A SYSTEM AND METHOD FOR MANAGEMENT AND MONITOWNG OF PRENATAL IMAGE DATA

FIELD OF THE INVENTION

[0001] The present invention relates in general to ultrasound medical diagnostic imaging systems and methods, and more particularly to a system and method for the management of prenatal images produced by the ultrasound machine while diagnosis.

BACKGROUND OF THE INVENTION

[0002] Prenatal diagnosis using ultrasound machines is carried out widely in hospitals throughout the world. Medical imaging systems are used as diagnostic tools for viewing internal areas of a patient's body. Imaging systems based on ultrasound technology are desirable because such systems are non-invasive, portable and generally easy to use.

[0003] Pre-natal Diagnostic Techniques (PNDTs) are generally used to determine the health of a fetus in mother's womb. Ultrasound imaging system is a very popular tool to gain information on the health of the fetus. The ultrasound technology is non-invasive and can identify many abnormalities related to fetus.

[0004] The ultrasound technology is also employed in the prenatal diagnostics
for example in the sex determination of the fetus. Currently, the ease of sex determination through this technology has given rise to a large number of volimtary abortions of female fetuses every year. This may be one of the major reasons that has led to an increasingly smaller percentage of girls bom each year in India. Studies have reported a constant decline in the child sex ratio against females in India. In 1990 it was 945 and in 2001 it was 927 per 1000 males.

[0005] Prenatal sex determination can also be done by using genetic methods or various chemical tests. However, ultrasound technology is mostly used because it is much easier than the other methods.

[0006] To prevent the female feticides, the Pre-natal Diagnostic Techniques (Regulation and Prevention of Misuse) Act, 1994, was enacted and brought into operation from 1st January 1996 by the Indian govermnent. The Act prohibits determination and disclosure of the sex of fetus. It also prohibits any advertisements relating to prenatal determination of sex and prescribes pimishment for its contravention. The person who contravenes the provisions of this Act is punishable with imprisormient and fine.

[0007] Although, most laboratories and centers comply with the law, misuses of this technology in female feticides are also being reported in a very large number.

[0008] Therefore, a novel system and method is required for managing and monitoring prenatal image data in order to prevent the misuse of the ultrasound technology.

SUMMARY OF THE INVENTION

[0009] The present invention relates to a method and apparatus for the management of prenatal images produced by the ultrasoimd machine while diagnosis. The system according to an embodiment of the present invention comprises an ultrasound engine which scans tlie prenatal images from the ultrasound machine and produces random data samples, an encryption module to encrypt the random data samples such that the data can only be accessed with a decryption key, a storage device to store the encrypted data and a decryption module to decrypt the encrypted data upon receiving the decryption key. The method for managing and monitoring prenatal images from an ultrasound machine comprising the steps of scanning the prenatal images from the ultrasound machine, capturing random data samples from the scaimed prenatal images, encrypting the random data samples, such that it can only be decrypted using a decryption key; storing the encrypted data in a secure location, seeking decryption key, checking the authenticity of the decryption key, prohibiting access to the encrypted data and stopping the method if the decryption key is not authentic, decrypting the encrypted data and continuing the method to next step if the decryption key is authentic, allowing access and management of the decrypted data; and storing the managed data in the secure location.

BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a schematic diagram of the prenatal image data management and monitoring system, according to one embodiment of the present invention.

[0011] FIG. 2 is a flowchart of the method for managing and monitoring prenatal images, according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0012] Referring to FIG 1, a schematic diagram of the prenatal image data management and monitoring system 100, according to one embodiment of the present invention is shown. The system 100 comprises an ultrasound engine 101 which scans the prenatal images from the ultrasound machine and produces random data samples, an encryption module 103 to encrypt the random data samples such that the data can only be accessed with a decryption key, a storage device 104 to store the encrypted data and a decryption module 105 to decrypt the encrypted data upon receiving the decryption key,

[0013] In a preferred embodiment of the present invention, the random data samples also contain information about external genital patterns of a fetus. This data is misused for sex determination of the fetus.

[0014] In a further preferred embodiment of the present invention, the storage device 104 is coupled to the encryption module 103 and stores the encrypted data in a secured location within it, such that the secure location can only be accessed by using the decryption key.

[0015] FIG 2 is a flowchart of the method 200 for managing and monitoring prenatal images, according to one embodiment of the present invention. The method 200 starts with step 201 of scaiming the prenatal images from the ultrasound machine.The ultrasound engine 101 scans the images of fetus or the prenatal images. Normally,in ultrasound scan, the images are freezed and processed and the processed image may be then printed by using a thermal printer if required.

[0016] Next step 202 comprises capturing random data samples from the scanned prenatal images. The scanned image is captured at random. The captured data also contains the information on external genital patterns of the fetus.

