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Martin Fletcher, hub topic lead for professionalisation and regulation, has been part of transformational change in professional regulation through his tenure as Chief Executive of the Australian Health Practitioner Regulation Agency (Ahpra). In a new blog for the hub, Martin asks: How do we better connect the work of professional regulation with a systems focus on improving patient safety? And how do we navigate this interface in a health and societal context which is rapidly changing? Zubin Austin writes eloquently about the challenges of the ‘chaotic tumult’ of the many wicked problems that face professional regulators and, indeed, our health system more widely.[1] These form both the context and scaffolding for our work in years to come. The rise of entrepreneurial and profit-driven models of care, telehealth, unregulated medicines for sale online, the role of social media and AI-driven therapeutics are disruptors which have introduced new risk profiles. Traditional regulatory frameworks and approaches to patient safety must adapt. These shifts demand new thinking around safety, accountability, transparency and equity. Traditionally, professional regulation has more narrowly focused on the conduct, competence and performance of individual health practitioners, with an emphasis on public protection. However, we know that the safety of patients is shaped by a wider range of inter-related factors, including clinical governance, team dynamics, design of systems and processes, technology and organisational safety culture. There can be no healthcare without a health workforce. And an ethical, safety-conscious, competent and accountable health workforce is critical for a safe, high quality healthcare system. I have previously written for Patient Safety Learning on the need to more closely link the work of service, product and system regulators, and patient safety improvement bodies. Shared goals, role clarity, information flows and aligned actions are critical. When we operate in silos, we risk missing the bigger picture. Without coordinated action across agencies, patients remain vulnerable. The rapidly growing cosmetic practices sector illustrates these challenges vividly. In both Australia and the UK, reviews have shown that regulating practitioners alone isn’t enough.[2] [3] Products, procedures, facilities, social media, information asymmetry, service licensing arrangements and weak professional ethics all contribute to the potential risk of harm to patients. More widely, there are significant opportunities to better use and share data and intelligence to both anticipate and understand risks of patient harm. The legalisation of medicinal cannabis in Australia powerfully illustrates this need. Incident reports, notifications and complaints are often lag indicators—we need to get ahead of emerging risks of harm to patients, especially in the face of the many healthcare disruptors we face. I hope the hub community is a vehicle for sharing ideas, strategies and real-world examples of how to build foundations and bridges between professional regulation and patient safety improvements more widely. New thinking and approaches are needed. And despite many differences in the way that health systems are organised and funded across the world, there are many common challenges. References Austin Z, Haji A. Regulation of wicked problems: opportunities, responsibilities, and threats. J Med Regulation. 2023;109(3):6–11. doi:10.30770/2572-1852-109.3.6. Brown A, Duggan A, Kirkland A, McCausland R. Independent review of the regulation of medical practitioners who perform cosmetic surgery: Final report. Melbourne: Australian Health Practitioner Regulation Agency; August 2022. UK Parliament. The regulation of non-surgical cosmetic procedures in England. House of Commons Library, 10 September 2025. Further blogs on the hub from Martin Professional regulation and patient safety systems: parallel planets or partners in improvement?

The pharmaceutical industry plays a vital role in protecting human life and health. Medicines, vaccines and healthcare products directly impact millions of people around the world. Because of this, pharmaceutical companies must operate ethically and responsibly and social due diligence is becoming increasingly important. Social due diligence helps pharmaceutical companies identify, assess and manage social risks related to people, communities and ethical practices. It ensures that business operations respect human rights, employee welfare, patient safety and community well-being. Understanding social due diligence Social due diligence is a structured process used to evaluate how a company’s activities affect people. It focuses on social risks such as unsafe working conditions, unfair labour practices, community health impacts, and ethical issues in clinical trials and supply chains. In the pharmaceutical industry, where trust is critical, social due diligence is essential to maintain transparency, compliance and long-term sustainability. Why social due diligence is critical in the pharmaceutical industry 1. Protecting human rights and worker safety Pharmaceutical manufacturing involves chemical handling, laboratory work and high-risk processes. Social due diligence ensures: Safe working conditions. Fair wages and working hours. Protection from workplace hazards. This helps prevent accidents and promotes employee well-being. 2. Ethical clinical trials and ersearch Clinical trials involve human participants. Social due diligence ensures: Informed consent is properly taken. Participants are treated ethically. Vulnerable groups are protected. Ethical research practices build public trust and meet international standards. 