WO2024189650A1

WO2024189650A1 - A system and method for secure management of electronic health and medical records

Info

Publication number: WO2024189650A1
Application number: PCT/IN2024/050262
Authority: WO
Inventors: Vijayaraja Rathinasamy; Prabhu Rajagopal
Original assignee: Indian Institute of Technology Madras
Current assignee: Indian Institute of Technology Madras
Priority date: 2023-03-14
Filing date: 2024-03-14
Publication date: 2024-09-19
Anticipated expiration: 2025-09-14

Abstract

The present invention discloses a system (100) and method (1300) for secure management of electronic health and medical records. The system (100) relates to a private blockchain enabled smart Internet of Healthcare Things (IoHT) gateway device to improve medical data security, patient care and diagnostic efficiency, and automate health record management in healthcare institutions. The system (100) comprises at least one user (102), a patient authentication unit (104), a sensor unit (106), a smart medical device gateway (SMDG) (108), a communication network (110) and at least one server (112). The smart medical device gateway (108) is a stand-alone component that acts as an interceptor for acquiring medical records, and as a router to connect with wireless medical sensors enabling the easy transmission of data.

Description

Title of Invention A system and method for secure management of electronic health and medical records)

Technical Field

[1 ] The field of invention generally relates to a system and method for secure management of electronic health and medical records. More specifically, it relates to a private blockchain enabled smart Internet of Healthcare Things (loHT) gateway device to improve medical data security, patient care, and diagnostic efficiency, and automate health record management in healthcare institutions.

Background Art

[2] The Internet of Things (loT) has revolutionized communication by connecting everyday sensors and devices to the internet through an IP-based architecture. loT enables physical and virtual objects to be linked using data capture and communication capabilities. The healthcare industry is adopting loT technology to make healthcare more accessible and efficient. Further, wireless sensors are now more efficient and convenient for health data monitoring, but there are challenges in storing and validating the data collected by these sensors.

[3] The healthcare industry is modernizing and transitioning to electronic medical records (EMR), but many large institutions struggle to organize data in a traceable and easily accessible format. There are concerns about data security when transmitting data through the cloud or from a radio access point to the cloud, and no reliable security solution is available for transmitting personalized healthcare data from loT sensors on a patient's body to the radio access point, which creates vulnerabilities in data security.

[4] Manufacturers of wireless devices often share data with unsecured cloud services, making end-to-end data security in healthcare monitoring impossible. Each brand has its own application, making it difficult for healthcare professionals to track the data. Further, converting medical data into electronic medical records (EMR) is difficult and expensive. Presently, EMRs are created by scanning hundreds of papers, requiring significant manpower and infrastructure costs. [5] Currently, the existing systems are encountering several challenges such as an increased risk of infection due to direct patient contact, time-consuming processes of collecting vital signs, the need to monitor patients from a central location, manual record handling with high chances of mismatch and duplication, a lack of technology to connect doctors with patients promptly, a lack of interoperability and inter-entity transactions, a requirement for multiple devices for monitoring, and a shortage of medical staff and ICU beds. Furthermore, chronic conditions, prenatal patients, or neonatal care require the regular monitoring of multiple vital parameters, and healthcare providers seek a one-stop software and hardware solution for medical device communication and telemedicine services. To improve patient care and the transmission of critical device operational data, hospitals require a connectivity solution that can overcome network infrastructure connection challenges and comply with network infrastructure security requirements.

[6] Other existing systems have tried to address this problem. However, their scope was limited to telemedicine services. They have not effectively addressed the maintenance of personal health records (PHR), data safety, and interoperability concerns. This has led to limited facilities provided by these systems, and PHRs maintained by digital healthcare led generators are not patient-centric. Furthermore, the healthcare system faces issues with interoperability due to clientserver architecture, which leads to the loss of patients' access to their records stored in an organized database. Existing systems also contain single points of failure, which are easily breached, and patients have no control over their data. Additionally, electronic health record (EHR) and EMR storage is non-standardized and inaccessible to patients digitally.

[7] Thus, in the light of the above discussion, it is implied that there is a need for a system and method for secure management of electronic health and medical records which is reliable and does not suffer from the problems discussed above.

Object of Invention

[8] The principal object of this invention is to provide a system and method for secure management of electronic health and medical records (EHR/EMR).

[9] A further object of the invention is to provide a flexible, secure, and compliant solution for loT medical devices in the healthcare industry. [10] Another object of the invention is to resolve complex challenges, including gaps in Wi-Fi coverage and outbound internet connection limitations.

[11] A further object of the invention is to provide an encrypted and reliable medical device communication, ensuring that critical patient data is private and protected using blockchain technology.

[12] Another object of the invention is to develop a decentralized health data fiduciary platform that is unique, user-centric, and interoperable within a given Healthcare Provider (HCP) ecosystem.

[13] A further object of the invention is to build a smart gateway device that can handle, secure, and analyze patient data in a patient-centric manner, overcoming several challenges, such as 3-factor authentication, patient recognition, voice-to- text mechanism implementation, inbuilt speaker for emergency alerts, indicators for power, and a screen to serve as HMI (Human Machine Interface).

[14] Another object of the invention is to enable the generation of electronic health/medical records using high-throughput devices to scan hundreds of pages per patient in a medium-size hospital.

[15] A further object of the invention is to index sensor data appropriately, ensure secure data storage and retrieval, and remote monitoring of primary health care and home healthcare using a blockchain-based method for managing health records that enables indexing patient-centric data using immutable, one-of-a-kind tags that can be traced safely across organizations and locations.

[16] Another object of the invention is to develop a smart device gateway that can withstand heavy computation and run AI/ML engines to give preventive and predictive results for both health information providers and patients to keep track of their medical habits.

[17] A further object of the invention is to make hospital data interoperable and available across multiple hospitals using the Internet of Healthcare Things (loHT)/ Internet of Medical Things (loMT).

[18] Another object of the invention is to provide a standardized and digitally readable EHR and EMR storage system accessible to patients. Brief Description of Drawings

[19] This invention is illustrated in the accompanying drawings, throughout which, like reference letters indicate corresponding parts in the various figures.

[20] The embodiments herein will be better understood from the following description with reference to the drawings, in which:

Fig. 1

[21 ] [Figure 1 ] depicts/i llustrates a schematic diagram, showing high-level overview of the gateway’s working, in accordance with an embodiment of the present disclosure;

Fig. 2

[22] [Figure 2] depicts/illustrates a schematic diagram, showing block diagram of patient data interoperability between medical devices and EHR systems, in accordance with an embodiment of the present disclosure;

Fig. 3

[23] [Figure 3] depicts/illustrates a schematic diagram, showing input-output peripherals of the smart medical device gateway, in accordance with an embodiment of the present disclosure;

Fig. 4

[24] [Figure 4] depicts/presents an illustration diagram, showing different layer representation in smart medical device gateway, in accordance with an embodiment of the present disclosure;

Fig. 5

[25] [Figure 5] depicts/illustrates the information flow incorporating biosensors into the Blockchain-based health record management system, in accordance with an embodiment of the present disclosure;

Fig. 6 [26] [Figure 6] depicts/presents an illustration diagram, showing features of smart medical device gateway, in accordance with an embodiment of the present disclosure;

Fig. 7

[27] [Figure 7] depicts/illustrates a schematic diagram, showing voice recognition flow using smart medical device gateway, in accordance with an embodiment of the present disclosure;

Fig. 8

[28] [Figure 8] depicts/illustrates a schematic diagram, showing fingerprint Sensor architecture within the smart medical device gateway, in accordance with an embodiment.