[0017] In step 203 the random data samples are encrypted such that it can only be decrypted using a decryption key. Encryption module 103 is employed to encrypt the data and prevent any unauthorized user from misusing this information.

[0018] The random data samples are captured from the scanned image of the fetus and sent to the encryption module 103. The encryption module 103 encrypts the random data sample such that no user is allowed to access the data without having a decryption key or a password. This is to avoid anybody trying to access the hard disk
content by any means.

[0019] In step 204 the encrypted data is stored in a secure location. The encryption module 103 is coupled to a storage device 104 that stores the encrypted data in a secured location within that storage device 104. The access to this secure location is not allowed without having the decryption key or the password.

[0020] The authentic users such as PNDT (Pre-natal Diagnostic Techniques)authorities or administrators may be provided with the decryption key.

[0021] Step 206 is seeking decryption key. Whenever a user want to access the data stored at the secured location, the system 100 will ask the user to insert the decryption key. The authentic user may enter the decryption key to retrieve the actual data scanned by the ultrasound engine 101.

[0022] In step 207 the decryption key is checked for authenticity. The access of the encrypted data may be allowed to a user upon receiving the valid encryption key else, the user may be prohibited from accessing the data from the secure storage. Depending on the decryption key is authentic or not the control goes to steps 208 or 211 respectively.

[0023] In step 211 the access to the encrypted data is prohibited and the method is stopped if the decryption key is not authentic.

[0024] Step 208 and next steps are carried out if the decryption key is authentic. In step 208 the encrypted data is decrypted. A decryption module 105 is provided in the system 100 that decrypts the encrypted random data samples upon
receiving the decryption key from the user.

[0025] In step 209 the authentic users are allowed access and management of the decrypted data. The actual image 106 of the fetus or the actual data 106 may then be managed and monitored by the authentic users. Even, PNDT authorities are not allowed to delete the data in this module 209.

[0026] In step 210 the authentic users are also allowed to store the managed data in an alternate location apart from the secure location. For example, the authentic users such as PNDT authorities may delete the information on the genital patterns of the fetus. Thus, the normal users such as local ultrasonic engine operator may have access only to the data that do not reveal the information for prenatal sex
determination.

[0027] In a preferred embodiment of the present invention, the encrypting is done by using common encryption algorithms known in the art,

[0028] In a fiirther preferred embodiment of the present invention, the decryption key is machine specific. No two passwords will thus be corrunon for any two ultrasound machines.

[0029] In a further preferred embodiment of the present invention, a log file provides a detailed view on the management of the decrypted data with date, time and measurements performed at the time of saving. PNDT authorities who inspects the data will see a consolidated LOG file which provides a detailed view on the images saved with date, time and measurements performed by the user on that at the time of saving.

[0030] Thus, the system and method described above saves prenatal images at-random, and patient demographics in a 'secure location', which is accessible, only by a password or any other encryption method known only to PNDT authorities. Although, the system, may not affect routine ultrasound scanning performance in any way, it makes difficult for the user to guess what / when the images are getting stored for monitoring by the authorities. Thus the misuse of the ultrasound technology for sex determination and female feticide can be prevented.

We claim:

1. A prenatal image data management and monitoring system in an ultrasound
machine comprising of:

- an ultrasound engine which scans the prenatal images to generate data samples;

- an encryption module to generate and store encrypted data samples; and

- a decryption module configured for receiving encrypted data and decrypting the encrypted data upon receiving the decryption key.

2. The system according to claim 1, wherein the generated data samples can have information about external genital patterns of a fetus.

3. The system according to any of the preceding claims, wherein the storage device is coupled to the encryption module and stores the encrypted data in a secured location within it, such that the secure location can only be accessed by using the decryption key.

4. A method for managing and monitoring prenatal images from an ultrasound machine comprising the steps of:

- scanning the prenatal images from the ultrasound machine;

- capturing random data samples from the scanned prenatal images;

- encrypting the random data samples, such that it can only be decrypted using a decryption key;

- storing the encrypted data in a secure location;

- seeking decryption key;

- checking the authenticity of the decryption key;

- prohibiting access to the encrypted data and stopping the method if the decryption key is not authentic;

- decrypting the encrypted data and continuing the method to next step if the
decryption key is authentic;

- allowing access and management of the decrypted data; and

- storing the managed data in the secure location.

5. The method according to claims 4 or 5, wherein the decryption key is machine specific.

6. The method according to any of the claims 4-6, wherein a log file provides a
detailed view on the management of the decrypted data with date, time and measurements performed at the time of saving.

7. A prenatal image data management and monitoring system, wherein the prenatal
image data generated, stored in encrypted form, and decryption of the encrypted data is achieved by the method as claimed in claims 4 -6.

8. A prenatal image data management and monitoring system as illustrated by drawings and as described in the specification.