Outcomes-Based Regulation
Healthcare regulation has traditionally focused on prescribing rules to regulate inputs, processes and outputs. However, emerging and rapidly evolving trends such as the convergence of health products and services, direct-to-consumer genetic testing and the use of generative artificial intelligence present significant challenges to traditional regulatory approaches.
As part of its efforts to address these challenges, the Health Regulation Group, Ministry of Health (MOH) has worked with the Centre for Regulatory Excellence (CoRE) to evaluate the application of Outcomes-Based Regulation (OBR) in MOH’s regulatory framework.
The OBR initiative aims to regulate not only products and services but also the contextual environment in which these outputs are utilised. This method acknowledges that outcomes can vary significantly based on factors such as the recipient's attributes and environmental conditions. For instance, identical health products may produce different results for different users depending on their physical constitution and lifestyle. The perception of these outcomes as "successful" or "desirable" can also differ among stakeholders, making collaboration essential for a successful and sustainable OBR implementation.
Adopting an iterative, collaborative approach could potentially allow stakeholders to agree on what the desired outcomes are, how they can be better regulated, and ultimately build much-needed mutual trust that promotes best practice, encourages improvement and facilitates innovation. A workshop on the 'Outcome-Based Collaboration Model' was conducted with Professor Christopher Hodges to educate regulatory professionals on the OBR model as well as to deepen our understanding of effective collaboration.
This project highlights the transformative potential of OBR in enhancing flexibility, innovation, and collaboration across diverse sectors. By addressing implementation challenges and fostering mutual understanding among stakeholders, OBR can pave the way for more effective and sustainable regulatory frameworks that adapt to evolving needs while promoting trust and continuous improvement.