Medical law refers to the complex system of state and federal laws that regulate the practice of medicine in the United States.
Medical law includes educational and licensing requirements, civil litigation involving physicians or their employees (such as lawsuits for malpractice or negligence), criminal cases in which physicians are called as expert witnesses, duties involving birth or death certificates, and duties to report diseases and suspected abuse. Laws related to these aspects of medical practice are usually administered at the state level. Federal laws affecting medical practice include such matters as regulation of controlled substances (narcotics); laws related to fair hiring and employment practices, occupational safety and health, and workers' compensation; laws concerning credit reporting and debt collection practices; and similar matters.
The practice of medicine in the United States was not always as highly regulated as it is in the early twenty-first century. Prior to the early twentieth century, medical education was not even standardized. People could enter the profession in one of three ways: by serving an apprenticeship with a practicing physician; by completing a course of study at a proprietary school (a medical college owned by a group of local physicians); or by graduating from a medical school affiliated with a university and a teaching hospital. There was no standard curriculum. The various schools taught osteopathy, homeopathy, chiropractic, and naturopathy as well as scientific medicine. Of the 155 medical schools in the United States in 1900, three were open only to women and eight only to African Americans.
In 1904 the American Medical Association (AMA) formed a Council on Medical Education (CME) in order to standardize requirements for entry into the profession. The CME pressed for two reforms: the standardization of undergraduate premedical course requirements, and the institution of an "ideal" curriculum for the MD degree—two years of laboratory work in science followed by two years of clinical rotation in a teaching hospital. In 1908 Abraham Flexner was hired by the Carnegie Foundation for the Advancement of Teaching to survey all 155 medical schools in the United States. He issued a report in 1910 that emphasized the importance of raising admission standards and educational requirements for medical practice. The Flexner Report became the basis for a gradual elimination of the proprietary medical colleges and the other schools that were academically weak. One of the unfortunate side effects of the Flexner Report was the closing of all but two of the African American medical schools, resulting in a large underserved rural and minority population, particularly in the South.
Medical practice acts and licensure regulations
In addition to curricular reform, Abraham Flexner was also responsible for proposing that medical licensure should be regulated by the government of each state. State licensing boards were formed in quick succession after 1910. In 1912 a group of these new boards formed the Federation of State Medical Boards (FSMB), currently based in Dallas, Texas. Three years later, the National Board of Medical Examiners (NBME) was established in Philadelphia to provide a nationwide voluntary examination that the various state boards could accept as a standard for a medical license. Prior to 1992, the NBME administered a three-part certifying examination, while the FSMB offered a Federation Licensing Examination, or FLEX. The NBME and FSMB then jointly sponsored a successor examination called the United States Medical Licensing Examination, or USMLE. The USMLE is a three-step examination administered all year round by computer at various test centers. Step 1 assesses the candidate's knowledge of basic science and ability to apply it to the practice of medicine, while Step 2 assesses the candidate's clinical skills. These portions of the USMLE can be taken at test centers outside as well as inside the United States. Step 3, which must be taken at a test center within the United States, measures whether the candidate is competent to practice medicine without supervision.
The next phase in obtaining licensure is the submission of a resumé or curriculum vitae (CV) to the state licensing board. This document allows the board to evaluate potential problem areas as well as verify the candidate's credentials. The AMA advises candidates "never [to] try to hide derogatory information from the licensing board," as false statements on an application for licensure are usually grounds for denial. It may take 60 days or longer for a state board to grant a license after all the documentation has been submitted. A valid license is an absolute necessity for practicing medicine in the United States, in that anyone who practices without one is liable to lawsuits for malpractice.
SPECIALTY CERTIFICATION. In addition to general state licensure, the majority of practicing physicians in the United States are certified by one or more specialty boards. Board certification is one form of professional self-regulation for physicians. The first specialty board, the American Board for Ophthalmic Examinations, was formed in 1917; others soon followed. As of 2005, the American Board of Medical Specialties (ABMS) has twenty-four member specialty boards in fields ranging from allergy and immunology to thoracic surgery and urology. The boards issue 37 general and 92 subspecialty certificates.
Important changes in specialty board certification are being implemented as of 2005 in response to concerns about quality of care and standards set by such entities as the Joint Commission on Accreditation of Healthcare Organizations. The first change is that board certification will no longer be lifelong. Some specialty boards began issuing time-limited certificates as early as 1970, but most have not. By 2006, all member boards of the ABMS will issue time-limited certification for periods of ten years or less.
The second change in the board certification process is that each specialty board will submit a plan for eventually moving from recertification through examinations every six to ten years, to an ongoing "maintenance of certification" assessment of physicians' competence. As of late 2005, five specialty boards have plans for the transition approved by the ABMS, with 14 others under review.
