AU2003269594A1 - A new method for storing data - Google Patents

Description

WO 2004/038604 PCT/AU2003/001358 A NEW METHOD FOR STORING DATA BACKGROUND OF THE INVENTION The present invention relates to the storage of files electronically. For convenience the invention will 5 be described having regard to the medical field and the storage of medical files for patients. Computers enable electronic storage of files relating to many different matters. For example Accountants utilise accounting software to store files on 10 each client and to enable manipulation of data for a particular client. Likewise, other service based industries utilise computers and computer networks for storing files relating to various matters. In many service based industries provision and 15 maintenance of complex computer systems can be a more difficult task where there are limited manpower resources to manage such systems. FIELD OF THE INVENTION The present invention provides an alternative 20 method for storing files on individuals by a service provider such as a medical practitioner. In its preferred form the invention also has the advantage of ensuring maximum privacy for individual files and also enabling easy access to research data relating to information 25 stored on a database. SUMMARY OF THE INVENTION According to the present invention there is provided a method for storing data comprising the steps of providing a database, storing data regarding a plurality 30 of individuals on the database, whereby a plurality of personal files are established with each personal file having data relating to a service provider and data relating to a service provided to the individual by the service provider, storing data relating to at least one 35 product used in the service provided by the service provider, storing a notification of consent for the provision of the service to the individual, whereby each WO 2004/038604 PCT/AU2003/001358 -2 personal file is accessible by the individual for that file by using a personal password and by the service provider for that individual by using a service provider password. Research data relating to personal files may be 5 able to be gathered using a research password by retrieving selected data relating to personal files, with the selected data excluding personal information relating to an individuals name and any other data which could identify the individual. 10 it is preferred that the individuals are patients and the personal files are patient files. It is preferred that the service provider is a medical practitioner such as a surgeon and that the service provided relates to a medical procedure. 15 It is preferred that details of any manufacturer of any product used in the medical procedure is stored on the database in the file of the patient for which the product was used. Preferably the method includes the step of 20 retrieving the selected data and collating the selected data. The selected data may include one or more of the following: manufacturer of one of more products, number of 25 successful medical procedures, number of complaints after medical procedure, location/address where medical procedure carried out, name of medical practitioner, information about the patient including age, weight, prior medical history and any other factor which could be 30 pertinent to the success of the procedure or otherwise. The collating step may include the step of totalling the number of patients for a selected type of data. The collating step may include making 35 mathematical analysis of the selected data. Mathematical analysis of the selected data may include calculating the average, standard deviation etc of WO 2004/038604 PCT/AU2003/001358 -3 sampled data. It is preferred that the method includes the step of providing a website with the database accessible therefrom. 5 The website preferably includes a home page with menu options including new patient, existing patient, surgeon identification, research identification. A patient may be able to establish a patient file by accessing the website and completing personal details 10 in an electronic page questionnaire. Preferably the patient is emailed a password after completing personal details in the questionnaire. The method preferably includes the step of using computer software to control the website to issue a 15 password to a new patient and email the password to the patient at their email address. The method may include the step of receiving data relating to a patient and storing this in the patient file either from the medical practitioner for the patient or 20 from the patient directly. The method may include the step of retrieving patient files for a particular medical practitioner after receiving a request from the medical practitioner and receiving the medical practitioners password. 25 The method may include the step of periodically emailing from the website a questionnaire to a patient after the patient has undergone a medical procedure and receiving the completed questionnaire from the patient and recording the completed questionnaire in the patients 30 file, the questionnaire relating to questions regarding patient well being as a result of the medical procedure they have received. It is preferred that the method includes the step of storing patient files in folders relating to a 35 particular region such as a country. Preferably the method includes providing the research password to a controlling body of the service WO 2004/038604 PCT/AU2003/001358 -4 provider. It is preferred that the method relates to a database for patients receiving plastic surgery and the supervising society is the Plastic Surgeons Society. 