Fig. 9

[29] [Figure 9] illustrates a schematic diagram, showing Near Field communication (NFC) enabled blockchain smart card architecture, in accordance with an embodiment of the present disclosure;

Fig. 10

[30] [Figure 10] depicts/illustrates a schematic diagram, showing working architecture of printer connected with loT enabled smart medical device gateway, in accordance with an embodiment of the present disclosure;

Fig. 11

[31] [Figure 11] depicts/illustrates a schematic diagram, showing working architecture of loHT powered teleconsultation, in accordance with an embodiment of the present disclosure;

Fig. 12

[32] [Figure 12] depicts/illustrates a schematic diagram, showing working architecture of quick response (QR) code, in accordance with an embodiment of the present disclosure; and

Fig. 13 [33] [Figure 13] depicts/illustrates a method for secure management of electronic health and medical records, in accordance with an embodiment of the present disclosure.

Statement of Invention

[34] The present invention discloses a system and method for healthcare management, for efficient and secure handling of patient data in healthcare environments. The system comprises a user device, a patient authentication unit, a sensor unit, a smart medical device gateway, and a communication network, all interconnected to facilitate seamless healthcare operations.

[35] The user device serves as a control interface for the system, enabling users to manage and oversee healthcare-related tasks. The patient authentication unit plays a crucial role in verifying the identity of patients accessing healthcare services, ensuring the right individual receives appropriate care while safeguarding against identity fraud and medical errors. The sensor unit is responsible for monitoring and measuring physiological and environmental parameters of patients, enabling real-time data collection for informed decision-making and personalized healthcare delivery. Further, the smart medical device gateway, is configured to act as a centralized hub for handling, analyzing, and securing patient data. The gateway comprises distinct layers comprising a device layer, a fog layer, a cloud layer, a blockchain layer, and an inverter module, each contributing to secure data handling and storage.

[36] The method for healthcare management disclosed comprising identity verification, data monitoring, analysis, and secure transmission. Users are authenticated through the patient authentication unit using biometric methods such as fingerprint or NFC technology. Patient data is collected, analyzed, and securely transmitted to federated blockchain servers and hospital servers for storage and retrieval. The sensor unit connects to patients through various protocols, ensuring flexibility and compatibility with different healthcare devices. The smart medical device gateway, equipped with input and output peripherals, serves as a versatile platform for healthcare data processing and communication. It facilitates real-time data collection, secure encryption, and output generation, enhancing the efficiency and effectiveness of healthcare management practices. Description of Embodiments

[37] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and/or detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

[38] The present invention describes a system and method for automating Electronic Medical Record (EMR) and Electronic Health Records (EHR). The aim is to address the challenges of acquiring EMR by scanning a large number of patient medical records and maintaining untraceable medical records. The Smart Medical Device Gateway (SMDG) is a self-contained unit that serves as an interceptor for acquiring medical records and a router to connect with wireless medical sensors, enabling secure and easy data transmission.

[39] Figure 1 depicts/illustrates a schematic diagram, showing a high-level overview of the gateway’s working, in accordance with an embodiment of the present disclosure.

[40] In an embodiment, the system 100 comprises at least one user 102, a patient authentication unit 104, a sensor unit 106, a smart medical device gateway (SMDG) 108, a communication network 110, and at least one server 112.

[41 ] In an embodiment, the system 100 may comprise at least one user 102 and the user 102 may comprise as many user devices as required. The user devices may comprise one or more of wearable device, mobile phones, PDAs, smartphones, smart bands, smart watches, laptops, computers, etc. The user device may have a user application that can control the operations of the system 100.

[42] The patient authentication unit 104 is configured to verify the identity of a patient before enabling them to access healthcare services. It is used to ensure that the right patient receives the right treatment and care, and to prevent medical errors and identity fraud. [43] The sensor unit 106 is configured to monitor and measure various physiological and environmental parameters of patients.

[44] In an embodiment, the smart medical device gateway 108 is configured to handle, analyze and secure the patient data. The smart medical device gateway 108 is a stand-alone component that acts as an interceptor for acquiring medical records, and as a router to connect with wireless medical sensors enabling the easy transmission of data.

[45] Typically, the system 100 is connected to the at least one user 102, the patient authentication unit 104, the sensor unit 106, the smart medical device gateway 108, and the at least one server 112 via the communication network 110. One skilled in the art may recognize that the communication network 1 10 may be a wired network or wireless network.

[46] Furthermore, the wired communication may be carried out by any one of the network configurations such as LAN, WAN, etc. and the wireless communication may be carried out through Mobile Service Provider (MSP) and Internet Service Provider (ISP) having internet connection provided by an ISP provider, 2G/3G/4G/5G internet connection provided by the mobile service provider. The standard protocols such as TCP/IP, HTTP, FTP, UDP, IPV4, IPV6 etc. as known in the art, may be used for the wireless communication.

[47] In an embodiment, the system 100 may comprise as many servers 112 as required by the users 102. The servers 1 12 may comprise one or more of mobile phones, PDAs, smartphones, laptops, computers, etc.

[48] Figure 2 depicts/illustrates a schematic diagram, showing block diagram of patient data interoperability between medical devices and EHR systems, in accordance with an embodiment of the present disclosure.

[49] In an embodiment, the at least one user 102 may comprise at least one of a hospital 202, a doctor/ Health information provider (HIP) 204, a pharmacy 206 and a patient/ patient’s guardian/ Health information user (HILI) 208. The users 102 are authorized to access the patient 208 details.

[50] The patient authentication unit 104 authorizes the users 102 to access the patient details and smart medical device gateway 108 by using at least one of a fingerprint module 210 and an NFC module 212. The fingerprint module 210 is a high-quality in-built biometric fingerprint sensor or external USB interfaced biometric fingerprint scanner used for fingerprint authentication. The NFC module 212 is configured for a smart card authentication by NFC technology with a single tap. The use of patient authentication units is becoming increasingly common in healthcare organizations, especially with the shift towards electronic health records (EHRs) and telemedicine. By ensuring that patients 208 are properly identified, healthcare providers can improve the accuracy and safety of medical care, as well as protect patient privacy and prevent medical identity theft.

[51 ] The sensor unit 106 may comprise at least one of a biosensor, a blood pressure measuring instrument, a pulse oximeter, a glucometer, a spirometer, an incentive spirometer, and digital thermometers. The sensors in the sensor unit 106 are connected to the patients by wireless protocols comprising at least one of Bluetooth, Wi-Fi, RF and even through wired protocols comprising at least one of RS232, Ethernet, Type C, etc., through a connector holder.

[52] In an embodiment, the smart medical device gateway 108 comprises a device layer 214, a fog layer 216, a cloud layer 218, a blockchain layer 220, and an inverter module 222. The smart medical device gateway 108 is configured to receive the inputs from at least one of sensor data, hospital data, from homes, and other healthcare information providers (HIPs) 208. The received medical data are routed to the smart medical device gateway 108 and medical data is encrypted by blockchain layer 220, and data is saved.

