FIELD OF INVENTION
[0001] This invention relates generally to authenticating medical imaging devices and more particularly to, a method and system for validating an imaging device user before installing the imaging device.
BACKGROUND OF INVENTION
[0002] Generally, certain medical imaging device users need to be registered with a regulatory authority, before purchasing and using a medical imaging device. The primary intent of this registration process is to prevent the unauthorized use of imaging devices. For example, an ultrasound imaging device user need to be registered with government authorities in countries like India and China. This is done to ensure that ultrasound scans are not used for unwanted fetal sex determination, which could be used for terminating pregnancies for a preference to gender.
[0003] Currently, before installing an ultrasound imaging device, the user has to obtain a valid registration certificate from the government. The registration information is provided by appropriate regulatory authority and the document is preserved by the user and displayed at the place of operation. This document is required by the device manufactures before shipping the ultrasound imaging device to the user. Once the manufacturer receives the registration information, they ship the product and currently, there is no mechanism to validate the registration information. However, the usage of registration number is not required at the installation stage or during the daily operation of the ultrasound imaging device. This might result in unauthorized use of the device.
[0004] Further, the registration may be given for a limited period to a user and there is no mechanism to stop the usage of the imaging device by the user after expiry of the validity date. The regulatory authorities are finding it difficult to enforce the concept of having a valid registration for using the ultrasound imaging device. Another problem faced by the imaging device users and the imaging device manufactures are requirement of registration certification before shipping the imaging device to the user and the delay

in getting the registration certificate. Since, the device manufacturers have to wait for the registration certificate to ship the imaging device to the user, this causes delay in the shipping process and the revenue of the manufactures as well as the device user gets affected.
[0005] Currently there is no mechanism to validate the registration information automatically, thereby preventing unauthorized use of the medical imaging devices. Thus there exist a need to provide a method and system for authorizing a medical imaging device user, automatically.
SUMMARY OF INVENTION
[0006] The above-mentioned shortcomings, disadvantages and problems are addressed herein which will be understood by reading and understanding the following specification.
[0007] One embodiment of the present invention provides a medical imaging device authentication system. The system comprises: an imaging device having an imager for acquiring patient images; and a user interface associated with the imager for obtaining a registration information corresponding to an imaging device user, the registration information being provided by a regulatory authority; a server stored with the registration information corresponding to various medical device users; a communication channel for facilitating interaction of the imaging device with the server; wherein the imaging device interacts with the server through the communication channel to validate the registration information and authorize the installation or use of the imaging device.
[0008] In another embodiment, an ultrasound image device is disclosed. The device comprises: an imager for acquiring images; a user interface associated with the imager for obtaining a registration information from a user, the registration information includes unique registration number corresponding to an ultrasound imaging device user and validity date; a processor configured to verify the registration information with a server having registration information of ultrasound image device users; the server being

associated with a regulatory authority; a communication device associated with the processor to interact with the server for verifying the registration information; and a memory for storing the registration information.
[0009] In yet another embodiment, a method of authenticating an imaging device is disclosed. The method comprises: obtaining registration information corresponding to an imaging device user; registration information being provided by a regulatory authority; prompting for registration information while installing an imaging device; communicating the obtained registration information to a server having registration information pertaining to various imaging device users; and validating the registration information corresponding to the imaging device.
[0010] Various other features, objects, and advantages of the invention will be made apparent to those skilled in the art from the accompanying drawings and detailed description thereof
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG.l is a block diagram of a medical imaging device authentication system as described in an embodiment of the invention;
[0012] riG.2 is a block diagram of an ultrasound imaging device as described in an embodiment of the invention;
[0013] FIG. 3 is a flowchart illustrating a method of authenticating an imaging device as described in an embodiment of the invention;
[0014] FIG. 4 is a flowchart illustrating a method of validating an imaging device user before installing an imaging device, as described in an embodiment of the invention;