5 It is preferred that each patient file is only accessible by the use of passwords given to an individual patient or a medical practitioner. It is preferred that the database includes a research database containing research data which is in a 10 collated form ready for access by a research organisation having the research password. Preferably the website includes a research option as one of its menu items. Preferably the method includes accessing research 15 data by entering the website through the research data option and choosing from a number of options a sample of data to be collected from the database. The words "comprising, having, including" should be interpreted in an inclusive sense, meaning that 20 additional features may also be added. BRIEF DESCRIPTION OF THE DRAWINGS A preferred embodiment of the present invention will now be described by way of example only with reference to the accompanying drawings which in Figure 1 25 and 2 show a flow diagram of a website based database in accordance with a preferred embodiment of the present invention. In its preferred form the present invention relates to breast implant surgery and the provision of a 30 database which is accessible through an internet website. As shown in the drawings a person wishing to have breast implant surgery is identified as a patient 9 who in an initial step accesses the database website referenced in step 10. The home page of the database website 35 provides an initial menu in step 11 which allows the patient to select their country and language in step 12 and view options in step 13 in the language they have WO 2004/038604 PCT/AU2003/001358 -5 selected. One of the options after step 13 is whether the patient is a new or existing patient. If the patient is a new patient then in step 15 5 the patient fills in particulars in fields provided following the selection of a new patient option. The fields may be typical fields covering personal particulars of the patient or may be in a questionnaire type format. Once the particulars have been completed and 10 checked by the website checking software the website advises the new patient that they must log off from the website and wait for receipt of a password which will be sent to them in step 16 by email. Once the new patient has received their personal 15 password they are then able to access the website as in step 17 and then select "existing patient" from the menu option provided and type in their password in step 18. In step 19 they are provided with an option of providing consent to store their personal particulars on 20 the website database. In addition they are given the option of completing a questionnaire which relates to patients who have already undergone surgery by a plastic surgeon. In the event that the patient has already 25 received surgery they are able to follow the above procedure to access their own file whenever they wish and will be able to access their own basic data with respect to type of implant used, manufacturer, serial no. The surgeon accessing the patients data will see expanded data 30 including operative details, complications etc. This occurs in step 20. If the patient has not yet undergone any surgery then it would be expected that their file would not contain any information about surgery having been 35 completed. However the patient is able to access standard documentation relating to the breast implant surgery procedure so that they can fully understand the procedure WO 2004/038604 PCT/AU2003/001358 -6 involved and ask any questions. A further questionnaire may be provided at the end of this information so that the patient can assess their own understanding of the procedure they are about to undergo. 5 As an alternative to providing personal information directly to the website database a patient may deal through a plastic surgeon. Prior to the operation the patient is given the opportunity to become a subscribed user of the site, so as to register their new 10 device (breast implant) with the device registry at the website. In this event the patient provides all their personal particulars to the plastic surgeon who then accesses the website with their own personal password as shown in step 21, enters their password in step 22 and 15 creates a new patient file with a patient ID or password. The patient is advised of their password or alternatively the surgeon may ask the patient for their password if the patient has already accessed the website and received a password as in step 23. Thus the patient is given the 20 option of entering preliminary information about themselves by accessing the website themselves or alternatively the surgeon can do all this for them. According to one embodiment when a patient file is created and stored at the website, information stored 25 at that time is date stamped. Any time additional information is added to the file this information is also date stamped and therefore stored on the patient's file in chronological order. According to one option the patient file may be divided into separate sub files which can be 30 separately accessible. For example the patients file may include a complaints section and information in this section may be downloaded separately from other information on the patient file. The patient's file may be divided into a number of different fields including 35 data such as the product type, medical practitioners name, pharmaceutical substances used and any other information pertinent to the breast implant surgery procedure.

