Medical Legal and Ethical Issues: An Introduction
Healthcare is a burgeoning area of potential litigation and liability exposure. The twin disciplines of medical and healthcare law have grown rapidly to encompass the many aspects of the regulation of healthcare in the United States: the physician and hospital-patient relationships, licensing of physicians and other health professionals, practice formularies, credentialing, hospital bylaws, contactual and tort law, real estate, tax exempt status, peer review, antitrust, fraud and abuse, managed care regulation, corporate structure, merger and acquisition, tax, and data protection issues.
Medical legal and ethical issues are of critical importance to all persons involved in the healthcare system. For the physician, they may impact on professional liability and the risk of licensure discipline. Individual patients may be personally responsible for paying for healthcare, may have their access to healthcare limited, or may suffer injury.
The history of medical and legal ethics in the United States starts with the Hippocratic Oath, widely acknowledged as the ethical guide to medical practice, and retaining its authority in many medical schools and to some extent in courts today . Other sources of medical ethics include the modern "informed consent" doctrine, the best interests of the injured person standard of ethical conduct for healthcare professionals, and "autonomy rights" of healthcare consumers.
Medical and legal ethics also include the proposed protection of our right to privacy, derived in part from the right to be free from abusive and offensive touching by healthcare providers, but also inclusive of our personal information, control over whether or not to undergo an operation, and the right to control the time and circumstances of one’s death.
Medical-legal and ethical issues form the background against which the practice of medicine and the delivery of medical care must be measured. Issues of standard of care, adequacy of informed consent, confidentiality, nonmaleficence and beneficence all impact upon the quality and appropriateness of healthcare. In practicing medicine, physicians and other healthcare providers face many of the same risks, and are subject to many of the same ethical dilemmas as their patients.
Legal Issues Pertaining to the Practice of Medicine
Healthcare professionals must face numerous legal considerations. Chief among these are compliance with relevant federal and state laws and regulations, the privacy rights of patients and the potential of lawsuits for malpractice. Failure to comply with the relevant laws and regulations can result in adverse judgments, criminal prosecution and serious financial penalties. The following is an overview of these three key legal considerations faced by medical professionals.
Compliance
The Health Insurance Portability and Accountability Act (HIPAA) is one federal law that targets medical professionals charged with protecting patient information. HIPAA was enacted in 1996 to protect the privacy of patients’ medical records and other health-related information. At the state level, there are many laws and regulations that have a considerable impact upon medical practice. For example, every state requires medical professionals to be licensed to practice within it. Some states also have mandatory reporting laws that require physicians to report certain injuries or illnesses, as well as suspected cases of abuse and neglect.
Privacy Rights
Healthcare professionals are also required to follow laws that ensure the protection of patients’ privacy rights. In general, these laws limit the release of information about patients without their consent, although there are exceptions.
Malpractice
Malpractice refers to violation of a standard of care that results in injury to a patient. Medical malpractice may be intentional or unintentional. Sometimes referred to as negligence, unintentional malpractice occurs when a healthcare professional fails to exercise the degree of care that would be expected of a reasonably competent and careful medical professional in his or her field under the same or similar circumstances. When a healthcare professional willfully violates professional standards, this type of malpractice is referred to as intentional misconduct. The threshold required to prove malpractice can be difficult to meet, in part because the standard of care is sometimes vague and may vary by jurisdiction. Malpractice claims are sometimes difficult to establish if the patient suffered an injury for which there was no reasonable basis upon which to predict.
Ethical Issues Concerns with the Practice of Medicine
The complexity of medical science and the myriad of ways in which it interacts with the practice of law raise difficult ethical questions on a regular basis. Indeed, lawyers who handle medical malpractice or personal injury cases would point to ethical dilemmas that arise in many contexts. When a surgeon moves to a new state, for instance, are there any limits on the role that the patient can play in her career? Should the surgeon reveal her licensing issues in her previous state to her new patients? Is the patient owed an explanation about the surgeon’s issues and does an informed consent process demand such a conversation? What are a physician’s ethical obligations to a patient who refuses treatment, prognosis, or a diagnosis that is in the patient’s best interests?
However, the ethical controversies surrounding health care are not limited to malpractice litigation. Health care providers must frequently make difficult decisions in the course of their work. These include respected sources of ethical conflict like end-of-life care, informed consent, allocation of scarce resources, patient confidentiality, and informed consent.
