Abstract: The invention is related to a system (100) with a blockchain-enabled (101) authentication and access control framework (102) for early-stage preterm birth detection. The system provides continuous fetal health monitoring remotely by integrating machine learning and blockchain with IoMT devices to provide the effective management of preterm birth and its related complications. The analytical module implemented in machine learning (107) collects data from the IoMT sensors (108), processes, and analyses at various data points to identify patterns for early detection of any indications of preterm birth. It also generates and sends real-time anomaly alerts to the patient as well as to the medical service care provider for a timely intervention to make more accurate predictions about preterm birth and take proactive measures. The system is implemented with a blockchain-enabled framework that utilizes smart contracts, ECC (104), and SRRBAC (104A), to provide authentication and access control to the users. Representative Figure 1
Description:FIELD OF THE INVENTION
[001] The present invention is generally related to a system to provide access to healthcare services to a broader population including remote and underserved areas, where medical services and trained medical practitioners/medical professionals are unavailable. In particular, it is related to the system with blockchain-enabled authentication and access control framework for early-stage preterm birth detection.
BACKGROUND OF THE INVENTION
[002] Preterm birth, also known as premature birth, is when a baby is born before 37 weeks of gestation (full-term) is completed. Preterm birth is a leading cause of death among children under five years old, and babies born prematurely are at a higher risk of various health complications compared to babies born at full term. Some of the common complications faced by preterm or premature infants include respiratory distress syndrome, feeding difficulties, weaker immune systems, and neurological complications. In some cases, premature infants are at a higher risk of long-term health issues, including developmental delays, cerebral palsy, vision or hearing impairments, and learning disabilities.
[003] Preterm birth is a significant global health issue as it is a leading cause of neonatal mortality and morbidity worldwide. Premature birth is a significant global health issue, with millions of babies born prematurely each year. India, in particular, faces a high burden of preterm births, contributing significantly to the global preterm birth rate. The high prevalence of premature births highlights the urgent need for effective and scalable systems and methods for continuous fetal health monitoring for early-stage preterm birth detection and effective management of preterm birth and its complications. Continuous fetal health monitoring may help healthcare providers to identify potential issues early on, allowing for timely interventions, thus improving the overall health outcomes for both the mother and the infant, thereby reducing the burden of preterm birth-related mortality and morbidity.
[004] At present, there are several methods used for the detection of preterm birth risk, which usually include a combination of clinical assessments, medical history review, physical examination, examination of ultrasounds, diagnostic tests, blood tests, etc. Electrohysterography (EHG) is reported as a potential tool for predicting preterm labour. EHG is used to record and monitor electrical signals (EHG signals) generated by the uterine contractions by placing electrodes on the maternal abdomen. The changes in the EHG signals provide valuable information about the timing, frequency, intensity and duration of contractions. Monitoring these electrical signals over time can help healthcare providers to identify patterns or abnormalities in uterine activity that may assess the risk of preterm labour. Though the EHG technique has the potential to be a valuable tool for predicting preterm labor, there are some disadvantages and limitations associated with it. One of the disadvantages is a lack of standardised protocols and guidelines for performing EHG, which leads to variability in the analysis of EHG signals. Another limitation of the EHG technique is that EHG signals are affected by factors such as maternal movement, electrode placement, and signal noise, which makes it challenging to obtain accurate and reliable measurements. Another challenge in the EHG technique is the requirement of specialised knowledge and expertise to analyse and interpret EHG signals, as the signals can be complex and may require advanced signal processing techniques for interpretation. Moreover, EHG instruments may not be widely available in all healthcare settings, which could limit their use in routine clinical practice.
