Continuing Education Activity

Patient rights are a subset of human rights. The concept of human rights refers to minimum standards for the ways persons can expect to be treated by others. The concept of ethics refers to customary standards for the ways persons should treat others. As such, rights and ethics are in some sense 'flip sides of the same coin,' with 1 or more ethical principles justifying every right. As ethics change over time, so do rights. A right occurs when an organization that has the authority to enforce an ethical standard actually enforces it. 

This activity discusses, on an introductory level, ethical principles that translate into patient rights, patient rights currently enforced in the United States, with some comparisons to past rights and rights in other countries, and a history of how these rights came to be. Participants will gain insights into the role of healthcare professionals as advocates for patients' rights and will enhance their application of patients' rights and ethical practices in clinical practice.

Objectives:

• Identify the most frequent ethical principles that apply to healthcare.

• Interpret the historical record of how philosophical views have escalated human rights and how those rights relate to healthcare.

• Differentiate instances in which American lawmakers and policymakers have declined to establish patient rights and how those decisions differ from decisions made in other developed countries.

• Assess how patient rights affect decisions made by different types of clinicians in their function as an interprofessional healthcare team.

Introduction

"Rights aren't rights if someone can take them away. They're privileges." (Carlin C. It's Bad for Ya. Eardrum Records; 2008).

Minimum enforceable standards for the ways persons can expect to be treated by others are human rights. Customary standards for the ways persons in a given society are expected to treat others are ethics. As such, every patient right is derived from 1 or more medical or social ethical principles.[1] See StatPearls' companion reference, "Medical Ethics," for more information.

The concept of healthcare quality contains 2 primary facets as follows:

1. Providing a service that meets the expectations of the primary customer/stakeholder (the patient) in the service transaction                       
2. Standardizing the service so that the same level of service is provided across patients [2] 

Since each patient/customer has different preferences and all services have associated costs (related to time and equipment), individuals establishing rights must balance the costs with an objective quality level that can be maintained across all patients/customers across different healthcare fields and facilities. Furthermore, nearly all rights have associated responsibilities. Legislators hesitate to establish and protect rights unless they believe people can act in a way that shows responsibility or has 'earned' them.  

Healthcare in the United States is unique among developed countries as follows:

• It is by far the most expensive per national capita (Organisation for Economic Co-operation and Development; 2023. https://stats.oecd.org/Index.aspx?DataSetCode=SHA. Accessed Apri 4, 2024).                     
• Most types of services are not granted as a right irrelevant of cost.                                                               
• There is no single location where Americans can find a list of their healthcare rights.

In response to the last point, various American healthcare organizations (HCOs) have created their own non-enforceable healthcare bills of rights. This process began in the 1970s with the American Cancer Society and American Hospital Association. The American Cancer Society published the opinion that bills of patient rights "empower people to take an active role in improving their health... strengthen the relationships people have with their health care providers... [and help patients] in dealing with insurance companies and other specific situations related to health coverage" (American Cancer Society. 2019. The Patient Bill of Rights. https://qa.cancer.org/content/dam/CRC/PDF/Public/6706.00.pdf. Accessed April 17, 2024). The American Medical Association (AMA) is the largest American physician organization (although only about 15% of American physicians belong) [3] and keeps the longest-standing ethics code of any healthcare professional (HCP) organization in the world.[4] For the first time in 2017, it created a list of patient rights (https://code-medical-ethics.ama-assn.org/ethics-opinions/patient-rights. Accessed April 17, 2024).

Prevailing American political and philosophical perspectives generally use language that preserves individual preferences while avoiding promises that would allow such preferences to harm others or prevent the government from protecting society. In other words, the function of rights in any 1 society is to find a middle ground between the wellness of individuals with the wellness of the collective society. A recent example of this includes measures that government administrators took to restrict the spread of the SARS-CoV-2 virus (COVID-19), such as the use of vaccines, tissue testing, respiratory tract masking, and barring of entry to public places by unvaccinated and unmasked persons.[5][6][7]

Commonly developed patient rights derive from a limited set of ethical principles guiding patient treatment. These include the following:

• Placing a high value on the patient's dignity as a person                                                                                  
• Acting with goodwill toward the patient, in particular, seeking to preserve the patient's life and autonomy             
• Avoiding actions or inactions known to expose the patient to potential harm                                                        
• Distributing resources equitably across patients

HCPS need to know how to prioritize ethical principles because usually, an enforceable standard for how to prioritize principles (eg, based on positions of a government vs a national healthcare society, local institution, or religious organization) does not exist. This article reviews some historical precedents for prioritizing the principles.[1] See StatPearls' companion reference, "Medical Ethics," for more information.

Function

Brief History of Normative Ethics

The first known writings containing ethical obligations date from the Egyptian Old Kingdom, eg, the 24^th century BCΕ tomb inscription of Nefer-seshem-re (Morenz S. 1973. Egyptian Religion. Cornell University Press). Ethics as a scholarly pursuit began in 5^th century BCE Greece, particularly with Socrates, Plato, and Aristotle. In these respective Egyptian and Greek cultures, discussions of ethical duties of both citizens in general and physicians, in particular, occurred concurrently, eg, a 24^th century BCE tomb inscription of Nenkh-Sekhmet, "chief of the physicians (Ibid)," and 5^th century BCE teachings of the Hippocratic school at Cos. The ethical and legal philosophy of the ancient Greeks subsequently influenced all developed countries, which now comprise what is termed Western civilization.

