RO135783A2 - Device and information system for the automation of recording and processing of medical information - smartid - Google Patents

Abstract

The invention relates to a device for receiving digital signatures and to an information system for the automation of recording and processing of personal and medical information in order to increase the effectiveness of medical services provided and to secure this information. According to the invention, the information system comprises a client entity that can run on a plurality of computing devices, exchanges information with a database system and communicates with a server entity comprising an adaptive processing unit capable of applying an encryption algorithm on the generated documents.

Description

ORCUL OE STATE FOR INVfâ^T^ Application for patent of invention ί

No........^....42.^..5^

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SmartID device and computer system for automating the registration and processing of medical information

The invention falls within the priority field of research Information and Communications Technology, space and security.

The invention relates to an integrated computer system intended for the automatic recording of personal and medical information. Through its composition, this system ensures: digitization of medical reports, consultations and patient history databases and compliance with GDPR provisions, as well as their storage and security in the PrivateSky platform.

in the description of the invention we will use the following notions:

• API - Application Programming Interface • CNAS - National Health Insurance Company • DRPCIV - Directorate of Driving Licenses and Vehicle Registration • EKG - Electrocardiogram • GDPR - General Data Protection Regulation Data) • OCR - Optical Character Recognition • O.R.L - Otorhinolaryngology • PrivateSky - project financed under the Competitiveness Operational Program 2014-2020, priority axis 1, action 1.2.3, project type - PARTNERSHIPS FOR KNOWLEDGE TRANSFER, contract 13/01.09.2016, SMIS 106611, ID P_40_371, project co-financed by the European Regional Development Fund.

• SIUI - Single Integrated Information System

Research in the fields of medical and bio-medical technologies is booming, currently companies and research laboratories abound with innovations in the form of smart devices that measure various medical parameters, including: body temperature, weight, pulse, blood pressure, blood sugar, level hemoglobin oxygenation, etc. Complementarily, there are methods for monitoring the evolution of these dynamic metrics over time and in various stages (at effort, at rest), which are used in the operation of portable devices or various objects in the "Internet of Things" sphere.

Company

RO 135783 Α2

The solution according to the present invention aims to build in this ecosystem a cloud-type, secure IT platform that allows the solidification of a comprehensive database with information such as: diagnostic elements, medical conditions, evolution vectors, treatment schemes, over which to similarity or transfer functions can be applied.

in the field of bio-medical data processing, several patents are known that describe systems and methods related to the present invention, by the nature of the physical quantities analyzed or by the way they are processed and displayed to the user. We quote as a reference for comparison and definition of the claims of the present invention two of them, considered relevant: patents US 8195479 - (Ubell et al.) and US 8195480 - (Ubell et al.).

in US patent 8195479 - (Ubell et al.), the invention relates to a portable device that stores medical history information and an inherent computer program that facilitates accessing existing information and adding new records. The device can be connected to "PC" computing systems via a USB port or a proprietary reading adapter. This information is stored exclusively on the client device and is encrypted so that it cannot be accessed by unauthorized persons. This patent is complemented by US patent 8195480 - (Ubell et al.), which presents an invention that allows the storage of an encrypted backup copy of the information stored on the client device defined above. This backup copy is kept on a storage device external to the client device, and is accessible on the Internet.

in these patents, taken individually or complementary, we identify the following disadvantages:

- The system architecture does not provide for an adaptive processor or any other processing unit capable of correlating the patient's bio-medical parameters with another subset of parameters belonging to a general population;

- The client device is a dedicated hardware tool, which means that the user will have to carry a physical object with him;

- The information is accessible only if there is physical access to the client device, which is unique; hence the limitation that makes the information accessible only when both the patient and the doctor are in the same place. This restriction prevents the exercise of the medical act where there is a lack of medical personnel;

Data acquisition is done exclusively through classic input devices (mouse, keyboard, etc.). The system cannot connect via communication interfaces with

Company /' Rector,]

A Prof. Dr. TnemsFwader s biometric sensors, nor with the APIs of external services providing bio-medical information;

The information is not synchronized with a database in the cloud, which raises problems such as: availability, resistance to errors, durability, scalability;

- the adoption of a cloud solution, such as the one proposed by us, makes it possible to process data at a centralized level with the aim of identifying patterns of evolution of medical conditions under the influence of treatment schemes, general predispositions of a population to certain diseases according to parameters demographic or lifestyle etc.

