Professional and ethical principles guiding the appropriate use of technology in healthcare

Expanding the code of ethics and the principle of “do no harm” within the social and technical context of healthcare to designers

TLDR: As designers, the decisions that we make through the design process have the potential to create significant benefits for the people who use our products, but they also have the capability to create harm as well. We have an obligation, especially for those of us working in healthcare, to consider the downstream effects of our decisions from an ethical perspective.

The design of technology products in both the clinical and consumer segments of healthcare frequently relies upon any number of assumptions which ultimately impact how products are implemented and used by the intended user. The designers and product teams who implement these technologies must often make ethical and social assumptions on behalf of their users with limited abilities to prospectively examine whether or not these assumptions are warranted and how they will affect the adoption and use of a particular health technology or innovative product (Lehoux et al., 2014). With design being an intentional activity focused on problem-solving it is also a normative practice that seeks to establish, improve, or support better practices. Within healthcare, the design of solutions is often influenced by a number of interests where each individual involved in the process may have a perspective that is grounded in their particular expertise or area of responsibility (Lehoux et al., 2014). As a result, designers of healthcare technology often rely on various kinds of qualitative and quantitative methods with their work being influenced by a number of factors such as internal goals, informed clinical champions and subject matter experts, organizational strategic plans, profitability aims, market factors, and the requirements of both the business and regulatory environment. Each of these factors brings with them different perspectives and judgments with socially legitimate, but often myopic and untested, assumptions and claims towards efficacy, safety, and what is considered to be either valuable or good for the end user — which for the designer produces a requirement to combine both these normative assumptions and knowledge when creating a solution to a healthcare problem.

Within the healthcare environment, ethical concepts and constraints significantly impact the design of technology products and applications as well as the use of these technologies as clinical or consumer health tools and interventions. In many organizations, it is often the case that the design of new healthcare technology products are not questioned in terms of having been well researched or thought out nor are products examined in the context of the final design of a concept, the functions that a product performs, or the results that a user may accomplish in using the product as long as basic product design requirements are fulfilled. However, once implemented many design assumptions that were taken in during the planning, design, and development phases of the products creation become apparent and unique features such as the intended use, complexity, the products impact on the autonomy of the user, physical and cognitive ergonomics, and the appropriateness of the product may all align poorly with the expectations of both stakeholders and users in terms of their needs and expectations as well as macroergonomic environment where there may be issues with the sustainability of the solution, access, and even equity (Lehoux et al., 2014).

Within the landscape of the healthcare ecosystem, the industry is dramatically being impacted by advances in healthcare information technology (HIT) and consumer health informatics technology (CHI) through mechanisms such as Electronic Health Care Records (EHRs), Clinical Decision Support Systems, Health Information Exchanges, Computerized Physician Order Entry (CPOE) and Prescribing Systems, mHealth and telemedicine applications, remote monitoring and sensor tracking, among others. These advances are allowing for increased efficiencies in how care is being delivered to patients as well as improving the effectiveness of the care that is provided, especially with the introduction of machine learning and advanced data science.

At the same time, these advances are creating the potential for increased harm to patients in terms of unauthorized disclosure of protected health information, inaccurate computer-generated diagnoses, or even improperly calculated medication dosages. Computer systems can be and are often wrong in many cases and much of that stems from how these systems are being created and also from the subjective nature of how medicine is practiced, which is often based on the clinical experiences of a physician — something that is extremely difficult to incorporate into the design of a clinical or consumer-facing system. While healthcare technologies are generally believed to improve healthcare efficiency, quality, safety, and cost it is not without risk and the downsides are rarely considered in terms of errors and adverse events that these technologies can introduce. In many areas of healthcare, technology has been described by users as part of the solution for safer healthcare and also as part of the problem with some observers highlighting “yet-to-be errors after the adoption of new technologies” (Powell-Cope et. al, 2008). Provided the scale in which technology is being used in both clinical and consumer health, device and system problems are inevitable and issues may be introduced through poor technology design that does not adhere to human factors and ergonomic principles, poor technology interface with the patient, consumer, or environment, the complexity of devices, lack of system communication (ie. interoperability with multiple systems), inadequate planning for the implementation of a technology into practice, and inadequate maintenance and support plans. (Powell-Cope et. al, 2008).