Normative ethics are ethics that describe how behaviors' should' be. Normative ethics include 3 forms that dominate present-day ethics and are as follows:

• Virtue ethics, which
• stem primarily from Aristotle's writing in the 4^th century BCE
• balance intent and outcome
• impose obligations on persons to uphold certain categories of behavior, such as courage and perseverance                                                                                                                                           
• Deontological ethics, meaning "duty," which                                                                                       
• stem primarily from Immanuel Kant's writing in the late 1700s
• prioritize intent over or at the expense of outcomes
• impose obligations on persons to live according to various forms of the Golden Rule                                                                                                                                                             
• Consequentialist ethics, also called utilitarian ethics, which
• stem primarily from Jeremy Bentham and John Stuart Mill's writing in the 1800s
• prioritize outcomes over or at the expense of intent
• impose obligations on persons to achieve results that may be quantified, to achieve the maximum quantity possible

Modern normative ethics largely fuse these 3 perspectives, essentially yielding "duty virtuism." In healthcare, for example, this means that people demand HCPs practice particular virtues. 

Brief History of Laws and Writings that Led to Today's Patient Rights

Nearly all humans become patients; patient rights are an integrated subset of human rights. Lawmakers shift how they prioritize ethical principles over time, which shifts human rights over time. Lawmakers tend to expand human rights only after someone speaks out against an injustice. The greatest expansions often follow mass casualties. The following list summarizes landmarks in rights expansion (and several notable exceptions), focused on rights/ideas (1) in Western civilization, (2) that persist, and (3) that lead/relate in some way to health care and/or patients.

• 21^st century BCE: The Sumerian Ur-Nammu Code became the oldest legal code (ie, the oldest charter establishing rights and obligations) for which evidence survives. 

• Post 450s: After the Roman Empire fell, Western governments continued to emphasize the (divine) rights of monarchs, not citizens. Previously influential secular schools of thought (Socratic, Stoic, Epicurean, etc) that taught virtue/piety lost relevance until the Renaissance and Enlightenment. In that interim, Greco-Roman natural law theory dominated philosophers' and lawmakers' viewpoints when it became necessary for them to form a rational defense for their decisions apart from appealing to religious authority.

• 1215: Protesting the actions of King John of England, landowners forced him to sign the first Magna Carta, a treaty conferring rights to the landowners and persons serving them. It included the right to have due process of law before the possibility of a criminal conviction. It was neither the first post-Roman European law to establish citizens' rights nor a long-lasting success. However, more than any other document since the Roman Empire collapsed, it began a power transfer from the governing to the governed.

• 1374: An English judge set the precedent of allowing patients to establish legal rights through civil suits against their HCPs after adverse outcomes.[8]

• 1625: Having been exiled for his political views and living through religious battles, jurist Hugo de Groot wrote a highly influential book regarding human rights expansion laws based on secular (natural law) reasoning (Grotius, H. 1625. On the Law of War and Peace. Book 1; Chapter 1).  

• 1648: The post-30 Years War Treaty of Westphalia established as an international law that each country's government has an independent right to determine its citizens' human rights. This law established that no philosophical school, religious institution, international judicial body, or foreign government has a right to interfere with a national government over people in that nation's rights. This treaty has yet to be rescinded.

• 1651: In response to changes in government power during the English Civil War, Thomas Hobbes argued that there is a naturally occurring, non-written social contract between the governing and the governed (Hobbes, T. 1651. Leviathan. Book 2. Chapter 17). Ironically, with Hobbes being pro-monarchy, others used his social contract theory as the philosophical basis for establishing the first democratic legislatures since ancient Rome.

• 1688: Protestant English nobles invited the Protestant Dutch Republic Prince William to overthrow Catholic English King James II, who believed in the divine rights of kings. In the aftermath, the subsequent took place as follows:                                                                                                                                            
• 1689: The English Parliament passed the first bill of rights, law 1 William & Mary Session 2 Chapter 2, which included the first law establishing some degree of free speech. A bill, charter, or declaration of rights lists in 1 place citizens' most important rights.                                                                                   
• 1689: Using natural law ethics, John Locke argued that citizens deserved at least limited rights to religious freedom (Locke J. 1689. Letter Concerning Toleration).                                                              
• 1690: Locke revised Hobbes' dissertation (Locke J. 1690. Second Treatise of Government. Chapter 7) to justify why the consent of the governed is what gives kings and other government officials the privilege of remaining in office and individuals' rights to have property.  

• 1755: Starting with the Corsican revolution, the 'Age of Constitutions' began. A constitution is a document that explains fundamental principles and precedents that constitute a legal basis for a government's existence, including both a government's ability to enforce laws and limitations on its power. The Corsican Constitution included women's voting rights, although France abolished it in the 1760s.

• 1762: Dissatisfied with religion-based politics in his Swiss city-state of Geneva, Jean Jacques Rousseau argued that the social contract establishes the rights of citizens to control the use of their personal property (Rousseau, J. 1762. The Social Contract. Book 1; Chapter 9). Rousseau's premises have continued as the legal rationale for patient autonomy.  

• 1798: The 5th US Congress established its first American healthcare statute, the Act for the Relief of Sick and Disabled Seamen, which levied a tax to build hospitals and treat sick and disabled merchant sailors.

• 1864: Responding to the Second Italian War of Independence, the First Geneva Convention established a healthcare bill of rights (for wounded persons, ie, soldiers).

