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Health law is a field of law that encompasses federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the health care industry and its patients, and delivery of health care services, with an emphasis on operations, regulatory and transactional issues. [1] [2]
The Florida Bar defines "health law" as "legal issues involving federal, state, or local law, rules or regulations and health care provider issues, regulation of providers, legal issues regarding relationships between and among providers, legal issues regarding relationships between providers and payers, and legal issues regarding the delivery of health care services." [3] [4] American University's college of law, in health law and policy, divides health law into 4 areas: health care law (focused on treatment), public and population health law (focused on prevention), bioethics, and global health law.
The terms "legislation" and "law" are used to refer generically to statutes, regulation and other legal instruments (e.g. ministerial decrees) that may be the forms of law used in a particular country. [5]
In general, there are a wide range of regulatory strategies that may be used to ensure people's health and safety. Increasingly, regulators are taking an approach of "responsive regulation". This involves using mechanisms that are responsive to the context, conduct, and culture of those being regulated, providing for a range of regulatory mechanisms to achieve the behavior desired. Where appropriate, the aim is to use incentives before sanctions. However, when those being regulated do not respond accordingly, escalating sanctions can be invoked. These strategies may be broadly classified into five groups:
Areas of law that may fall under the umbrella of health law include:
In the U.S., medicine and the law are interconnected. The law intervenes to regulate the duty to treat, that essentially is ruled by contract law, which gives a doctor the right to refuse treatment, in the absence of an emergency, when no previous doctor-patient relationship existed. However Doctors cannot discriminate because of disability, ADA, abandon a patient, or not render services in an emergency according to EMTALA (it aims doctors in emergency rooms, where they need to screen, stabilize and transfer. It also regulates the fiduciary duties of doctor-patient, such as privacy HIPAA, informed consent (battery unlawful touch), conflict of interests, (Moore case), etc.
Health Law was first adopted as a separate legal specialty in which attorneys could become "board-certified" and in which they could hold themselves out as a "legal specialist" or "legal expert" by The Florida Bar's Board of Legal Specialization in 1995. [6] Later Texas adopted a similar program in 2002 modeling its program after Florida's. [7]
One way in which an attorney in the United States can obtain additional education to practice health law or to use in becoming certified in the specialty of health law is through Master of Laws (LL.M.) programs offered by certain law schools. The LL.M. is considered to be a postgraduate law degree which shows a higher level of course work and study above the basic law degree (J.D. or B.S.L.). Some law schools with graduate law programs do offer a general LL.M. with course emphasis on health law, global health law, public health law, forensic medicine or similar studies. [8]
Medical malpractice is also an area where law and medicine are interconnected, which relates to the standard of care, where custom similar locality rule may apply. [9] There may be different schools of thought, where reputability is the issue at hand and alternative theories that can be based on the hand formula.
There are other aspects of importance within the area of medical malpractice, such as causation, where medical probability and loss of chance are present. Damages, where the value of life and tort reforms appear to differ, and affirmative defenses, within the doctrine of informed consent, where waivers cannot suffice. There are rules such as the discovery rule that states that the statute of limitations starts to run when the injury has been discovered and not when it took place. [10]
Informed consent is a principle in medical ethics and medical law and media studies, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatments, alternative treatments, the patient's role in treatment, and their right to refuse treatment. In most systems, healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is informed. This principle applies more broadly than healthcare intervention, for example to conduct research and to disclose a person's medical information.
In the United States, a health maintenance organization (HMO) is a medical insurance group that provides health services for a fixed annual fee. It is an organization that provides or arranges managed care for health insurance, self-funded health care benefit plans, individuals, and other entities, acting as a liaison with health care providers on a prepaid basis. The Health Maintenance Organization Act of 1973 required employers with 25 or more employees to offer federally certified HMO options if the employer offers traditional healthcare options. Unlike traditional indemnity insurance, an HMO covers care rendered by those doctors and other professionals who have agreed by contract to treat patients in accordance with the HMO's guidelines and restrictions in exchange for a steady stream of customers. HMOs cover emergency care regardless of the health care provider's contracted status.
Bioethics is both a field of study and professional practice, interested in ethical issues related to health, including those emerging from advances in biology, medicine, and technologies. It proposes the discussion about moral discernment in society and it is often related to medical policy and practice, but also to broader questions as environment, well-being and public health. Bioethics is concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, theology and philosophy. It includes the study of values relating to primary care, other branches of medicine, ethical education in science, animal, and environmental ethics, and public health.
Medical ethics is an applied branch of ethics which analyzes the practice of clinical medicine and related scientific research. Medical ethics is based on a set of values that professionals can refer to in the case of any confusion or conflict. These values include the respect for autonomy, non-maleficence, beneficence, and justice. Such tenets may allow doctors, care providers, and families to create a treatment plan and work towards the same common goal. It is important to note that these four values are not ranked in order of importance or relevance and that they all encompass values pertaining to medical ethics. However, a conflict may arise leading to the need for hierarchy in an ethical system, such that some moral elements overrule others with the purpose of applying the best moral judgement to a difficult medical situation. Medical ethics is particularly relevant in decisions regarding involuntary treatment and involuntary commitment.
Confidentiality involves a set of rules or a promise usually executed through confidentiality agreements that limits the access or places restrictions on certain types of information.
