Blockchain data storage system and method

The blockchain data storage system addresses the lack of objective tracking and immutability in patient medical data by utilizing a decentralized network for secure, traceable, and immutable data storage, enhancing data integrity and access for healthcare stakeholders.

WO2025016629A1PCT designated stage expired Publication Date: 2025-01-23BIOTRONIK SE & CO KG
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Patent Information

Application Number
PCT/EP2024/066335
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-07-18
Filing Date
2024-06-13
Publication Date
2025-01-23

AI Technical Summary

Technical Problem

Existing systems for managing patient medical data lack objective tracking and immutability, making it difficult for healthcare practitioners, patients, and regulatory authorities to access and verify the data accurately.

Method used

A blockchain data storage system is implemented to store data from patient medical devices and medical data communication devices, ensuring traceability, immutability, and secure access through a decentralized network with nodes for data storage and a communication interface for data receipt.

Benefits of technology

The system provides an immutable and traceable record of patient medical data, enabling efficient identification of false programming or component issues, and ensuring secure access for authorized stakeholders, thereby enhancing data integrity and security.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to a blockchain data storage system (1) for storing first data (D1) of patient medical devices (10) and / or second data (D2) of medical data communication devices (12), comprising a communication interface (14) configured to receive the first data (D1) of the patient medical devices (10) and / or the second data (D2) of medical data communication devices (12), and a plurality of nodes (16, 18, 20) configured to store the first data (D1) of the patient medical devices (10) and / or the second data (D2) of the medical data communication devices (12). Furthermore, the invention relates to a computer-implemented method for storing first data (D1) of patient medical devices (10) and / or second data (D2) of medical data communication devices (12) on a blockchain data storage system.
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Description

[0001] Blockchain data storage system and method

[0002] The invention relates to a blockchain data storage system for storing first data of patient medical devices and / or second data of medical data communication devices.

[0003] Furthermore, the invention relates to a computer-implemented method for storing first data of patient medical devices and / or second data of medical data communication devices on a blockchain data storage system.

[0004] At present, data captured by patient medical devices is regularly transmitted to an IT system of a manufacturer and / or a health care service provider for further analysis and processing of said patient medical data.

[0005] WO 2021 / 237345 Al discloses a method to manage exposure of confidential user information in a user data record to a third party, the method comprising providing an electronic record system managed by a server arrangement, the server arrangement being configured to interact with a user device associated with the user, implementing with the server arrangement a data privacy configurator including a GUI allowing the user at the user device to specify data access parameters, the data access parameters distinguishing between first data in the user data record that the user is willing to expose to a third party from second data in the user data record that the user is not willing to expose to the third party, and in response to a request received at the server arrangement to communicate user data from the user data record to the third party, processing the user data record according to the data access parameters to allow the third party to access the first data while precluding the third party to access the second data. However, such systems usually do not provide objective tracking of the patient medical data by all involved parties such as health care practitioners, patients and regulating authorities.

[0006] The object of the invention is thus to store the data generated by patient medical devices and / or medical data communication devices in a traceable and immutable manner and to ensure access for the stakeholders in a suitable way.

[0007] This object is solved by a blockchain data storage system for data generated by patient medical devices and / or medical data communication devices having the features of claim 1.

[0008] Furthermore, the object is solved by a computer-implemented method for data generated by patient medical devices and / or medical data communication devices on a blockchain data storage system having the features of claim 14.

[0009] Moreover, the object is solved by a computer program having the features of claim 15.

[0010] Further developments and advantageous embodiments are defined in the dependent claims.

[0011] The present invention provides a blockchain data storage system for storing first data of patient medical devices, in particular implantable medical devices, and / or second data of medical data communication devices. The blockchain data storage system comprises a communication interface configured to receive the first data of the patient medical devices and / or the second data of medical data communication devices and a plurality of nodes configured to store the first data of the patient medical devices and / or the second data of the medical data communication devices.

