desktop computer, a mainframe or a supercomputer. A multi-processor system, network computer, processor-based consumer electronic devices, or the like.
“Computer device 10, which includes system bus 12, may be used to connect different components and allow data to be exchanged between them. One of many bus structures that system bus 12 can include is a memory bus, memory controller, peripheral bus, or local bus that makes use of any one of the various bus architectures. The typical components that are connected to system bus 12 include memory 16 and processing system 14. Other components could include input interfaces 20 and 22 for mass storage devices 18, as well as network interfaces 24. Each of these will be discussed later.
“Processing System 14” includes one or more processors. This could include a central processor or one or more processors that are specifically designed to execute a specific function or task. Processing system 14 executes instructions from computer-readable media such as memory 16, magnetic hard drives, removable magnetic disks, magnetic cassettes, optical disks, and communication connections. These can also be considered computer readable media.
“Memory 16” may include one or more computer-readable media that can be configured to contain or include data or instructions for manipulating it. It may be accessed through processing system 14 via system bus 12. For example, Memory 16 could include ROM 28 used to store data permanently and/or RAM 30 used to temporarily store data. ROM 28 could include a basic input/output (?BIOS?) One or more routines used to establish communication such as when the computer is first started up. RAM 30 could include one or several program modules such as operating systems, applications programs and/or data.
“One or more mass-storage device interfaces 18 can be used to connect one, or more mass-storage devices 26, to the system bus 12. Computer device 10 may include or be connected to mass storage devices 26, which allow it to store large amounts of data. One or more mass storage devices 26 can be removed from computer device 10. Some examples of mass storage devices are hard disk drives (magnetic disk drives), tape drives (tape drives), and optical disk drive(s). A mass storage device 26 can read and/or write from a magnetic hard drive, removable magnetic disk or magnetic cassette. It may also be able to access an optical disk or other computer-readable media. Mass storage devices 26 along with their computer-readable media can store nonvolatile data and/or executable instruction. These instructions may contain one or more program module, such as an operating system, one, two or more applications programs, other modules, or data. These executable instructions can be used to implement steps of the methods described herein.
One or more input interfaces 20 can be used to allow a user to input data and/or instructions to a computer device 10 via one or more corresponding inputting devices 32. You can use a keyboard or alternative input devices such as a trackball, light pen and stylus to point at the computer. Examples of input interfaces 20 may also be used to connect input devices 32 and 12 to the system bus 12. These include a serial port or parallel port, as well as a game port or universal serial bus (?USB). ), a firewire, (IEEE 1394), and another interface.
One or more output interfaces 22 can be used to connect one or several corresponding output devices 34 on the system bus 12. A monitor, display screen, speaker, printer and other output devices are some examples. One particular output device 34 can be connected to or peripheral to another computer device 10. A video adapter, an adapter for audio, or a parallel port are examples of possible output interfaces.
“One or more network interfaces 24 allow computer device 10 to exchange data with one another local or remote computer device, illustrated as computer units 36 via a network 38 which may include hardwired or wireless links. A network adapter is a device that connects to a local network (?LAN?) as an example of a network interface. or a modem or wireless link to connect to a wide-area network (?WAN?) The Internet is an example of a network interface 24. The network interface 24 can be integrated with or peripheral to a computer device 10. Accessible program modules and portions of them may be stored in remote memory storage devices in a networked environment. In a networked environment computer device 10 can participate in a distributed computing environment where tasks or functions are performed by a number of computer devices.
“While the invention can be used in networked computing environments that support many different types of computer systems configurations, those who are skilled in the art will recognize that it may also be practiced in such environments. FIG. 2. This is an embodiment of the invention in a networked environment with clients connected to a server through a network. FIG. 2 illustrates an embodiment that includes two clients connected to the network. Other embodiments include one client connected to a server via a network. FIG. 2. illustrates an embodiment with two clients connected via a network. Other embodiments may include one client or multiple clients connected to a single network. The embodiments of the present invention also include many clients connected to the network. This is where the network is a large area network such as the Internet.
“In FIG. 2 clients 50 and 60 exchange information via network 70 with information retrieval software 40. Information exchanges can be described as a request by a client for information to the information retrieval network. These requests can be made in electronic data. The network interfaces 42-52 and 62 allow the exchange of information between clients fifty and sixty and the information retrieval system forty, which includes servers 44, 46, and storage devices 46. Servers 44 respond to clients 50-60 with information requests. The stored information is kept at storage device(s). 46. Once the requested information has been selected, system 40 preserves the report and transmits a copy to the requestor as a response. As will be discussed further below.