[005] Nowadays, the Internet of Medical Things (IoMT) is indeed a rapidly emerging field within the broader Internet of Things landscape. IoMT refers to the connected infrastructure of medical sensors/devices and applications that communicate with various healthcare service providers through the Internet. The use of IoMT enables access to healthcare services to a broader population, including remote areas where medical services and trained medical practitioners /medical professionals are unavailable. IoMT sensors/devices collect and transmit medical or health-related data of patients in real-time. With access to real-time patient data, healthcare providers can track vital signs and other metrics to monitor patients' health remotely and continuously. The main advantages associated with remote and continuous monitoring are that it reduces the need for frequent hospital visits, enables early detection of health issues, and allows for timely interventions of healthcare providers. IoMT represents a promising frontier in healthcare innovation, offering numerous advantages for improving patient outcomes and enhancing the quality of care. However, it also presents challenges regarding data privacy, security, confidentiality, and integrity.
[006] In healthcare applications involving sensitive medical information, ensuring privacy, confidentiality, and data integrity are critical. Due to the sensitive nature of the information, healthcare service providers/organisations must implement robust security measures to protect patient medical data. In addition, ensuring the accuracy of diagnoses is crucial for the patient. Incorrect diagnoses can lead to inappropriate treatment plans or delays in necessary interventions, which can have serious consequences. Implementing robust security measures, such as encryption, access control, data integrity checks, etc., can help mitigate the risks of unauthorised access, breaches, and tampering with data intentionally or accidentally.
[007] The present disclosure presents a system with blockchain-enabled authentication and access control framework for early-stage preterm birth detection that integrates machine learning and blockchain with IoMT sensors/devices. The system provides continuous fetal health monitoring of expectant mothers (the patients) remotely to detect early-stage preterm birth and effectively manage preterm birth and its complications. The system is implemented using a blockchain-enabled authentication and access control framework. Blockchain technology offers a decentralized storage solution for sensitive medical data, thus providing enhanced privacy, security, confidentiality, and data integrity. The blockchain-enabled framework, along with the smart contract, uses Elliptic Curve Cryptography (ECC) and Selective Ring Role-Based Access Control (SRRBAC). ECC generates an encrypted ticket for each user, providing security and authorisation for users (patients, medical professionals, or health care service providers) to access patients' sensitive medical data. SRRBAC defines and differentiates the levels of access control to the medical data. The use of ECC and SRRBAC enhances security, privacy, and confidentiality and ensures that only authorized personnel can access sensitive medical data.
[008] IoMT has the potential to play a significant role in early birth term detection by enabling remote monitoring of expectant mothers. The group of IoMT sensors/devices is used to continuously monitor expectant mothers' vital signs and other health metrics. The data from the IoMT devices is collected, stored, and transmitted in real-time to healthcare providers, processed, and analyzed at various data points to identify patterns for early detection of any abnormalities or signs/indications of preterm birth. In the present invention, the data collection, transmitting, and analyzing data and sending anomaly alerts is performed by an analytical module implemented in the machine learning algorithm. By analyzing large amounts of data from multiple sources (group of IoMT sensors/devices), the analytical module identifies complex patterns and relationships that may not be apparent to human observers. The module generates and sends real-time anomaly alerts to the patient as well as to the health care providers (medical professionals associated with an organization/hospital) for a timely intervention to make more accurate predictions about preterm birth and take proactive measures to prevent it.
OBJECT OF THE INVENTION
[009] The object of the invention is to implement a system with a blockchain-enabled authentication and access control framework for early-stage preterm birth detection. The blockchain-enabled framework (101) utilizes smart contracts (103), ECC (104) and SRRBAC (104A) to provide authentication and access control to the users to access the patient’s sensitive medical data. The disclosed system enhances security, privacy, and confidentiality and ensures that only authorized personnel can access sensitive medical data.
[0010] Another object of the invention is to provide access to healthcare services to a broader population including remote and underserved areas, where medical services and trained medical practitioners/medical professionals are unavailable.
[0011] Yet another object of the invention is to provide continuous fetal health monitoring remotely by integrating machine learning and blockchain with Internet of Medical Things to provide the effective management of preterm birth and its related complications.
SUMMARY OF THE INVENTION
[0012] The following summary of the present invention is provided to facilitate an understanding of some of the innovative features unique to the present invention. It is intended to be a partial description. A full description of the various aspects of the invention can be gained by taking the entire specification, claims, drawings, and abstract as a whole.