[0012] The present invention further provides a computer-implemented method for storing first data of patient medical devices and / or second data of medical data communication devices on a blockchain data storage system.

[0013] The method comprises receiving the first data of the patient medical devices and / or the second data of medical data communication devices by a communication interface, and storing the first data of the patient medical devices and / or the second data of the medical data communication devices on a plurality of nodes of the blockchain data storage system.

[0014] In addition, the present invention provides a computer program with program code to perform the method of the present invention when the computer program is executed on a computer.

[0015] In context to a blockchain network, nodes are the electronic devices connected to the network and possessing an IP address. Generally, nodes are the communication endpoints which means that any user or application that wants to interact with the blockchain does so through nodes. Therefore, nodes are also a point of communication redistribution. Furthermore, nodes are storage devices, wherein a copy of the blockchain can be stored in each node configured for data storage.

[0016] Blockchain works by adding blocks of data and the essence of consensus is to ensure that every block that is added to the chain is the one and only version of the truth that’s agreed upon by all the nodes in the system. It is a key feature of the decentralised nature of blockchain.

[0017] The base rules for consensus in blockchain include the objective of coming to an agreement; collaboration, cooperation, and equal rights to every node / peer; and mandatory participation of each node in the process.

[0018] An example of a consensus mechanism is proof of X (PoX). The idea behind this proof of something consensus is to use some scarce resources X where malicious attackers cannot get X easily. In doing so, the system can remain safe in a decentralized and permissionless manner.

[0019] In order to gain the privilege of validating transactions, nodes on a PoX network must provide evidence that they have successfully fulfilled X criteria. Oftentimes, this process involves some sort of sacrifice. For example, computational power and effort in proof of work. An idea of the present invention is thus to provide immutable storage and tracking of said first data of patient medical devices and / or said second data of medical data communication devices by means of the blockchain data storage system.

[0020] Thus, in case of a technical issue of the patient medical device such as it being used with a false programming and / or in a false operation mode, an objective tracking of the events triggering said false programming and / or said false operation mode can advantageously be provided to all parties involved.

[0021] According to an aspect of the invention, the first data of patient medical devices comprises a programming of the patient medical devices, patient medical data acquired by the patient medical devices and / or manufacturing data of the patient medical devices.

[0022] The blockchain network thus advantageously stores a complete history of data generated and communicated by the respective patient medical devices and / or medical data communication devices.

[0023] According to a further aspect of the invention, the programming of the patient medical devices comprises an initial programming of the patient medical devices and any modifications to the programming of the patient medical devices since the initial programming.

[0024] It is thus easy for all involved parties to track and identify any modifications made to the programming of patient medical devices, i.e., when, by whom and for what reason a modification was made.

[0025] According to a further aspect of the invention, the patient medical data acquired by the patient medical devices comprises an implantation and / or explantation date of the patient medical devices, and wherein the manufacturing data of the patient medical devices comprises a manufacturing date and / or a serial number of components, in particular a battery, of the implantable medical device. Storing manufacturing data of the patient medical devices on the blockchain network facilitates an identification of a subgroup of patient medical devices, e.g., in case of a manufacturer recall of specific patient medical devices.

[0026] According to a further aspect of the invention, the second data comprises configuration and / or programming data of the medical data communication devices, in particular a patient communication device.

[0027] By also including configuration and / or programming data of patient communication devices it is, in case of a technical issue of a device, easier to identify and track the source of the technical issue.

[0028] According to a further aspect of the invention, the blockchain data storage system is configured to create a notification to a data processing system of a health care service provider when identifying false implant programming and / or a recalled, broken or expired component, in particular a capacitor, an electrode and / or a battery, of the patient medical device, and wherein the blockchain data storage system is configured to store the notifications to the data processing system of the health care service provider.

[0029] Providing the blockchain network with the added functionality of creating notifications to the data processing system of the health care service provider, an additional layer of security is advantageously provided.