WO 2004/038604 PCT/AU2003/001358 -7 The patient file may include a list of possible problems including side effects so that a patient can tick an appropriate box in their patient file. According to one embodiment when a particular number of boxes are 5 ticked signifying a particular type of problem this may activate a prompt or flag for a surgeon to consult with the patient on whether action is necessary to overcome the problem. The prompt or flag may be sent to a management 10 centre of the website or may be sent directly to the surgeon by email for example. The email may not necessarily include information about the prompt, but may merely advise the surgeon to access the patient's file for further information. 15 If a prompt is acted on a patient will have the opportunity of indicating on their patient file that action has been taken to address the problem(s). When this occurs the prompt can be turned off. If no action is taken to address the problem, 20 after a particular period of time the prompt could be sent to a governing body of the plastic surgeon for appropriate follow-up. According to a further embodiment a prompt may be sent to the manufacturer of the breast implant if 25 particular problems are entered into a patient file which signify a need for action such as a removal of the breast implant. It is preferred that information once entered into a patient file cannot be removed. Alternatively 30 information stored on a patient file can only be removed if the patient and surgeon agree to the removal of such information. Once a patient file has been created the surgeon is able to enter the database website to add any 35 information at any stage by entering their-password as in step 24 and also entering the patients particular ID or password. Once the patient has undergone the operation WO 2004/038604 PCT/AU2003/001358 -8 and received the implant the doctor collects all relevant data about the patient and the operation including specific implant or device information. This data is then input into the patients file on the website and submitted 5 to the system. The surgeon may then add any particular details required about the patient such as any allergies to anesthetics. Accordingly prior to commencing surgery the surgeon may access the patients file and may record the 10 details of any meeting with the patient as well as details of the surgery once completed. This occurs in step 25. A patient can log onto the system and view information pertaining to the type of device they have in situ. They are given the ability to update their contact 15 details on the site. As the preferred embodiment relates to breast implant surgery the surgeon would also enter details about the type of breast implant being used and any manufacturers details in step 26. At any time the patient 20 is able to access their file and view any updates. Once the surgery has been completed the website may intermittently email questionnaires to the patient to obtain feedback on the success of the surgery and identify any problems. This occurs in step 27. In step 28 the 25 patient completes the questionnaire and emails this to the website which then stores this questionnaire in the patients file in step 29. The questionnaire would relate to matters such as the patient's operation and would provide valuable information regarding the patient's 30 satisfaction. The surgeon can access their own patient's records at any time. A surgeon can add information regarding possible follow up operations done and a three month review. The review would include complication -35 details and surgeon comments as well. It is preferred that every four months the system will check for and delete information that links patients WO 2004/038604 PCT/AU2003/001358 -9 to a specific surgeon. Surgeons' will be given the chance to obtain this information before it is deleted from the system. The data would be downloadable in a simple data base format. A surgeon has the choice to download this 5 data off the website and store it in their own system. It is preferred that the data includes all relevant audit information and patient data. It is noted that because each surgeon has a surgeon password, they are only able to access files of 10 their patients. In addition the website database provides an audit option whereby the surgeon.is able to enter their password and select a menu option which has "audit" as an option in step 30. The surgeon is then able to download all their patients files. 15 According to another embodiment of the present invention product information includes procedural information. Thus a patient may be subjected to a new type of procedure and subsequent monitoring of the effects of this procedure can be monitored by storing data 20 relating to this procedure on a patient file. For example the new procedure may involve a new method for dealing with an aneurysm. According to another embodiment of the invention the surgeon is able to access the records of a patient to 25 which they were not the primary treating surgeon. This is achieved by the patient having two passwords, a personnel password (which will allow the patient to log in and change their details) and an external password which can be divulged to the doctor so the doctor will have access 30 to that patient's data as if they were their own patient. In this case the doctor will have access to that patient's records and will be able to add information to their profile. This feature is useful where patient's change surgeons/doctors. Therefore details and device history 35 will always be stored by the system for that patient although not always associating the patient with their surgeon.