[53] The inverter is built within the smart medical device gateway 108. The inverter module 222 comprises an inverter mechanism that works when the direct power goes OFF and supply is disconnected, the backup inverter turns ON and the sensitive medical data can be secure and can continuously run on inverter mode for hours without incurring a loss on data.

[54] The server 1 12 comprises at least one of a blockchain cloud server 224 and a hospital server 226. The blockchain cloud server 224 is a federated blockchain server. The hospital server 226 may comprise at least one of hospital local server and hospital cloud server. The encrypted data will be saved to a federated blockchain server, and a copy of the encrypted data will be sent to the hospital database, either the hospital’s local server or/and hospital’s cloud database.

[55] Figure 3 depicts/illustrates a schematic diagram, showing input-output peripherals of the smart medical device gateway, in accordance with an embodiment of the present disclosure.

[56] In an embodiment, the input peripherals of the smart medical device gateway 108 comprises at least one of a camera module 302, a fingerprint module 304, a mic module 306, an ethernet module 308, a USB module 310, an NFC module 312, and a touch module 314.

[57] The camera module 302 comprises a high-quality optimal camera with high resolution for a live video teleconsultation by the HlUs and HIPs. The fingerprint module 304 comprises a high-quality fingerprint sensor 802 for HlUs and HIPs authentication. The mic module 306 is used for voice recognition. The ethernet module 308 is a wired communication technology for connecting devices in a wired local area network (LAN) or wide area network (WAN). It enables devices to communicate with each other via a protocol, which is a set of rules or common network language.

[58] The USB module 310 provides a USB port for wired connection of other peripherals to the smart medical device gateway 108. The NFC module 212 is configured for a smart card authentication by the NFC technology with a single tap. The touch module 314 comprises a capacitive touch screen with inbuilt customized or proprietary operating system for seamless operation by healthcare professionals.

[59] In an embodiment, the output peripherals of the smart medical device gateway 108 comprises at least one of a speaker module 316, a High-Definition Multimedia Interface (HDMI) module 318 and a display module 320.

[60] The speaker module 316 is used for output & alerts. The HDMI module 318 provides an audio/video interface for transmitting uncompressed video data and compressed or uncompressed digital audio data from an HDMI-compliant source. The display module 320 connected to an interface module which comprises one or more hardware, software and firmware components for receiving, sharing and displaying data or signal from other devices. [61 ] Figure 4 depicts/illustrates an illustration diagram, showing different layer representation of smart medical device gateway, in accordance with an embodiment of the present disclosure.

[62] In an embodiment, in the device layer 214, the patients have sensors 106 and monitors attached to take care of their health. In real time, these devices can sense and transmit data. These devices are located on the device layer 214, have responsibility for healthcare selection and transmission of healthcare data to the fog layer for accessing via Wi-Fi or mobile network.

[63] In the fog layer 216, the layer of fog computing extracts medical details from different loT health tracking devices. This layer is used for loT health information collection and analysis in real-time.

[64] The cloud layer 218 is responsible for the storage and preparing and executing activities that the fog layer 216 is unable to handle and execute. For future actions, patient conditions and reports are moved to the cloud layer 218 from the fog layer 216.

[65] The blockchain layer 220 encrypts the data and the encrypted data will be saved to a federated blockchain server, a copy of the encrypted data will be sent to the hospital database, either the hospital local server and hospital’s cloud database.

[66] The EHR and EMR are saved in a cloud storage or a local server, with each treatment having its own folder. The folder contains the patient's anonymous ID, rather than any personal information. The changes to the files and folder are monitored to maintain a history of documentation and modifications. The system involves using tokenization to de-identify patient-sensitive data, which is then stored in a blockchain using the smart medical gateway device 108. Further, data can only be retrieved using the associated patient ID.

[67] Figure 5 depicts/illustrates the information flow incorporating biosensors into the Blockchain-based health record management system, in accordance with an embodiment of the present disclosure.

[68] The present invention aims to establish a tele-medical laboratory service where hospital staff can conduct clinical examinations using loT medical devices. Further, the results are automatically transmitted via the hospital cloud to physicians in federated hospitals for validation and consultation.

[69] The smart medical device gateway 108 serves as a node on the blockchain network and is placed between data creation and output devices. It captures the patient ID, receives data from multiple input pathways, and indexes it to the patient ID. The data is then digitalized and standardized according to existing standards, and a transaction is proposed on the blockchain database system. Once the transaction is confirmed, the data is recorded on the blockchain database, and the output devices are triggered to function. This process ensures the standardized digitalization of medical data without human intervention, minimizing the chances of errors. Thus, the medical gateway device facilitates EHR management automation.

[70] Figure 6 depicts/illustrates an illustration diagram, showing features of smart medical device gateway, in accordance with an embodiment of the present disclosure.

[71 ] In an embodiment, the smart medical device gateway 108 comprises of the camera module 302, the fingerprint module 304 and the touch module 314, as shown in figure 6. The smart medical device gateway 108 uses wired and wireless communication technologies.

[72] The wireless technology comprises at least one of Bluetooth 602, Wi-Fi 604, and Z-Wave 606 etc.

[73] Bluetooth 602 is a wireless technology used to exchange data over short distances between electronic devices, such as smartphones, headphones, and speakers. It operates on radio waves and is commonly used for connecting peripheral devices to a computer or for transferring files between devices.

[74] The Wi-Fi 604 is a popular wireless networking technology that enables devices to connect to the internet or other wireless networks. It uses radio waves to transmit data over short distances and can support high data transfer rates.

[75] The Z-Wave 606 is a wireless communication technology that is often used in smart home devices for home automation. It operates on low-frequency radio waves and uses a mesh network to communicate between devices. Z-Wave devices can communicate with each other directly or through a central hub, enabling users to control devices remotely or set up automated routines.

[76] The wired technology comprises at least one of Universal Serial Bus (USB) B,C 608, RS485 610, HDMI 612, Ethernet 614, and RS232 618. These are types of computer interface standards used for transmitting data between electronic devices.

[77] USB B,C 608 are types of universal serial bus connectors commonly used for connecting peripherals such as keyboards, mice, printers, and external hard drives to computers and mobile devices.

[78] RS485 610 is a serial communication standard used for transmitting data over long distances between electronic devices, often used in industrial automation and control systems.

[79] HDMI 612 is a digital interface commonly used for transmitting high-definition video and audio signals between devices such as TVs, monitors, and computers.

[80] Ethernet 614 is a wired networking standard commonly used for connecting devices such as computers, routers, switches, and servers to form local area networks (LANs) and wide area networks (WANs).

[81 ] RS232 618 is a serial communication standard used for transmitting data over short distances between electronic devices, often used for connecting devices such as modems, printers, and digital cameras to computers.

[82] The type C port is a newer type of USB port that is smaller and more versatile than previous versions. It supports faster data transfer speeds, higher power delivery, and can be used for a wide range of purposes, including charging devices and connecting to external displays.

[83] Figure 7 depicts/illustrates a schematic diagram, showing voice recognition flow using the smart medical device gateway, in accordance with an embodiment of the present disclosure.

