R. Chavarriaga, C. Carey, C. Tom, B. Ash
The field of Brain-Machine Interfacing (BMI) is going through a very exciting period where the state-of- the-art in research is currently being tested on its intended end-users. Evidently, this translation from laboratory proof-of concepts to viable clinical and assistive solutions entails a large set of challenges. Furthermore, the possibility of deploying and commercializing BMI-based solutions requires researchers, manufacturers, and regulatory agencies to ensure these devices comply with well-defined criteria on their safety and effectiveness. In consequence, there is an increased interest on development of appropriate standards for BMI systems.
For this reason, the IEEE Brain Initiative, in collaboration with the IEEE Standards Association held a full-day special session on BMI-related standards at the BMI workshop of the IEEE SMC conference 2016. Several invited speakers from research, industry and regulatory agencies presented their views on the topic and discussed on the necessary steps to define such standards (see list of speakers below). This meeting complemented previous activities on the topic, also sponsored by IEEE Brain Initiative and IEEE Standards, which took place at the National Health Institute (June 2016)  and at the IEEE EMBS conference (August 2016) .
A first conclusion of this meeting is that despite the existence of several brain-related standards that can be applicable to BMI ; these systems present some unique characteristics that may require the development of new standards. In particular, BMI systems decode the neural activity in order to interact with other devices; for instance, to provide motor assistance (e.g. control of neuroprosthetic devices) or feedback to the user (e.g. by means of augmented or virtual reality). As such, the modularity of the system and the interoperability of its different sub-components are key aspects to be considered when designing appropriate standards.
Another aspect to consider is that potential BMI applications comprise both clinical and non-clinical use. Each case has particular considerations and as such, participants conclude on the importance of identifying appropriate use cases and suggest considering a continuum of standards between clinical and non-clinical applications. Interestingly, some participants state that, as much as it is possible, that consumer-oriented technology should aim at fulfilling the same standards as clinical devices as a way of leveraging economies of scale to reduce cost in the clinical environment.
Participants identify as a starting point for standardization the need of a common nomenclature for BMI devices. Currently different terminologies are used depending on the specific field of research. The current IEEE 11073 standards suite can be a good starting point to develop a BMI-specific standard on nomenclature. Another topic where standards seem to be necessary regards data formats. Existing formats are not suitable since they cannot be efficiently used to properly annotate all the relevant information of closed-loop BMI operation. Such standards are of particular importance to achieve efficient data sharing across research laboratories.
Last but not least, the meeting highlighted the need for stakeholders to know better the procedure necessary to establish an IEEE standard. Participants agreed on the need of continuing these discussions in future events and call for interested stakeholders to join in the establishment of a working group to advance in the establishment of appropriate standards. People interested are invited to contact the authors to receive more information on this respect.
List of Speakers:
- Christoph Guger (g.Tec, Austria)
- Gangadhar Garipelli (Mindmaze, Switzerland)
- Khizer Kaderi (Vizzario/VSP, USA)
- Tim Mullen (Qusp, USA)
- Louis Mayaud (Mensia Technologies, France)
- Cherry Tom (IEEE Standards Association)
- Carole Carey (IEEE EMB Society Standards Committee; C3 Carey Consultants LLC)
- José Contreras-Vidal (U. Houston, USA)
- Reinhold Scherer (TU Graz, Austria)
- Hasan Ayaz (Drexel U., USA)
- Felipe Aguel (NIH/NINDS, USA)
- Walter Besio (U. Rhode Island, USA)
- NIH Workshop on Standards and Modularity of Brain-Computer Interfaces and Neuroprostheses
- M. Kumar. IEEE Standards for ‘Enabling Ability in Disability’ EMBS Standard Committee
- IEEE Standards Related to the Brain. The Institute, November 2016
Ricardo Chavarriaga (IEEE member) is a senior researcher at the Center for Neuroprosthetics of the École Polytechnique Fédérale de Lausanne (EPFL), Switzerland. He holds a B.Sc. degree in Electronics Engineering from the Pontificia Universidad Javeriana in Cali, Colombia and a PhD in computational neuroscience from EPFL. He co-chairs the IEEE SMC technical committee in BMI systems, and is part of the steering committee of the IEEE Brain Initiative. His research focuses on robust brain-machine interfaces and multimodal human-machine interaction. Specifically, the decoding of cortical potentials that convey information about the user’s cognitive processes. Furthermore, He investigates on how the exploitation of such processes can be integrated with shared control principles and hybrid approaches for BMI control of complex devices.
Carole Carey (IEEE senior member) serves as chair of the EMBS Standards Committee, liaison to the IEEE Standards Association, and was recently selected as a recipient of the 2016 IEEE-SA Standards Medallion Award. She is a former U.S. FDA official in the Center for Devices and Radiological Health (CDRH) with over 23 years of regulatory science experience as a Scientific Reviewer and Director of International Staff. Carole served as Mansfield Fellow and collaborated with regulatory counterparts in Japan’s Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA) — on regulatory device issues, scientific matters concerning device safety and effectiveness, the recognition of international standards and global harmonization initiatives. Currently, she is a regulatory consultant and founder of C3-Carey Consultants, LLC. Carole is a graduate of Johns Hopkins University (BSEE) and Loyola University of Maryland (MEng).
Cherry Tom (IEEE member) is Emerging Technologies Intelligence Manager for the IEEE Standards Association (IEEE-SA). In her role, she is seeking to establish IEEE communities in emerging technologies for standards and/or standards related projects. This involves collaboration with experts in IEEE-SA and other parts of IEEE as well as organizations outside of IEEE including corporations, universities, government agencies, and consortia. Among current topics of interest are Brain Machine Interface, Big Data and Artificial Intelligence. Prior to joining IEEE, she worked for a large telecommunications company and a wireless startup where she managed standards and regulatory strategies, and participation in US and global standards developing organizations.
Bill Ash (IEEE member) is the Strategic Technology Program Director for the IEEE Standards Association. Bill received his BSEE from Rutgers University School of Engineering. His background is in the RF industry, where he worked as an applications engineer on wireless communications systems. Bill has been with the IEEE Standards Association (IEEE-SA) for over 13 years, working with standards development groups covering technologies such as RF emissions, distributive energy resources, smart grid, and the National Electrical Safety Code® . He has been working in strategic standards area since 2009. He is currently overseeing activities related to the eHealth, smart cities, and smart grid for the IEEE-SA.