WO 2004/038604 PCT/AU2003/001358 - 10 According to one variation of the present invention the patient files may be divided into different accessible regions. These may include personal particulars which are only accessible by the patient and 5 the surgeon and other particulars such as manufacturers product information, comments about the surgery performed as well as information about the surgeon. This information may be accessible by the Plastic Surgeon Society and in special circumstance may be accessible by 10 manufacturers of products used in surgery. According to another embodiment of the invention manufacturers of devices such as breast implants may also be registered users of the above described system. Thus manufacturers will have the ability to record operation 15 details associated with implant devices that they sell to surgeons. A representative from a subscribing implant manufacturer will log onto the site and add entries to the system relating to a patient, surgeon, operation, implant/device as well as fee information. In this event 20 it is noteworthy that only when a surgeon and the appropriate implant/device manufacturer have added entries for the same patient and implant details, that the entry of data will be considered complete. It is also intended that an implant manufacturer will have access to 25 statistics and information gathered from the analysis of the data in the system. It is preferred that details which are downloaded by manufacturers exclude personal details of patients such as names and addresses. With the database website system described above 30 plastic surgery for all patients anywhere in the world can be stored on the database of the website. Each patients file is only accessible by the patient or their plastic surgeon so complete privacy is maintained. In addition to above research data can be 35 obtained from the website without breaching any privacy concerns. In this respect a governing body such as The Plastic Surgeons Society in step 30 may be provided with a WO 2004/038604 PCT/AU2003/001358 - 11 research password which enables them to select a research option provided in the menu of the home page of the website and to enter the research password to review the different research data which is available at the website. 5 The website will typically provide data relating to aspects of the breast surgery such as whether the surgery was successful and any complaints received from the patients after the surgery. In addition any complaints will be able to be matched with particulars relating to 10 the patient, but excluding their personal details which would enable them to be identified personally. In addition details of manufacturers of products used in the surgery such as the breast implants can be accessed to identify any trends as far as the success or otherwise of 15 the surgery involving those products. It is preferred that the website database has a research options page which is able to collate data dependant upon particular sample options available. For example selected data may include the number of successful 20 medical procedures, the number of complaints after procedures, the general location or address of patients experiencing problems after surgery, names of plastic surgeons associated with complaints received after surgery, etc. 25 In addition to the above relevant medical societies will be able to gain access to audit information for surgeons collectively registered with the system. This will provide them with useful and relevant statistics about the use of implants in a particular region such as 30 Australasia. Medical societies will also be able to access patient profile information in a similar way as the surgeon by using the patient's external password. For instance this may occur if a patient contacts the society wanting to retrieve their device information because they 35 cannot access the internet based system. In addition to the above the software of the website may perform mathematical operations to calculate WO 2004/038604 PCT/AU2003/001358 - 12 averages, standard deviations etc. to help identify any trends. For example data may reveal that a particular breast implant is associated with many more complaints than those of another type of breast implant. In addition 5 the research may find that a particular plastic surgeon may be associated with a greater number of complaints than an acceptable average. Thus from the above The Plastic Surgeons Society may be able to collate research data and in a preferred 10 form be able to manipulate processing software to identify any particular pattern or trends which may indicate a problem or successful outcome which can be reported to all plastic surgeons so as to improve the overall service provided to patients. 15 With the above system it is not necessary for plastic surgeons to install expensive software to establish their own database. Instead this procedure is effectively contracted out to a website database which is able to gather and store all relevant patient information 20 and in addition provide an easy method for researching any aspect of plastic surgery for a patient to enhance quality and safety for patients. Although the above system has been described in relation to breast implant surgery it is equally 25 applicable to other devices such as orthopaedic devices, heart devices etc. It is to be understood that, if any prior art publication is referred to herein, such reference does not constitute an admission that the publication forms a part 30 of the common general knowledge in the art, in Australia or in any other country.