A medical license is an occupational license that permits a person to legally practice medicine. In most countries, a person must have a medical license bestowed either by a specified government-approved professional association or a government agency before they can practice medicine. Licenses are not granted automatically to all people with medical degrees. A medical school graduate must receive a license to practice medicine to legally be called a physician. The process typically requires testing by a medical board. The medical license is the documentation of authority to practice medicine within a certain locality. An active license is also required to practice medicine as an assistant physician, a physician assistant or a clinical officer in jurisdictions with authorizing legislation.
Medical privacy, or health privacy, is the practice of maintaining the security and confidentiality of patient records. It involves both the conversational discretion of health care providers and the security of medical records. The terms can also refer to the physical privacy of patients from other patients and providers while in a medical facility, and to modesty in medical settings. Modern concerns include the degree of disclosure to insurance companies, employers, and other third parties. The advent of electronic medical records (EMR) and patient care management systems (PCMS) have raised new concerns about privacy, balanced with efforts to reduce duplication of services and medical errors.
The Health Insurance Portability and Accountability Act of 1996 is a United States Act of Congress enacted by the 104th United States Congress and signed into law by President Bill Clinton on August 21, 1996. It modernized the flow of healthcare information, stipulates how personally identifiable information maintained by the healthcare and healthcare insurance industries should be protected from fraud and theft, and addressed some limitations on healthcare insurance coverage. It generally prohibits healthcare providers and healthcare businesses, called covered entities, from disclosing protected information to anyone other than a patient and the patient's authorized representatives without their consent. With limited exceptions, it does not restrict patients from receiving information about themselves. It does not prohibit patients from voluntarily sharing their health information however they choose, nor does it require confidentiality where a patient discloses medical information to family members, friends, or other individuals not a part of a covered entity.
A dietitian, medical dietitian, or dietician is an expert in identifying and treating disease-related malnutrition and in conducting medical nutrition therapy, for example designing an enteral tube feeding regimen or mitigating the effects of cancer cachexia. Many dietitians work in hospitals and usually see specific patients where a nutritional assessment and intervention has been requested by a doctor or nurse, for example if a patient has lost their ability to swallow or requires artificial nutrition due to intestinal failure. Dietitians are regulated healthcare professionals licensed to assess, diagnose, and treat such problems. In the United Kingdom, dietitian is a 'protected title', meaning identifying yourself as a dietitian without appropriate education and registration is prohibited by law.
Medical malpractice is professional negligence by act or omission by a health care provider in which the treatment provided falls below the accepted standard of practice in the medical community and causes injury or death to the patient, with most cases involving medical error. Claims of medical malpractice, when pursued in US courts, are processed as civil torts. Sometimes an act of medical malpractice will also constitute a criminal act, as in the case of the death of Michael Jackson.
The terms medical record, health record and medical chart are used somewhat interchangeably to describe the systematic documentation of a single patient's medical history and care across time within one particular health care provider's jurisdiction. A medical record includes a variety of types of "notes" entered over time by healthcare professionals, recording observations and administration of drugs and therapies, orders for the administration of drugs and therapies, test results, X-rays, reports, etc. The maintenance of complete and accurate medical records is a requirement of health care providers and is generally enforced as a licensing or certification prerequisite.
Health technology is defined by the World Health Organization as the "application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures, and systems developed to solve a health problem and improve quality of lives". This includes pharmaceuticals, devices, procedures, and organizational systems used in the healthcare industry, as well as computer-supported information systems. In the United States, these technologies involve standardized physical objects, as well as traditional and designed social means and methods to treat or care for patients.
Medical advice is the provision of a formal professional opinion regarding what a specific individual should or should not do to restore or preserve health. Typically, medical advice involves giving a diagnosis and/or prescribing a treatment for medical condition.
Conscience clauses are legal clauses attached to laws in some parts of the United States and other countries which permit pharmacists, physicians, and/or other providers of health care not to provide certain medical services for reasons of religion or conscience. It can also involve parents withholding consenting for particular treatments for their children.
The Patient Safety and Quality Improvement Act of 2005 (PSQIA): Pub. L. 109–41 (text)(PDF), 42 U.S.C. ch. 6A subch. VII part C, established a system of patient safety organizations and a national patient safety database. To encourage reporting and broad discussion of adverse events, near misses, and dangerous conditions, it also established privilege and confidentiality protections for Patient Safety Work Product. The PSQIA was introduced by Sen. Jim Jeffords [I-VT]. It passed in the Senate July 21, 2005 by unanimous consent, and passed the House of Representatives on July 27, 2005, with 428 Ayes, 3 Nays, and 2 Present/Not Voting.
Medical law is the branch of law which concerns the prerogatives and responsibilities of medical professionals and the rights of the patient. It should not be confused with medical jurisprudence, which is a branch of medicine, rather than a branch of law.
Medical malpractice is a legal cause of action that occurs when a medical or health care professional, through a negligent act or omission, deviates from standards in their profession, thereby causing injury or death to a patient. The negligence might arise from errors in diagnosis, treatment, aftercare or health management.
Canterbury v. Spence was a landmark federal case decided by the United States Court of Appeals for the District of Columbia Circuit that significantly reshaped malpractice law in the United States. It established the idea of "informed consent" to medical procedures.
The authority for patient rights in New Zealand comes from the Health and Disability Commissioner Act 1994, the specific rules come from Health and Disability Commissioner Regulations 1996. This code improves the quality of healthcare in New Zealand and ensures that there is a consistent expectation for all consumers.
Kathryn M. Zeiler is the Nancy Barton Scholar and Professor of Law at Boston University School of Law. Zeiler's work primarily focuses on health law, torts law, law and economics, medical malpractice, and disclosure law.
Media related to Health law at Wikimedia Commons