[84] The process of converting user speech input into a text output comprises at least one of a speech enhancement 702, a feature extraction 704, a speaker modeling 706, a feature matching 708, and a decision-making module 710. [85] The user 102 speaks into the mic 304, and the speech signal is processed to remove any noise or interference in the background, thereby performing speech enhancement 702. Further, the feature extraction 704 is carried out by extracting relevant features of the speech signal such as pitch, duration, and spectral characteristics. Thereafter, the speaker modeling 706 is performed by modeling the speaker's identity using statistical techniques or neural networks.

[86] The extracted features are then compared to the speaker models in a process called feature matching 708, to determine which model best matches the input speech signal. Based on the feature matching 708 results, a decision 710 is made about the identity of the speaker, and the corresponding text output is generated using voice-to-text 712 technology. This process may involve accessing a speaker database 714 stored on the cloud, which contains information about different speakers and their associated models for comparison during feature matching 708.

[87] In an embodiment, the voice-operated systems will function using audio input within the frequency range of 300 Hz and 3000 Hz. The incorporation of preexisting chatbots like Alexa or Google would simplify the process of making hospitals smarter and utilizing voice commands to manage appointments, prescriptions, drug-related queries, data retrieval, billing, and other services. The voice input can be transcribed into text format for easy handling of tasks such as filling prescriptions or generating reports.

[88] Figure 8 depicts/illustrates a schematic diagram, showing fingerprint sensor architecture within the smart medical device gateway, in accordance with an embodiment of the present disclosure.

[89] In a healthcare ecosystem, a patient's 208 identity can be verified and authenticated using a fingerprint sensor 802 and a fingerprint database 804. When a patient 208 registers with a healthcare provider, their fingerprint is captured and stored in a fingerprint database 804. When the patient 208 returns for subsequent visits, their fingerprint is scanned using the sensor 802, and compared to the stored fingerprint in the database 804 for verification and identification purposes. This process ensures that the right patient 208 is receiving the appropriate medical care and treatment and can also help prevent medical errors due to misidentification or incorrect record keeping. [90] The fingerprint data is typically stored within the patient's electronic health record (EHR) in the patient database 804. This information is subject to strict privacy regulations, such as the Health Insurance Portability and Accountability Act (HIPAA), which safeguard patient confidentiality and privacy. Access to the fingerprint data and patient database 804 is usually restricted to authorized HIPs 204, such as doctors and nurses, who require this information to provide medical care and treatment to the patient.

[91 ] In an embodiment, a high-quality USB fingerprint biometric device is used for fingerprint authentication. In the preferred embodiment, an in-built fingerprint sensor is used. It utilizes optical sensing technology, which enables it to recognize poor quality fingerprints with ease. The sensor surface is scratch-resistant and it employs a 500 DPI optical fingerprint sensor.

[92] Figure 9 illustrates a schematic diagram, showing NFC enabled blockchain smart card architecture, in accordance with an embodiment of the present disclosure.

[93] The patient's 208 identity can also be authenticated in a healthcare setting using a Near Field Communication (NFC) card 312, a host controller 902, a secure element 906, and a mobile One-Time Password (OTP) 908. When a patient registers with a healthcare provider, they are issued an NFC card 312 that contains their unique identity information, such as their name, date of birth, and medical record number. When the patient 208 returns for subsequent visits, their NFC card 312 is scanned using the host controller 902, which communicates with the secure element 906 on the card 312 to retrieve the patient's 208 identity information. The patient 208 may also be required to provide the mobile OTP 908, which is a onetime password generated by a mobile app on their smartphone, to further authenticate their identity. The retrieved patient identity information is then compared to the information stored in the patient database 808 for verification and identification purposes. This process ensures that the right patient is receiving the appropriate medical care and treatment and can also help prevent medical errors due to misidentification or incorrect record keeping.

[94] In an embodiment, the smart medical device gateway 108 features a built-in ISO SAM slot to enhance its security. It utilizes a high-speed tag access rate of up to 424 Kbps, enabling it to read data faster and more efficiently. The proximity operating distance of the device's NFC reader is up to 5 cm, depending on the type of tag used.

[95] Additionally, the device is equipped with a smart card reader that comes with an ISO 7816 SAM slot to further enhance its security. It includes a buzzer and two LEDs for user interaction. The NFC reader on the smart medical device gateway 108 can also read and write data at a high speed of up to 424 Kbps, and its proximity operating distance is up to 5 cm, based on the type of tag used.

[96] Figure 10 depicts/illustrates a schematic diagram, showing working architecture of a printer connected with loT enabled smart medical device gateway, in accordance with an embodiment of the present disclosure.

[97] In an embodiment, the users 102 can submit their print instructions to a queue 1004 of printers 1002/1 -3. This queue 1004 of printers 1002/1 -3 is managed by a hub blockchain queue 1006, which is a decentralized system that operates on a blockchain network. When the user 102 submits a print instruction, it is added to the queue 1004 in the hub blockchain queue 1006. The print instruction is then sent to the printer 1002/1 -3 that is available and authorized to print. The hub blockchain queue 1006 records the transaction on the blockchain, ensuring the immutability and integrity of the queue 1004. Each print instruction is copied to the federated blockchain server 224. This federated blockchain server 224 is a decentralized system that operates on a network of multiple blockchain nodes. In addition to the federated blockchain server 224, each print instruction is also copied to the hospital's local and cloud servers 226. This ensures that the print instructions are readily accessible to authorized personnel for retrieval, tracking, and auditing purposes.

[98] The USB printers 1002/1 -3 although designed for direct connection to a single computer, can also be shared wirelessly with a hospital network group. There are two approaches to sharing printable data to multiple computers over a wireless/wired network.

[99] One approach is to connect the printer 1002 to a print-server-equipped Smart Medical Device Gateway 108 that acts as a router. Another option is to connect the USB printer 1002 to the smart medical device gateway 108 and select the SSID of the gateway when giving a print command from the computer. Using a wireless print server that supports Wi-Fi-protected setup makes the process extremely simple, with the data getting printed, analyzed, converted to digital format using Al, and saved as an EMR in the patient’s repository in the cloud secured by blockchain.

[100] The smart medical device gateway 108 uses Internet Printing Protocol (IPP) to manage printers, print requests, and print queues, and supports network printer browsing and postscript printer description-based printing options. Additionally, it provides a common printing interface across a local network. The saved data is visible to the patient with an encrypted key, and they have the right to delete any record at any time. A QR code 1202 will be printed on the record/ prescription/ document for anytime viewing, while the printed copy will be given to the patients. The user 102 may sent print instruction to the printing module 1000.

[101 ] Figure 1 1 depicts/illustrates a schematic diagram, showing working architecture of loHT powered teleconsultation, in accordance with an embodiment of the present disclosure.

[102] The user 102 can utilize the smart medical device gateway 108 or mobile device equipped with a camera 302 and internet connectivity 1 10 to facilitate remote medical consultations with healthcare providers such as HIP/doctor 204. In the preferred embodiment, the user is the patient 208. During the consultation, the user 208 can use the device's camera 302 to capture visual information such as their symptoms or injuries, which can be transmitted over the internet 1 10 to the doctor 204. The smart medical device gateway 108 can also be equipped with medical sensors 106 to capture vital signs such as heart rate, blood pressure, and temperature, which can also be transmitted over the internet to the healthcare provider. The doctor 204 can then view the visual information and vital signs on their screen in real-time and make an assessment of the user's 208 medical condition. The smart medical device gateway 108 can also be integrated with a medical database 808, which stores the user's 208 medical history and other relevant information. The medical database 808 can be accessed by the doctor 204 during the consultation to provide more informed medical advice and treatment.