[0015] FIG. 5 is a flowchart illustrating a method of authorizing an imaging device user before allowing the user to use the image device, as described in an embodiment of the invention; and
[0016] FIG. 6 shows diagrammatic representation of display during the authorization process, as described in an embodiment of the invention.
DETAILED DESCRIPTION OF INVENTION
[0017] In the following detailed description, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific embodiments that may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the embodiments, and it is to be understood that other embodiments may be utilized and that logical, mechanical, electrical and other changes may be made without departing from the scope of the embodiments. The following detailed description is, therefore, not to be taken as limiting the scope of the invention. To the extent that the figures illustrate diagrams of the functional blocks of various embodiments, the functional blocks are not necessarily indicative of the division between hardware circuitry. Thus, for example, one or more of the functional blocks (e.g., processors or memories) may be implemented in a single piece of hardware (e.g., a general purpose signal processor or a block of random access memory, hard disk, or the like). Similarly, the programs may be stand alone programs, may be incorporated as subroutines in an operating system, may be fiinctions in an installed software package, and the like. It should be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings.
[0018] Embodiments of the present invention provide a method and system for authorizing a medical image device user for installing and using a medical imaging device. The user is authenticated automatically with the regulatory authority upon

installing or using the imaging device; thereby enforcing the usage of the device by authorized users only.
[0019] The term "imaging device" referred in the specification need not limit to medical imaging device and its users, but could include any imaging device user that need prior authorization. The term "imaging device user" could include imaging center/laboratory/clinic/body or person, but need not be limited to the examples. Each imaging device user will have a registration with the regulatory authority. However upon getting the registration the user can use one or more imaging devices.
[0020] FIG.l is a block diagram of a medical imaging device authentication system as described in an embodiment of the invention. The medical imaging device authentication system 100 comprises an imagining device 110 configured to acquire the medical images, a server 120 configured to store the registration information of various medical imaging device users and a communication channel 130 to facilitate communication between the server 120 and the imaging device 110.
[0021] Each imaging device user such as a practicing clinician, a healthcare environment, a genetic clinic, or genetic counseling centre wherein medical imaging devices 110 are used, are provided with registration information by the regulatory authorities in the relevant countries. The registration information includes a unique registration number corresponding to the user and a validity date for the unique registration number.
[0022] The imaging device 110 includes an imager 112 configured to acquire patient images. In an embodiment, the imaging device 110 could be an ultrasound based imaging device. The imaging device 110 is associated with a user interface 114. The user interface 114 may be part of the imaging device 110 or could be an external user interface connected to the imaging device 110. In an example, the user input device 114 could include a mouse, a touch screen and stylus, a keyboard with cursor keys, or combinations thereof

[0023] The imaging device 110 could include a processor 116 configured to receive the registration information and communicate this information to the server 120 through the communication channel 130.
[0024] The server 120 includes a set of information corresponding to the registration of various medical imaging device users with the regulatory authority. For example, all the ultrasound imaging device users have to be registered with the government authority and the authority maintains a record of the registration information of all the ultrasound device users. The server 120 stores unique registration number and validity date. The server could include a computer or processing unit along with a database stored with registration information of all the image device users. The server could be associated directly with the regulatory authority or could be associated with a third party. The server could be accessed by any existing communication network.
[0025] The imaging device 110 communicates with the server 120 through the communication channel 130. The registration number and validity date provided by the user to the imaging device 110 is communicated to the server 120 through the communication channel 130 automatically. The communication channel 130 could include Internet, GPRS, DSL cable etc, however the examples need not be limited to these. The communication channel 130 could be any existing channel depending on the location of the imaging device 110 or the server 120. The registration information communicated is validated with the server 120 and validity status is communicated to the imaging device 110. If the registration information is valid, the processor 116 unlocks the imaging device 110 and user can proceed with the installation of the imaging device 110.
[0026] In an embodiment, upon validating the registration information, the registration information could be stored in an internal memory 118 of the imaging device 110. Upon booting the imaging device 110, the registration information including the validity date stored in the internal memory 118 of the imaging device 110 is accessed and is validated. Upon expiring the validity, an alert is given to the user and the imaging device 110 is