The present invention offers the efficiency of procedural steps in the administrative sphere and the improvement of medical services for both the patient and the doctors. The SmartID invention becomes an aggregator of all users' medical information using a cloud database, this information being encrypted in the database and can only be decrypted by the client-side application installed on the doctor's computer based on credentials. the SmartID invention also includes the lists of general diagnoses from CNAS, patients will have online access to the documents issued by the medical unit through the API of the PrivateSky platform. With the help of the PrivateSky platform, the security and encryption of documents uploaded to the platform is ensured, and to access them, patients are given access codes. Also, the consent of the persons regarding compliance with the GDPR regulation will be taken through the digital signature of the patient on a digital pad, connected via USB to the PC.

A software addressed to medical clinics close to SmartID is BizMedica Clinici Medicale. This software is dedicated to specialist clinics operating exclusively in private or mixed practice (private and under contract with CJAS). Some of the functions offered by BizMedica are: access to the patient's medical history and medical forms, real-time viewing of own appointments from the phone, the clinic manager can view all doctors' appointments in real time, simple and fast management with collaborating firms and companies of private insurance, sending sms to patients, printing receipts on cash registers, monitoring receipts. Since this software is dedicated to clinics with exclusively private or mixed practice, when patients want to access the medical services of other clinics and hospitals, they must request the transfer of information or keep their own medical history.

Company /) Rector,] he Toader

Another medical software variant close to SmartID is Pharmec Healthcare Software. This application provides efficient IT management of health care systems. Pharmec for medical offices and clinics is the most used software solution dedicated to family doctors and medical specialists, with more than 2,500 users. The main advantages are: CNAS accreditation and compatibility with SIUI, technical support available by phone, by e-mail and remote connection, CNAS reports, management of patients and all IT activities in the office, reduction of operating time through complete reports on patient movement and the services provided, the verification and correction of errors, the security of patient data. A major disadvantage is that this software requires major improvements, and certain functionalities are not accessible to patients because they do not yet work.

Unlike BizMedica, respectively Pharmec Healthcare Software, the SmartID invention offers the following advantages:

- Reading the data from the identity card through the OCR module and a scanner and inserting them into the database of the medical unit;

- Make the forms prepared by the medical unit available to patients online through the PrivateSky platform, complying with the provisions of the GDPR regulation through an electronic signature pad and by integrating the PrivateSky platform.

SmartID uses a scanner to retrieve information from the patient's ID card;

in SmartID, for each reading of a new identity card, it is mandatory to take the patient's signature, with his consent for the processing of personal data;

SmartID implements the provisions of the GDPR regulation through the PrivateSky platform (project that is part of the Competitiveness Operational Program 2014-2020, priority axis 1, action 1.2.3), and also through the PrivateSky platform, the documents issued by the medical unit are made available to patients online.

Therefore, the purpose of the invention is to increase the precision and efficiency of medical services by digitizing reports, consultations and databases with patient history, to decrease the time required for the preparation of documents and appointments, respectively to decrease the incidence of human errors that can delay diagnosis or interfere with the correct application of

Rector, /

Prof. Di/TudoreiToader

Medical record company. By using this system, working times will be much shorter, so that medical operations become more efficient and oriented more on patient analysis and not on entering data into the system (filling in the patient's record).

Another important objective of the invention is to increase the safety of patient data in accordance with the GDPR regulation by integrating the PrivateSky platform that facilitates the online availability of documents prepared by medical facilities to patients.

