JMIR Publications

ABSTRACT

Background:

The introduction of the fourth industrial revolution brings high levels of digitization and increasing use of artificial intelligence in healthcare services, accompanied by safety risks that continue to emerge as digitization becomes increasingly sophisticated. Safety is expressed in three levels; Safety-I (learning from and correcting mistakes), Safety-II (predicting and avoiding mistakes), and Safety-III (creating freedom from avoidable mistakes). It is no longer a governance-only issue or something confined to continuous quality improvement – it is a systems issue that affects everyone (users and providers of healthcare services alike). Safety is becoming increasingly complex. It touches on policy, leadership, clinical practice, learning, evaluation, cultural safety, and research. Digital clinical safety (DCS) is the avoidance of harm to healthcare consumers and staff and is linked to the digitization of healthcare services. DCS practices are currently incohesive and not well-established in the fabric of healthcare in Aotearoa New Zealand (NZ) compared with global counterparts. Existing DCS strategies are not inclusive of indigenous peoples’ needs as consumers and part of the healthcare workforce. The development of a DCS Framework, tailored for the NZ context and implemented as a foundation of DCS, is required in establishing the infrastructure needed to enable the change required for healthcare to be really digitally and clinically safe.

Objective:

The aim of our project was to develop a Digital Clinical Safety Framework tailored for the NZ context.

Methods:

A participatory design approach, framed in the deliberative paradigm, was selected to enable framework development from interactions between the framework developers and an engaged, educated, diverse community of healthcare professionals and leaders, digital health specialists, and healthcare consumers. The framework process consisted of an initial open-source literature review, consultation workshops/meetings with over 463 participants, iterative Framework development, and a rapid literature review to confirm the final draft.

Results:

The framework consists of six principles of embedding equity, culture of safety, balanced decision-making, collaborative design, semantic interoperability, and continuous quality improvement, each with associated goal, description, and practice notes. These principles are built into a framework that provides a structure for design, testing, implementation, and evaluation of digital tools in the clinical environment to enable safety by design.

Conclusions:

The development of the DCS Framework highlights the importance of the six interconnected principles to achieve safety by design tailored for NZ healthcare organizations, ensuring the application of the Treaty of Waitangi principles in a robust safety infrastructure for DCS for all. Fundamental change is aimed at to achieve DCS and will involve everyone in the workplace and those who use healthcare services. It is all about the people.