locked, preventing further usage of the imaging device 110. Upon nearing the expiry of validity date, the imaging device 110 may generate a reminder to renew the registration.
[0027] In an embodiment, address of the server 120 could be provided in the internal memory 118 of the device. The server address could be provided on the internal memory 118 by the manufacturer at the time of manufacturing/ shipping or could be provided at the time of installation. If required, the address of the server could be altered at a later stage.
[0028] In an embodiment, existing General Packet Radio Service (GPRS) network may be used to establish connection with the server 110 and validate the registration information. Usage of existing GPRS network will facilitate easy implementation of the method.
[0029] In an embodiment, the registration information is PNDT (Pre Natal Diagnostic Test Regulations) registration information provided by the Indian government authorities. In an example, PNDT registration number is provided in a particular format. In the event of un accessibility or the server such as failure of the server, the device may validate the PNDT number by checking for the existing format. Each time the user uses the imaging device, either the PNDT number along with its validity date or the validity date is verified.
[0030] In an embodiment, the validation need not be done before the installation of the imaging device. After installation, while the device 110 is booting up, the imaging device 110 may validate the registration information.
[0031] The processor 116 may include dedicated hardware, software and/or firmware for performing information processing, or a combination of dedicated hardware and software, or software in combination with a general purpose processor, or a digital signal processor. Once the requirements for such software and/or hardware and/or dedicated hardware are gained from an understanding of the descriptions of embodiments of the invention contained herein, the choice of any particular implementation may be left to a

hardware engineer and/or software engineer. However, any dedicated and/or special purpose hardware or special purpose processor is considered subsumed in the block labeled processor 116.
[0032] The internal memory 118 may include, for example, random access memory (RAM), flash memory, or read-only memory. For purposes of simplicity, devices that can read and/or write media on which computer programs are recorded are also included within the scope of the term "memory."
[0033] FIG.2 shows block diagram of an ultrasound imaging device as described in an embodiment of the invention. Ultrasound imaging devices provide the capability of determining the gender of the fetus, thereby indirectly aiding selectively terminating pregnancies of a specific gender. The ultrasound device 200 comprises an imager 210 for imaging. The imager 210 could include ultrasound probe having transducer array. The ultrasound imaging devices 200 are used for ultrasound imaging or ultrasound image guided procedures. A user interface 220 is provided in association with the imager 210 for a user to interact with the imaging device 200. The user interface 220 could assist user in providing registration information to imaging device 200. The registration information is provided to an imaging device user by a regulatory authority. In an embodiment, the ultrasound imaging device 200 could have a keypad or keys as user interface 220 to input the registration information to the ultrasound imaging device 200.
[0034] The imaging device 200 comprises a processor 230 configured to process the image data acquired by the imager 210. The ultrasound imaging device 200 further includes a display 240. While installing the ultrasound imaging device 200, a pop up widow may appear on the display 240 prompting the user to input the registration information including registration number and the validity date. To validate the registration information, a communication device 250 is provided in association with the processor 230. The communication device 250 acts as an interface between the ultrasound imaging device 200 and a communication network. The ultrasound imaging device 200 uses the communication network to interact with a server, the server being

stored with registration information of all the imaging device users. In an embodiment, the communication network may be existing General Packet Radio Service (GPRS) network and the communication device 250 may be a Personal Computer Memory Card International Association( PCMCIA) GPRS modem or a Universal Serial Bus (USB) GPRS modem. The processor 230 may be associated with an internal memory 260 of the ultrasound imaging device 200. Once the registration information is inputted, the ultrasound imaging device 200 may search in its internal memory 260 and access the server address from the memory 260. Alternately, it may prompt the user to provide the server address. Once the server address is obtained, the ultrasound imaging device 200 establishes a communication with the server through the communication device 250. The communication device 250 uses the external communication network to communicate the registration information to the server.
[0035] The server stores or has a database with registration information of users of ultrasound scanners. The database will have information of all the registered users along with their registration number and validity date. This database or server could be maintained by the regulatory authority that gives the registration information to the user. The ultrasound imaging device 200 communicates the registration information of the user to the sever through existing communicating network. The server is queried and the registration information is validated. The validated registration information is sent to the imaging device 200 and the imaging device 200 receives the validity status from the server. Once the registration information is validated, the processor 230 internally unlocks the ultrasound imaging device 200 so that the ultrasound imaging device 200 can be used by the user.
[0036] Once the imaging device 200 receives the validity status, if the registration information is valid, the registration information is stored in the internal memory 260 of the imaging device. Upon booting the ultrasound imaging device 200 subsequently, the registration information is accessed from the memory and validated within the imaging device or with the server.

