Medical Law 101
The realm of medical law encompasses a wide array of legal issues concerning healthcare services and the responsibilities of healthcare providers in various capacities. It is a multifaceted field that touches upon multiple aspects such as the rights of patients, the responsibilities of healthcare professionals, informed consent, confidentiality, malpractice, and the ever-changing regulations that govern healthcare practices. The intersection between healthcare service delivery and legal practice, exemplified by medical malpractice law, has broad impact on how healthcare providers operate, how patients receive care, and how damages are addressed when those two collide. Medical law is not strictly confined to cases arising out of negligent care of patients, but encompasses the relationship between the patient and the practitioner, and considers the responsibility of the patient in following the recommendations of their healthcare providers. Medical law is also concerned with financial issues, including the structuring of personal injury settlements affecting the treatment of injuries, the payment of bills by third-party payers, collection procedures for debt collection firms utilizing health-related data , and these statutes and regulations’ interplay with fraud enforcement efforts by the federal government against the health insurance industry. In addition, medical law covers the licensing of physicians and other individuals who provide professional healthcare services, the requirements for licensing institutions providing training of medical professionals, and related regulatory matters. Among the most common types of medical malpractice cases are those involving hospitals, nursing homes, medical clinics, and other medical facilities. These collectively are referred to as institutional medical malpractice. Hospital acquired infections, the misdiagnosing of tumors, the misreading of x-rays, typos in charts, over-medication and under-medication are frequent causes of institutional malpractice. Failure to obtain informed consent, electrical burns from faulty medical equipment, burns and injuries sustained in explosions, improper laboratory processing, and storage and contamination are also causes for liability on the part of an institutional care provider. There is a numerous and extensive list of cases and issues which fall under the broad characterization of medical law. It is a complex area of practice, and one that is essential for both healthcare lawyers, and other members of the legal profession, as well as for healthcare professionals.
Major Concepts of Medical Law
At the heart of medical law are the key principles of patient autonomy, informed consent and duty of care. While patients still might expect out of date conventions which allow doctors to ‘tell’ the patient what they need, medical law today means that patients can no longer be seen as mere hands to do the doctor’s bidding. A patient has the entitlement to be an active participant in their care. It is imperative that a patient be fully informed of the current state of her medical condition, the risks and benefits of treatments available and collect the information necessary to make her own decisions about medical treatment. It is the role of the medical practitioner to ensure that the patient is fully informed. This includes full disclosure of risks, benefits and consequences of intended treatments, communicating complex and detailed information, and providing reassurance and alternative suggestions when needed. The ability to communicate these issues effectively is therefore a core duty of a medical practitioner.
The duty of care is a legal obligation to avoid causing patient harm which may result from the negligent act or omission of a health care professional. Consequently, the law imposes a broad duty on health care practitioners to take reasonable care that their acts and omissions do not cause patients to suffer avoidable injury. The ramifications for injury caused by breaches of this duty could possibly be catastrophic.
Negligence results when the health care practitioner fails or neglects to provide treatment with the same degree of competence and care that would be provided by a skilled, competent, and experienced practitioner in the same discipline. However, the standard of care is objectively determined; perceived low standards of care may not be a reflection of reality. Indeed, the position in medical negligence cases is that difficulties in determining the prevailing standards of the medical profession generally will not be regarded as sufficient grounds for reducing them. Consequently, a health care practitioner acting in accordance with good practice will have a complete defence against negligence claims. In contrast, a practitioner whose treatment is found to constitute ‘bad practice’ will attract liability for damages sustained by a patient.
Consent refers to voluntary agreement to undergo treatment or preventive medicine. Individuals have a right to make choices freely and without coercion or interference regarding their medical condition and treatment options. The legal requirements of patient consent are to see whether the correct legal standards were applied to the consent process. Informed consent requires that those involved have a full understanding of the medical procedure and the risks associated with the proposed treatment. The term ‘informed’ is essential to informed consent, and refers to the principles that patients are competent to consent, have been sufficiently informed, understand the information provided and choose voluntarily.
Adequate record keeping and note taking will protect health care practitioners and their staff from medical malpractice claims. There is a duty of care which requires doctors to be familiar with their patients’ medical histories and be familiar with the risks that particular patients face. Medical practitioners should document their patient consultations, observations, test results, the advice given, and they should ask their patients to sign a receipt for the information they have received. Medical practitioners have the obligation to document medical history correctly, understand pathology results accurately, and record symptoms. Good medical record-keeping is a crucial part of this since it breaches everything.