[0013] The present invention is related to a system with a blockchain-enabled authentication and access control framework for early-stage preterm birth detection. The system provides continuous fetal health monitoring remotely by integrating machine learning and blockchain with the IoMT devices/sensors to provide the effective management of preterm birth and its related complications. IoMT sensors/devices are used to continuously monitor vital signs and other health metrics of expectant mothers. The data from the IoMT devices is collected, stored, and transmitted in real-time to healthcare providers, processed, and analyzed at various data points to identify patterns for early detection of any abnormalities or signs/indications of preterm birth. In the present invention, the data collection, transmitting, and analyzing data and sending anomaly alerts is performed by an analytical module implemented in the machine learning algorithm. By analyzing large amounts of data from multiple sources (various IoMT devices), the analytical module identifies complex patterns and relationships that may not be apparent to human observers. The module generates and sends real-time anomaly alerts to the patient as well as to the health care providers (medical professionals) for a timely intervention to make more accurate predictions about preterm birth and take proactive measures to prevent it.
[0014] The system disclosed in an invention is implemented using a blockchain-enabled authentication and access control framework. Blockchain technology offers a decentralized storage solution for sensitive medical data, thus providing enhanced privacy, security, confidentiality, and data integrity. The blockchain-enabled framework utilizes smart contracts, ECC, and SRRBAC to provide authentication and access control to the users. ECC and SRRBAC define and differentiate various levels of access control to the medical data. The system enhances security, privacy, and confidentiality and ensures that only authorized personnel can access sensitive medical data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] For a complete understanding of the present invention and its advantages, reference is now made to the following description, taken in conjunction with the accompanying drawings listed below. The components of the drawings/figures are illustrated to emphasise the general principles of the present disclosure and are not necessarily drawn to scale. Therefore, reference characters designating corresponding components are repeated as necessary throughout the figures for the sake of consistency and clarity.
[0016] Figure 1 presents a block diagram that outlines the system disclosed in the present invention.
[0017] Figure 2 presents a flowchart that illustrates the working of the system disclosed in the present invention.
DETAILED DESCRIPTION OF DRAWINGS
[0018] The detailed description below is intended to describe various configurations of the subject technology. It is not intended to represent the only configurations in which the subject technology may be practised. The appended drawings are incorporated herein and constitute a part of the detailed description. The detailed description includes details to provide a thorough understanding of the technology. However, it will be apparent to those skilled in the art that technology may be practised without these specific details like similar components are labelled with identical element numbers for easy understanding. Numerous other changes, substitutions, variations, alterations, and modifications may be ascertained by those skilled in the art, and it is intended that the present invention encompass all such changes, substitutions, variations, alterations, and modifications as falling within the spirit and scope of the appended claims.
[0019] As used throughout this description, the word "may" is used in a permissive sense (i.e., meaning having the potential to) rather than the mandatory reason (i.e., meaning must). Further, the words "a" or "an" mean "at least one”, and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including", “comprising”, "having", "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed after that, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the words "including" or "containing" for applicable legal purposes.
[001] Figure 1 presents a block diagram of the system disclosed in the present invention. The system (100) is implemented by integrating a blockchain-enabled (101) authentication and access control framework (102) with the machine learning with IoMT sensors to achieve the objective of early-stage preterm birth detection. The framework (102) offers a decentralised storage solution for sensitive medical data, thus providing enhanced privacy, security, confidentiality, and data integrity. The framework (101) utilises smart contracts (103), ECC (104) and SRRBAC (104A) to provide authentication and access control to the users to access the patient’s sensitive medical data. The smart contract (103) is a self-executing contract signed beforehand between the patient (105) and the medical professionals of the associated healthcare or medical care service provider (organizations/hospitals) (106).
[002] The system (100) provides continuous fetal health monitoring remotely by integrating a machine learning analytical module (107) and blockchain with the IoMT devices/sensors (108) to provide the effective management of preterm birth and its related complications in the expectant mothers (the patient (105)) and their new-borns. IoMT refers to a variety of medical devices and sensors that are connected to the internet and can collect, transmit, and analyze medical data. The IoMT sensors are calibrated and arranged or set to gather or capture relevant data/information from expectant mothers (the patients). The authenticated calibrated IoMT devices (108) provided by the associated healthcare service provider (106) are installed at the patient (105) site for the remote monitoring of the vital signs and other health metrics.