[103] In an embodiment, the smart medical device gateway 108 is equipped with a high-quality camera 302 with high resolution, which enables live video teleconsultation by the HIPs 204 at the hospital 202. This camera 302 is optimized for providing clear and detailed video output. The digital data from the biomedical devices connected to the smart medical device gateway 108 is also transmitted to the doctor 204 during the teleconsultation, enabling them to have a better understanding of the patient's condition.

[104] In the preferred embodiment, the smart medical device gateway 108 is equipped with a high-quality camera with high resolution.

[105] Figure 12 depicts/illustrates a schematic diagram, showing working architecture of QR code, in accordance with an embodiment of the present disclosure; and

[106] In an embodiment, the QR Code 1202 image is generated based on a universal Patient ID. The QR Code 1202 assigned to each patient can be scanned by at least one of any user 102 comprising the hospitals 202, the Health Information Providers (HIPs) 204, the pharmacy 206 and the patient’s guardian 208 to access the patient's medical records, which are saved in a federated blockchain ecosystem. The QR Code 1202 contains the public blockchain key linked to the patient's ID.

[107] Further, the pharmacy 206 can issue medicines to a patient by scanning the QR code 1202 on their prescription. This process involves using a QR code reader 1204, comprising at least one of a smartphone or a barcode scanner, to capture the QR code 1202, which contains information about the patient's prescription. Once the QR code 1202 is scanned, the pharmacy's system can retrieve the relevant prescription data, including the medication details and dosage instructions. This enables the pharmacy to prepare and dispense the medication accurately and efficiently, while also ensuring that the patient receives the correct medication.

[108] Figure 13 depicts/illustrates a method for secure management of electronic health and medical records, in accordance with an embodiment of the present disclosure.

[109] The method 1300 begins with installing a smart medical device gateway 108 at the hospital that will ensure that all sensors and devices have the same set of IP addresses, by acting as a router and generating its own family of IP addresses, as depicted at step 1302. Subsequently, the method 1300 discloses registering the patient with basic health details, nominee details and Know Your Customer (KYC) details, thereby generating a public-private key and a smart card, as depicted at step 1304.

[1 10] Thereafter, the method 1300 discloses booking doctor's appointment for a patient by using an application or a smart card and booking doctor's appointment for the patient by the nurse in case of emergency and intimating the nominee immediately, as depicted at step 1306. Subsequently, the method 1300 discloses scanning QR of patient application or smart card by the H IPs or Hospitals to access the User’s medical database stored in a federated blockchain ecosystem, as depicted at step 1308. Thereafter, the method 1300 discloses assigning the sensors to the patient to monitor and measure various physiological and environmental parameters of patients and check vitals of the patient by using wired or wireless devices, as depicted at step 1310.

[1 1 1 ] Subsequently, the method 1300 discloses transferring the collected data from the patient to a database mapped to his private key after being approved by the doctor, as depicted at step 1312. Thereafter, the method 1300 discloses Computing the collected data from the devices via FOG computation to understandable and universal standard metrics, as depicted at step 1314. Subsequently, the method 1300 discloses generating prescription with QR code upon completion of diagnosis and scanning QR code of the patient's prescription by the pharmacy for issuing the medicines, as depicted at step 1316.

[1 12] Advantages of a federated blockchain enabled loHT gateway device with an inbuilt inverter for healthcare comprises decentralization, improved data collection, real-time data processing, secure data storage, and easy authentication.

[1 13] The decentralized blockchain-based loHT gateway device provides a secure and tamper-proof network for healthcare data exchange. It eliminates the need for a centralized authority and reduces the risk of data breaches. Further, integration of point-of-care devices for vital data collection from various medical sensors and association of the data with Unique Health ID, patient ID, hospital ID, enables accurate and efficient data collection, which can be used for diagnosis, treatment, and research purposes. [1 14] Additionally, the processing of real-time sensor data during consultation helps in improving the quality of diagnosis and enables faster decision-making by the healthcare provider.

[1 15] Furthermore, the smart medical device gateway 108 with its inbuilt inverter acts as an interceptor, which maps the document to the right patient and saves a copy of the document as an EMR in the following data storage systems: Hospital cloud server (or) Hospital local server and Blockchain cloud Server. Further, Smart Card authentication by NFC technology by a single tap provides easy and secure access to patient data. Data stored will be compliant with FHIR, HIPAA, HL7, GDPR and ICD standards, ensuring that patient privacy is protected.

[1 16] The loHT based smart medical device gateway 108 offers robust communication capabilities using secure BLE, Wi-Fi, and ethernet connectivity. Its features include remote access for troubleshooting and remediation, automated firmware updates for critical security patches, telemetry data for remote event monitoring, and a device ID for authorized user visibility.

[1 17] The device is designed to minimize hardware footprints or use a single board computer for hospital or home settings. This gateway device combines 5G modem and Wi-Fi capabilities in one product to provide portable network connectivity without separate cabling. It also offers easy "out-of-the-box" configuration and connection to enterprise networks, as well as a unique Device ID feature for authorized user recognition. Developers can take advantage of the Linux SDK and React, Python, Java runtime services to quickly develop and deploy custom apps.

[1 18] Furthermore, this device has Wi-Fi Alliance and USB Certification, low infrastructure costs, and can make ICUs completely wireless. Healthcare staff can easily manage and monitor a large number of patients, and the device has a quick and easy deployment/activation time.

[1 19] Applications of the current invention include loT enabled healthcare ecosystem, medical records management, and secure data storage.

[120] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described here. ]

Claims

[Claim 1 ] A system (100) for secure management of electronic health and medical records, comprising: a patient authentication unit (104) configured to verify the identity of a patient (208) and enabling them to access healthcare services; a sensor unit (106) configured to monitor and measure physiological parameters of patients (208); and a smart medical device gateway (108) configured to act as an interceptor for acquiring medical records, and as a router to connect with wireless medical sensors.

[Claim 2] The system (100) as claimed in claim 1 , wherein the patient authentication unit (104) comprises at least one of a fingerprint module (210), and an NFC module (212) for verification of the identity of the patient (208).

[Claim 3] The system (100) as claimed in claim 1 , wherein the sensor unit (106) comprises at least one of a biosensor, blood pressure measuring instrument, pulse oximeter, glucometer, spirometer, incentive spirometer, and digital thermometer.

[Claim 4] The system (100) as claimed in claim 1 , wherein the smart medical device gateway (108) comprises at least one of: a device layer (214) equipped with sensors (106) and monitors for monitoring patient health, wherein the sensors and monitors are configured to sense and transmit healthcare data in real-time; a fog layer (216) configured for collecting and analyzing medical details extracted from multiple Internet of Things (loT) health tracking devices for facilitating real-time healthcare information processing; a cloud layer (218) configured for storing, preparing, and executing healthcare activities beyond the capabilities of the fog layer (216), wherein patient conditions and reports are transferred from the fog layer (216) to the cloud layer (218) for future actions; a blockchain layer (220) configured for encrypting healthcare data, wherein the encrypted data is stored in a federated blockchain server, and a copy of the encrypted data is transmitted to a hospital database, comprising at least one of a hospital local server or a hospital's cloud database; an inverter module (222) configured for secure data handling and storage.