[0030] According to a further aspect of the invention, false implant programming is identified if the implant programming and / or an implant operation mode does not match at least one of a current patient condition and a location and / or in an event of a battery drain. This advantageously enables an efficient automated detection of a false implant programming and / or of a false implant operation mode.

[0031] According to a further aspect of the invention, the blockchain data storage system comprises an authorization module configured to grant a write permission to a first group of users, in particular manufacturers, suppliers and physicians and a read permission to a second group of users, in particular patients and authorities.

[0032] Said added data is then verified by a consensus mechanism when adding new blocks to the chain.

[0033] According to a further aspect of the invention, the communication interface is an app of a mobile communication device and / or a web-interface accessible by a computing device usable by the first group of users and / or the second group of users, wherein the communication interface is configured to receive data transmissions of the first data of patient medical devices and / or the second data of medical data communication devices.

[0034] The usage of an app of a mobile communication device advantageously enables an easy and convenient interaction and / or data upload to the blockchain network.

[0035] According to a further aspect of the invention, the communication interface is configured to receive manual data input and / or provide voice-to-text data conversion. This advantageously provides an increased range of data input sources to the blockchain network.

[0036] According to a further aspect of the invention, a separate blockchain is used for each patient medical device and / or each medical data communication device or a single blockchain is used for multiple patient medical devices and / or multiple medical data communication devices.

[0037] Providing a separate blockchain for each patient medical device e.g. provides enhanced privacy and data protection of patient medical data. Alternatively, when using a single blockchain for multiple patient medical devices any patient identification data can be aliased in order to anonymize the data.

[0038] According to a further aspect of the invention, the communication interface is configured to receive wearable data, in particular generated by a smartring, a smartphone and / or a smartwatch, wherein the wearable data is part of the first data of patient medical devices and / or the second data of medical data communication devices.

[0039] This advantageously provides an increased range of data sources with which the communication interface is capable of exchanging data with in order to expand the data set for each patient medical device and / or each medical data communication device stored in the blockchain data store system.

[0040] According to a further aspect of the invention, the blockchain data storage system is configured to provide secure access to medical data, in particular by means of (modern) symmetric and / or asymmetric cryptography. Thus, only the participants with access to some secret key can decrypt the medical data embedded in a blockchain transaction. The cryptography may include or use a cryptographic has function to ensure data integrity.

[0041] Asymmetric cryptography (a.k.a. public key cryptography) uses a pair of keys, a public and a private key, to encrypt and decrypt data. While the public key can be shared among users, the private key needs to kept secret. Symmetric encryption only uses one secret key for both encryption and decryption Hybrid cryptosystems are often preferred. They combine the convenience of asymmetric cryptography with the efficiency (in terms of less computing power) of symmetric cryptosystems.

[0042] The herein described features of the blockchain data storage system for storing first data of patient medical devices and / or second data of medical data communication devices are also disclosed for the computer-implemented method for storing first data of patient medical devices and / or second data of medical data communication devices on a blockchain data storage system and vice versa.

[0043] For a more complete understanding of the present invention and advantages thereof, reference is now made to the following description taken in conjunction with the accompanying drawings. The invention is explained in more detail below using exemplary embodiments, which are specified in the schematic figures of the drawings, in which: Fig. 1 shows a diagram of a blockchain data storage system for storing first data of patient medical devices and / or second data of medical data communication devices according to a preferred embodiment of the invention; and

[0044] Fig. 2 shows a flowchart of a computer-implemented method for storing first data of patient medical devices and / or second data of medical data communication devices on a blockchain data storage system according to the preferred embodiment of the invention.

[0045] The blockchain data storage system 1 for storing first data DI of patient medical devices 10, in particular implantable medical devices, and / or second data D2 of medical data communication devices 12 shown in Fig. 1 comprises a communication interface 14 configured to receive the first data DI of the patient medical devices 10 and / or the second data D2 of the medical data communication devices 12.