MONITORING SYSTEMS. In addition to state and specialty board regulations of medical licensure, the United States Department of Health and Human Services maintains a National Practitioner Data Bank (NPDB), which serves as a flagging system to alert state licensing boards, hospitals, insurance companies, and other entities to records of malpractice payments or other adverse events on a physician or dentist's record. The NPDB was set up in 1990 following several high-profile cases involving incompetent or mentally disturbed physicians who moved from state to state to conceal negative histories, including criminal records. The data bank is prohibited by law from revealing information about a specific practitioner to the general public.
The concept of professional liability has been expanded in recent years to include all healthcare professionals associated with a specific case. As a result, physicians must assume legal responsibility for actions performed by their employees as well as their own acts. Most lawsuits against physicians are brought for either malpractice or negligence.
MALPRACTICE AND NEGLIGENCE. Malpractice in law refers to "any professional misconduct, unreasonable lack of skill or fidelity in professional or fiduciary duties, evil practices, or immoral or illegal conduct." As was mentioned earlier, practicing medicine without a valid license is grounds for a malpractice suit. Negligence refers to carelessness or failure to take reasonable and prudent measures to ensure that others are not harmed by one's actions It may include performing an action incorrectly (commission) as well as failing to take appropriate action (omission). Incorrect performance of an otherwise proper or lawful act is known as misfeasance, while failure to perform a necessary action is called nonfeasance. Malpractice and negligence are classified as torts, which are civil cases involving wrongful acts that result in harm to another person or to property. Tort law covers intentional as well as unintentional acts. It is decided by common (court) law rather than statutory law; that is, a civil court rather than the legislature determines whether a wrongful act involves tort liability.
Malpractice litigation is generally considered a contributing factor in the shortage of physicians in many parts of the United States and in the rising cost of healthcare. In February 2005 the AMA reported to the United States House of Representatives that 20 of the 50 states are in a crisis situation because of the numbers of physicians leaving the practice of medicine altogether, relocating to other states, or no longer performing certain procedures because of the risk of litigation. One study found that 48% of medical students mentioned liability as a factor in their choice of specialties, as some specialties (emergency medicine, obstetrics/gynecology, neurosurgery, orthopedic surgery, and radiology) are at considerably higher risk of malpractice lawsuits than others. Another group of researchers reported in 2005 that 93% of the physicians they surveyed practiced so-called defensive medicine; that is, they ordered imaging tests and diagnostic procedures that were not always clinically necessary. Another 42% of survey respondents reported that they had restricted their practice in the preceding three years by eliminating complex procedures or by avoiding patients perceived as likely to sue.
RESPONDEAT SUPERIOR. Respondeat superior is a Latin phrase that means "let the master (employer) answer," and refers to the legal principle that an employer is legally responsible for the actions of an employee carried out "in the course of employment." Since most physicians have an office staff of two or more employees, anything that a staff member does that injures a patient may lead to a lawsuit against the physician as well as the medical assistant or other staff member. The doctrine of respondeat superior is one reason why the type of medical practice known as sole proprietorship, in which one doctor hires other doctors and pays them salaries, is rapidly disappearing in the United States. In this type of practice, the doctor who owns the practice is legally responsible for the actions of all the other doctors he or she employs.
REDUCING THE RISK OF LITIGATION. Legal professionals advise physicians to take the following steps to protect themselves against lawsuits for malpractice or negligence:
- Keep a copy of all signed applications for licensing or specialty board credentials in a safe place so that the documents can be consulted for consistency when later applications are made or if questions are raised by the certifying board.
- Make sure that all members of the practice are properly licensed and qualified to perform their tasks, and that they are not carrying out tasks for which they are not licensed or certified.
- Make sure that all members of the practice carry their own malpractice insurance.
- Be sure that hospital staff privileges and federal drug registrations for members of the practice who write prescriptions are maintained in good standing. A violation of the Controlled Substances Act of 1970 is a criminal offense that can result in the loss of licensure as well as a fine and a prison sentence.
- Verify that all offices, surgery centers, and laboratories are properly licensed.
- Insist that office staff handle patient complaints promptly and properly.
- Make sure that all patient files, billing records, and computer documents are handled with strict confidentiality.
- Maintain prompt and appropriate compliance with all third-party payor rules and requirements.
A recent innovation that appears to be effective in reducing the number of malpractice suits is the "Sorry Works!" program for review and compensation of medical errors. In June 2005, Illinois became the first state to institute a pilot program for dealing with adverse incidents. The Illinois program outlines four steps for dealing with medical errors:
- The hospital(s) and physician(s) involved investigate the incident thoroughly without regard to the outcome.
- The hospital contacts the patient and/or family and schedules a meeting with the family's attorney present.
- If a mistake was made, the hospital and physician apologize and (if appropriate) offer compensation. They then draw up a plan to prevent recurrence of the error.
- If no mistake was made, the hospital and physician offer their sympathy together with full disclosure of the patient's file and investigation findings.
