Holding up the crystal ball: using regulatory intelligence insights to support quality in healthcare

Internationally, healthcare is undergoing rapid transformation, catalyzed by technology advancements, the proliferation of generative artificial intelligence (AI), and the growth of online business models driven by consumer demand. Within Australia, the use of regulatory intelligence has assumed heightened significance for the Australian Health Practitioner Regulation Agency (Ahpra) to navigate current regulatory challenges and prepare for emerging health disruptors. To improve patient safety and quality in healthcare, a prevention-focused approach that moves away from relying on patient complaints towards the proactive identification and monitoring of risks is required [1]. As many countries are finding, while the need to do this is recognized, knowing how to achieve the outcome is a major challenge. Hence the key question: what does a new approach to identifying regulatory risks through employing active monitoring and forecasting tools look like? The Australian experience offers insights for other countries.

Ahpra’s regulatory intelligence function

Drawing on domestic and international regulation best practice, Ahpra is adopting a systems approach to identify issues that may escalate and threaten patient safety. Curating regulatory intelligence involves the gathering, analysis, and interpretation of regulatory data and information to anticipate, monitor, and respond to emerging regulatory issues. Information about emerging issues comes through a variety of mechanisms, including the regulated health professions, profession specific National Boards, research activities, engagement with other regulators and professional stakeholders, and from within Ahpra [2]. This is underpinned by trend analysis of health practitioner notifications, monitoring and compliance data collected during the course of regulatory functions, supported by media monitoring activities and social media analytics.

Emerging issues are triaged by Ahpra subject matter experts, added to a regulatory issues matrix, and categorized according to criteria to identify priorities for action [3]. Key internal decision-makers review the matrix to ensure organization-wide understanding of identified issues and input into regulatory responses.

Fostering regulatory collaboration and capitalizing on regulatory tools

Like many countries, regulation of health practitioners, medicines, technology, and facilities in Australia involves the work of multiple regulatory bodies, each wielding distinct mandates, powers, and expertise. Different agencies need to work together to achieve comprehensive and cohesive regulatory outcomes. Regulatory intelligence serves as a conduit for collaboration, enabling regulators to exchange information, coordinate response efforts, and harmonize regulatory approaches.

Gathering regulatory information amidst the increasing deluge of data available requires robust analytical tools and judgement [4]. Responding to emerging risks requires agility and flexibility, using a toolkit of responses tailored to the specific issues. Ahpra views proactive communication and engagement with the regulated health workforce as an important tool for educating and supporting practitioners to meet expected standards in an evolving environment.

Ahpra has established a proof-of-concept Rapid Regulatory Response Unit to connect its regulatory intelligence with its response to individual practitioners. The unit is focussing on consumer-driven healthcare models where inappropriate professional conduct may not be evident due to few notifications to Ahpra. The unit will also seek to actively identify the actions of practitioners warranting closer scrutiny and investigation.

Regulation in practice: responding to emerging unsafe performance and conduct

A recent example is Ahpra’s response to intelligence gathered about medicinal cannabis prescribing in Australia. Given only a small number of notifications made to Ahpra, concerns about potential patient harm arose from other sources, including a rapid rise in prescriptions and the identification of potential regulatory gaps in response to emerging models of tele-health prescribing and dispensing. A national forum [5] of Australian health regulators was held to discuss the challenges of protecting the public from harm and inappropriate prescribing, while ensuring legitimate access to medications. Discussions will continue with the aim to monitor issues, share data, and identify any gaps in the regulatory and wider response to this rapidly growing industry.

In response to further intelligence indicating a small number of practitioners may be prioritizing profits over patient care in the face of rising consumer demand for the prescription of medicinal cannabis, compounded semaglutide, and online medical certificates, Ahpra issued a position statement [6] reminding practitioners of their responsibilities when prescribing and dispensing medicines, and their obligation to abide by them in the context of evolving tele-health business models.

Looking forward through the crystal ball: an upstream focus informed by practice insights

Ahpra’s approach continues to adapt to the ever-changing landscape of healthcare regulation with plans to integrate diverse data streams, including advanced analytics, to optimize decision-making for patient safety and quality in healthcare [7]. The framework continues to evolve, building upon the key strengths of Ahpra’s Regulatory Intelligence function: cross-directorate teamwork, co-regulatory collaboration, and the active contribution of insights from a wide range of sources. This collective effort shifts the healthcare regulatory paradigm to one that applies an upstream systems approach prioritizing proactive actions and early intervention while balancing safe consumer access. We offer these insights from our collaborative practice to inform the work of other countries and improve healthcare globally.

Conflict of interest statement

None declared.