• 1868: In the aftermath of the US Civil War, the US Constitution's 14^th Amendment prevented (1) US federal and nonfederal governments from depriving any citizen of "life, liberty, or property without due process of law" and (2) chattel slavery.

• 1879: After the US government forced most Native Americans to live in wastelands, a US circuit court first declared they were "persons" and thus entitled to rights for being so.

• 1893: In a landmark for women's equality, New Zealand's Electoral Act became the first permanent law giving female citizens equal voting rights to male citizens (though it excluded some women based on race). North American countries followed in 1920 (United States), 1951 (Canada), and 1953 (Mexico).

• 1914-1919: The World War I healthcare crisis (including an international virus pandemic) and crimes against humanity resulted in the following:                                                                                                                                            
  • 1919: During the Treaty of Versailles, the US government refused to (1) accept racial equality as truth and (2) relinquish control of the rights of people living within its borders to an international council, defending its right to do so in accordance with the Treaty of Westphalia.                                                                  
  • 1924: The new international council, the League of Nations, proposed the first children's bill of rights (Declaration of the Rights of the Child).                                                                                         
• 1939-1945: The World War II healthcare crisis and crimes against humanity gave way to the following:                                                                         
• 1944: The US Congress re-indexed healthcare, public health, social welfare, and civil rights laws into US Code (USC) Title 42. The US government's executive branch matched this by placing most of its health-related laws under its Code of Federal Regulations (CFR) Title 42 (Public Health), although it places some under other titles, such as Title 45 (Public Welfare).                                                    
• 1946: In its constitution, the World Health Organization (WHO) created the first health bill of rights meant to apply to all persons, not just soldiers.                                                                                        
  • The WHO set preventive and therapeutic healthcare rights but was extremely vague, directing governments on how to enable the rights.                                                                                   
  • The WHO did not establish penalties for governments' failure to meet expectations other than losing voting rights and undisclosed 'services.'                                                                                          
• 1948: The United Nations created the Universal Declaration of Human Rights, which included articles relevant to health care. 

• 1959: Akin to Hobbes, 300 years before declaring an unwritten social contract between governed and governing exists based on natural law, American federal Judge John Wisdom declared an unwritten contract between a patient and doctor exists based on natural law. In his words, a physician's duty of beneficence "has its foundation in public considerations which are inseparable from the nature and exercise of his calling; it is predicated by the law on the relation between physician and patient... (The) duty of due care is imposed by law and is something over and above any contractual duty (Kozan v Comstock, 270 F.2d 839 [5th Cir. 1959])." This precedent-setting language is used in American common law for justifying that a HCP must meet a 'standard of care.'

• 1966: Canada, following other developed countries, became the only North American country to grant citizens the right to access most forms of health care without fees-for-service or self-purchased insurance (universal health care).

• 1970s: Numerous US civil court cases and statutes set new informed consent requirements that improved patient autonomy and reduced medical paternalism, but HCP discretion (and juries after the fact) still control what minimum informed consent is on a case-by-case basis. 

• 1973: The American Hospital Association (AHA) created the first patient bill of rights specifying aspects of patient relationships with HCPs and HCOs, although it had little enforceability (eg, hospital loss of AHA membership).

• 1986: While overhauling policies for its healthcare insurance plans (the main one being Medicare), the US government executive branch established 42 CFR § 482.13, the foundational list of enforceable American patient rights that still exists today. However, the rights are only directly enforceable for citizens and HCOs using federal healthcare insurance programs.

• 1990s-2000s: Multiple calls for a bill/charter of patient rights that protected all citizens met different fates based on location as follows:                                                                                                                      
  • 1999-2007: Multiple US Congressional sessions rejected passing any form of the Norwood-Dingell Bill (also called the American Bipartisan Patient Protection Act), which would have established a charter of patient rights for all Americans. The US president exiting office in 2000 used his executive powers to try establishing a 'workaround,' but the government scattered the new protections in a piecemeal fashion across CFR Titles 26 (Taxes), 29 (Labor), and 45 (Public Welfare).                                     
  • 2001: Canada's Parliament twice rejected passing a charter of patient rights:
    • Standing Senate Committee on Social Affairs, Science, and Technology Bill
    • C-261 Bill                                                                                                                                     
  • 2002: The European Union (EU), established in 1993, passed the legally enforceable European Charter of Patients' Rights.

• 2010s-Present: The US Congress' Patient Protection and Affordable Care Act established (1) all American citizens' right to buy healthcare insurance having annual and lifetime expense limits for most nonelective healthcare needs and (2) some rights of HCP choice. Its No Surprises Act improved some rights to HCP continuity of care. The US government's primary manner of increasing patient rights remains executive branch regulations that only directly affect patients and HCOs using federal healthcare insurance programs. If not overturned by courts or subsequent presidents, such regulations can slowly increase other US patients' rights through a trickle-down mechanism.

Synopsis of Medical Ethics Principles that Provide Justifications for Patient Rights

As presented above, writings that specify ethical obligations (both of citizens in general and of physicians) predate and serve as the justification for writings that specify human rights. When 2 entities have a relationship, 1 entity's acceptance of an ethical principle as a duty creates a right for the other; thus, key medical ethical principles (in rough chronological order of development) are discussed here before their associated patient rights. When principles or virtues conflict, logic, custom, and specific factors within the particular situation determine which principle/virtue takes precedence.[1] 

Beneficence

Beneficence means "bringing goodness." When perfected, it means doing what is in the patient's best interest throughout the diagnosis and treatment process. The first physician ethical code, from the Hippocratic school at Cos, included a vow to "help the sick." This vow's vagueness regarding how much help is owed persists in modern times. Recently, a subset of Western physicians have adopted an Eastern approach to practicing benevolence, which 'holistically' considers patients' emotional, social, and spiritual well-being in addition to therapies intended only for their bodies.