[0037] FIG. 3 is a flowchart illustrating a method of authenticating an imaging device as described in an embodiment of the invention. At step 310, registration information corresponding to an imaging device user is obtained. A regulatory authority provides this registration information. This registration is required for all the imaging device users such as clinicians or hospitals who intend to use certain medical imaging devices. The registration provided by corresponding regulatory authority, maintains a record of all the registered image device users. At step 320, while installing an imaging device, the imaging device prompts for user registration information. The user registration information includes unique registration number and validity date. At step 330, the registration information is communicated to a server, the server is stored with registration information pertaining to different medical imaging device users. The imaging device may communicate the registration information to the server through any existing communication network. At step 340, the registration information is validated with the server.
[0038] FIG. 4 is a flowchart illustrating a method of validating an imaging device user before installing an imaging device, as described in an embodiment of the invention. At step 410, an engineer inputs the registration information of a user to the imaging device. The engineer is in the process of installing the imaging device at a particular site. According to an embodiment of the invention, the installation is allowed only after the registration of the user is verified with a regulatory authority. Each imaging device user should have valid registration information to get the imaging device installed and use it. The registration information includes unique registration number and the validity date provided by the regulatory authority. Upon starting the installation process, the imaging device prompts the installation engineer to enter the user registration information. At step 420, the imaging device accesses a server having registration information of all the imaging device users. The imaging device communicates with the server through existing communication network. In an example, existing GPRS network is used to communicate with the server. At step 430, the device communicates the registration information of the user to the server through the existing communication network. At step 440, the

registration information is validated with the server. The server is stored with information of all the registered imaging device users and their validity and the registration information corresponding to a particular user is validated with the server. At step 450, the imaging device checks whether the registration information is valid. If the not valid, the installation process is stopped as at step 480. If valid, the imaging device is unlocked for installation, as at step 460. At step 470, the registration information is stored in the internal memory of the imaging device. At step 490, the installation is completed.
[0039] FIG. 5 is a flowchart illustrating a method of authorizing an imaging device user before allowing the user to use the image device, as described in an embodiment of the invention. At step 510, the imaging device installed at a particular site for a particular user is booted for starting its operation. At step 520, registration information of the user is validated. In an embodiment, the registration information including registration number and validity date is stored in the internal memory of the imaging device. The system accesses the validity date and checks whether the date is valid. Alternately, the imaging device may validate the registration information with server having registration information of all the imaging device users. At step 530, the imaging device checks whether the registration is valid. In an embodiment, the device checks whether the validly of the registration has been expired. If the registration is valid, the device may proceed with the normal operation as at step 560. If the registration is not valid, the imaging device could alert the user as at step 540 and lock the system preventing from further usage of the system as at step 550.
[0040] FIG. 6 shows diagrammatic representation of display during the authorization process, as described in an embodiment of the invention. The imaging device has a display configured to prompt a user to input the registration number and validity date as shown in FIG.6A and FIG.6B. The imaging device validates this information with a server and the validity status is displayed as in FIG.6C. Once the registration information is validated, the device is unlocked for use or installation as shown in FIG.6D.

