A view on incidental findings and adverse events associated with neurowearables in the consumer marketplace

Privacy Challenges to the Democratization of Brain Data

“…Through a structured secondary analysis (Cabrera et al, 2015) of interviews with neurowearable company leaders or their senior level designates (Minielly et al, 2020), we identified privacy concerns that clustered into four major thematic categories: data collection and management, ethics principles, exceptionalism of brain data, and international policies, laws, and standards (Table 1).…”

“…neurowearables may comply with international standards such as Canada's Personal Information Protection and Electronic Documents Act (PIDEDA) and Europe's General Data Protection Regulation (GDPR), their use transcends borders and differing regulations and laws globally create inefficiencies overall. The US medical sector-specific HIPAA does not apply to data from wearable brain devices today, despite murky lines between health and wellness (Kreitmair, 2019;Minielly et al, 2020).…”

“…Eight executives or their senior level representatives from DTC neurowearable companies that produce recording devices offered their time to speak with us. These semi-structured interviews took place in the context of larger study on incidental findings and adverse events involving representatives from both recording and stimulating device companies (Minielly et al, 2020). Interviews were conducted online via Zoom between August and November 2019 by either JI or NM and ranged between 11 and 35 minutes.…”

Projections and the Potential Societal Impact of the Future of Neurotechnologies

“…Brain-interfacing devices are unique in that this recorded data may well be considered not to be medical or health data (and may thus may not qualify for protections offered by some current laws); scientists may learn to extract more brain-signal information post-recording than originally identified for a specific use; and brain stimulation may alter users’ behavior or personalities ( Minielly et al, 2020a ; Naufel and Klein, 2020 ).…”

Recommendations for Responsible Development and Application of Neurotechnologies

“…In 2012, Martinovic presented "brain spyware," which can extract confidential information about an individual via a BCI-enabled malicious application [54]. Preventing or deterring efforts to gain unauthorized access to the information contained in brain data and building effective safeguards against accidental data release should be a priority [55][56][57]. Effective policies will require a diverse set of approaches tailored to the circumstances and method of collection, as well as the type of data and format of storage.…”