Not unique to the medical profession but essential to its function is the trust (Latin: Fiducia) that a client places in the hired professional. The client in a fiduciary relationship must rely on that professional to serve the client's best interests because there is inherently unequal power within the client-professional relationship. The Illinois Supreme Court stated as follows:

 "[T]he physician-patient relationship has its foundation on the theory that the former [physician] is learned, skilled and experienced in those subjects about which the latter [the patient] ordinarily knows little or nothing, but which are of the most vital importance and interest to him since upon them may depend the health, or even life, of himself or family. [T]herefore, the patient must necessarily place great reliance, faith, and confidence in the professional word, advice, and acts of the physician" (Witherell v. Weimer, 421 N.E.2d 869. Ill. 1981).

Clients differ in how passive or active they want to be within the fiduciary relationship. Emanuel and Emanuel described 4 patient-physician relationship models, listed in order of increasing patient proactiveness.[9] 

1. Paternalistic Relationship: The doctor decides on the patient's behalf without trying to learn the patient's individual goals and values.                                                                                                                               
2. Interpretive Relationship: The doctor first discerns the patient's goals and values and then recommends treatment in ways the doctor believes could achieve and preserve them.                                                                    
3. Informative Relationship: The doctor gives information without swaying the patient, and the patient decides what actions to take or not to take.                                                                                                                  
4. Deliberative Relationship: The doctor interprets and informs the patient, and the patient actively seeks information besides that offered spontaneously by the doctor to help the patient decide what steps to take in diagnosis or treatment. 

Deliberative interactions are most likely to achieve patients' healthcare goals and preserve their values. Whereas the paternalistic relationship was the most common model for most of history, within the last 50 years in the United States, the informative model has become the minimum standard in circumstances where a patient has the capacity to understand and independently form logical, consistent opinions regarding the consequences of decisions.

Beneficence commonly conflicts with the following:

• Respect for patient autonomy, which:                                                                                                               
  • happens when a patient makes a decision against medical advice, and                                                                                                                  
  • results in the need for physicians to assess and document capacity. When a patient indicates the desire to proceed against medical advice, the HCP should still explain reasons for their recommendations using a level of information that a "reasonable person" would need to know to make a decision.[10]                                                                                                      

• Nonmaleficence [1]

Nonmaleficence

Complementary to beneficence, nonmaleficence means "not bringing harm." HCPs acting nonmalevolently try to prevent a patient from being worse after treatment than before. Like beneficence, medical nonmaleficence dates to early Egyptian writings. After first prescribing acts of beneficence, the Hippocratic Oath prescribed nonmaleficence, including avoiding the following:

• Euthanasia                                                                                                                                                  
• Abortion                                                                                                                                                                   
• Attempting a risky procedure outside the HCP's competence                                                                                   
• Stealing property                                                                                                                                                
• Making sexual advances, and                                                                                                                           
• Violating privacy (Hippocrates. The Oath. Edited and translated by Paul Potter. Loeb Classical Library 538. Cambridge, MA: Harvard University Press, 2018)

Consideration of whether a plan for diagnosis/therapy contains or does not contain malevolent components extends to all healthcare measures, including imaging, [11] medications, physical manipulations, and invasive procedures. Concerning other ethical principles, nonmaleficence (like respect for patient autonomy) most commonly conflicts with beneficence. Examples include the following:

• Procedures in which a surgeon must cut into a patient's body, and                                                                          
• Certain drugs, such as chemotherapies, where the whole body is essentially poisoned so that a tumor may be destroyed before the tumor kills the body

In each case, the HCP's ethical goal is to make a recommendation after weighing the odds and degree of suspected harm against that of the suspected benefit. Since physicians cannot control all responses to treatments or estimate the above equation with high degrees of accuracy, they can still act under the principle of nonmaleficence by (1) taking measures within their control to minimize the chances of harm and (2) preserving patient autonomy so that patients have the opportunity to determine which parts of the equation matter most to them and then to accept or decline the risk.

Preservation of a Person's Dignity/Sanctity/Life

Of all the principles discussed, this particular one is the most controversial. Dating to the earliest literate societies, widespread belief in a creator divinity or set of divinities is a common anthropological finding. Before 500 BCE, the Egyptians, Babylonians, Assyrians, Vedic culture of ancient India, Greeks, and Israelites all associated ethics with both their theology and belief in an afterlife. Preparation for one's own afterlife was a major facet of present life for ancient Egyptians. Later, ancient Greek philosophers, including Plato and Aristotle, developed a systematic belief structure to differentiate the properties of bodies and souls. Ancient and present-day cultures have not upheld all humans as persons equally deserving of citizenship or life. For example, a longstanding tradition across many societies is to hold lesser value for and limit the rights of older individuals and (particularly) young humans for being 'lesser' than full persons. The dominant ethical view across Western societies until after the Enlightenment is that an individual's worth and qualification as a person (therefore deserving of rights) is tied to factors such as clan membership, family membership, wealth, skills, virtues, religious qualifications, and/or physical appearance.