3. Responsible supply chain management Pharmaceutical companies rely on global suppliers for raw materials and active ingredients. Social due diligence helps identify risks such as: Child or forced labour. Poor working conditions. Human rights violations. Monitoring suppliers ensures ethical sourcing and compliance. 4. Community health and social impact Manufacturing plants and research facilities affect nearby communities. Social due diligence evaluates: Community health risks. Access to healthcare. Social disruptions caused by operations. This helps companies reduce negative impacts and support local development. Key elements of social due diligence in pharmaceutical companies Employee welfare assessment This includes reviewing labour policies, safety standards, training programmes and grievance mechanisms to ensure employees are treated fairly and respectfully. Stakeholder engagement Engaging with employees, patients, regulators and local communities helps identify concerns early and improves decision-making. Risk identification and mitigation Social risks can be identified through audits, assessments and surveys. Companies can then create action plans to reduce or eliminate these risks. Compliance with regulations and standards Social due diligence ensures compliance with: National labour laws. International human rights standards. Industry-specific guidelines. Benefits of social due diligence for pharmaceutical companies Builds trust with patients and regulators. Reduces legal and reputational risks. Improves employee morale and productivity. Supports sustainable and ethical growth. Enhances brand credibility in global markets. Companies that invest in social due diligence are better prepared to face regulatory challenges and social expectations. Conclusion Social due diligence in the pharmaceutical industry is not just a regulatory requirement—it is a moral responsibility. By focusing on people, ethics and transparency, pharmaceutical companies can ensure safe operations, protect human rights and contribute positively to society. In an industry where human lives are at stake, responsible practices create long-term value and sustainable success. Social due diligence helps pharmaceutical companies move forward with integrity, accountability and trust.

Dan Cohen is an international consultant in patient safety and clinical risk management, and a Trustee for Patient Safety Learning. In this blog, Dan discusses the four principles of medical ethics, specifically focusing on how each applies to providing safe patient care. Our moral imperative Having spent more than 50 years as a doctor, I have come to appreciate that everything in my, and our, professional life comes back to the basics of why we entered the healthcare professions in the first place. We genuinely wanted to help people, to keep them healthy and to return them to their maximum healthy state when they became ill. We wanted to serve our patients by being helpful. This has been our moral imperative and our beacon. This moral imperative is the reason we get up every day and go about our jobs, often working under stressful circumstances confounded by environmental stressors, liabilities related to human factors and process inefficiencies. All of these factors have an impact on our effectiveness in clinical settings, with stress and burnout also trickling over into our personal lives. Providing healthcare is challenging, especially when so much of our work environment is seemingly out of our control. Yet we keep coming back for more because we really care. Healthcare professionals may be viewed as special and unique people by many in society, sometimes even put on a pedestal. But really, they are mostly ordinary women and men, drawn by an important calling with highly specific and serious responsibilities. What we do is special and unique! Healthcare professionals try to provide the highest quality care, focusing on optimal clinical outcomes while avoiding mistakes, errors and harm to patients. We also acknowledge that what matters most to patients influences our approach to their care. How we satisfy our moral imperative is governed substantially by adhering to the medical ethics; i.e., the behaviours, actions and deeds that are held within the moral imperative. Behaviours that do not align with the moral imperative are considered unethical. The principles of medical ethics The principles of medical ethics have been best characterised by four foundational pillars, first elucidated by Tom L. Beauchamp and James F. Childress in 1979 in their seminal book, Principles of Biomedical Ethics.[1] These principles remain as relevant today as they were when first described. I will discuss briefly these foundational pillars, specifically focusing on how each applies to providing safe patient care. Principle 1: Respect for patient autonomy Providing healthcare should be a collaborative process with professionals and patients working together to achieve the best outcomes. Therefore, patients’ needs, wants and expectations should be foremost. Optimal outcomes, especially in outpatient care, cannot be achieved without patient engagement, as the patients are generally the implementers of care, certainly after they leave their doctors’ surgeries. Patients are entitled to be informed about the risks and benefits of interventions that may cause them harm, surgical interventions most notably, and this requires discussions and sharing of information to ensure patients are appropriately involved in decision making. The practice of obtaining signed patient consent for surgical procedures acknowledges this. However, consent is often obtained in a 'slap-dash' way by having patients sign forms that may be incomplete or incompletely understood by patients. The informed consent process, as it has been operationalised, may