[0020] The analytical module (107) implemented in machine learning collects the data gathered/generated by the sensors (108). Additionally, the data generated by IoMT sensors get stored on a storage system that may be (but is not limited to) an Interplanetary File System (IPFS) (109). IPFS is a decentralized protocol and network designed to create a content-addressable, peer-to-peer method of storing and sharing data. In the present invention, the data is stored in IPFS as a CSV file.
[0021] Figure 2 presents a flowchart that illustrates the working of the system disclosed in the present invention. The working of the system comprises of execution of smart contract between patient & medical care provider (201), providing authentication and access control to medical professionals and patients using ECC and SRRBAC (202), authentication of IoMT devices by the medical care provider (203), installation of IoMT devices at the patient’s site connected wirelessly to the IT system of medical care provider (204), collection of patient’s medical data captured by IoMT devices (205), storing data in a decentralized storage system (206), analysis of data to detect any anomalies (207), sending an alert to patient and medical care provider (208), accessing medical data by patient and medical care provider (209) and timely intervention to take proactive measures (210).
[0022] As illustrated in Figure 1, the smart contract (103) is signed beforehand between the patient (105) and healthcare or medical care-providing organizations/hospitals (106). It is a self-executing contract with the terms and conditions of the agreement executed between the two parties. The agreement contained therein exists across a distributed, decentralised blockchain network without the need for a central authority, legal system, or external enforcement mechanism. The smart contract defines the rules for authorised access to the patient's sensitive medical data. It enforces access control rules and ensures that only authorized entities/parties/people can access the data, thus ensuring the privacy and security of the data.
[0023] The various IoMTs used in the present invention include, but are not limited to, blood pressure sensors, fetal heart rate sensors, temperature sensors, and blood glucose sensors. IoMTs also include other IoT-enabled ultrasound devices, including transvaginal ultrasound sensors, point-of-care sensors, biosensors, and uterine activity monitors. All IoMT devices are calibrated and arranged or set to gather or capture relevant data/information from expectant mothers (the patients). The data/information captured by the IoMTs gets stored on the Interplanetary File System (IPFS) and is collected by an analytical module. The module is robust and accurate in analyzing the data to identify patterns and anomalies that could indicate preterm birth. IPFS is a decentralized protocol and network designed to create a content-addressable, peer-to-peer method of storing and sharing data. Unlike traditional centralized systems where data is stored on specific servers, IPFS allows data to be distributed across a network of nodes. This decentralized approach ensures that data remains available even if some nodes go offline.
[0024] Further, the analytical module is implemented using machine learning algorithms. The data stored in a decentralized storage system is further categorized into different classes or categories using a machine learning classification algorithm, depending on the type of data. In the present invention, the random forest classification algorithm is implemented to detect any anomalies in the medical data captured. The algorithm can handle complex data with high dimensionality, and it works on the concept of bootstrap sampling. In bootstrap sampling, the algorithm creates multiple decision trees, and each tree is trained on a random subset of the training data. In addition to using a random subset of the training data, the algorithm also utilizes a random subset of features for each split in the decision tree. Once all the trees are trained, the random forest classification algorithm uses them to make predictions. Each tree in the forest independently performs prediction, and the final prediction is determined by a majority vote among all the trees.
[0025] Furthermore, the analytical module analyses data generated by IoMT sensors to identify patterns and anomalies that could indicate preterm birth. It thereafter sends real-time anomaly alerts to the patient and healthcare or medical care service providers. Sending real-time anomaly alerts to patients and healthcare providers is crucial for timely intervention and management to reduce or prevent the risk of preterm birth and its related complications. Based on the type of alerts received, the patient can take necessary action. The action (but not limited to) may be booking an online/virtual/remote appointment or physical appointment with the medical professionals (including but not limited to doctors and nurses) of the associated health care service providing organisations/hospitals. In case of an emergency, the patient may call an ambulance to reach the associated healthcare service-providing organisations/hospitals. In case of an appointment, the medical professional or service provider can remotely prescribe medications to the patient.