Another key principle in medical law is managing contact with the media. Given the rise in digital and social media, it is vital that health practitioners are aware of the relevant legal obligations, responsibilities and their rights when responding to media inquiries or being interviewed by reporters and journalists. Dealing with the media can also be tricky and requires preparation and planning. But there is no single solution to dealing with the media. The guidelines should be reviewed regularly in response to the evolving digital environment, and the risk of online reputational damage.
Medical Negligence and Malpractice
To define medical negligence, also know as medical malpractice, you must first identify the key players involved. To hold a physician liable for negligent medical care, you must prove a professional relationship existed between the two of you.
For example, if your medical doctor (the health care provider) sent you to a physical therapist for treatment of a fractured wrist, then the physical therapist owes you the duty of reasonable care (the legal obligation). Likewise, if your plastic surgeon decided you also needed a leg amputation, he must act in a reasonable manner in the performance of that surgery. The same holds true for the anesthesiologist and the nursing staff.
If any of the medical staff held a reasonable belief he or she was deficient in doing the surgery, the anesthesiologist, or the nurse, should have called in an expert for you. That is the point at which liability is an issue in medical malpractice.
For example, say a plastic surgeon performed the amputation of your leg, but used a dull saw, then the medical staff may be held liable for the resulting errors. Perhaps the error was if the surgeon (the health care provider) made a mistake in the procedure, and the nurse (the person who assisted), did not question the surgeon to verify the accuracy of what he was doing, then the physician and the nurse must share the liability.
If you, as the patient, fail to properly follow the instructions of the physician, and your actions somehow contribute to your injury, this cannot be considered medical malpractice. In these circumstances, the court would likely rule on the side of the medical staff.
Consider a situation where you decide to take on your own medical care and skipped physical therapy as prescribed by your physician because it was too expensive. If you had gone through with the physical therapy, there would be no question of medical malpractice.
To prove negligence of the other medical staff (physical therapist, nurses, anesthesiologist), you must show that they failed to verify the accuracy of what the physician performed, or otherwise verified that the doctor was doing what he should have done. In this case, the burden of proof is on you as the patient to prove that the physician is the person at fault.
If you feel you have been injured as a result of medical malpractice, then you are well within your rights to (1) file a complaint with the medical board in your state, and (2) seek professional legal representation.
Rights of Patients Under Medical Law
Patient rights and legal protections are vested in statutes and case law. Issues surrounding confidentiality are governed by the HITECH Act and the Privacy Rule. Medical records are not owned by either the patient or the provider. They are owned by the provider which must maintain them for a period of time as established in state laws. Patients have the right to full and complete access to their own medical records.
Under HIPAA, patients have the right to request corrections in their medical records. However , they must show good cause for requesting a change. Pushback from providers may be the result of a belief that the requested change will render admissions or orders inaccurate.
In cases of serious medical malpractice, assumption of risk may be discussed between the medical malpractice attorney and the patients. Potential plaintiffs may then discuss their options with their medical malpractice attorney. These discussions will be based on liability and causation as well as the desires of clients.
Case Studies in Medical Law
Medical law, which is the intersection of medicine and law, comes into play in a multitude of circumstances. From physician licensure to medical malpractice claims, medical law is an area of legal practice rich with real-world applications.
One case that has had significant impact on medical law is Estelle v. Gamble, a landmark decision handed down by the Supreme Court of the United States in 1976. The case involved a 60-year-old inmate, Arthur Estelle, who was diagnosed with a sore back and a mild reaction to an experimental anti-cancer drug, compromising his immune system. He was hospitalized after slipping from his cell and, while in the hospital, suffered a series of seizures, leading to a stroke and resulting in permanent wrist and ankle drop. When Estelle was released the next year, he sued the prison doctors charging they had been deliberately indifferent to his medical needs, resulting in cruel and unusual punishment in violation of the 8th Amendment. The Supreme Court held that while the government is not required to provide care to prisoners above and beyond "basic societal standards of dignity," it is obligated to provide medical care to those who are incarcerated. Failure to provide such treatment, the court found, is tantamount to a violation of the Eighth Amendment, as it amounts to cruel and unusual punishment. As currently understood, the Eighth Amendment’s provision of healthcare to prisoners has evolved into the litigation of prison conditions under a legal doctrine known as "deliberate indifference." Under this doctrine, the government is prohibited from being aware of, deliberately ignoring, or negligently failing to provide for prisoners’ healthcare needs.