satisfy legal requirements but is often flawed as it may not generally include a thoughtful doctor to patient discussion of risks and benefits. Respect for patient autonomy absolutely requires adherence to the principle of candour in healthcare. If mistakes are made in providing care, patients deserve to have these mistakes discussed with them in a timely fashion. This generally means shortly after the mistake has been discovered and is especially crucial with mistakes that have caused harm or may cause delayed harm. Until patients release us from our responsibilities as their care provider, we must remain committed to satisfying their healthcare needs. This cannot be accomplished if we are not honest and candid when discussing what has happened. There is now good evidence that candid discussions decrease the frequency of medical negligence claims and lawsuits and the size of healthcare injury claims paid.[2] [3] Caring for patients means respecting them and sharing information with them, whether that's for the better or worse. Principle 2: Beneficence Healthcare professionals are required to provide care that is intended to be beneficial to patients. It may seem counterintuitive to say this, but what this really means is that the care provided should be evidence-based and comply with the highest standards designed to achieve best outcomes. There are certainly instances where evidence is lacking or controversial or where doctors and/or professional groups may disagree regarding the best care and how to achieve best outcomes. Yet each healthcare professional must aspire to provide the best possible care, even in the face of uncertainty. And if there is uncertainty, then that uncertainty also should be discussed with our patients. This principle requires that healthcare professionals be willing to discuss "alternative approaches" to standard healthcare therapeutics if patients bring these options into the discussion, including the use of acupuncture, homeopathic and/or herbal products, and other approaches that patients may wish to consider. After all, patient autonomy must be respected, so professionals, regardless of their own opinions regarding these interventions, must be willing to listen and provide relevant information in a compassionate way. It is important to point out to patients when some of these alternative approaches may be harmful in certain situations. For example, certain herbal treatments may pose risks for patients taking oral anticoagulants. Healthcare professionals must share their concerns about what risks are known and mention when risks are not known. I have come across this dilemma in my own practice and I would be honest and say something like: “I cannot say with confidence that what you wish to do will be safe or unsafe, because I simply do not know the answer, although I will look into this more thoroughly. However, if I cannot find evidence of safety, then I cannot fully support you using 'XYZ' because I will be concerned that it may be harmful. The choice is always yours, and I respect your decision even if it is not one that I would make myself". Principle 3: Nonmaleficence This principle, which some have interpreted simply as "do no harm" is actually more complex than that. By their very nature, some of our recommendations cannot always avoid harm. So, by extension "do no harm” really means to avoid unnecessary harm to the extent that this is possible. For example, for a patient undergoing surgery, the surgeon will use a scalpel to perform the surgery. Hence the surgeon must actually harm the patient in order to perform the surgery, and that harm could lead to further harm (e.g., bleeding, infection, etc.) that was never the intention of the intervention. In the same way, chemotherapy to treat cancer may carry substantial risks of harm because of medication side effects that cannot always be avoided. This is the reason that informed consent must address the risks and benefits of the treatment, and professionals must make sure their patients fully understand these risks and benefits. Nonmaleficence means to avoid unnecessary harm whenever possible. Principle 4: Justice Sadly, even in our caring professions, not all of our patients are treated fairly and equitably. The principle of justice requires that all patients be treated without reference to their genetic, biological, social and economic backgrounds, gender or gender identity, and political views. The impacts of prejudices and biases against individuals of differing ethnicities, skin colours, social classes, political views, and coincidental health and lifestyle issues have adversely influenced both access to healthcare services and the quality and timeliness of healthcare services provided, possibly resulting in adverse healthcare outcomes.[4] [5] [6] For example, individuals with obesity and smoking related comorbidities and illnesses are often viewed as "responsible" for their health challenges and subject to biases, whereas recreational middle distance runners are rarely viewed negatively for their anterior cruciate ligament (ACL) injuries or joint osteoarthritis. Healthcare professionals thus have a moral obligation to acknowledge this vulnerability in themselves and to never let these biases or prejudices interfere with our provision of care. Our prejudices may well harm patients and/or prevent them from achieving optimal healthcare outcomes. This is particularly an issue when professionals are working under stress and task saturation, when we tend to take shortcuts in diagnosis and may rush to solutions or be less sympathetic and compassionate to those who are "not like us". Disparities in care are dangerous variables when providing safe, high-quality healthcare for everyone. Summary The principles of biomedical