The invention provides a fully integrated system, starting from the collection and recording of information, the processing and generation of medical documents, to the storage and security of medical data.

The main problem solved by the proposed invention is that of the long period of time required for entering/completing the patient's data, and decreasing the incidence of human errors by introducing in the application a functionality to scan (with the help of a scanner) the identity card, and not only that, and automatic data completion in the application, using an OCR module. Another problem solved is the compliance with the provisions of the GDPR regulation by the medical units, by integrating the PrivateSky platform in the invention (project that is part of the Competitiveness Operational Program 2014-2020, priority axis 1, action 1.2.3).

The invention consists of a Signotec pad type device and a computer system for recording and processing information, respectively connecting with the cloud storage platform, PrivateSky.

the registration of information is carried out in accordance with the GDPR regulation. In order to streamline and eliminate human errors, regarding the registration of personal data, the proposed solution is to connect the computer system to a scanner that automatically takes the information from the patient's identity card, automatically completes the form through which the patient gives his consent to the processing personal data and to a pad-type device for electronic signature, called Signotec, through which the patient's consent is recorded.

The electronic signature is taken through the Signotec pad type device which presents the following technical characteristics: pad surface: 160 x 120 x 10 mm; 4 (10.5 cm) monochrome screen with a resolution of 320 x 160 pixels; special surface for a precise writing sheet; battery-free pen with special tip and 500 Hz sampling rate. This device is integrated into the computer system through the Signotec module made by integration

Company

Rector, a

Prof. Dr. Tudoiel Jefidfer to the library for the Java programming language, the sources being free to download (open source) offered by the company Signotec. This library provided has been modified and adjusted for the SmartID system so that through the classes and methods implemented in the project, the signature pad is functional and meets the requirements (retrieving the signature of the patient who consents to data processing in accordance with GDPR provisions) . in the SmartID invention it is not possible to replace the Signotec signature pad with another pad from another supplier company, because another signature pad requires a different way of integration and the Java libraries that we have implemented specifically in SmartID will no longer read another physical pad. Thus, the libraries we have implemented are specific only to this pad model that takes the digital signature. This pad is connected to any PC unit on which the invention is installed.

The reading of official documents, especially the identity card, will be done by means of the technology called Optical Character Recognition, abbreviated as OCR, a field of research in artificial intelligence.

OCR-izer helps to convert scanned images into text. The resulting text can be placed in a Word document or any other editable text document. OCR software is designed to ensure the conversion of holographically written or printed documents, digitized by scanning, into a form that lends itself to computational processing. in the case of the present invention, the OCR algorithm is used in extracting the information from the identity card in order to parse and enter the information into the database. This information from the ID card is extracted from the image delivered by the scanner, the image will be processed by algorithms in SmartID to remove white fields from the image. After this step, the information from the processed picture is extracted. Information such as name, surname, series and number of the identity card, CNP, date of birth, county, gender are extracted after parsing the lower part of the identity card, framed by a white border and called MRZ. The data contained in the MRZ is delimited by characters of the form "«". The person's address is also extracted from this image. The CNP is reconstructed based on the data extracted from the MRZ, which is composed of the following: the first digit represents the sex of the person, the last 2 digits of the year of birth, 2 digits representing the month of birth, 2 digits representing the day of birth, a number consisting of two digits that represent the code of the county where the person was born, a number consisting of 3 digits from the range 001-999 (the numbers in this range are divided by counties, Population Registration offices, so that a certain number in that range is assigned 0 and u

Company / Rector, I .

Prof. Dr. Tudefel to a single person on a given day), a control digit (a self-detecting code) in relation to the other 12 digits of the CNP. Encryption of this data is ensured by the PrivateSky platform and encryption algorithms developed in SmartID.