End-of-life care has become one of the most common ethical dilemmas facing doctors and nurses. Patients may seek aggressive management of their chronic conditions toward the end of their lives. Physicians may recommend aggressive and invasive treatment, for the sake of extending a patient’s life. If a patient, however, doesn’t want such treatment, what then? Who determines what type of care is provided? Parents or families of minor children – who is empowered to make the decision when a parent is unable or unwilling to make the choice? Geriatric patients suffering from dementia or other cognitive impairment – who has standing to advocate for the type of care that they want?
When it comes to informed consent, patients have a right to know the risks and benefits of treatment, as well as alternatives and consequences. How much information is enough information to allow an individual to be empowered and informed? Further, how much particularity is enough? Is a vague description of potential side effects merely sufficient for allowing a patient to sign off on consent, or does a more particularized disclosure of risks meet the more stringent standard of res ipsa loquitor (the thing speaks for itself)? Indeed, is it correct to view informed consent as an issue of adequacy of disclosure, or is it more accurate to understand it as a discussion involving the patient’s choices based upon the appetite for risk, severity of side effects, and potential for alternative courses of action?
What would you do when confronted with the following scenarios? We think that these questions are difficult, and they are illustrative of the way in which ethical inquiries tend to "do the dance" between strict principles and judgment calls. And, as we mentioned above, the answers here are just as difficult as any problem we’re likely to face!
Medical Ethics Committees
Medical ethics committees (MECs) are formal bodies within healthcare institutions that are tasked with addressing and resolving complex ethical issues arising in the context of patient care. The goal of these committees is to uphold ethical standards, guide medical decisions, and prevent, identify, and resolve conflicts between healthcare providers, patients, and their families.
MECs are commonly made up of healthcare providers, administrative personnel, legal counsel, and community representatives, all working collaboratively to provide expertise in the prevention and resolution of ethical issues affecting patient care. They draw on a wide base of knowledge regarding moral issues in healthcare settings and the pertinent state law. An MEC is therefore a specialized committee that can quickly interpret state law, and ensure that healthcare institutions are complying with the state’s legal requirements when it comes to consent, treatment, and other issues.
MECs typically take part in the analysis and resolution of complex issues such as organ donation, advance directives, end-of-life decision-making, involuntary treatment, informed consent, clinical trials, professional misconduct, and for-profit healthcare decisions. For example, if a patient’s wishes for an advance directive are ignored or overridden, an MEC may make a legal determination regarding the legal implications for the healthcare institution and devise a plan to remedy the situation, such as by providing counseling and education.
It’s important to note that the role of an MEC is not to assume the responsibilities of the healthcare providers affected by an ethical issue, or to make decisions for healthcare providers or patients involved in the conflict. Instead, a MEC facilitates communication among stakeholders and offers analysis and resolution to rectify the ethical implications of an issue that has developed.
Providing its services and expertise to the parties affected by a conflict, an MEC identifies and evaluates various courses of action that could be undertaken to resolve an ethical conflict. The MEC then investigates the potential outcomes of each option, and makes a final recommendation to the healthcare institution with the aim of preserving the ethical integrity of the institution while ensuring that the conflict amongst the parties is efficiently resolved.
The fact that the decisions made by an MEC are technically not legally binding means that there is no necessity for any party to follow the MEC’s recommendations or to employ its services. However, in most cases, healthcare providers and institutions respect MEC recommendations because of their influence in fostering preventive action and conflict resolution.
One of the most frequently cited advantages of employing an MEC is that the collaborative nature of the committee helps to preserve the patient-physician relationship, preventing costly and disruptive litigation from occurring. While not a universal truth, MECs can be an invaluable tool for healthcare practitioners in cases where ethical conflicts arise.
Medical Legal and Ethical Issues: A New Balance
Stakeholders in the healthcare industry are constantly facing issues that strike at the heart of clinical practice and patient care. While a clinician’s legal and ethical responsibilities often overlap, an individual’s responsibility with respect to providing care is generally limited to a determination of what is considered "reasonable" or "medical" from a legal perspective. When state law, federal law, payer policies or other regulations address specific issues, a provider must follow those laws and regulations whether or not they agree with them. Oftentimes, however, there is a grey area where there may be no clear indication of what is legally required. In those circumstances, the healthcare provider is faced with making a leap of faith into the unknown based on their own personal beliefs and standard of care.