Claims (27)

1. A method for storing data comprising the steps of providing a database, storing data regarding a plurality of individuals on the database, whereby a 5 plurality of personal files are established with each personal file having data relating to a service provider and data relating to a service provided to the individual by the service provider, storing data relating to at least one product used in the service provided by the service 10 provider, storing a notification of consent for the provision of the service to the individual, whereby each personal file is accessible by the individual for that file by using a personal password and by the service provider for that individual by using a service provider 15 password.

2. The method as claimed in claim 1 wherein research data relating to personal files is able to be gathered using a research password by retrieving selected data relate to personal files, with the selected data 20 excluding personal information relating to an individuals name and any other data which could identify the individual.

3. The method as claimed in claim 1 or 2, wherein details of any manufacturer of any product are 25 stored in the personal file of the person for which the product was used.

4. The method as claimed in claim 1 including the step of retrieving the selected data and collating the selected data. 30

5. The method as claimed in claim 2 including the step of providing a website with the database accessible therefrom.

6. The method as claimed in claim 5 wherein a patient is able to establish a patient file by accessing 35 the website and completing personal details in an electronic page questionnaire.

7. The method as claimed in claim 6 wherein WO 2004/038604 PCT/AU2003/001358 - 14 the website is controlled to issue an electronic message to an individual and to the service provider.

8. The method as claimed in claim 7 including the step of periodically emailing from the website a 5 questionnaire to the individual after the individual has received a service from the service provider and receiving the completed questionnaire from the individual and recording the completed questionnaire in the individual's file, the questionnaire relating to questions regarding 10 the condition of the individual as a result of receiving the service from the service provider.

9. The method as claimed in claim 8 where the individual is a patient and the service provider is a medical practitioner. 15

10. The method as claimed in claimed 9 wherein the patient has a patient password for accessing the patient's file and the medical practitioner has a medical practitioner password for accessing patient files for patients for whom the medical practitioner is acting. 20

11. The method as claimed in claim 1 including the step of providing a research password to a controlling body of the service provider whereby the controlling body is able to access the research data.

12. The method as claimed in claim 10 or 11 25 including a prompt means for prompting a service provider if a patient file has predetermined data relating to its condition stored in the patient file.

13. The method as claimed in claim 12 wherein each patient file includes a patient condition field which 30 is adapted to be completed by the patient for that file on a regular basis so that the surgeon for that patient is able to monitor the condition of the patient.

14. The method as claimed in claim 13 wherein the patient condition field includes a plurality of 35 multiple choice options regarding possible conditions including side effects of the product whereby the patient is able to identify any condition or side effect which is WO 2004/038604 PCT/AU2003/001358 - 15 listed.

15. The method as claimed in claim 14 wherein a prompt is adapted to be produced if any patient file includes a predetermined combination of conditions or side 5 effects.

16. The method as claimed in claim 15 wherein the prompt is adapted to be sent to the medical practitioner for the patient whereby the medical practitioner can access the patient file to determine the 10 condition of the patient.

17. The method as claimed in claim 16 including a manufacturers database which is adapted to automatically receive relevant data about a product used by a patient when relevant data is stored in the patient file. 15

18. The method as claimed in claim 17 wherein one or more patient files for a medical practitioner are able to be downloaded and stored on a personal storage system of the medical practitioner.

19. The method as claimed in claim 18 wherein a 20 patient file is divided into different accessible regions including a personal particulars region which is only accessible by the patient and the medical practitioner, a product details region accessible by the patient, medical practitioner and manufacturer of the product and a general 25 region including non personal information accessible by a research organisation.

20. The method as claimed in claim 1 including a product database, including details of products provided by manufacturers, which product database is accessible by 30 service providers to determine a product most suitable for use by an individual.

21. The method as claimed in claim 20 wherein the product database includes statistical information relating to historical use of the product. 35

22. The method as claimed in claim 21 wherein the historical information is automatically retrieved from patient files, collated and stored in the product WO 2004/038604 PCT/AU2003/001358 - 16 database.

23. The method as claimed in claim 22 including an audit means for enabling a medical practitioner to audit information on patients for the medical practitioner 5 collectively stored at the website.

24. The method as claimed in claim 23 wherein the website includes a trends database for recording details relating to the performance of products used by patients. 10

25. The method as claimed in claim 24 wherein the trends database includes a means for flagging any product which is characterised by problems which exceed an acceptable established threshold value.

26. A method of storing data substantially as 15 hereinbefore described with reference to the accompanying figures.

27. A method of controlling use of medical products in medical procedures substantially as hereinbefore described with reference to Figures 1 and 2. 20