Professional, commercial solutions were evaluated for automatic character recognition. No matter how powerful the OCR-izer is, there is the problem of errors introduced through the optical character recognition process. We refer to the errors that arise from various physical causes: old ID card, traces of scratches or unevenness on the characters, discoloration or deletion of characters due to wear, characters covered by the reflection of the ID card material, faulty positioning of the ID card on the scanner, scanner glass damaged or showing marks or stains.

The SmartID computer system consists of the following modules (Fig. 2):

- Registry Module - in this module are present the functionalities that are intended for the staff of the registry department. From this module, users can scan ID cards, take patients' digital signatures and make appointments at available specialties;

Connection Module - this module is responsible for the connection of the application to the database stored in the cloud;

Internal Medicine module - this module is intended for users (doctors) specializing in internal medicine. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

- Neurology module - this module is intended for users (doctors) specializing in neurology. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

- Signotec module - this module is responsible for the operation of the digital signature pad and its settings;

Utility Module - this module contains the functions related to reading and retrieving the existing information on the identity card (OCR) and functions related to the correction of reading errors;

O.R.L module - this module is intended for users (doctors) specializing in O.R.L. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

Company and Rector, I

Prof. Dr.

Psychiatry module - this module is intended for users (doctors) specializing in psychiatry. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

Departments Utility Mode',

Objects module - in this module there are the objects necessary for data manipulation inside the application;

- Ophthalmology module - this module is intended for users (doctors) specializing in ophthalmology. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

Orthopedics-traumatology module - this module is intended for users (doctors) specializing in orthopedics and traumatology. This is where the documents are drawn up and the fields necessary to draw up the consultation are filled in;

The PrivateSky module - within this module, the installation of a local server on the computer where the invention will work was carried out. The role of this server is to retrieve the file generated after the medical consultation, which contains personal information, and to encrypt (mask the information to make it unreadable without special knowledge) the information on that file.

The first step implemented, called Begin, consists of an HTTP query to a link running on the local PrivateSky server to obtain the transaction key that will be used in the following steps. This key is required in the communication between the program and the PrivateSky server to differentiate between simultaneous communications between the client in the program and the server. After successfully obtaining this key, the second step, also called Attach File, is performed, in which one or more files are uploaded. This is done by an HTTP query followed by the key obtained in the previous step plus the filename obtained and the files uploaded by the client user. in the third step, called Add backup, a backup copy is created to avoid certain errors that may occur during communication between the client and the server. This is also done through an http call to which the key obtained in the first step is added and the address where the backup copy will be available is also sent. in the last step, called BuildCSB (build character string), to obtain the token needed for the patient to access the files is also done through an HTTP request to which the same key is added

Company Pi Rector, I 77 / Prof. Dr./TudoT^Sadar obtained at the first step. If all 4 queries have been completed successfully, the PrivateSky server will return a token that will be saved and given to the patient to access the documents uploaded by the medical staff. Each module contains specific information for each medical specialty or functions that help to integrate them or provide the functionalities (OCR, digital signature pad) of the invention.

As can be seen in Figure 1, the software architecture of the system is built around the login window. From this window, users depending on the rights assigned by the administrators are redirected by roles to one of the three departments: Registry, Administrator and Medical specialist. A user in the registry department can take care of scanning the patient's ID card, taking and signing the GDPR agreement and scheduling the patient to one or more specialties. The rights assigned to a user in the administration department are to create a new user account, assign rights, change account data or passwords. A user with a role assigned to one of the 6 specializations can retrieve a scheduled patient and prepare the medical records assigned to the specialization.

Figure 1 shows the SmartID architecture together with the PrivateSky module. Through the API offered by the PrivateSky platform and integrated into the SmartID system, all documents issued by the medical unit are made available to the patient on a website. This functionality ensures compliance with the provisions of the GDPR and the safety of personal data. The SmartID system app uploads the documents to the PrivateSky server, which returns a unique access code for each patient to the app. This code is displayed in the app and given to the patient on paper to be able to access the documents online. SmartID will welcome the user upon opening with a log-in window, where authentication in the program is done with the help of a username and password. Each user has defined attributes (Figure 4), and for each user, after successful login, a new window will open that differs for each department. The invention presents 3 types of users: administrator (admin), registry operator and doctor.

