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70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

12.05. - 15.05.2019, Würzburg

Notification of a pilot neuromodulation implant registry based on blockchain technology

Ankündigung eines Pilot Projektes zur Einführung eines Neuroimplantatregisters auf der Basis der blockchain Technologie

Meeting Abstract

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  • presenting/speaker Jan Vesper - Heinrich-Heine-Universität, Universitätsklinikum, Sektion Stereotaktische und Funktionelle Neurochirurgie, Düsseldorf, Deutschland
  • Philipp J. Slotty - Heinrich-Heine-Universität, Universitätsklinikum, Sektion Stereotaktische und Funktionelle Neurochirurgie, Düsseldorf, Deutschland
  • Ursula Kieserg - Heinrich-Heine-Universität, Universitätsklinikum, Sektion Stereotaktische und Funktionelle Neurochirurgie, Düsseldorf, Deutschland; IBM, IT, Köln, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie. Würzburg, 12.-15.05.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocV235

doi: 10.3205/19dgnc254, urn:nbn:de:0183-19dgnc2548

Published: May 8, 2019

© 2019 Vesper et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.


Outline

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Objective: Besides the CE mark, which only covers technical aspects of medical devices, no registry exists for systematic control of active medical devices in neuromodulation. With the widespread use of different neuroimplants there will be a need for a systematic evaluation of different implants for reasons of safety, efficacy and health economy. We are investigating options to design such a register with blockchain technology meeting the needs of health care professionals, patients and state legislation.

Methods: A blockchain is a distributed register in which transactions are traceable and are stored invariably. Instead of the unidirectional approach of commonly used databases, it ensures a consensus between all participants of the network. Transactions are stored tamper-proof and secure, transactions are authenticated and verifiable. Implanters deposit surgery and implant data as a transaction in the blockchain for each patient. Access to perform specific tasks and view specific data can be granted depending on the role of the individual user in the network.

Results: A pilot project of two centers with high-volume neuromodulation units will be conducted. The blockchain technology will be provided by an experienced web service company. Collaboration exists with the DGNM and a medical device company. The technology offers various advantages over traditional databases: it can provide immediate backup and traceability of the data, there is no need for any central instance or maintenance and implants are clearly traceable by serial number. All participants have the opportunity to view details of the implants and related treatments based on their role assigned based on smart contracts. All transactions and participants are securely authenticated.

Conclusion: The design of such a database by the physicians and implanters themselves offers the opportunity to significantly influence the product. Input from the health-care providers should lead to a product that exceeds sheer implant documentation and offers options for reimbursement, safety and scientific use of the data entered. The blockchain technology likely provides an excellent technological backbone to ensure data quality, security and ease of use. We would like to communicate the need to discuss and confront the upcoming new requirements for documentation of medical implants from the field of neuromodulation. We would like to present and discuss our proposal of a blockchain based registry to finalize the design of our pilot study.