Abstract

Voice biomarker research is fueling a growing health-tech market, largely driven by start-ups. Yet, there is limited scholarship on how start-ups navigate the legal uncertainty surrounding voice data protection and the rising expectations for responsible AI. This study reviews the ethical, legal and regulatory practices as stated on the websites of 27 start-ups using voice as a biomarker in health-tech. The review reveals substantial disparities in the availability, readability and content of the information disclosed, especially regarding privacy policies, with only a few websites offering product-specific, transparent, and comprehensive privacy policies. Significant differences also emerged in the start-ups’ terms of use and regulatory compliance statements, likely reflecting the novelty of the field, disparity in legal and regulatory requirements, and the absence of sector-specific ethical guidance. For example, while most start-ups reference compliance with data protection frameworks (e.g., HIPAA, GDPR), many fall short of best practices for transparency, accountability, and user-centered communication. We argue that the success of start-ups in health-tech depends on their capacity to capture and retain the attention of potential end-users and investors. By adopting accessible, transparent and forward-looking communication on how they frame their legal and ethical responsibilities in practice, start-ups can not only ensure legal and regulatory compliance but build trust and support sustainable innovation. This work identifies key best practices for voice AI start-ups to consider and lays the foundation for future research, including surveys and longitudinal tracking, to better understand the evolving landscape of ethical and legal practices in voice biomarker and voice AI health-tech.

Original languageEnglish
JournalHealth Care Analysis
DOIs
StateAccepted/In press - 2025

Keywords

  • Artificial intelligence
  • Ethics
  • Health-tech
  • Legal compliance
  • Voice as a biomarker

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