The following software requirements are required for the successful implementation of the SmartID IT system:

- Windows 10 is an operating system for computers developed by the Microsoft company as part of the Windows NT family of operating systems. It was also announced

Company 1/ Rector, I

A Prof. Dr. /TuddreÎ^^aer made public in September 2014. The first version of the operating system entered the public beta testing process in October 2014, with the final version being officially released on July 29, 2015. Microsoft describes Windows 10 as an operating system delivered as a service that will continue to receive updates to its features and functionality, with the ability for enterprise systems to receive non-emergency updates or use long-term support to receive only emergency updates, such as security patches, during the 5-year mainstream support period;

- The Java Development Kit (JDK) is a software development environment used to develop Java applications. It includes the Java Runtime Environment (JRE), an interpreter/loader (java), a compiler (javac), an archiver (jar), a documentation generator (javadoc), and other tools necessary for Java development;

Locally installed PrivateSky server together with the documentation of the PrivateSky platform Api with the help of which its integration into SmartID was achieved;

- The Signotec signature pad plus the java libraries provided with it, which were used to integrate it into the invention;

- The OpenCV library (Open Source Computer Vision Library) is a software library for machine learning. OpenCV was built to provide a common infrastructure for computer vision applications and to accelerate the use of machine perception in commercial products. This library is used within the invention in the OCR module.

The advantages offered by the invention for medical units are: compliance with GDPR provisions; reducing the time required for patient registration and scheduling; self-completion of medical reports; scheduling patients; online access to the documents drawn up by the medical unit.

The platform installs on every registry/doctor system in the clinic having a friendly interface, being easy to use and working very quickly. Figure 6 shows the context diagram for the SmartID system, which consists of the presentation of the process between patients and the clinic. A patient is scheduled using the system

SmartID, the clinic offers the consultation through the SmartID system, and the patient receives the result of the consultation. >

The software is much simpler compared to what is now used in clinics because, if until now, when patients came to the clinic, they had to fill in the mandatory forms at the reception, now, with the help of this invention, these steps are no longer necessary.

Clinic staff will enter new patients into the database with a simple program run by scanning their ID card. at that moment the scan will take place and also then the patient will be entered into the clinic's database. this step also includes taking the patient's signature to comply with GDPR provisions.

After this step, the patient's data will enter the system and will be visible in the application. From that moment, medical records or any other type of document needed by the respective clinic can be generated, only the selection of the patient being necessary.

The first user interaction with the application is the Login part. in the database of the application there is a table called USER (users), in which I feel stored various data about users. Among these data can be found each user's ID, first and last name, role, personal numerical code (PNC), ID card series and number, username, address and status. The ID is automatically generated by the application when registering a user and used for various operations that we will detail later. The role is used to be able to differentiate between the rights granted to a user by the application. The CNP, series, identity card number and address are considered confidential data of the user. The username and password are used to authenticate the user to the application. Users with admin rights can change the status of a normal user to enable or disable the account associated with that user.

If the login was successful, the user's rights are identified and the intended windows are displayed. Each of these windows provides different functionality for user roles. The window assigned to the administrator right displays the list of users and gives the right to the user of this type to modify, enable or disable a normal user. The window assigned to the doctor contains the appointment list intended for him and submenus where he can perform the consultation by filling in the related fields, view the history and generate the specific documents.

All records/documents are retained in the system so as to enable statistics and complete history of a particular patient.

To exemplify the application of this invention, we have chosen two simple models: the efficiency of the registration of personal data by a patient and the efficiency of the automation of medical records for obtaining a driver's license.