[Claim 5] The system (100) as claimed in claim 5, wherein the inverter module (222) comprises an inverter mechanism that works when the direct power goes OFF and supply is disconnected, a backup inverter turns ON and the sensitive medical data can be secure and can continuously run on inverter mode for hours without incurring a loss on data.

[Claim 6] The system (100) as claimed in claim 1 , comprising a server (1 12), wherein the server (112) comprises at least one of: a blockchain cloud server (224), wherein the blockchain cloud server (224) is a federated blockchain server that saves at least one encrypted data from the blockchain layer (220); and a hospital server (226) that comprises at least one of hospital local server, and hospital cloud server, wherein a copy of the encrypted data is saved.

[Claim 7] The system (100) as claimed in claim 1 , wherein the smart medical device gateway (108) comprises one or more input peripherals and one or more output peripherals.

[Claim 8] The system (100) as claimed in claim 8, wherein the input peripherals of the smart medical device gateway (108) comprise at least one of: a camera module (302) configured with a high-quality optimal camera capable of providing high-resolution live video teleconsultation for healthcare institutions (HlUs) and healthcare professionals (HIPs); a fingerprint module (304) comprising at least one of a high-quality in-built biometric fingerprint sensor (802), and an external (Universal Serial Bus) USB interfaced biometric fingerprint scanner for fingerprint authentication of healthcare professionals (HIPs); a mic module (306) configured for voice recognition with noise cancellation techniques to enhance voice recognition accuracy in noisy environments; an ethernet module (308) configured for facilitating wired communication between devices within a local area network (LAN) or wide area network (WAN) using a communication protocol; a USB module (310) providing a USB port for wired connection of additional peripherals to the smart medical device gateway (108); an NFC module (312) configured for smart card authentication through NFC technology with a single tap; and a touch module (314) comprising a capacitive touch screen equipped with antiglare and scratch-resistant coatings for improved durability and usability, and wherein the touch module (314) is configured to incorporate gesture recognition technology to facilitate intuitive user interaction with the smart medical device gateway (108).

[Claim 9] The system (100) as claimed in claim 8, wherein the output peripherals of the smart medical device gateway (108) comprise at least one of: a speaker module (316) configured for output & alerts; a High-Definition Multimedia Interface (HDMI) module (318) configured to provide an audio/video interface for transmitting uncompressed video data and compressed or uncompressed digital audio data from an HDMI-compliant source; and a display module (320) connected to an interface module which comprises one or more hardware, software and firmware components for receiving, sharing and displaying data or signal from other devices.

[Claim 10] The system (100) as claimed in claim 1 , wherein the smart medical device gateway (108) is configured to: capture patient identification information; receive data from multiple input pathways; index received data to corresponding patient identification information; digitalize and standardize received data according to existing standards; propose transactions on a blockchain database system based on the standardized digitalized data; upon confirmation of transactions, record the standardized digitalized data on the blockchain database; and trigger output devices to function based on the recorded data, thereby facilitating automated management of electronic health records (EHR) through standardized digitalization of medical data without human intervention, reducing error occurrences.

[Claim 1 1 ] The system (100) as claimed in claim 1 , wherein the smart medical device gateway comprising voice recognition, is configured to: receive a speech signal from a user (102) via a microphone (304); process the speech signal to remove noise or interference, thereby performing speech enhancement (702); extract relevant features of the speech signal, comprising pitch, duration, and spectral characteristics, through feature extraction (704); model the identity of the speaker using statistical techniques or neural networks, as part of speaker modeling (706); compare the extracted features to speaker models to determine the best match, in a process called feature matching (708); make a decision about the identity of the speaker based on the feature matching results, utilizing a decision-making module (710); generate a corresponding text output using voice-to-text technology (712); access a speaker database (714) stored on the cloud to retrieve information about different speakers and their associated models for comparison during feature matching (708) and operate within a frequency range of 300 Hz and 3000 Hz for voice -ope rated systems; and incorporate pre-existing chatbots to simplify hospital operations and enable voice commands for managing appointments, prescriptions, drug-related queries, data retrieval, billing, and other services, with the voice input transcribed into text format for easy task handling.

[Claim 12] The system (100) as claimed in claim 2, wherein a fingerprint sensor architecture within the smart medical device gateway (108) is configured to: verify and authenticate a patient's (208) identity using a fingerprint sensor (802) and a fingerprint database (804); capture and store the patient's fingerprint in the database (804) upon registration with a healthcare provider; scan the patient's fingerprint during subsequent visits using the sensor (802), and compare it to the stored fingerprint in the database (804) for verification and identification purposes; ensure correct patient (208) identification to facilitate appropriate medical care and treatment, and prevent medical errors; store fingerprint data within the patient's electronic health record (EHR) in the patient database (804), adhering to strict privacy regulations such as the Health Insurance Portability and accountability Act (HIPAA); and restrict access to fingerprint data and the patient database (804) to authorized healthcare professionals (HIPs) (204) for patient care purposes.

[Claim 13] The system (100) as claimed in claim 2, wherein the smart medical device gateway (108) comprises an NFC enabled blockchain smart card architecture configured to: authenticate a patient's (208) identity using a Near Field Communication (NFC) card (312), a host controller (902), a secure element (906), and a mobile One- Time Password (OTP) (908); issue the NFC card (312) to the patient, comprising unique identity information such as name, date of birth, and medical record number upon registration with a healthcare provider; scan the patient's NFC card (312) during subsequent visits using the host controller (902), communicating with the secure element (906) on the card (312) to retrieve the patient's identity information; 1 request the patient to provide the mobile OTP (908), generated by a mobile app on their smartphone, to further authenticate their identity; compare the retrieved patient identity information to information stored in the patient database (808) for verification and identification purposes, ensuring correct patient identification and preventing medical errors; provide a built-in ISO SAM slot to enhance security within the smart medical device gateway (108), with a high-speed tag access rate of up to 424 Kbps for efficient data reading; operate with a proximity operating distance of up to 5 cm for the NFC reader on the smart medical device gateway (108), depending on the type of tag used; provide a smart card reader with an ISO 7816 SAM slot for further security enhancement, featuring a buzzer and two LEDs for user interaction; and enable the NFC reader on the smart medical device gateway (108) to read and write data at a high speed, with the specified proximity operating distance, based on the type of tag used.