[0046] Furthermore, the blockchain data storage system 1 comprises a plurality of nodes 16, 18, 20 configured to store the first data DI of the patient medical devices 10 and / or the second data D2 of the medical data communication devices 12.

[0047] The first data DI of patient medical devices 10 moreover comprises a programming of the patient medical devices 10, patient medical data acquired by the patient medical devices 10 and / or manufacturing data of the patient medical devices 10.

[0048] In addition, the programming of the patient medical devices 10 comprises an initial programming of the patient medical devices 10 and any modifications to the programming of the patient medical devices 10 since the initial programming.

[0049] Furthermore, the patient medical data acquired by the patient medical devices 10 comprise an implantation and / or explantation date of the patient medical devices 10. Moreover, the manufacturing data of the patient medical devices 10 comprises a manufacturing date and / or a serial number of components 22, in particular a battery, of the implantable medical device. The second data D2 further comprises configuration and / or programming data of the medical data communication devices 12, in particular a patient communication device.

[0050] The blockchain data storage system 1 is configured to create a notification 24 to a data processing system 26 of a health care service provider when identifying false implant programming and / or a recalled, broken or expired component, in particular a capacitor, an electrode and / or a battery, of the patient medical device 10, and wherein the blockchain data storage system 1 is configured to store the notifications 24 to the data processing system 26 of the health care service provider.

[0051] False implant programming is thus identified if the implant programming and / or an implant operation mode does not match at least one of a current patient condition and a location and / or in an event of a battery drain.

[0052] In addition, the blockchain data storage system 1 comprises an authorization module 28 configured to grant a write permission to a first group of users, in particular manufacturers, suppliers and physicians and a read permission to a second group of users, in particular patients and authorities.

[0053] The communication interface 14 is an app of a mobile communication device and / or a webinterface accessible by a computing device usable by the first group of users and / or the second group of users, wherein the communication interface 14 is configured to receive data transmissions of the first data DI of patient medical devices 10 and / or the second data D2 of medical data communication devices 12.

[0054] Furthermore, the communication interface 14 is configured to receive manual data input and / or provides voice-to-text data conversion.

[0055] A separate blockchain is used for each patient medical device 10 and / or medical data communication devices 12. Alternatively, a single blockchain can be used for multiple patient medical devices 10 and / or multiple medical data communication devices 12. The communication interface 14 is further configured to receive wearable data 30, in particular generated by a smartring, a smartphone and / or a smartwatch, wherein the wearable data 30 is part of the first data DI of patient medical devices 10 and / or the second data D2 of the medical data communication devices 12.

[0056] Moreover, the blockchain data storage system 1 is configured to encrypt the medical data, in particular by means of a cryptographic hash function.

[0057] Fig. 2 shows a flowchart of a computer-implemented method for storing first data DI of patient medical devices 10 and / or second data D2 of medical data communication devices 12 on a blockchain data storage system according to the preferred embodiment of the invention. The method comprises receiving SI the first data DI of the patient medical devices 10 and / or the second data D2 of medical data communication devices 12 by a communication interface 14.

[0058] Moreover, the method comprises storing S2 the first data DI of the patient medical devices 10 and / or the second data D2 of the medical data communication devices 12 on a plurality of nodes 16, 18, 20 of the blockchain data storage system.

[0059] Reference Signs

[0060] 1 system

[0061] 10 patient medical devices 12 medical data communication devices

[0062] 14 communication interface

[0063] 16, 18, 20 nodes

[0064] 22 components

[0065] 24 notification 26 data processing system

[0066] 28 authorization module

[0067] 30 wearable data

[0068] DI first data

[0069] D2 second data S1-S2 method steps

Claims

Claims1. Blockchain data storage system (1) for storing first data (DI) of patient medical devices (10), in particular implantable medical devices, and / or second data (D2) of medical data communication devices (12), comprising: a communication interface (14) configured to receive the first data (DI) of the patient medical devices (10) and / or the second data (D2) of medical data communication devices (12); and a plurality of nodes (16, 18, 20) configured to store the first data (DI) of the patient medical devices (10) and / or the second data (D2) of the medical data communication devices (12).