Ancient Israelites founded/developed Judaism, which legendarily began with a man whose name is translated into English as Abraham. Their religion was the first to propose that the divinity itself (1) authored the societal moral code, (2) specially created all human lives in its image (Genesis 1:26-27, 5:1-2, 9:6; Psalms 139:13), and (3) valued the lives of all believers in that divinity or even of all persons generally. Later Abrahamic religions, such as Christianity and Islam, retained these 3 tenets (Acts 17:25; Ayah al-Ma'idah 5:32-3). Non-Abrahamic physicians, such as the Hippocratic physicians of the Greek polytheist religion (which emphasized piety), have vowed to avoid measures intended to end human life either before birth or in the setting of gravely ill patients (Hippocrates. The Oath). However, the reason behind such vows is generally due to the patient harm (maleficence) associated with these measures (Ibid. Diseases of Women 1) and not a belief in personal sanctity.

Abrahamic religious authority lost power in governments in most Western countries starting after about 1700. In some cases, the secularization of philosophy and law has resulted in simple substitutions of secular terms for religious ones (eg, inviolability for sanctity). In others, secular philosophical arguments replaced religious ones. For example, Jean Jacques Rousseau and John Locke's arguments regarding persons' natural rights to maintain lawfully gained property continue as the basis for the secular defense that 1 lay citizen cannot destroy the life of another legally. Immanuel Kant's landmark dissertations provided a secular rationale that it is objectively proper to treat each individual human with dignity and respect (Kant, I. Groundwork of the Metaphysics of Morals. Chapter 2). Kant offered a logical justification for the Golden Rule in condensed form as follows:

1. It is objectively desirable for its own end (in and of itself) that a rational being (a person) acts with a good will.                                                                 
2. It is true that each rational being is capable of having or developing a good will.                                                     
3. Since 1 and 2 are true, it is morally proper that each rational being acts toward other rational beings with a good will.

Kant's secular view contrasts longstanding and widely held views (both secular and religious) that an individual human's dignity or value is based on the degree to which an individual did, does, or may in the future exhibit usefulness (eg, to their society, community, or family) or virtue.

Regarding ethical stances on personhood necessary to adopt patient rights, issues that continue in debate include (1) the biological moment when a human life gains or loses personhood and (2) the relationship of body to soul. Technology has allowed a better understanding of genetics, embryology, and neurobiology developed after the ethical positions stated above were formed. No longer debated are the points at which an embryo is a Homo sapiens or can survive to become a rational being, but still debated is when to grant it rights. It is usually possible to discern objectively whether central nervous tissues that control cognition, rationality, and personality may function again, but instances in which patients are declared as being in a persistent vegetative state then regain consciousness still occur.[12] Regarding the evaluation of souls, differences of opinion regarding whether or when a soul enters or departs a body will persist because objectively observing a soul is not possible. 

The number of situations in which lawmakers consider humans to be persons continues to expand, but lawmakers' consensus about when a human gains or loses its rights is not within sight. Authorities' ethical decisions shift over time in response to whatever human injustice takes central attention. In response to Nazi human experimentation and a lack of international enforceable standards, in 1947, the World Medical Association was formed. It issued statements echoing the Hippocratic Oath in protecting the rights of unborn humans, but subsequent revisions gradually removed them.[13] Whereas some jurisdictions still ban any attempts to kill a human fetus, others have constitutionalized the right to do so. Abortion proponents emphasize beneficence and patient autonomy for the mother, while pro-life proponents emphasize nonmaleficence and the sanctity of human life for the unborn human. Regarding the end of life, people still debate whether and when extending it is beneficent. Assigning blanket rights on 1 side or the other is difficult because instances exist on both sides where, based on the perception of "humaneness," it is clear (or clearer) that either the sanctity of life or beneficence trumps the other. In conclusion, as with all healthcare ethics principles discussed, reaching morally acceptable decisions and enforcing those decisions as rights involves examining how the ethical principles interplay to determine which should take precedence. 

Respect for Patient Autonomy

Autonomy ("self-rule") refers to a person's ability to live according to their own reasons and motives (rationality). While respect for patient autonomy is a form of beneficence, the former emphasizes being good toward the patient's psyche while the latter emphasizes being good to the patient's body, and some individuals consider these principles to be distinct. About 350 years ago, Western society began a radical change concerning prevailing views on the autonomy of ordinary citizens. Even until the end of World War I, most persons in the West lived under the rule of a monarch or similar type of autocrat. However, as Hobbes, Locke, Rousseau, and eventually lawmakers began advocating social contract theory, monarchs and other types of government officials accepted more limitations to setting ethical and political rules. Before the late 1700s and early 1800s, natural law ethics was the only non-religion-based Western ethics system to challenge the ancient Greek system of ethics (now called virtue ethics). Then, along with virtue ethics, 2 new competing ethical systems, deontology and consequentialism, became dominant systems in determining legal rights and responsibilities within a relatively short period. The leaders of both new schools, Immanuel Kant (the founder of deontology) and subsequently John Stuart Mill (a utilitarian liberalist), agreed that autonomy was a fundamental property and right of rational beings (Kant, I. 1788. Critique of Practical Reason. Book 1; Chapter 1) (Mill, J. 1859. On Liberty. Chapter 3). 

Western philosophers and jurists no longer debate whether autonomy in its various forms is a right of rational beings but what humans qualify as rational beings and to what degree. In the 1800s, legal rights for making autonomous decisions regarding personal property spread rapidly. In the 1900s, judges used property law precedents to declare that patients able to form and defend their own values and beliefs had a more sound right than physicians to make decisions regarding their bodies, even if contradicting physicians believed they knew what was most beneficent for the patients. The HCP relents decision-making power in direct proportion to the degree of respect for autonomy, which can lead to conflicts with all other principles. 

