Understanding Standard-Of-Care in an Evolving World

What do we mean by standard-of-care in medical practice?
The Development of Standards-of-Care in US-Medical Practice
Toward a More Uniform Practice?
The Evolution of Ethical Controversy in Standards-of-Care

What do we mean by standards-of-care? How did these standards evolve? This article attempts to answer these questions and to look at the part played by ethical debate in the development of standards-of-care.

In addition, we consider recent efforts to make the multifarious surfeit of “standards-of-care” now in existence much more streamlined and hence uniform.

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What do we mean by standard-of-care in medical practice?

While there is no standard definition for the meaning of ‘standard-of-care’ per se, a medical definition of what is meant by the term is given as follows (Stöppler, 2021).

  1. A diagnostic and treatment process that a clinician should follow for a certain type of patient, illness, or clinical circumstance.
  2. In legal terms, the level at which the average, prudent provider in a community would practice; how similarly qualified practitioners would have managed the patient's care under the same or similar circumstances.

The Development of Standards-of-Care in US-Medical Practice

Since World War Two medical experts and learned societies have been integral in the development of medical standards-of-care. This era saw the rise of biomedicine and an expansion in the prestige of individual medical specialities.

Along with elevations in funding the profession also experienced a rising interest in the of quality in clinical practice.

The development of medical standards-of-care was inaugurated in the 1980s. It is important to realise “standards of care” should not be thought about in a monolithic way; they do not comprise a single uniform whole.

In American medicine, health services research backed by governmental sponsorship has played a key part in the evolution of medical standards of care. Those working in health services research have, since the 1960s, investigated the cost, quality, and accessibility of health care services. The need for medical standards-of-care has been evidenced by research revealing wide disparities in standards according to geographical locale.

According to Kinney (2004) “The American health care sector has indeed moved from a paradigm of autonomous professional decision making to a paradigm of collective decision making based on empirically derived standards of care.”

The term ‘standard-of-care’ is not just applicable to US-based healthcare; rather it can apply to different multinational research contexts.

But who gets to decide what constitutes standard of care? Afterall medical standards come from a variety of sources. How can these various sources be reconciled? Although pluralism can be seen as healthy in the spirit of natural competition, it simultaneously presents a challenge to the medical profession and its patients.

Toward a More Uniform Practice?

In the late 1980s the Agency for Healthcare Quality and Research called for improvements in healthcare delivery.

Now known as the Agency for Healthcare Research and Quality (AHRQ) ––the agency was tasked with minimising healthcare inconsistencies through creating speciality-specific guidelines to better assist clinicians and their patients in better decision making.

In the wake of these changes, professional medical societies, governments, and insurers in turn created their own guidelines.

The AHRQ hoped that the creation of practice guidelines would result in a more uniform practice of medicine. In April 2017 there were over 8,000 individual guideline summaries in existence (Cooke, et al., 2017).

These thus comprise a surfeit of conflicting information that is limited on several fronts. First, guidelines are rapidly outmoded due to new and changing research and practice ––this can occur in as little time as just six years.

Another problem is a lack of scientific evidence to back the stated guidelines. As well as conflicting information, there is the problem of biased guidelines emanating from private health insurance companies and the like.

Keeping abreast of the latest innovations in research means keeping an eye on evolving standards-of-care. Take the advent of rapid genome testing and its transition from the research setting and into that of healthcare; its advent necessitates new standards-of-care initiatives for the efficient and effective delivery of this novel precision medicine. Often the development of a new standard-of-care is inextricably linked with ethical debate.

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The Evolution of Ethical Controversy in Standards-of-Care

In the 1990s there occurred ethical controversy over placebo-controlled trials of mother-to-child HIV transmission that took place in developing countries.

One side argued in favour of adherence to the “standard-of-care” in accordance with the native community in which the trial took place. Opponents to this view argued that where a proven intervention is known to exist, then it should be provided to the control group regardless.

Since then, the advent of HIV biomedical prevention trials of vaccines and microbicides have added another dimension to the debate. The answers to the questions posed have evolved over time.

These questions have moved away from whether treatment should be received and toward how it might be administered. A key reason for the shift in thinking has been the widespread availability of retroviral therapy in poorer countries, spurred by initiatives first established by the World Health Organisation (WHO) and The Joint United Nations Programme on HIV/AIDS (UNAID).

Since then, ethical debate has evolved once more, this time moving from issues of cost to those of agency on the part of those asked to participate in clinical trials. Here is it argued that the proffering of antiviral therapies is tantamount to an inducement to take part in a HIV prevention trial and thus at odds with ethical standards.

More recently there has been a growing consensus on the ethics of providing state-of-the-art prevention to those involved in clinical trials, though questions about who exactly should pay for this still nevertheless remain.


  • Cooke, B. 2017. The elusive standard of care. Journal of the American Academy of Psychiatry and the Law, 45 (3) 358-364.
  • Kinney, E. 2004. The origins and promise of medical standards of care. History of Medicine. AMA Journal of Ethics. Doi: 10.1001/virtualmentor.2004.6.12.mhst1-0412.
  • Macklin, R. 2008. Standard of care: an evolution in ethical thinking. The Lancet. Doi: 10.1016/S0140-6736(08)61098-3.
  • Stark, Z. et al. 2022. Rapid genomic testing for critically ill children: time to become standard of care? Eur J Hum Genet. Doi: 10.1038/s41431-021-00990-y.
  • Stöppler, M. 2021. Medical Definition of Standard of Care. MedicineNet. Online: https://www.medicinenet.com/standard_of_care/definition.htm.

Last Updated: Apr 14, 2023

Written by

Dr. Nicola Williams

I’m currently working as a post-doctoral fellow in the History of Science at the Leeds and Humanities Research Institute (LAHRI), at the University of Leeds. Broadly speaking my research area falls within the remit of the history of biology and history of technology in the twentieth century. More specifically I have specialist knowledge in the areas of electron microscopy and cellular and molecular biology, women in science and visual culture.

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