[Claim 14] The system (100) as claimed in claim 1 , wherein a printer connected to the smart medical device gateway (108) is configured to: receive print instructions submitted by users (102) to a queue (1004) of printers (1002/1 -3), managed by a hub blockchain queue (1006), operating on a decentralized blockchain network; add received print instructions to the queue (1004) within the hub blockchain queue (1006), and send them to available and authorized printers (1002/1 -3) for printing; record each print instruction transaction on the blockchain within the hub blockchain queue (1006) to ensure queue (1004) immutability and integrity; copy each print instruction to the federated blockchain server (224) and hospital's local and cloud servers (226) for accessibility to authorized personnel for retrieval, tracking, and auditing purposes; enable USB printers (1002/1 -3) designed for direct connection to a single computer to be shared wirelessly with a hospital network group, either through connection to a print-server-equipped smart Medical Device Gateway (108) acting as a router or by connecting directly to the smart medical device gateway (108) and selecting its SSID when issuing a print command from the computer; support Internet Printing Protocol (IPP) for managing printers, print requests, and print queues, as well as network printer browsing and postscript printer description-based printing options; provide a common printing interface across a local network, with saved data visible to the patient with an encrypted key, granting them the right to delete any record at any time; print a QR code (1202) on the record/prescription/document for anytime viewing by the patient, while providing the printed copy to the patients; and receive print instructions sent to the printing module (1000) by the user (102).

[Claim 15] The system (100) as claimed in claim 1 , wherein the smart medical device gateway (108) enables loT powered teleconsultation y being configured to: enable patients (208) to capture visual information such as symptoms or injuries using the device's camera (302) for transmission over the internet (1 10) to healthcare providers; communicate with medical sensors (106) within the smart medical device gateway (108) to capture vital signs like heart rate, blood pressure, and temperature, which are also transmitted over the internet to healthcare providers; display real-time visual information and vital signs to doctors (204) on their screens during consultations, enabling assessment of the user's (208) medical condition; communicate with a medical database (808) containing the user's (208) medical history and other relevant information, accessible by doctors (204) during consultations to provide informed medical advice and treatment; equip the smart medical device gateway (108) with a high-quality camera (302) with high resolution for live video teleconsultation by HIPs (204) at hospitals (202), ensuring clear and detailed video output; and transmit digital data from biomedical devices connected to the smart medical device gateway (108) to doctors (204) during teleconsultations, facilitating a comprehensive understanding of the patient's condition.

[Claim 16] The system (100) as claimed in claim 1 , wherein the smart medical device gateway (108) comprises an architecture for QR code configured to: generate QR Code (1202) images based on a universal Patient ID; assign a unique QR Code (1202) to each patient, scannable by users (102) including at least one of hospitals (202), Health Information Providers (HIPs) (204), pharmacy (206), and patient's guardian (208), for accessing the patient's medical records saved in a federated blockchain ecosystem; embed the public blockchain key linked to the patient's ID within the QR Code (1202); enable the pharmacy (206) to issue medicines to a patient by scanning the QR code (1202) on their prescription using a QR code reader (1204) comprising at least one of a smartphone, and a barcode scanner; and capture information about the patient's prescription from the scanned QR code (1202), including medication details and dosage instructions, to prepare and dispense the medication accurately and efficiently, ensuring the patient receives the correct medication.

[Claim 17] A method (1300) for secure management of electronic health and medical records, comprising: installing a smart medical device gateway (108) at a hospital to ensure all sensors and devices have a same set of IP addresses, by acting as a router and generating its own family of IP addresses; registering at least one patient (208) with basic health details, nominee details, and Know Your Customer (KYC) details to generate a public-private key and a smart card (step 1304); booking a doctor's appointment for the patient (208) using an application or a smart card, or booking a doctor's appointment for the patient by the nurse in case of emergency, intimating the nominee immediately; scanning the QR code of the patient (208) application or smart card by Health Information Providers (HIPs) or Hospitals to access the patient’s (208) medical database stored in a federated blockchain ecosystem; assigning sensors to the patient (208) to monitor and measure various physiological and environmental parameters, and checking vitals of the patient using wired or wireless devices; transferring collected data from the patient (208) to a database mapped to his private key after being approved by the doctor; computing collected data from the wired or wireless devices via FOG computation to understandable and universal standard metrics; and generating a prescription with a QR code upon completion of diagnosis and scanning the QR code of the patient's prescription by the pharmacy for issuing the medicines.

[Claim 18] The method (1300) as claimed in claim 17, comprising providing the patient authentication unit (104) with at least one of a fingerprint module (210), and an NFC module (212) for verification of the identity of the patient (208).

[Claim 19] The method (1300) as claimed in claim 17, comprising configuring the smart medical device gateway (108) for: monitoring patient health by using a device layer (214) equipped with sensors (106) and monitors, wherein the sensors and monitors are configured to sense and transmit healthcare data in real-time; collecting and analyzing medical details extracted from multiple Internet of Things (loT) health tracking devices, facilitating real-time healthcare information processing, by using a fog layer (216); storing, preparing, and executing healthcare activities beyond the capabilities of the fog layer (216) by using a cloud layer (218), wherein patient conditions and reports are transferred from the fog layer (216) to the cloud layer (218) for future actions; encrypting healthcare data by using a blockchain layer (220), wherein the encrypted data is stored in a federated blockchain server, and a copy of the encrypted data is transmitted to a hospital database, comprising at least one of a hospital local server or a hospital's cloud database; and securing data handling and storage by using an inverter module (222).

[Claim 20] The method (1300) as claimed in claim 19, comprising providing the inverter module (222) with an inverter mechanism that works when the direct power goes OFF and supply is disconnected, a backup inverter turns ON and the sensitive medical data can be secure and can continuously run on inverter mode for hours without incurring a loss on data.

[Claim 21 ] The method (1300) as claimed in claim 17, comprising configuring a server (1 12) for: saving at least one encrypted data from the blockchain layer (220) by using a a blockchain cloud server (224), wherein the blockchain cloud server (224) is a federated blockchain server; and saving a copy of the encrypted data in a hospital server (226) that comprises at least one of hospital local server, and hospital cloud server.

[Claim 22] The method (1300) as claimed in claim 17, comprising providing the smart medical device gateway (108) with one or more input peripherals and one or more output peripherals.

[Claim 23] The method (1300) as claimed in claim 17, comprising configuring the input peripherals of the smart medical device gateway (108) for: providing high-resolution live video teleconsultation for healthcare institutions (HlUs) and healthcare professionals (HIPs) by using a camera module (302) configured with a high-quality optimal camera; verifying and authenticating healthcare professionals (HIPs) by using a fingerprint module (304) comprising at least one of a high-quality in-built biometric fingerprint sensor (802), and an external (Universal Serial Bus) USB interfaced biometric fingerprint scanner for fingerprint authentication; enhancing voice recognition accuracy in noisy environments by using a mic module (306) configured for voice recognition with noise cancellation techniques; enabling wired communication between devices within a local area network (LAN) or wide area network (WAN) using a communication protocol, via an ethernet module (308); providing a USB port for wired connection of additional peripherals to the smart medical device gateway (108) by using a USB module (310); enabling smart card authentication through NFC technology with a single tap by using an NFC module (312); and enabling intuitive user interaction with the smart medical device gateway (108) by using a touch module (314) comprising a capacitive touch screen equipped with anti-glare and scratch-resistant coatings for improved durability and usability, and wherein the touch module (314) is configured to incorporate gesture recognition technology.

[Claim 24] The method (1300) as claimed in claim 17, comprising configuring the output peripherals of the smart medical device gateway (108) for: providing output & alerts, by using a speaker module (316); providing an audio/video interface for transmitting uncompressed video data and compressed or uncompressed digital audio data from an HDMI-compliant source, by using a High-Definition Multimedia Interface (HDMI) module (318); and receiving, sharing and displaying data or signal from other devices, by using a display module (320) connected to an interface module which comprises one or more hardware, software and firmware components.