Yet, unlike individuals from the more clinical facing sides of healthcare (such as licensed medical or health informaticists) who are held to an established professional standard, are bound by oaths of ethics, and face significant consequences for failure to comply by them, for those on the product development side of healthcare there is no comparable code of conduct or ethics that exists — despite the significant impact that their work has on patient’s and their potential outcomes. The fact of the matter is that, despite the best intentions, poorly designed and implemented health information technologies can cause significant harm and do wrong by a patient.

In classical medical ethics, there are several principles such as beneficence, nonmaleficence, autonomy, and justice which can be used to address the ethical dimensions of providing medical care. These same principles to address the ethical dimensions of healthcare technology products and applications as well, in addition to ethical issues that are not covered by medical or computing ethics — where the avoidance of harm and the preservation of an individual’s autonomy should be at the forefront of any design challenges. Other ethical considerations, such as privacy, confidentiality, and the impact of an individual’s behavior, their level of engagement with their care, and even the patient-provider relationship must be built into the scaffolding for the ethical application of design in healthcare in order to minimize risks and to realize potential benefits without unnecessary ethical conflict (Francis, 2017).

Traditional Ethical Standards in Healthcare: The Patient-Provider Relationship

In the medical field, trust is the cornerstone for the doctor-patient relationship. In times of need and ill health, this is considered the single most important factor which brings the patient and their provider together. It is essential to both the physician and the patient relationship as without this underlying trust in each other, how would the patient place their care in the provider and their knowledge, skill, and capabilities? How would the provider expect that the patient would reveal their medical history, consent to a physician’s exam, or follow through on the recommendations of the physician for diagnostic tests, treatments, and lifestyle changes?

Yet, the trust that a patient places in a healthcare provider or healthcare system goes far trust the that goes with clinical skills and knowledge of a particular physician and it extends to all aspects of the healthcare ecosystem, including everything from the receptionist at the front desk, to the entire care team, and even to the technology that a patient may come into contact with outside of the context of a clinical encounter. This trust speaks to the confidence that a patient has in the integrity of a clinician as the patient’s agent for care and the healthcare ecosystem in which they operate.

One of the core elements that instills this trust and confidence in a patient is the Hippocratic oath, which is the earlier expression of medical ethics in the Western world. Within the context of the oath, it establishes the principles of medical ethics such as confidentiality and non-maleficence and also establishes the ethical obligation of a provider to act in the interest of their patients and to “do no harm.” This establishes the Hippocratic bargain as the basis for the doctor-patient relationship where:

Physicians, explicitly or implicitly, said to their patients: “Allow me to examine you in ways that you would never permit any stranger, and tell me the most sensitive information about your body, mind, emotions, and lifestyle. These intrusions upon your privacy are essential in providing you with sound medical care. If you provide me with this intimate access to your person, I promise to maintain your secrets for as long as I live and to disclose them only if directed by you or others you have authorized.” Patients agreeing to be treated under this bargain relinquished aspects of their privacy in exchange for their physicians’ assurances of confidentiality — that they would not re-disclose the patient’s health and other sensitive information to others. Mark A. Rothstein

The patient-provider relationship is therefore based on the idea that the provider owes a duty to the patient due to the nature of the relationship. The same should be true in patient-technology and provider-technology relationships.

