The Doctor Will Hear You Now? Leveraging the potential of digital voice biomarkers

Abstract: Biomarkers, short for biological markers, are measurable indicators of a person’s physical or mental health. “Traditional” biomarkers are physiological, biochemical, molecular, or genetic variables which have been validated or qualified by regulatory authorities in most countries before they can inform diagnostic. Progress in artificial intelligence (AI) has given rise to new types of biomarkers captured digitally. Specifically, the human voice can become a powerful digital biomarker of health, indicative of issues such as stress, depression, Parkinson's, and heart diseases. As such, voice and speech biomarkers are fueling innovative, non-invasive and cost-efficient diagnostic tools that could transform patient care and outcomes. Yet, to date, no vocal biomarker has been validated by any regulatory authority, as current legal frameworks have not been adapted to properly evaluate digital biomarkers. The regulatory constraints around digital voice biomarkers reveal deeper philosophical questions about the nature of illness and the role of technology in healthcare, challenging traditional paradigms of medical diagnosis and treatment. Reliance on digital biomarkers may demand a reevaluation of the human aspect in healthcare, challenged by the digitalization of diagnostic tools. Issues surrounding patient consent, data privacy, and the validation process of digital biomarkers demand urgent attention. This presentation explores digital vocal biomarkers’ unique potential while critically examines existing legal, regulatory and ethical pitfalls. Any development in the field should be guided by ethical guidelines and robust regulatory frameworks, focusing on patients' safety and trust in digital health innovations.

Marie-Françoise Malo – Simon Fraser University; Jean-Christophe Belisle-Pipon – Simon Fraser University