[0026] In the disclosed invention, when the analytical module detects an anomaly, a smart contract is triggered that authenticates the user and performs access control checks through SRRBAC and ECC. The SRRBAC is an advanced security model that extends the traditional role-based access control (RBAC) model by incorporating the concept of "rings" to manage access permissions. It relies on ring and role rules to manage medical data access rights, and permissions are assigned based on both the user's role and the sensitivity of the data being accessed. SRRBAC provides a flexible and granular way to manage access to data based on the specific needs and requirements of different roles and data sensitivity levels. The use of SRRBAC reduces the risk of unauthorized access and helps improve overall security.
[0027] ECC generates a unique registration ID for each user (patients, medical professionals, or health care service providers) to access patients' sensitive medical data. ECC provides a high level of security with smaller key sizes, making it more efficient for resource-constrained environments like edge computing. ECC encrypts sensitive data, such as registration information, ensuring that it is protected from unauthorized access or tampering during the transmission. Furthermore, ECC is also used to generate a digital signature for each user. Each user's digital signature, issued by the associated organization/hospital, ensures that the user is genuine and authorized to access the data. There are several advantages of using ECC in the disclosed invention. The foremost advantage is that by using ECC for encryption and digital signatures in the registration process, the disclosed invention is ensured to be secure, efficient, and capable of protecting sensitive data and verifying the authenticity of users. Another advantage is that it reduces network load and ensures efficient authentication at the edge. This is because by authenticating users locally using digital signatures and ticket validation, the associated organisation minimizes the need to send authentication requests back to a central server, which helps to improve response times and reduces network traffic.
[0028] The working of SRRBAC involves the use of “Rings” to assign specific “Roles” to users based on their responsibilities and job functions. Each user is assigned a unique registration ID (RIDuser) that defines their “Roles” in the system. The “Rings” represent different levels of data sensitivity; for instance, there can be three rings with three different levels of data sensitivity: least sensitive, moderately sensitive, and highly sensitive. Each user is assigned distinct “Rings”, each ring having a unique ring identity (IDring). The “Roles” determine the set of permissions that the user will possess, and each role is assigned a set of permissions for each ring. For instance, a doctor role might have read-and-write access to moderately sensitive and highly sensitive rings, while a nurse role might have read-only access to moderately sensitive rings.
[0029] When any user attempts to access the medical data, the system checks their identity, role, and the sensitivity level of the data (i.e., the ring) to determine if the access is allowed based on the permissions assigned to the user's role for that ring. If the user's role has the required permissions, access is granted; otherwise, access is denied.
[003] The files associated with the RIDuser and IDring are stored in the IPFS storage system. When any user attempts to access the stored patient’s medical data, the disclosed system begins by identifying the identity of the user within the assigned ring through a verification process that checks the presence of the user's registration ID in the IPFS database. If the user is located, then access to the data will be granted; otherwise, access will be denied. In the next step, the system determines the role of the user from the unique ID provided to each user. Thereafter, it ascertains the type of the ring assigned to the user according to its role and provides access control permission to the medical data. It is also to be understood that the terminology used herein illustrates specific embodiments only and is not intended to be limiting since the scope of the present invention will be defined only by the claims appended to the claims in the complete specification.
, Claims:We Claim:
1. A system for early-stage preterm birth detection, the system (100) comprises of:
at least one IoMT device (108) to enable continuous remote fetal health monitoring of a patient (105);
at least one analytical module (107);
at least one storage system ( 109) to store data; and
characterised by;
a blockchain-enabled (101) authentication and access control framework (102) wherein the blockchain-enabled (101) authentication and access control framework (102) comprises a smart contract (103) executed between the patient and a medical care service provider; elliptic curve cryptography (104) to generate an encrypted ticket for the patient and the medical care service provider; and a selective ring role-based access control (104A) to provide access to the data.