In Bogan v. Scott-Harris, the Supreme Court considered the actions of a state-employed physician who involuntarily treated a patient in violation of state law and without her consent. The plaintiff, Heather Bogan, had suffered a cerebral hemorrhage and slipped into a coma. During her hospitalization, her physicians at a state mental hospital found her to be "definitely not mentally competent to consent to treatment," and sought and obtained a state court’s order for involuntary treatment. A state judge appointed Bogan’s husband as guardian and authorized the administration of any needed medical treatment. The Bogan case was pivotal in establishing the essential role of informed consent in medical malpractice. According to court documents, "The right to informed consent has its roots in the doctrine of self-determination." In other words, no one can be forced to undergo medical treatment without her say-so.
In Moore v. Regents of the University of California, the California Supreme Court ruled that a patient must give her informed consent before doctors can use any parts of her body to pursue medical research in any form. The decision marked the first time any state supreme court had issued such an opinion in the 25 years since the case was originally brought before the lower courts. Though the case has been cited as precedent in a number of other states, including Tennessee, the decision left the law surrounding informed consent muddied.
As demonstrated by these three cases, the practice of medical law is affected by many factors, from widely-accepted medical standards to physician licensing to regional customs and practices to popular perceptions about ethical behavior. Each new lawsuit establishes another precedent, which in turn informs the practice of medical law and the continued development of these diverse components.
The Future of Medical Law
Emerging trends related to the use and configuration of technology, as well as the challenges they pose, are sure to test the understanding of experienced lawyers. Evolving concepts of medical law will challenge existing paradigms in several key respects.
No aspect is so difficult to gauge, due to the inherent uncertainties of developing technology, as the role to be played by artificial intelligence (AI). Most agree that AI will, one day, surpass human intelligence. In health care, this "singularity" will have profound and bewildering impact, affecting medical practice, bioscience, ethics, health insurance practices, the organization and delivery of health care, and myriad other issues.
AI’s incorporation into medicine is already evolving in a number of different ways. For example, the FDA recently issued guidance outlining a structured regulatory approach for the collection and review of real-world electronic data, including but not limited to data obtained from certain AI devices used by patients with chronic conditions at home. Another new law adopted by congress authorized a national program to analyze and share data on drug prescribing, combining information technology and AI to reduce fraud and abuse. The National Academy of Medicine has recommended the use of AI-based diagnostic techniques, aiming to improve detection, diagnosis, and treatment of disease.
AI is, it seems, particularly well-suited to such tasks as examining and analyzing patient data and predicting possible outcomes. The use of AI for these core activities will potentially lead to improvements in the safety and quality of medical services, but also raise troubling new questions of liability and governance.
As an adjunct to real-world data, AI increases the quantity and accuracy of diagnostic, clinical, treatment, and outcome databases, which tend to grow much larger than a human practitioner could feasibly assimilate and analyze . In the future, practitioners will rely heavily upon increasingly intuitive computer-assisted decision support systems (and thus the accuracy of their underlying rule-bases, and to a lesser extent the medical wisdom of their endorsing users) in order to "customize" the best treatment. Machine learning will be used to combine large datasets and compare them against past experiences, in hopes of attaining optimum conclusions especially regarding rare or complex cases.
Artificial intelligence will also be applied to the detection of dangerous or fraudulent patterns of prescribing behavior — in real time, as prescriptions are written.
AI’s increasing intrusion into medical practice raises a number of daunting legal and ethical questions. For instance, it is almost certain that widespread reliance upon AI systems will, in many cases, lead to patients’ successful claims of malpractice arising from the exercise of "faulty" AI-driven decisions of their physicians.
At the same time, the unprecedented growth of physician-operated telemedicine poses additional complex legal and ethical issues, and presents yet another amplitude of potential liability. Patient privacy will be an ongoing challenge, zoonotic diseases constitute looming danger, and physicians who provide cross-state treatment without face-to-face contact may easily transgress state and national legal barriers.
The heightened complexity of increasingly globalized medicine will also confront many would-be lawyers by imposing unaccustomed capabilities and responsibilities. As globalization continues to permeate medical practice, so too will the need to expand pending medical concepts for the delivery of medical care, and the specialized expertise essential to ensure effective cross-jurisdictional practice and liability management.