Data integrity for medical devices using blockchain solutions
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Publication Number
US-11458322-B2
Publication Date
2022-10-04
Expiration Date
Abstract
Methods and apparatus are provided for enhancing data integrity for implantable medical devices. A medical device is provided that is at least partially implantable. The medical device includes an application component configured to apply a therapeutic treatment and/or stimulation signals to a patient. The medical device includes a wireless communication transceiver and a computer memory storing a parameters library and computer readable instructions. A processor is configured to execute the computer readable instructions so as to perform the following steps: control application of therapeutic treatment and/or stimulation signals, via the application component, based on parameters stored in the parameters library; receive, via the wireless communications transceiver, update data representing an update to the parameters library from an external device or system; transmit at least the update data for verification by a blockchain network and addition of the update data to a verified blockchain public ledger including the update data; receive, via the wireless transceiver, blockchain public ledger data based on the verified blockchain public ledger; validate the update to the parameters library based at least on a first condition that the received blockchain public ledger data includes the update data; when the update to the parameters library is validated, control application of therapeutic treatment and/or stimulation signals, via the application component, based on parameters stored in the parameters library including the update data; and when the update to the parameters library is not validated, control the therapy application component so that the update data is not used.
Core Innovation
The invention relates to a medical device that is at least partially implantable and applies therapeutic treatment and/or stimulation signals to a patient based on parameters stored in a parameters library held on the medical device. The medical device receives update data representing an update to the parameters library via a wireless communications transceiver and transmits the update data for verification by a blockchain network so that the update data is added to a verified blockchain public ledger.
After transmission, the medical device receives blockchain public ledger data based on the verified blockchain public ledger and validates the update to the parameters library based at least on a first condition that the received blockchain public ledger data includes the update data. When the update to the parameters library is validated, the medical device controls the application of therapeutic treatment and/or stimulation signals via the application component based on parameters stored in the parameters library including the update data.
In system and method aspects, a blockchain network of computer devices maintains verified blockchain public ledger versions of medical device parameter libraries for a distribution of medical devices, while an external programmer or cloud update system transmits parameters data to the blockchain network. The at least partly implantable medical device retrieves the verified blockchain public ledger version, compares the local parameters library including the parameters data to validate it, and applies therapeutic treatment and/or stimulation signals based on the validated local parameters library.
Claims Coverage
The document includes three independent claims. Across them, the core coverage is a verified blockchain public ledger decision gate for accepting update data and/or updated parameters or software data for use in therapy application.
Ledger-verified parameters update for implanted therapy
A medical device that is at least partially implantable is configured to apply therapeutic treatment and/or stimulation signals based on a parameters library, receive update data, transmit the update data for verification by a blockchain network and addition to a verified blockchain public ledger, receive blockchain public ledger data, validate the update based at least on a first condition that the received blockchain public ledger data includes the update data, and control the therapy application component so the update data is not used when not validated.
System with blockchain-maintained verified parameter library versions and local validation
A system comprising a blockchain network of computer devices maintaining verified blockchain public ledger versions of medical device parameter libraries for each medical device of a distribution, an external programmer or cloud update system that transmits parameters data to the blockchain network, and a first at least partly implantable medical device that retrieves the verified blockchain public ledger version of the parameters library, compares the local first medical device parameters library including the parameters data to validate it, and applies therapeutic treatment and/or stimulation signals based at least partly on parameters stored in the validated local first medical device parameters library including the parameters data.
Method ensuring implantable device data integrity via public ledger match for installing updates
A method for ensuring data integrity of an implantable medical device comprising recording parameters or software data transactions with respect to an implantable device in a public ledger, receiving updated parameters or software data from a cloud server or an external computing device for storage in a local storage medium, installing the updated parameters or software data in the local storage medium when a public ledger version of parameters or software data matches a local storage version including the updated parameters or software data, not installing when the public ledger version does not match the local storage version including the updated parameters or software data, and using parameters or software data installed in the local storage medium in applying therapeutic treatment and/or stimulation signals to a patient.
Across the independent claims, update data and/or updated parameters or software data are accepted for use only when a verified blockchain public ledger basis is satisfied, including a matching condition that ledger data includes the update data or that a verified ledger version matches a local storage version.
Stated Advantages
Ensures data integrity of an implantable medical device by recording parameters or software data transactions in a public ledger and installing updates only when a public ledger version matches a local storage version.
Prevents use of update data when the update to the parameters library is not validated.
Applies therapeutic treatment and/or stimulation signals based on parameters installed only after ledger-based validation via a verified blockchain public ledger.
Documented Applications
Deep brain stimulation example with stimulation signal parameters and a patient-trained “meaning” field used in the context of ledger-audited updates and parameter library control.
Remote update workflows in a system where a viewing server can remotely host verified blockchain public ledger versions of medical device parameter libraries for patient-accessible viewing.
Software updates for implantable devices recorded as parameters or software data transactions in a public ledger and installed only when the ledger version matches the local storage version.
Example applicability to neuroprosthetic neural-network weight tracking using hashes/checksums in the context of blockchain-audited data integrity.
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