2. Blockchain data storage system of claim 1, wherein the first data (DI) of patient medical devices (10) comprises a programming of the patient medical devices (10), patient medical data acquired by the patient medical devices (10) and / or manufacturing data of the patient medical devices (10).

3. Blockchain data storage system of claim 2, wherein the programming of the patient medical devices (10) comprises an initial programming of the patient medical devices (10) and any modifications to the programming of the patient medical devices (10) since the initial programming.

4. Blockchain data storage system of claim 2 or 3, wherein the patient medical data acquired by the patient medical devices (10) comprises an implantation and / or explantation date of the patient medical devices (10), and wherein the manufacturing data of the patient medical devices (10) comprises a manufacturing date and / or a serial number of components (22), in particular a battery, of the patient medical devices (10).

5. Blockchain data storage system of any one of the preceding claims, wherein the second data (D2) comprises configuration and / or programming data of the medical data communication devices (12), in particular a patient communication device.

6. Blockchain data storage system of any one of the preceding claims, wherein the blockchain data storage system (1) is configured to create a notification (24) to a data processing system (26) of a health care service provider when identifying false implant programming and / or a recalled, broken or expired component, in particular a capacitor, an electrode and / or a battery, of the patient medical device (10), and wherein the blockchain data storage system (1) is configured to store the notifications (24) to the data processing system (26) of the health care service provider.

7. Blockchain data storage system of claim 6, wherein false implant programming is identified if the implant programming and / or an implant operation mode does not match at least one of a current patient condition and a location and / or in an event of a battery drain.

8. Blockchain data storage system of any one of the preceding claims, wherein the blockchain data storage system (1) comprises an authorization module (28) configured to grant a write permission to a first group of users, in particular manufacturers, suppliers and physicians and a read permission to a second group of users, in particular patients and authorities.

9. Blockchain data storage system of claim 8, wherein the communication interface (14) is an app of a mobile communication device and / or a web-interface accessible by a computing device usable by the first group of users and / or the second group of users, wherein the communication interface (14) is configured to receive data transmissions of the first data (DI) of patient medical devices (10) and / or the second data (D2) of medical data communication devices (12).

10. Blockchain data storage system of any one of the preceding claims, wherein the communication interface (14) is configured to receive manual data input and / or provides voice-to-text data conversion.

11. Blockchain data storage system of any one of the preceding claims, wherein a separate blockchain is used for each patient medical device (10) and / or each medical datacommunication device (12) or a single blockchain is used for multiple patient medical devices (10) and / or multiple medical data communication devices (12).

12. Blockchain data storage system of any one of the preceding claims, wherein the communication interface (14) is configured to receive wearable data (30), in particular generated by a smartring, a smartphone and / or a smartwatch, wherein the wearable data (30) is part of the first data (DI) of patient medical devices (10) and / or the second data (D2) of medical data communication devices (12).

13. Blockchain data storage system of any one of the preceding claims, wherein the blockchain data storage system (1) is configured to provide secure access to medical data, in particular by means of asymmetric and / or symmetric cryptography.

14. Computer-implemented method for storing first data (DI) of patient medical devices (10) and / or second data (D2) of medical data communication devices (12) on a blockchain data storage system (1), comprising the steps of: receiving (SI) the first data (DI) of the patient medical devices (10) and / or the second data (D2) of medical data communication devices (12) by a communication interface (14); and storing (S2) the first data (DI) of the patient medical devices (10) and / or the second data (D2) of the medical data communication devices (12) on a plurality of nodes (16, 18, 20) of the blockchain data storage system (1).

15. Computer program with program code to perform the method of claim 14 when the computer program is executed on a computer.

Citation Information

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