Distributive Justice

In healthcare ethics, justice refers explicitly to the concept of distributive justice. This principle asserts that all persons (patients) should be treated equitably. It implies treating all patients the same (offering a uniform standard of quality) in any situation, regardless of who they are. In Canada, this principle led to a 1966 law that granted healthcare access to all persons. In the United States, it led to a 1986 law that granted healthcare access to all when necessary to preserve life (ie, medical emergencies) and a 2010 law allowing all to buy healthcare insurance at a maximum price.

Distributive justice, as defined by John Rawls (Rawls, J. 1971. A Theory of Justice. Chapters 2 and 5), offers equitable respect and services for persons. Persons with greater levels of need should be entitled to greater healthcare services when there is no discernible direct injury to others with lesser levels of need.

Issues of Concern

Recurring patterns for all US patient rights discussed in this section include the following:

• The court system has usually been the manner in which patients or their representatives initially secured and/or advanced rights. Congresspersons and/or government executives often have instituted laws to prevent recurrences only after lawsuits with a 'high enough profile.'                                       
• Lawmakers in larger jurisdictions often leave contentious rights for lawmakers in smaller jurisdictions to decide, the approach initially taken with chattel slavery. Rights to life and minimum informed consent are still decided at the state level.                                                                                                 
• Lawmakers often extend rights only to patients and/or HCPs/HCOs participating in programs for which the lawmakers control at least some of the funding, which is a sort of shield against lawsuits claiming that new laws are unconstitutional: 'You can do what you want if you don't ask me for money, but if you take money from me then you must play by my rules.' The federal government executive branch uses this strategy to expand 42 CFR § 482.13, the document best serving the function of a US patient rights charter.                                                                                 
• Any given right has a rank order and 1 or more limits, exceptions, and/or associated responsibilities.

The subsections below primarily focus on statutes, executive regulations, and ethical principles from which they derive.

Health Information Privacy and Control

A federally-protected patient right to confidentiality initially occurred under 42 CFR § 482.13 via the Healthcare Quality Improvement Act of 1986. In 1996, the Health Insurance Portability and Accountability Act (which is disseminated over 45 CFR § 160 and § 164) established patient rights, including the following: 

• To view one's own medical records (with some exceptions)
• To request corrections to medical record errors
• To control (in large part) who has access to medical records

Exceptions to confidentiality rights include HCPs'/HCO business persons' sharing of patient information when necessary, as follows:

• For medical, revenue, quality, or risk management by persons operating within the HCO or with business partners (called 'covered entities')                   
• To thwart imminent physical danger to the patient or others                                                                                 
• To assist a criminal investigation as demanded by a law official                                                                              
• To preserve public health. Reportable sexually transmitted infections (STIs) include human papillomavirus, genital herpes, chlamydia, gonorrhea, HIV/AIDS, and syphilis.                                                                          
• To communicate with a patient surrogate when a patient lacks legal privileges for capacity, such as children. However, state laws usually grant confidentiality to emancipated minors and sexually active minors seeking contraception or STI treatment.

Privacy derives primarily from the physician's beneficence in the physician-patient fiduciary relationship, which has a history dating back to the Hippocratic Writings (Hippocrates. The Oath). The patient trusts the HCP not to share information that others could use to take advantage of the patient. Confidentiality gives the patient this autonomy.

Informed Consent Prior to Treatment

Not until the 1800s did physicians call for each other to give patients enough information to understand their own states of health.[14] Many HCPs today remain opposed to explaining aspects of health care to patients, particularly treatment risks, costs, and alternatives; furthermore, HCPs receive no financial gain for doing so. Physicians' null assumption for most of Western medicine's history is that patients naturally accept the fiduciary relationship and whatever plans the physicians think are most beneficent. In contrast, judges' null assumption under the rules of client autonomy is that professionals cannot assume what clients want. American legal decisions beginning in the late 1800s progressively working their way up higher courts forced HCPs to adopt minimum requirements, especially the 1972 cases including the following:

• Canterbury v Spence, No. 22099 (Washington D.C. Cir. 1972), a US federal court decision,
• Cobbs v Grant, 8 Cal. 3d 229, 502 P.2d 1, 104 Cal. Rptr. 505 (California 1972), and
• Wilkinson v Vesey, 295 A.2d 676 (Rhode Island 1972)

Only thereafter did the AMA recognize informed consent as "a basic social policy" needed to preserve patient autonomy (Council on Ethical and Judicial Affairs of the AMA. 1981. Code of Medical Ethics, Current Opinions with Annotations). Many state-level legal decisions and/or statutes specify that informed consent rights trump a HCP's desire to withold information out of nonmaleficence to avoid inducing patient fear/anxiety, unless the patient specifically requests it or would be subject to imminent risk of being physicially harmed by themselves or others. Federal executive protection for the right to informed consent began in 1986, with laws now including both 42 CFR § 482.13 and 45 CFR § 46.116. 42 CFR § 482.13, which state the following:

"(T)he patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient's rights include being informed of his or her health status (and) being involved in care planning and treatment…"

Nearly all states have created statutes that provide more detail regarding jurisdiction-specific informed consent rights, with physicians per se held responsible for informed consent adequacy in most situations. Statute-specified minimums for informed consent discussion in most American jurisdictions are as follows:

• The therapy's nature
• The therapy's benefits
• The therapy's risks
• The therapy's reasonable alternatives, and
• Assessment of the patient's capacity

A federal court established that a patient must be informed of any risk of harm as low as 1% if that harm entails death or a life-altering complication, such as paralysis (Canterbury v Spence). Nevertheless, largely because of all 3 government branches' vagueness regarding what they consider minimum standards for informed consent, the judicial branch usually enforces informed consent rights as part of tort claims brought after the fact by patients against physicians.