[0041] Currently, though the end users have confirmed the order of ultrasound imaging devices, the shipment and revenue recognition of the manufacturer is delayed due to delay in obtaining the registration and certificate of registration prior to shipment of the device. Since the device disclosed in the invention requires a valid registration information to activate the imaging device, the manufacturer need not have to wait for the registration information to ship the device to the user. Registration and activation can be done by the end user at his convenience.
[0042] Currently, though the regulation requires registration for the imaging device users, the imaging devices may be used without any registration number thereby making the enforcement of regulation difficult for the regulators. Since the device disclosed in the invention requires a valid registration information to activate the imaging device and locks the imaging device from further usage if the registration number is not valid, it facilitate the enforcement of the regulation.
[0043] As used herein, an element or step recited in the singular and proceeded with the word "a" or "an" should be understood as not excluding plural elements or steps, unless such exclusion is explicitly stated. Furthermore, references to "one embodiment" of the present invention are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. Moreover, unless explicitly stated to the contrary, embodiments "comprising" or "having" an element or a plurality of elements having a particular property may include additional such elements not having that property. Moreover, the terms "computer" and "processor" are used interchangeably herein to refer to either specialized hardware to perform digital signal processing, control, data manipulation, and/or calculations, or a general purpose computer that can be programmed to perform the same functions and/or adapted to interface with external digital signals. The phrases "computer or processor" and "processor or computer" are therefore intended to have equal scope with either of the individual terms and are not intended to imply a dichotomy between the two terms.

[0044] Exemplary embodiments are described above in detail. The assemblies and methods are not limited to the specific embodiments described herein, but rather, components of each assembly and/or method may be utilized independently and separately from other components described herein. Further the steps involved in the "workflow need not follow the sequence in which there are illustrated in figures and all the steps in the work flow need not be performed necessarily to complete the method.
[0045] While the invention has been described with reference to preferred embodiments, those skilled in the art will appreciate that certain substitutions, alterations and omissions may be made to the embodiments without departing from the spirit of the invention. Accordingly, the foregoing description is meant to be exemplary only, and should not limit the scope of the invention as set forth in the following claims.

We Claim:
1. A medical imaging device authentication system comprises:
an imaging device having an imager for acquiring patient images; and a user interface associated with the imager for obtaining a registration information corresponding to an imaging device user, the registration information being provided by a regulatory authority;
a server stored with the registration information corresponding to various medical device users;
a communication channel for facilitating interaction of the imaging device with the server;
wherein the imaging device interacts with the server through the communication charmel to validate the registration information and authorize the installation or use of the imaging device.
2. The system as claimed in claim 1, wherein the user interface is configured to obtain a unique registration number corresponding to the imaging device user and the validity date of the registration number.
3. The system as claimed in claim 1, wherein the imaging device further comprises a processor for validating the registration information with the server.
4. The system as claimed in claim 1, wherein the imaging device further comprises a memory for storing the registration information upon validating the same with the server.
5. The system as claimed in claim 1, wherein processor is further configured to access the registration number and validity date from the internal memory for validating the same, while booting the imaging device.

6. The system as claimed in claim 1, wherein the communication channel includes Internet, GPRS and DSL cable.
7. A ultrasound image device comprising:
an imager for acquiring images;
a user interface associated with the imager for obtaining a registration information from a user, the registration information includes unique registration number corresponding to the ultrasound imaging device users and validity date;
a processor configured to verify the registration information with a server having registration information of ultrasound image device users; the server being associated with a regulatory authority;
a communication device associated with the processor to interact with the server for verifying the registration information; and
a memory for storing the registration information.
8. The device as claimed in claim 7, wherein the processor is configured to access the registration number and validity data from the internal memory for validating the same upon booting the imaging device.
9. The device as claimed in claim 7, wherein the processor is configured to generate an alert based on the registration information.
10. The device as claimed in claim 7, wherein the processor is configured to lock the ultrasound imaging device upon failing the validation of registration information.
U. A method of authenticating an imaging device comprising:
obtaining registration information corresponding to an imaging device user; registration information being provided by a regulatory authority;

prompting for registration information while installing an imaging device;
commimicating the obtained registration information to a server having registration information pertaining to various imaging device users; and
validating the registration information corresponding to the imaging device.
12. The method as claimed in claim 11, wherein the step of prompting includes
prompting for registration number and validity date corresponding to the imaging
user.
13. The method as claimed in claim 11, wherein the step of communicating includes
communicating the registration information via a communication network.
14. The method as claimed in claim 11, further comprises: storing the registration
information in internal memory of the imaging device.
15. The method as claimed in claim 14, further comprises: validating the registration
information internally while booting the imaging device.