“The capability of computer systems or algorithms to imitate intelligent human behaviour."  (Merriam-Webster, 2024).

A machine learning paradigm where models can adapt to new data without forgetting previously learned concepts. This is crucial for scenarios where data distributions change over time, such as real-world applications with evolving environments or data streams (Lesort et al., 2020).

The ecosystem is made up of various stakeholders, such as innovators, regulators, implementers, and end-users.

Interoperability means different systems can work together smoothly. For data, it ensures data from various sources can be integrated, shared, and analysed seamlessly. There are two main challenges: semantic interoperability (meaning of data) and technical interoperability (formats, standards, processing). Overcoming these is key for extracting value from large datasets. (Yadav, Murria, and Sharma, 2021)

Action-guides that indicate what needs to be done to achieve certain desirable governance outcomes.

• Governance principles specify governance objectives and spell out the means to achieve them.

• Governance principles are directed to specific actors who have the capacity and the responsibility to follow them in practice. 

• A set of governance principles for a specific policy domain constitutes a governance framework for that domain.

People who create and enforce policies; allocate public funding, and occasionally guide or instruct law enforcement.

Programs that fast track and expedite the review process for drugs or technologies that are expected to have a great impact on a treatment’s safety or efficacy compared to standard applications (U.S. Food and Drug Administration, 2024).

Responsible digital health is defined as “any intentional systematic effort designed to increase the likelihood of a digital health technology developed through ethical decision-making, being socially responsible and aligned with the values and well-being of those impacted by it” (Ahmadpour et al., 2020)

Develop legislation and policy, supervise innovators, and enforce legislation.

“individuals’ inability to predict the future state of the regulatory environment” due to a lack of clear regulations, guidelines, or standards (Hoffmann,Trautmann, and Schneider, 2008).

“ensures that companies meet international regulatory standards, enabling global product distribution and promoting international collaboration in a complex marketplace” (Johns Hopkins University Advanced Academic Programs, 2024).

Refers to the testing of products, services, or regulatory approaches in controlled environments before being widely implemented (OECD, 2021).

A type of regulatory experimentation. Regulatory sandboxes provide a controlled environment for testing innovative technologies for which standards and guidance still do not exist (OECD, 2023).

A multidisciplinary field that ensures the safety, efficacy, and quality of products within regulated industries, including pharmaceuticals, medical devices, biotechnology, cosmetics, and food (Johns Hopkins University Advanced Academic Programs, 2024).

Integrated care systems (ICSs) are local partnerships that bring health and care organisations together to develop shared plans and joined-up services. Their aim is to improve health and care services – with a focus on prevention, better outcomes and reducing health inequalities (NHS England, 2024).

This refers to the underlying structure, components, and interactions that make up a technological system. For example, hardware components (processor, memory, screen), software (operating system, apps), and how they interact to perform various functions (Waldo, 2006).

The existence of many interdependent variables in a given system, where more variables and higher interdependence mean greater complexity and uncertainty. Complexity is subjective (Dorner, 1996).” (Rothwell, 2011).

“uncertainty on the part of the regulator that involves a lack of technological or scientific understanding of a specific type of product and its use in the human body. This definition of technological uncertainty is, by its nature, comprised of both uncertainty about how a product works as well as uncertainty about how the regulator will know that a new product works” (Stern, 2017).