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Personalized Aerosol Therapies: Understanding the Data Privacy Barrier

Devlin Capizzi M, Newcom QY, Lyapustina S.

Respiratory Drug Delivery 2020. Volume 1, 2020: 261-270.

Abstract:

While personalized aerosol therapy devices (smart inhalers) intend to offer more efficacious, cost-effective, and tailored treatments for patients’ specific ailments or unique genetic characteristics, these ‘smart’ devices are often a long way from achieving ‘security by design’. The orally inhaled and nasal drug products (OINDP) industry has recently seen a wave of new legislation or regulatory frameworks around the globe that signal the growing public awareness of data privacy and security. Notably, many countries’ views of what legal obligations may be implicated by the processing of personal data have significantly expanded, as evidenced by increasing discussions of personal data in the context of intangible asset, property rights, and national security. This article highlights recent advancements of digital personalized medicines in the inhaled therapeutic space and the challenges they face in terms of user choice in relation to their personal information, cross-border data transfer during research and development collaboration, and other special considerations under recent data privacy laws and trade policies.