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Telemedicine and implanted brain stimulation devices: a review of legal issues

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Abstract

Introduction

: One recent development in telemedicine is the remote management of implanted brain stimulation technologies. Deep brain stimulation (DBS) is widely used to treat Parkinson’s disease and other movement disorders. Treatment requires optimal post-surgical programming of the device through numerous in-person visits. Remote programming is increasingly being used to address the risks and inconveniences of in-person programming adjustment. This review presents an overview of the legal issues that are associated with this telemedical innovation.

Methods

An authorship team comprised of health law experts from Canada and Germany and a clinician experienced in caring for patients with Parkinson’s disease was assembled for this review. The team identified the key areas of law applicable to remote management of DBS, and then used standard legal research methods to identify relevant legal issues, primarily using the jurisdiction of Ontario, Canada, as an example, with additional references to the laws applicable in the European Union and United States.

Results

Technological and clinical evolution toward the use of remote programming of DBS and adaptive or “closed loop” DBS raises important questions related to (1) privacy and data protection law, (2) cybersecurity and medical device regulation, (3) medical negligence and physician liability and (4) cross-border issues related to licensing, malpractice insurance and physician payment.

Conclusions

Remote programming of DBS offers many important advantages in improving access to care, reducing travel risks, and improving efficiency for patients, caregivers and clinicians. At the same time, this will involve modification of implanted devices influencing patient physiology as well as the exchange of significant amounts of information that bear upon patients’ physiological states. As a result, important ethical and legal questions should be considered in the development and deployment of remote DBS programming platforms.

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Funding

This research was supported by the Canadian Institutes of Health Research – CIHR through the EU Joint Programme – Neurodegenerative Disease Research (JPND) project number HESOCARE-329-073.

Author information

Authors and Affiliations

  1. Faculty of Law, University of Ottawa, Ottawa, ON, Canada

    Elisabeth Oliviero & Jennifer A Chandler

  2. Center for Life Ethics, Bonn University, Bonn, Germany

    Björn Schmitz-Luhn

  3. Division of Neurology, Department of Medicine, University of Ottawa, Ottawa Hospital – Civic Campus, C2 Neurosciences, Ottawa, ON, Canada

    Tiago A Mestre

Authors
  1. Elisabeth Oliviero
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  2. Björn Schmitz-Luhn
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  3. Tiago A Mestre
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  4. Jennifer A Chandler
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Contributions

All authors contributed to the study conception. Legal research was conducted by LO, BS-L and JC. The first draft of the manuscript was written by LO and JC and all authors commented on all versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Jennifer A Chandler.

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Conflict of interest

EO and BSL have no disclosures. JAC sits on an Advisory Board to INBRAIN Neuroelectronics. TAM has received personal compensation for serving as a Consultant for CHDI, Sunovion, Roche, Biogen and nQ Medical. TAM has received personal compensation serving on a Speakers Bureau for Abbvie, Valeo Pharma and the International Parkinson and Movement Disorder Society.

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Oliviero, E., Schmitz-Luhn, B., Mestre, T.A. et al. Telemedicine and implanted brain stimulation devices: a review of legal issues. Health Technol. 14, 329–338 (2024). https://doi.org/10.1007/s12553-024-00821-2

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