“Managing Data in Compliance With Regulation Standards”
“As mentioned above, embodiments according to the present invention are in association with one or several computer devices that are used as part of a system to manage data in accordance with regulated privacy and security standards. Particularly, embodiments include a single point for entry for external and/or inner requests and/or one point for exit for information transmissions.
“With reference to FIG. 3 illustrates a representative system that allows a requestor to interface with a gatekeeper 90 to select information from one or several sources within an information repository 100. Any person or entity who wishes to receive information is called requestor 80. These requesters could be insurance companies, research organizations, patients, or care providers.
“Enabling the patient to view their personal information”
“For instance, a requester 80 might request specific information from a covered medical entity. This capability is provided by the enterprise via retrieval request or processing procedures that are made available to the requestor (e.g. An insurance underwriter who has the patient’s signed authorization. Patients can request a copy at any time of all their patient-specific information. The entity will respond by promptly sending the requested information.
The illustrated embodiment includes information/data sources from a variety of locations, including those that are located remotely. The data sources illustrated include the enterprise clinical data repository (104a), pathology laboratory system(s), 104b, in-patient pharmacie system(s), 104c, clinical laboratory systems(s), 104d), enterprise master person index (104f), and other data source(s). When information is requested, data is selected from one or more data sources using an interface engine (102). This interfaces with gatekeeper 90 to produce a response to requester 80.
“As shown, the gatekeeper system 90 provides one point of entry for all requests. Requests can come from internal or external requesters. Anyone authorized can enter requests through one point of entry. One embodiment of the system allows the point-of-entry to receive fully digital authorizations and consents for retrieval form external sources. This allows the entry point access to diverse data feeds from outside sources to improve patient safety.
“As we will discuss below, the processing that an enterprise does to respond to requests includes processing an authenticated request to obtain a copy of a patient’s specific record. Flags are used to facilitate processing in embodiments of the invention. For example, a flag is set for the output of all retrieval functions to be in a desired format so that the entity may easily print the information/documents or electronically transmit them to the requestor in a format that is useful to the requestor. An index of gatekeeper systems 90 and the specific record in the gatekeeper archive 90 indicate that the request is patient-driven. The flag is placed in the index gatekeeper system 90, and in the specific record of the audit trail archive at gatekeeper system90 that the patient has not yet commented on the information.
“Other processing” includes the creation of a cover page with specific information and instructions to the patient describing their rights under a particular regulation or law. A record is assigned an internal reference number so that future referencing can be done quickly. For information transmission via facsimile, a dedicated FAX number is used. This includes the actual cover sheet used to send back comments. The patient is notified in writing and the output is sent to him in a secure way.
“As such, gatekeeper system 90 receives requests and the information is retrieved from one or more data sources. This includes system 90 locally. The report will provide the requested information to requestors as a report. As we’ll discuss below.
“Embodiments” of the invention include the ability for patients to comment on particular information. Patients can send comments to the gatekeeper system in a variety of formats, including via facsimile or standard courier mail. A specific fax number can be assigned to requestor information if it is sent via facsimile. In one embodiment, it’s a fax modem set to receive facsimiles only. The comments are therefore received at a particular location to ensure that they won’t be lost.
“When a patient responds (e.g. “When a response (e.g., comment) is received by a patient the mechanisms for attaching all comments as though they were attached files to an original request/response are invoked. This audit trail will be discussed later. Facsimile stores can receive information. The images of patient responses are stamped with the appropriate date and time. All flags and mechanisms that allow tracking of all communications with patients are enabled in one embodiment.
“Embodiments” of the invention include the management of comments received by requestors such as patients. Patients may respond in a variety of ways, and there are mechanisms that can address and handle each one. One embodiment allows the entity to support the patient in all aspects of their interactions, as required by the regulations. One example is setting a flag to indicate the patient has answered with the status set for the verification of completeness and/or accurate of the information, providing minor comments, providing substantial comments, adding to records, or making requests to modify the information.
“As illustrate in FIG. 3. Once the requested information has been obtained, it is to be given to the requestor. A single point of exit is provided by gatekeeper 90 for the transmission individually identifiable patient data. This is done in response to legitimate patient requests. This single point of exit allows for a potential revenue stream through completely de-identified, certified data. De-identified data can then be sold to select buyers such as researchers, pharmaceutical companies, and insurance companies. One embodiment of the provided information is encrypted. If the information cannot be de-identified the patient’s individually identifiable data is sent to patient-approved, legitimate requests.
“In accordance to the invention, all information that is released to a requestor goes through a gatekeeper system. The information is not directly provided to the requester from any of the data sources. Instead, the information is sent through the gatekeeper system to be provided as a report to the requestor.