The time elapsed per patient during data recording is estimated at 90 seconds. It seems like a short time to complete the data, but scaled to a number of more than 50 patients per day, the estimated lost time can add up to about an hour for each specialist. Translated into the number of consultations, it means, by approximation, 7-8 patients, which added to the total number of patients per day would lead to an increase of more than 10% of patients consulted.

Thus, the automation of the process will thus bring 10% higher revenues within the medical facility, keeping costs at a constant level.

A niche in the medical field where the need to automate the registration process is seen is in the area of mandatory medical records for police driving licenses. Medical clinics register a large number of requests for the issuance of these medical records, especially during the summer. According to the reports issued by DRPCIV, in 2017 a total of 1,111,828 car permits were issued. This effectively translates into a number of 1,200,000 - 1,300,000 medical records because there are candidates who do not pass the exams (practical and/or theoretical), whose driving school term or the validity of the medical record expires.

another point that must be carefully followed concerns the statistical finding provided in the DRPCIV Report: "in 2017 [...] 1,111,828 driving licenses were issued (+42.47% compared to 2016 and 108% more than in 2015!).”

Putting these numbers together, the amount of driving licenses issued in 2015 was around 534,533, and in 2016 it was around 761,549. The number of clinics remaining the same for the last two years, if the registration method is maintained in the same style as before, it can only mean a suffocation of the units responsible for issuing medical permits.

The implementation of the API of the PrivateSky platform as well as the communication between the client and the server have been tested by a number of well-known integrity, system, performance and security testing methods (known in the international IT architecture as Integration Testing, System Testing, Performance Testing , Security Testing). After applying these testing methods, several performance and security issues (bugs) were found and eliminated. It was also with the help of these test methods that the present invention was fully tested. In addition to these methods, a test of the OCR module was performed on

Company /) Rector, I

Prof. Dr. Tudofel/oăeer a significant number of identity cards, to eliminate possible scanning errors. Manual testing was also carried out on the components and functionalities offered by the invention, contributing in this way to increasing the degree of stability.

We recall that in software engineering, ease of use is a quality attribute that shows the degree to which the system can be used effectively and the extent to which users are satisfied in accomplishing certain goals in specific environments. The test results proved that the invention is stable and fully functional.

Company

Rector

Dust. Dr. Dad rerfo^sler

Claims (4)

demand 1. Device and integrated computer system for the digitization of medical reports, consultations and patient history databases, characterized by the fact that: it is composed of the client entity including an computer system that can run on a plurality of computing devices, exchange information with a database system and communicates with the provided server entity, which is composed of an adaptive processing unit capable of applying an encryption algorithm to the generated documents; 2. Device and computer system according to claim 1, characterized in that: the invention has integrated through the Signotec module made by integrating the library for the Java programming language, modified and adjusted for the SmartID system, a physical digital signature pad, pad area: 160 x 120 x 10 mm; 4 (10.5 cm) monochrome screen with a resolution of 320 x 160 pixels; special surface for a precise writing sheet; pen and battery with special tip and 500 Hz sampling rate, connected via a cable with a USB port to the PC on which the SmartID software is installed; 3. Device and computer system according to claim 1, characterized in that: the invention has an OCR module that is composed of a scanner that delivers the image of the document, this image being loaded manually into SmartID and processed using the Tesseract and OpenCV libraries to extract text with personal information; 4. Device and computer system according to claim 1, characterized in that: The integration of PrivateSky in the SmartID application aims to comply with the provisions of the GDPR agreement, to encrypt medical documents and make them available online to patients in complete safety. This integration results in a code returned by the PrivateSky server that gives the patient access on the online platform to the documents issued by the medical unit. In order to obtain this code, the medical staff must upload the documents automatically generated by the application into the program, and the server repeats the code that must be given to the patient in various forms (on the sheets issued by the medical unit, the patient can note it in his own diary). Rector/ Dust pr.^UdcJrel Company.