Standards Roadmap: Neurotechnologies for Brain-Machine Interfacing, IEEE Standards Association This document aims at providing an overview of the existing and developing standards in the field of neurotechnologies for brain‐machine interfacing. It is mainly focused on systems that provide a closed‐loop interaction with artificial devices based on information extracted from measures of the activity in the nervous system. In addition to …
Medical Application: Regulatory Landscape – Binding Regulation
Medical Device regulation at country level
Medical Application: Regulatory Landscape – Agencies
Distinct regulatory agencies currently govern the administration of legal frameworks for each of these classes. Binding regulations for medical neurotechnologies are enforced in America by the Food and Drug Administration (FDA) and in Europe by the European Union. Additionally, the World Health Organization (WHO) is mandated to encourage the national adoption of regulatory practices in its member states, which currently …
Medical Application: Regulatory Landscape – Statutory Types
Legal frameworks for regulation of medical devices have traditionally been classed in one of three ways, binding regulation, standards, and soft law. Binding regulations are legally enforceable statutes required for the development and use of technologies in a medical setting. Standards provide for safety and risk control in technology use through the establishment of acceptable design practices and tolerances. Soft …
Medical Application: Regulatory Landscape – Principles
Legal frameworks for medical neurotechnologies can be expected to find their normative origin in universally agreed upon principles that have been developed to guide biomedical practice and bioethics. The 2005 Universal Declaration on Bioethics and Human Rights, for example, formulates a set of norms to guide biomedical practice, assigning first place to a principle of respect for “human dignity, human …
Medical Application: Regulatory Landscape overview
A fundamental aspect of medical neurotechnologies is their intervention within the nervous system, including the human brain. Developers of medical neurotechnologies must therefore confront the deeply ethical nature that such intervention entails. Accordingly, while existing regulatory agencies have traditionally limited prioritization to the risk and safety issues of medical devices, ethical and societal concerns associated with the creation, development, and …
Medical Application: ELSCI by Technology Categories
In addition to the general issues outlined above, each category of neurotechnology has ethical, legal, social, and cultural issues that are particularly salient. These are outlined below. Medical Technologies for Recording/Sensing There are multiple issues pertinent to sensing and recording devices, with privacy and data misuse being particularly relevant. These portable implementations have the intention of recording data in real-time ...
Medical Application: Social & Cultural
There are several key issues that arise when considering the social and cultural implications of neurotechnologies and the conditions on which they intervene. First, it is important to consider these interventions in the context of the social stigma that is experienced by people with disabilities and mental health conditions. The social pressures toward an approximation of species-typical functioning (“healthy” or …
Medical Application: Legal
Data Legal considerations vary depending on personal or third party use of neural data. The data collected is extremely important. First, the companies need the data for their algorithms to learn and improve. These data are extremely valuable. In fact, big data in healthcare is proposed to be worth upwards of US$78 billion by 2027. In most cases, legally individual ...
Medical Application: Ethical Issues
This section includes five key areas of ethical consideration: safety, risk, and well-being; authority, power and coercion; justice and fairness; agency and identity; and surveillance and privacy. These five areas emerged through the development of the IEEE Brain neuroethics framework and capture the main dimensions of potential ethical issues with neurotechnology across the IEEE Brain neuroethics working groups. Safety, Risk, ...