Ethical Principles

Ethical principles are utilized across all forms of medical practice and service delivery and are frequently codified in professional codes of ethics in efforts to avoid causing harm. The four most widely used ethical principles in healthcare are:

• Autonomy which encompasses self-determination or the ability to access information pertinent to decision making, independence or following one’s own values, freedom to choose a course of action free of coercion, and agency or the power to be in control of and responsible for one’s actions
• Beneficence which obligates the health care professional to promote good and provide assistance to others and to promote the patient’s unique view of health and individual perception of good health
• Nonmaleficence which is the principle that one should do no harm. Included is avoidance of risk of harm where it is known that certain interventions carry risks or harms, but beneficial outcomes may outweigh the harms.
• Justice which is central to the core concepts of ethical behavior, and rests upon mutual recognition of human dignity and requires that all people be treated fairly and equally

As technology continues to be integrated with medical practices and consumer health applications, it becomes clear that these systems carry with them other considerations and ethical implications for healthcare organizations, clinicians, patients, and other consumers of these technologies. Professionals, such as designers and product teams, within the health information and technology space are directly involved and embedded in the dynamically evolving relationships between individuals and technologies and must also consider the ethical concerns related to their products, which might include:

• The individual's willingness or ability to use the technology and the appropriateness of fit (eg. technological and health literacy)
• Distance or disconnection from the human aspects of care
• The potential of inequitable availability and limited availability of use (ie. socioeconomic and geographical considerations)
• Consequences of information if presented incorrectly or if it is misunderstood (ie. data interpretation)
• The individual's dependence on technology
• Evidence of the effectiveness of a technology solution or intervention
• The harm that might arise as a result of actions allowed by the technology
• The harm that might result if the technology fails
• Privacy, security, and confidentiality — especially related to personal health information
• Threats to autonomy related to informed consent and understanding
• The effects on the individual’s relationship to health and care related to the technology (eg. patient-provider relationship)

Ethical Obligation for the Digital Age of Healthcare

From this brief perspective on the social and technical context of healthcare technology, it should be clear that the ethical aspects of clinical and consumer health IT should be aligned with those of healthcare in general care.

Those involved with designing technology products and solutions need to be cognizant of the ethical issues that are inherent to their creations and should to consider these factors in their practices with an awareness that they have an ability to affect human health through their designs and products. As designers, a code of ethics that generally defines a standard of behavior can guide us in making ethical decisions when making our creations and in how they interact with people.

A Designers Oath of Ethics for the Digital Age of Healthcare

I swear to fulfill, to the best of my ability and judgment, this covenant:

I will respect the hard-won technical and scientific gains of those researchers, informaticists, engineers, designers, and other information technologists in whose steps I walk, and gladly share such knowledge as is mine with those who are to follow.

I will apply, for the benefit of humanity, all measures required, avoiding those twin traps of over-optimism and uniformed pessimism.

I will remember that there is an art to healthcare technology design and implementation, as well as that science, evidence, and human concerns, outweigh technological ones.

Most especially must I tread with care in matters of life and death. If it is given me to save a life using information technology, all thanks. But it may also be within technologies power to take a life; this awesome responsibility must be faced with great humbleness and awareness of my own frailty and the limitations of information technology. Above all, I must not play at God nor let my technology do so.

I will respect the privacy of humans for their personal data are not disclosed to technological systems so that the world may know.

I will consider the impact of my work on fairness both in perpetuating historical biases, which is caused by the blind extrapolation from past data to future predictions and technological implementations and in creating new conditions that increase economic or other inequality.

My designs, code, and systems will prevent harm whenever they can, for prevention is preferable to cure.

My designs, code, and systems will seek to collaborate with, inform, and assist people for the greater good, rather than usurp the human role and supplant them.

I will remember that through my work I will be dealing not only with data, algorithms, and design artifacts, but human beings, whose interactions with my applications and products may affect the person’s welfare, freedom, family, or economic stability. My responsibility includes these related problems.

I will remember that I remain a member of society, with special obligations to all my fellow human beings.

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References

What are the ethical principles related to health and health informatics?

What is ethical issues related to technology in the delivery of health care?

What ethical issues have arisen or might arise from use of technology and informatics in professional nursing?

What are some of the ethical issues surrounding the development and use of medical technology?