A patient's right to medical informed consent derives from the principle of autonomy and, in turn, from the social contract theorists of the 1600s and 1700s. Under this construct, apply the following:

• Patients own their bodies (their "property").                                                                                                      
• No one has a right to deprive them of their bodies' functions.                                                                             
• Patients have the right to decide independently what risks and costs to incur regarding their bodies.                             
• Medical therapies may have a realistic possibility of damaging those functions, and there are alternatives to any recommended course of action.         
• Patients cannot anticipate what risks or alternatives might be without obtaining that information from the professional.                                                     
• It is the professional's responsibility to divulge the risks and alternatives.

Medical Treatment

The first American law protecting this right for all citizens occurred in 1986 in response to HCPs refusing patients who were known or suspected to lack the ability to pay for services. 42 US Code § 1395dd (established by the Emergency Medical Treatment and Active Labor Act [EMTALA], itself part of the Consolidated Omnibus Budget Reconciliation Act [COBRA]) requires all HCOs that offer at least one-third of their services as emergency services to attempt stabilizing a patient's emergency condition regardless of the patient's ability to pay. HCOs differ in their extension of this right because the law gives them leeway to interpret precisely as follows:

• What constitutes an emergency                                                                                                                        
• At what point is a patient stable enough to discontinue treatment or to require some guarantee of future compensation before providing additional treatment, and                                                                                  
• How to stabilize emergency conditions

In 2010, the US Congress moved the United States closer than ever to approaching universal health care. The Patient Protection and Affordable Care Act (ACA) took effect over several years and distributed patient rights across USC titles 21, 25, 26, 28, 29, 30, 36, and 42. Based on the ACA, the executive branch established 45 CFR §§ 146, 147, 148, 153, 155, 156, and 158. These laws gave American citizens rights for the first time, which included the following: 

• Many types of preventive healthcare services without fee-for-service                                                                       
• Previously nonrequired health insurance benefits, such as:
  • for mental conditions
  • for pregnancy contraception                                                                                                                           
• Insurance
  • despite having a preexisting health condition, in many circumstances (eg, for children), without facing additional charges
  • despite becoming sick
  • for non-preventive services
  • without lifetime and yearly dollar limits on coverage of essential health benefits                                                               
• Specific protections against employer retaliation for health-related issues

A right to receive medical treatment derives from the principles of beneficence, sanctity of life, and distributive justice. 

Treatment Refusal (by Both Patient and Physician)

The 1970s to1980s were a time of many US HCO ethics debates and lawsuits regarding patients/families who demanded not to be forced to accept treatments against their wills. In 1986, as part of 42 CFR § 482.13, the president agreed with prior court decisions that any patient who has capacity also has the right to refuse any treatments, regardless of whether other persons deem them to be acts of beneficence. In 1990, the US Supreme Court expanded this right, even for life vs death determining measures, to all Americans via its decision in Cruzan v Director, Missouri Department of Health, 497 U.S. 261. This patient right derives from the principle of autonomy and its associated features, including the right to informed consent.

Conversely, in many circumstances a physician has a right not to accept a patient-physician relationship or offer a treatment, such as when the physician believes that accepting a referral for a specific treatment is unwarranted or because the treatment is not indicated based on the provided history (AMA. 2024. Code of Medical Ethics. Opinion 1.1.2. Prospective Patients. https://code-medical-ethics.ama-assn.org/ethics-opinions/prospective-patients. Accessed April 17, 2024). This physician 'right of refusal' dates to the Hippocratic era (Hippocrates. The Oath), and dozens of federal laws that cover it date to 1968, shortly after the institution of Medicare, the federal health insurance program. However, no law protects the privilege/right to the degree the AMA states. Laws protecting it are usually derived from the principle of freedom of religion: they largely deal with objections to providing medical therapies for procreation, abortion, and euthanasia but also include other issues, such as vaccines and counseling. 

Treatment Complaints

A patient's right to elevate treatment quality and billing concerns is protected by several laws, such as 42 CFR §§ 482.13 and 149.620 and 42 USC §§ 6 and 157. HCPs' right to defend themselves from complaints is stipulated below federal jurisdictions. Patients have these rights because HCPs and HCO businesspersons may fail to uphold beneficence, justice, or respect for autonomy. 

HCP Choice and Continuity

The ACA gave Americans using any insurance company the right to some choice of primary HCP (42 USC § 6A.300gg–19a). In 2020, Congress passed the No Surprises Act (NSA), which became part of the Consolidated Appropriations Act of 2021. The NSA added the right of certain patients to have up to 90 days of 'healthcare continuity' after a change in health insurance acceptance by any of their HCPs (42 USC § 6A.300gg–138). Longer-term continuity of care is unlikely to become a right anytime soon. Insurance companies (third-party payers, [TPP]) control what prices they will pay for services and determine which HCPs and HCOs they will make available by contract to patients using their insurance. Patients rarely can afford or wish to pay on a fee-for-service basis. 

