A
brain‐machine interface (BMI),
also known as a Human-Computer Interface (HCI), is a system that establishes a
direct communication channel between the human (or animal) brain and a computer
or an external device. BMIs record or stimulate activity of the central (CNS) or
peripheral nervous system (PNS) to replace, restore, enhance, supplement, or
improve natural output/input. Thereby the BMI is able to change the ongoing interactions
between the CNS and its external or internal environment. BMIs usually measure
neural activity through sensors placed inside the brain or body (invasive or
implanted technologies) or external sensors (non‐invasive technologies). This
activity is processed in real‐time to extract information about the intentions
or states of the subject, and then generate an action or stimulus in the
external world that is provided as direct or indirect feedback to the user.
BMI systems are the product of integrating
multiple technologies. They consist of systems for the acquisition and decoding
of neural and biophysical signals to actuators providing sensory, mechanical,
and electrical feedback to the user.
Ethical
and social / legal concerns are being addressed by related IEEE guidelines for
ethically aligned‐Intelligent systems, and the IEEE Brain Neuroethics
framework.
BMI
standardization should also consider regulatory frameworks for technology‐based
systems (both clinical and consumer oriented) in fields like AI, IoT, and
cybersecurity. A particular challenge in this aspect is the global disparity in
regulatory approaches.
Standards
for neurotechnologies
Currently,
sensing and actuation technologies (e.g., IEEE 21451-1-2010 - ISO/IEC/IEEE Standard for Information
technology -- Smart transducer interface for sensors and actuators -- Part 1:
Network Capable Application Processor (NCAP) information model) are well
standardized. These standards are mainly focused on safety aspects
of those technologies. Data management Standards (e.g., various Standards from ISO / JTC 1/SC
32) cover aspects such
as cybersecurity and data representation in medical applications.
On
the other hand, system‐level aspects of BMI such as user needs and
performance assessment require standards. Although there are existing
standards regarding human factors and usability, they are not widely applied by
the BMI research and development community.
Remarkably,
recent advances in the field and the prospect of commercialization of both
clinical and consumer‐oriented applications have motivated multiple efforts to
develop guidelines and standards. An important milestone is the release of the
FDA draft guideline on implanted brain‐computer interfaces in spring 2019.
To
bring forth concerted efforts of Standardization, IEEE Working Group P2731 has
recently been established to create a standard for Unified Terminology for
Brain‐Computer Interfaces, while IEEE Working Group P2794 is working to
formulate a Reporting Standard for in vivo Neural Interface Research (RSNIR),
to serve as a framework for the precise, comprehensive reporting of human and
animal research throughout the growing ecosystem of neurotechnology.
References
1.
K.
Bowsher et al., “Brain‐computer interface devices for patients with
paralysis and amputation: a meeting report.,” J Neural Eng, vol. 13, no.
2, p. 23001, Feb. 2016.
2.
Food
and Drug Administration (FDA), “Implanted Brain‐Computer Interface Devices for
Patients With Paralysis or Amputation—Nonclinical Testing and Clinical
Considerations.” 2019.
3.
IEEE
SA, Standards Roadmap: Neurotechnologies for Brain-Machine Interfacing,
IEEE SA Industry Connections Activity No. IC17-007,New York, USA, 2020.