[Claim 25] The method (1300) as claimed in claim 17, comprising configuring the smart medical device gateway (108) for: capturing patient identification information; receiving data from multiple input pathways; indexing received data to corresponding patient identification information; digitalizing and standardizing received data according to existing standards; propose transactions on a blockchain database system based on the standardized digitalized data; recording the standardized digitalized data on the blockchain database, upon confirmation of transactions; and triggering output devices to function based on the recorded data, thereby facilitating automated management of electronic health records (EHR) through standardized digitalization of medical data without human intervention, reducing error occurrences.

[Claim 26] The method (1300) as claimed in claim 17, comprising configuring the smart medical device gateway with voice recognition for: receiving a speech signal from a user (102) via a microphone (304); processing the speech signal to remove noise or interference, thereby performing speech enhancement (702); extracting relevant features of the speech signal, comprising pitch, duration, and spectral characteristics, through feature extraction (704); modelling the identity of the speaker using statistical techniques or neural networks, as part of speaker modeling (706); comparing the extracted features to speaker models to determine the best match, in a process called feature matching (708); making a decision about the identity of the speaker based on the feature matching results, utilizing a decision-making module (710); generating a corresponding text output using voice-to-text technology (712); accessing a speaker database (714) stored on the cloud to retrieve information about different speakers and their associated models for comparison during feature matching (708) and operate within a frequency range of 300 Hz and 3000 Hz for voice -ope rated systems; and incorporating pre-existing chatbots to simplify hospital operations and enable voice commands for managing appointments, prescriptions, drug-related queries, data retrieval, billing, and other services, with the voice input transcribed into text format for easy task handling.

[Claim 27] The method (1300) as claimed in claim 18, comprising configuring a fingerprint sensor architecture within the smart medical device gateway (108) for: verifying and authenticating a patient's (208) identity using a fingerprint sensor (802) and a fingerprint database (804); capturing and storing the patient's fingerprint in the database (804) upon registration with a healthcare provider; scanning the patient's fingerprint during subsequent visits using the sensor (802), comparing it to the stored fingerprint in the database (804) for verification and identification purposes; ensuring correct patient (208) identification to facilitate appropriate medical care and treatment, and prevent medical errors; storing fingerprint data within the patient's electronic health record (EHR) in the patient database (804), adhering to strict privacy regulations such as the Health Insurance Portability and accountability Act (HIPAA); and restricting access to fingerprint data and the patient database (804) to authorized healthcare professionals (HIPs)(204) for patient care purposes.

[Claim 28] The method (1300) as claimed in claim 18, comprising configuring an NFC enabled blockchain smart card architecture within the smart medical device gateway (108) for: verifying a patient's (208) identity using a Near Field Communication (NFC) card (312), a host controller (902), a secure element (906), and a mobile One- Time Password (OTP) (908); issuing the NFC card (312) to the patient containing unique identity information such as name, date of birth, and medical record number upon registration with a healthcare provider; scanning the patient's NFC card (312) during subsequent visits using the host controller (902), communicating with the secure element (906) on the card (312) to retrieve the patient's identity information; requesting the patient to provide the mobile OTP (908), generated by a mobile app on their smartphone, to further authenticate their identity; comparing the retrieved patient identity information to information stored in the patient database (808) for verification and identification purposes, ensuring correct patient identification and preventing medical errors; providing a built-in ISO SAM slot to enhance security within the smart medical device gateway (108), with a high-speed tag access rate of up to 424 Kbps for efficient data reading; operating with a proximity operating distance of up to 5 c m for the NFC reader on the smart medical device gateway (108), depending on the type of tag used; providing a smart card reader with an ISO 7816 SAM slot for further security enhancement, featuring a buzzer and two LEDs for user interaction; and enabling the NFC reader on the smart medical device gateway (108) to read and write data at a high speed, with the specified proximity operating distance, based on the type of tag used.

[Claim 29] The method (1300) as claimed in claim 17, comprising configuring a printer connected with the smart medical device gateway (108) for: receiving print instructions submitted by users (102) to a queue (1004) of printers (1002/1 -3), managed by a hub blockchain queue (1006), operating on a decentralized blockchain network; adding received print instructions to the queue (1004) within the hub blockchain queue (1006), and send them to available and authorized printers (1002/1 -3) for printing; recording each print instruction transaction on the blockchain within the hub blockchain queue (1006) to ensure queue (1004) immutability and integrity; copying each print instruction to the federated blockchain server (224) and hospital's local and cloud servers (226) for accessibility to authorized personnel for retrieval, tracking, and auditing purposes; enabling USB printers (1002/1 -3) designed for direct connection to a single computer to be shared wirelessly with a hospital network group, either through connection to a print-server-equipped smart Medical Device Gateway (108) acting as a router or by connecting directly to the smart medical device gateway (108) and selecting its SSID when issuing a print command from the computer; supporting Internet Printing Protocol (IPP) for managing printers, print requests, and print queues, as well as network printer browsing and postscript printer description-based printing options; providing a common printing interface across a local network, with saved data visible to the patient with an encrypted key, granting them the right to delete any record at any time; printing a QR code (1202) on the record/prescription/document for anytime viewing by the patient, while providing the printed copy to the patients; and receiving print instructions sent to the printing module (1000) by the user (102).

[Claim 30] The method (1300) as claimed in claim 17, comprising configuring loT powered teleconsultation in the smart medical device gateway (108) for: enabling patients (208), to capture visual information such as symptoms or injuries using the device's camera (302) for transmission over the internet (1 10) to healthcare providers; capturing vital signs like heart rate, blood pressure, and temperature, which are also transmitted over the internet to healthcare providers, by incorporating medical sensors (106) within the smart medical device gateway (108); displaying real-time visual information and vital signs on the screens during consultations, enabling assessment of the user's (208) medical condition; communicating the smart medical device gateway (108) with a medical database (808) containing the user's (208) medical history and other relevant information, accessible by doctors (204) during consultations to provide informed medical advice and treatment; equipping the smart medical device gateway (108) with a high-quality camera (302) with high resolution for live video teleconsultation by HIPs (204) at hospitals (202), ensuring clear and detailed video output; and transmitting digital data from biomedical devices connected to the smart medical device gateway (108) to doctors (204) during teleconsultations, facilitating a comprehensive understanding of the patient's condition.

[Claim 31 ] The method (1300) as claimed in claim 17, comprising configuring architecture of QR code in the smart medical device gateway (108) for: generating QR Code (1202) images based on a universal Patient ID; assigning a unique QR Code (1202) to each patient, scannable by users (102) including hospitals (202), Health Information Providers (HIPs) (204), pharmacy (206), and patient's guardian (208), for accessing the patient's medical records saved in a federated blockchain ecosystem; embedding the public blockchain key linked to the patient's ID within the QR Code (1202); enabling the pharmacy (206) to issue medicines to a patient by scanning the QR code (1202) on their prescription using a QR code reader (1204) comprising at least one of a smartphone, and a barcode scanner; and capturing information about the patient's prescription from the scanned QR code (1202), comprising medication details and dosage instructions, to prepare and dispense the medication accurately and efficiently, ensuring the patient receives the correct medication.