HCP choice and care continuity can be beneficial as follows:

• To empower the patient to make decisions over his or her own treatment (respect for autonomy)                           
• To preserve a patient-physician fiduciary relationship and joint patient-HCP decision-making (beneficence)               
• To reduce medical errors and wasted resources due to having to start over again with new HCPs (beneficence)

Treatment Quality and Safety

Laws such as the ACA have claimed to enforce treatment quality standards. However, federal laws use a trickle-down approach to enforcing healthcare quality (HCQ). For example, the ACA made law the following:

• HCPs/HCOs participate in measures of HCQ transparency, not that HCPs/HCOs meet specified measures per se.                                                       
• Hospitals with more than 50 beds have a patient safety evaluation system as described in 42 USC 299b–21 et seq, not that hospitals meet patient safety specifications per se.                                                                    
• The secretary of the Department of Health and Human Services could enact quality measures for HCOs and HCPs to meet as the secretary saw fit.

HCQ standards derive primarily from the principles of beneficence and nonmaleficence. See StatPearls' companion reference, "Standards and Evaluation of Healthcare Quality Safety and Person-Centered Care," for more information.[2] 

Patient Rights in Other Developed Nations

The EU of 1958 has set an example of ways to improve (1) healthcare standards, (2) patient rights breadth, and (3) the enforcement thereof. All EU countries that the Commonwealth Fund assessed in 2010 outperformed the United States in HCQ. The EU has both a patient rights bill (the 2002 European Charter of Patient Rights [ECPR]) and a legal system (an international parliament, court, and police force) to protect/enforce European rights. However, even with those measures, there is more variability in the enforceability of patient rights than rights protected by other laws, such as laws pertaining to employment, social security, and tax (European Commission. Patients' Rights in the European Union. https://op.europa.eu/en/publication-detail/-/publication/8f187ea5-024b-11e8-b8f5-01aa75ed71a1/language-en. Accessed April 17, 2024). The ECPR protects all rights listed above, as well as others, like the rights as follows:

• "Of access to innovative procedures..."                                                                                         
• "To avoid as much suffering and pain as possible, in each phase of... illness...," and 
• Not to have one's finances seized by a HCP or healthcare insurer

Notable advances in non-US North American patient rights have included the following:

• 1984 Canada Health Act
• 2005 Mexican Constitution Article 4

Other US Patient Rights

Like other human rights, patient rights typically include the right not to be discriminated against for reasons such as religious affiliation, political affiliation, ethnicity, gender, and, in many cases, socioeconomic status, sexual orientation, and gender identity. ACA section 1557 (42 USC § 18116(a)) became the first federal patient discrimination prohibition on the basis of sex, including sexual orientation and gender identity. Such rights derive from respect for individual persons' dignity.

The list of other patient rights is extensive and varied, including rights as follows: 

• Provision of advanced directives (Patient Self Determination Act of 1990, 42 USC § 1395-6),                                      
• Freedom from physical restraint or seclusion (42 CFR § 482.13), and                                                                 
• Visitation and refusal of visitation 42 (CFR § 482-5)

Since no federal patient bill of rights exists, readers interested in learning more about patient rights are advised to begin by researching 42 USC, 42 CFR, and/or their local patient bill of rights, which many individual states/ provinces and HCOs have created. These charters have variability in the degree of enforceability and standards. An example of a current patient bill of rights at a US federal hospital can be obtained from the National Institutes of Health (https://clinicalcenter.nih.gov/participate/patientinfo/legal/bill_of_rights.html. Accessed April 17, 2024). 

Clinical Significance

Healthcare practice is affected by ethical principles and the historical contexts in which they developed and laws that establish patient rights, primarily in the United States. Basic tenets of clinical practice include the following:

• Patient rights are a subset of human rights that governing bodies grant in the specific context of medical treatment.

• Although patient rights can be traced to ancient cultures, the idea of a formal patient bill of rights is a relatively recent development, with the first such composition occurring in 1864 or 1973, depending on one's definition of 'patient.'

• Patient rights extend to the treatment of the whole person, not just the body. They preserve aspects of the patient's relationship with their HCP and, in some cases, third parties, such as a healthcare insurer.

• Generally speaking, establishing patient rights is a cause of healthcare quality outcome improvement.

• HCPs and HCO businesspersons' knowledge of certain ethical principles is necessary as follows:                                          
  • for understanding when, how, and why patient rights factor into healthcare decisions, and                                       
  • for performing a cost vs benefit determination on a case-by-case basis when ethical principles conflict and no patient right has been previously established

• Though American federal laws enforce some patient rights nationally, many issues related to patient rights vary by healthcare institution location. The EU and other individual countries provide models for improving healthcare quality processes and outcomes, including patient rights.

Enhancing Healthcare Team Outcomes

Shared decision-making between physicians per se and between physicians and non-physicians often helps HCPs and HCO managers apply elements of medical ethics and preserve patient rights. HCPs with different insights from their various areas of expertise can use these differences to collaborate with each other and the patient when trying to reach healthcare goals in line with the patient's goals. Non-physician HCPs should (1) actively preserve patients' right to confidentiality and refusal of treatment and (2) help establish informed consent to the extent allowed by their national organizations' guidelines in their scope of practice. 

In a review of 105 randomized controlled studies involving over 31,000 participants, Stacey et al concluded that shared decision-making helps patients have clarity about healthcare recommendations, accurately perceive risk, and engage in decision-making. A shared decision-making approach resulted in better treatment and increased patient satisfaction without longer consultation times for outpatients with depression and orthopedic problems.[15][16][17]