“Embodiments” of the invention include source data systems that are protected from physical and electronic intrusion. To control physical and electronically accessible information, organizations use a combination biometric and digital signature technology.
“As stated above, all requests for data received electronically from requestor 80 are entered into the gatekeeper system to be processed. All requests, regardless of origin, are included in this system. Requests received by facsimile with a signed authorization are also scanned into the gatekeeper software. These documents are compressed and digitized images, which are linked to the information being retrieved. Both are kept in an audit trail maintained by gatekeeper 90.
“Since system 90 is the exclusive mechanism for receiving incoming requests for information, it consolidates all facets of the requesting process, including validation, verification, and authentication of not only the requests but also the accompanying patient-signed authorization/consent. System 90 provides the ability to authenticate electronic requests from any industry, such as the insurance industry, and all legitimate, patient-authorized requestors including patients. The system allows patients to submit requests to the enterprise to retrieve, review and comment on data they have on file. The system removes the need for data sources to directly provide information to requesters and in compliance with established regulations.
“Refer to FIG. “With reference now to FIG. 4, a representative system according to the present invention is shown that allows a requestor 110 interface with a clearinghouse 120. This provides the single point for entry and exit. Clearinghouse 120 is composed of one or more servers 122, one or two storage devices 124 and is connected to a variety 140 medical centers (e.g. hospitals, clinics and laboratories). Each medical center 140 has a gatekeeper system 142. FIG. FIG. 4. Each gatekeeper system 142 provides information to clearinghouse 120. In response to a request, 110 receives a report. To meet the regulation-imposed time limit, the report’s information is archived for 6 years.
“With reference to FIG. 5 illustrates a flowchart that shows how to create, archive and transmit a patient-specific reports. FIG. FIG. 5 shows the execution of step 150. This is where an authenticated request is received. Decision block 152 determines whether the request has been authorized by the patient. Execution proceeds to step 54 if the patient has not authorized the request. The patient authorization then goes to step 56. Alternativly, execution can proceed directly to step 56 if the decision block 152 determines that the patient has authorized the request.
“In step 56, the requested information was retrieved. Step 158 is where a report is assembled. At step 158, a report is assembled. At decision block 160, a decision is made about whether or not the report should be reviewed. Execution proceeds to step 162 if a review of a report is required. Then to step 164 if the review is included in a report. Execution proceeds to step 162. Or, execution can proceed directly to step 162 if it is decided at decision block 160 that the report is not up for review.
“At step 166, the report is encrypted, and at step168 the report’s archive is created in a storage device. Execution proceeds to decision block 170 to determine if the archive is complete. Execution returns to block 168 if the archive is not complete. This allows the report to be archived completely. Alternately, execution can continue to step 172 if the report’s archival is complete at decision block 170. A copy of the report will be sent to the authorized requester.
“FIG. “FIG. FIG. FIG. 6. Execution begins at step 180. This is where an authenticated request is received. Step 182 retrieves the requested information and step 184 deidentifies it. The report is then assembled at step 186. Execution proceeds to decision block 188, where it is decided whether or not to conduct a review. Execution proceeds to decision block 191 for the execution of the review. If not, execution proceeds to decision block 192. Or, execution can proceed directly to decision block 192 if it is decided at decision block 188 that no review should be performed.
“A decision block 192 is where the report assembled will be archived. If the decision block is 192 that the report should be archived, execution proceeds to step 194 to archive the report and then to decision block number 196. Alternativly, execution can be initiated directly at decision block 194 if the report is not to archived.
“A decision block 196 is where the decision is made about whether or not to encrypt a report that has been assembled. Execution proceeds to step 198 to encrypt the report, and then to step 200 if it is decided at decision block 194. Alternativly, execution can proceed directly to step 200 if the report cannot be encrypted. The report will then be transmitted to the requester.
“Refer to FIG. “With reference now to FIG. 7, a representative system allows a requestor select information from a public realm clearinghouse (214) and/or a member clearinghouse (216), wherein members can selectively update or modify their personal information. The member clearinghouse 216 receives information from information sources 218, which include personal information such as financial, academic, medical, and any other information that could be of use to the requester. To manage and monitor the information provided to the requester, the member clearinghouse is a single point for entry and exit.
“The embodiments of this invention include information management, as we have discussed. The present invention is a system and method for managing data in accordance with electronic transaction, privacy and security standards. You can incorporate the present invention in different forms without departing substantially from its essence or characteristics. These embodiments should be considered only as examples and not as restrictive. The appended claims indicate the scope of the invention and not the description. All modifications that fall within the scope of the claims’ meaning and range of equivalentity are to be included.
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