For example, as mentioned above, when state, federal or third-party payers impose restraints on a clinician that are not necessarily congruent with their own ethical opinions (which may be based on years of experience), the healthcare provider is left to make a difficult decision as to how to proceed. From a legal perspective, the provider likely has to follow the law or risk administrative or legal liability for a failure to do so. However, such guidance can still leave gaps in a provider’s analysis of how to proceed when the law does not provide that guidance. The result may be an incomplete and ultimately unhelpful evaluation of the situation that may even lead to incorrect conclusions. For example (hypothetically), there are no JCAHO or OSHA regulations guiding a clinician’s treatment of a morbidly obese 22 year-old woman who is at risk for blood clots and has a slight tear in her rotator cuff. Does that mean she should be treated with regard to the blood clot risk and not with regard to the shoulder injury , as the standard ACLS/HIPAA release requires that employers regulate the employee’s "care" rather than her "position"? There is clearly no guidance given by JCAHO or OSHA, leaving the healthcare provider in no better position than he or she was before assuming the patient’s case.
The issue becomes further complicated when state law weighs in on a situation that is still simultaneously governed by a federal law, payer policy and facility policies. For example, a physician treating an employee has to be cognizant of the employee’s rights under state workers’ compensation law, federal privacy laws, and the facility’s billing policies concerning "global" timeframes. In each one of these areas, the provider’s opinion about what is in the patient’s best interest conflicts with what is required under the law or a policy, at least in the provider’s mind. The facility’s requirement to use a new patient address creates further hurdles from a privacy perspective, in that the physician’s audit of his or her records may be in violation of HIPAA if he or she takes patient files home to prepare to treat the employee. From a practical standpoint, therefore, the physician feels hamstrung by JCAHO, HIPAA, OSHA and state workers’ compensation privacy regulations in a way that creates a potentially dangerous situation for the patient, which he or she may know about, but cannot do anything to address due to potentially conflicting laws.
In the case of these competing regulations, the physician or other healthcare provider may be put in a situation where he or she needs to think outside the box, in order to prevent creating an unsafe situation for the employee/patient.
Medical Legal and Ethical Issues in the Future
The landscape of medical legal and ethical issues is ever-evolving, influenced by technological advancements, shifting societal values, and the ever-increasing complexity of the healthcare system. As we look to the future, a number of key trends can be observed that are likely to shape the medical legal and ethical landscape:
- Technology and Telemedicine: As technology continues to advance at a rapid pace, its role in healthcare becomes increasingly significant. This includes the use of telemedicine, big data analytics, and artificial intelligence. These tools raise new medical legal challenges, such as the need for obtaining informed consent from patients via digital means, addressing privacy concerns related to data sharing and storage, and determining liability in cases where technology fails.
- Genetic Testing and Personalization: The ability to conduct genetic testing has opened up new avenues for personalized medicine. This presents a host of medical legal and ethical issues such as genetic discrimination, informed consent for testing and treatment based on genetic information, and questions regarding the ownership of genetic data.
- Patient Autonomy and Informed Consent: With a growing emphasis on patient autonomy, there is an ongoing debate about the extent of a patient’s right to make decisions regarding his or her health care, even when such decisions may not align with medical advice. This raises questions about the scope of informed consent, particularly in cases where the risks and benefits of treatment are complex and not well-understood.
- Globalization of Healthcare: As healthcare becomes more global, the question of how to regulate and resolve conflicts that arise across international borders becomes increasingly relevant. Issues such as medical tourism, malpractices that transcend borders, and cross-border organ trafficking require new legal frameworks and international cooperation.
- Regulatory Changes: As governments worldwide grapple with the complexities of regulating healthcare, we can expect to see continued changes in medical laws and ethics. This may include changes in physician licensing, malpractice liability, reimbursement policies, and privacy regulations in order to keep pace with the changing healthcare landscape.
- Shifting Demographics: Changes in population demographics, such as aging populations, rising prevalence of chronic diseases, and increased health awareness, are likely to influence the types of medical legal and ethical issues that arise. For example, healthcare providers may be called upon more frequently to address end-of-life issues or the allocation of scarce medical resources.
In conclusion, while it is impossible to predict the future with certainty, medical legal and ethical issues will continue to be a dynamic area of focus for healthcare practitioners, legal professionals, and policymakers alike. A commitment to addressing these issues with foresight and sensitivity will be essential in fostering a healthcare system that is both ethically sound and legally protected.
Medical Legal and Ethical Issues: A Conclusion
As is clear from the above discussion, there is a great interaction between the legal, business and ethical issues in health care. Many, if not most, business decisions have some legal and ethical implications and many, if not most, legal decisions have business and ethical implications .
It will only become more important than health care practitioners, administrators and legal counsel have a good understanding of the current and anticipated laws in the area of medical-legal-ethical issues. It is hoped that the viewer was able to gain an understanding and appreciation of these matters from a historical perspective and how the past continues to apply to the present.
