Facilitators, Barriers to Implementing Dynamic Consent in Digital Health

Dynamic consent offers promise in addressing ethical concerns in digital health. However, it has not yet been widely used in clinical practice. A study aimed to identify the drivers of and barriers to adopting dynamic consent in digital health ecosystems.

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This review is published in BMC Medical Ethics.

“Regarding the ethical obligation of consent in digital health, respect for individuals, with an emphasis on their right to autonomy and self-determination, is fundamental to ethical medical research and practice,” the researchers of the study wrote. “While conventional consent practices have been historically accepted, they have struggled in rapidly evolving digital health environments.”

The review was conducted in December 2022 and included a comprehensive search across Web of Science, PubMed, and Scopus. A total of 100 articles were discovered using the search words “Dynamic consent AND Health OR Medical OR Patient.” After exclusion, 22 articles remained.

Additionally, the study conducted a thematic analysis of an individual’s historical trajectory, user perspectives, and technical dimensions to gain a better understanding of the development of this digital landscape.

Of the articles selected, ethics and genetics were the most prevalent topics concerning dynamic consent. The researchers indicated the relationship between dynamic consent and ethics is due to an emphasis on data sovereignty of individuals, while dynamic consent is associated with genetics due to its principal application area in biobanks.

Three overarching themes were identified, including conceptual evolution, feasibility analysis, and technological advancement. These articles highlighted the advantages of dynamic consent in terms of transparency and efficiency and that most patients showed positive feedback regarding digital-based consent. However, the patients also raised concerns regarding the risks of handling sensitive data and the need for improved identity verification procedures.

Several articles provided insight into the necessity of digital interfaces in dynamic consent systems, with significant interest in incorporating blockchain technology into these systems along with the use of smart contracts.

Overall, the main facilitators of dynamic consent in digital health included flexibility, tailored options, continuous 2-way communication, and afterward communication. Furthermore, dynamic consent in digital health can meet internationally accepted ethical and legal standards, with most studies promoting dynamic consent as a way to improve transparency and public trust in complex research networks.

However, the review identified barriers to implementing dynamic consent in digital health, including an excessive role to individuals, digital inequities, system implementation, and privacy and security. For example, some people may perceive dynamic consent to be burdensome because of the excessive number of decisions that are required.

Additionally, isolated areas that lack access to technology may not be equipped to depend on these digital tools, which cost time, money, personnel, and stakeholder willingness to implement. Furthermore, some individuals noted concerns about the disclosure of their information because of health data that contained sensitive personal information.

Despite these barriers, the researchers expressed the review showed several characteristics of dynamic consent that may be applicable in a digital health setting due to its flexible and dynamic nature.

“Based upon the review, we summarized that DC [dynamic consent] has strengths in several ethical problems, including respect for autonomy and trustworthiness,” the researchers wrote. “However, so far, it still raises justice issues regarding the digital divide, the cost of implementation, and accountability.”

Reference

Lee AR, Koo D, Kim IK, et al. Identifying facilitators of and barriers to the adoption of dynamic consent in digital health ecosystems: a scoping review. BMC Med Ethics. 2023;24(1):107. Published 2023 Dec 1. doi:10.1186/s12910-023-00988