ethics apply directly to the fundamental moral imperative to provide the highest quality care while avoiding mistakes, errors and harm to patients. We must ensure that what matters most to patients influences our approach to their care and, thus, to adherence to this moral imperative. The foundational pillars of medical ethics also require professionals to be honest with patients when things go wrong and to focus on sustaining the relationships between patients and their care providers. Therefore, healthcare professionals are advised that before walking into their clinics, surgeries, hospitals, etc., they should stop and pause momentarily to reflect upon who they are as professionals, the moral imperative they work under and the professional behaviours that must align with the moral imperative. We must recognise the challenges of working in a complex environment and be especially careful. Stress degrades behaviour for all of us and, from time to time, I have been as much at fault as anyone. It’s called being human. Be part of the solution, not part of the problem. References Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 8th Ed. Oxford University Press, USA, 2019. Kachalia A, Kaufman SR, Boothman R, et al. Liability claims and costs before and after implementation of a medical error disclosure program. Annals of Internal Medicine 2010; 153(4): 213–21. Kachalia A, Sands K, Van Niel M, et al. Effects Of A Communication-And-Resolution Program On Hospitals’ Malpractice Claims And Costs. Health Affairs 2018; 32(11): 1836–44. Lavizzo-Mourey RJ, Besser RE, Williams DR. A Half-Century of Progress in Health: The National Academy of Medicine at 50: Understanding and Mitigating Health Inequities — Past, Current, and Future Directions. N Engl J Med 2021; 384:1681–4. Sabin JA. Tackling Implicit Bias in Health Care. N Engl J Med 2022; 387:105–7. Fernandez A, Chin MH. Keep Your Eyes on the Prize – Focusing on Health Care Equity. N Engl J Med 2024; 390:1733–6. Further reading on the hub from Dan: Clarity and the Art of Communication for Patient Safety Late night reflections on patient safety: commentaries from the frontline (2014) Diagnostic errors and delays: why quality investigations are key Patient Safety Spotlight Interview with Dr Dan Cohen, Patient Safety Learning Trustee Structures, processes and outcomes for better or worse: Personal responsibility in patient safe care What does all this safety stuff have to do with me? How one professional’s arrogance led to new insights Interview with Dr Dan Cohen on human performance

This course will offer an overview of the law relating to medical treatment decisions, both children and adults, and both for patients able to make a decision for themselves, and where best interests decisions must be made for those who cannot, and how to tell the difference. We will also look at how, and when, it may be necessary to involve the court to resolve disputes and – better – how to avoid disputes altogether. Decisions about medical treatment can be about life and death, such as withdrawal of treatment or (not) providing CPR. Or about quality of life, liberty and independence, which can be just as important. But the legal (and ethical) framework around these decisions is often misunderstood, leading to distress and disputes at the very worst of times, as we have seen in a few very high-profile cases. It can also cause uncertainty and doubt in clinicians, where the law is misunderstood as a stick to beat them with, rather than a shield to protect their reasonable decision-making. We will cover whether a patient should always get what they want, or does “doctor know best”? When a patient cannot make a decision for themselves, who gets to decide, and how should these decisions be made? What is the role of so-called “next of kin” (and did you know that there’s actually no such thing)? Can parents insist on treatment for a child when doctors think it futile? How are disputes in this context resolved and, better yet, how are they avoided? Throughout, we will talk in particular about the importance of good communication, and managing expectations, and how to ensure that clinicians are doing the right thing for the patient, as well as avoiding getting sued. Key learning objectives: To understand and apply in practice the fundamental legal framework around decisions about medical treatment, including: Rationing and resource allocation The limits of choice and autonomy The relationship between law and ethics The importance of good communication, and how to not get sued The law on consent Mental capacity and best interests decision for adults Decisions about children – Gillick competence, parental responsibility and disputes Restraint and deprivation of liberty Going to court Register

As the adoption of artificial intelligence (AI) in health and care continues to progress rapidly, it's essential that clinicians ensure this technology is used for the benefit of patients and to assist us in providing equitable and high-quality care both now and in the future. However, it's also crucial that we are aware of the potential risks and unintended consequences of using AI. This month, the RSM will delve into the development of machine learning (ML) and AI and their applications to healthcare. It will also debate the need for ethical guidelines and regulation in this field. By attending this event, you will understand: What is machine learning and artificial intelligence. How AI is being currently applied to healthcare and the potential future uses. How data drives AI and the potential bias within the data. The way ML and AI can lead to errors and harm. The ethical issues surrounding the use of AI in healthcare. The need for regulations and governance, both in healthcare and the broader society. Register