2. The system (100) as claimed in claim 1, wherein the blockchain-enabled authentication (101) and access control framework (102) integrates machine learning and blockchain with the IoMT device for early-stage preterm birth detection.
3. The system (100) as claimed in Claim 1, wherein the blockchain-enabled authentication (101) and access control framework (102) enhances security, privacy, and confidentiality and ensures that only authorized personnel can access sensitive medical data.
4. The system (100) as claimed in claim 1, wherein the analytical module (107) is implemented in the machine learning algorithm.
5. The system (100) as claimed in claim 1, wherein the storage system is an interplanetary file system (109) that provides a decentralized storage solution providing enhanced privacy, security, confidentiality, and data integrity.
6. The system (100) as claimed in claim 1, wherein the analytical module (107) analyzes data generated by the IoMT device (108) to identify pattern and anomaly indicating preterm birth and send real-time anomaly alert to the patient and the healthcare provider for timely intervention.
7. The system (100) as claimed in claim 3, upon detecting an anomaly, the smart contract (103) is triggered and authentication and access control is provided through SRRBAC (104A) and ECC (104).
8. The system (100) as claimed in claim 1, wherein the ECC (104) generates a unique registration ID for each user of the system to access sensitive medical data and generates a digital signature for each user to ensure authenticity and authorization.
9. The system (100) as claimed in claim 1, wherein the SRRBAC (104A) assigns specific roles to users based on their responsibilities and job functions and assigns different levels of data sensitivity represented by "rings" to manage access permissions.
| # | Name | Date |
|---|---|---|
| 1 | 202411033890-FORM 1 [29-04-2024(online)].pdf | 2024-04-29 |
| 2 | 202411033890-DRAWINGS [29-04-2024(online)].pdf | 2024-04-29 |
| 3 | 202411033890-COMPLETE SPECIFICATION [29-04-2024(online)].pdf | 2024-04-29 |
| 4 | 202411033890-ENDORSEMENT BY INVENTORS [09-05-2024(online)].pdf | 2024-05-09 |
| 5 | 202411033890-FORM-9 [13-05-2024(online)].pdf | 2024-05-13 |
| 6 | 202411033890-FORM-26 [14-05-2024(online)].pdf | 2024-05-14 |
| 7 | 202411033890-FORM 3 [23-05-2024(online)].pdf | 2024-05-23 |
| 8 | 202411033890-FORM 18A [23-05-2024(online)].pdf | 2024-05-23 |
| 9 | 202411033890-EVIDENCE OF ELIGIBILTY RULE 24C1f [23-05-2024(online)].pdf | 2024-05-23 |
| 10 | 202411033890-Proof of Right [07-06-2024(online)].pdf | 2024-06-07 |
| 11 | 202411033890-FORM 3 [14-06-2024(online)].pdf | 2024-06-14 |
| 12 | 202411033890-FER.pdf | 2024-07-04 |
| 13 | 202411033890-FORM-8 [16-08-2024(online)].pdf | 2024-08-16 |
| 14 | 202411033890-FER_SER_REPLY [02-09-2024(online)].pdf | 2024-09-02 |
| 15 | 202411033890-COMPLETE SPECIFICATION [02-09-2024(online)].pdf | 2024-09-02 |
| 16 | 202411033890-US(14)-HearingNotice-(HearingDate-15-10-2024).pdf | 2024-09-03 |
| 17 | 202411033890-Correspondence to notify the Controller [08-10-2024(online)].pdf | 2024-10-08 |
| 18 | 202411033890-Written submissions and relevant documents [24-10-2024(online)].pdf | 2024-10-24 |
| 19 | 202411033890-Annexure [24-10-2024(online)].pdf | 2024-10-24 |
| 20 | 202411033890-PatentCertificate11-12-2024.pdf | 2024-12-11 |
| 21 | 202411033890-IntimationOfGrant11-12-2024.pdf | 2024-12-11 |
| 1 | SearchHistoryE_04-07-2024.pdf |