Criminal charges against a physician are a serious matter because they can end a career in medicine. State medical boards usually revoke the license to practice if the accused physician is convicted of a crime. Most criminal cases against physicians have involved one of five charges: sexual misconduct, tax evasion, murder, counterfeiting, and violation of federal narcotics laws.
Criminal cases in the United States differ from civil suits in two important respects. The first is that a higher standard of proof is required in criminal cases. In a malpractice or other civil suit, the case is decided on the basis of "preponderance of the evidence," which means that the evidence presented by one party in the case is considered more believable than that that produced by the other. In criminal cases, however, the defendant's guilt must be shown "beyond a reasonable doubt," which is a much more stringent criterion. The second major difference is that professional liability insurance cannot be used to cover the costs of defending oneself against a criminal charge.
Physicians are required by law to carry out certain public duties. These include signing certificates of live births and natural deaths. Most states require death certificates to be signed within 24-72 hours after death. In cases of violent death, suicide, suspected murder, no physician present at the time of death, death of an unknown or unidentifiable person, death in prison, or other types of suspicious death, the certificate usually requires the signature of a medical examiner or coroner.
Physicians are required by law to report any of the following:
- Cases of communicable diseases that are considered a public health threat. These include tuberculosis, rubella, tetanus, cholera, polio, rheumatic fever, diphtheria, AIDS and other sexually transmitted diseases, and meningococcal meningitis. Case reports of influenza or West Nile virus may be required during epidemics. Some states add Lyme disease and other communicable diseases to the list.
- Adverse reactions to any childhood vaccines and toxoids.
- Suspected child abuse, elder abuse, or spouse abuse.
- Abuse of prescription medications.
- Many states require the filing of reports for such noncommunicable diseases as cancer or epilepsy in order to maintain accurate public health statistics.
Most states also require physicians to report instances of malpractice or inappropriate treatment on the part of colleagues.
Ethical violations refer to breaking rules that reflect the values or goals of the medical profession. The AMA has a formal Code of Ethics that enjoins physicians to exemplify the values of integrity, honesty, respect for all humans, fairness, and responsibility to the community. A physician who is accused of such unethical behavior as fee splitting, falsifying data for a drug research study, performing medical procedures while impaired by the use of drugs or alcohol, sexual relationships with patients, violating patient confidentiality, or other types of professional misconduct, may be censured by the AMA. The AMA's Board of Examiners may also recommend expulsion or suspension of membership in the physician's state or local medical association. Although expulsion is a professional rather than a legal penalty, it severely limits a physician's ability to practice medicine. The AMA recommends that patients who wish to report a physician for ethical violations contact the state medical society first before reporting the incident(s) to the AMA itself.
Forensic medicine refers to the practice of medicine in courtroom settings or otherwise related to legal matters. It includes such matters as investigating the causes of violent or suspicious deaths and providing advanced training for physicians or dentists to serve as expert witnesses in criminal or civil trials. An expert witness is a person called by a judge to explain specialized information in a case in which the subject matter is outside the competence of most jurors, court reporters, or others in the courtroom. Physicians or dentists may be called as expert witnesses to explain the causes of death in a murder case, or to testify to generally accepted standards of care in a medical malpractice case.
Expert witnesses are paid a fee for their service to the court. The fee, however, should not depend on the outcome of the trial, as the law considers physicians who appear as expert witnesses to be engaged in the practice of medicine. This point is an important safeguard against any temptation to present a biased account of the evidence or to lie intentionally in order to benefit from one of the parties in the case. A physician who knowingly presents false information in court can be punished for perjury, which is defined as the willful making of verifiably false statements under oath in a court of law. Perjury does not, however, include unintentional errors or offering an interpretation of the evidence that later turns out to be incorrect.
From the standpoint of legal definitions and tax regulations, there are six basic types of medical practice:
- Solo practice. In a solo practice, one doctor practices alone. Many dentists still maintain solo practices; physicians, however, are increasingly reluctant to set up solo practices because of the need to repay loans for their medical education and the high cost of maintaining an independent office.
- Sole proprietorship. In this type of practice, one doctor employs other physicians as salaried professionals, pays all the expenses of the practice, and retains control of all assets.
- Partnership. In a partnership, two or more physicians draw up a legal agreement to share in the business operation of a medical practice. Each partner is legally responsible for the actions of all the other partners.
- Associate practice. In this type of practice, the physicians share staff and facilities but not the profits and losses. They also do not share legal responsibilities for one another's actions.
- Group practice. In a group practice, three or more physicians share the same facilities and practice medicine together. They share all expenses, income, staff, equipment, and records. Group practices may be legally defined as either health maintenance organizations (HMOs) or independent practice associations (IPAs). Large group practices of over 100 physicians are no longer unusual.
- Professional corporation. Professional corporations for physicians were made possible by changes in state legislation in the 1960s. The physicians who participate in the corporation become shareholders and are eligible for such fringe benefits as disability insurance or profit-sharing arrangements. Another advantage of forming a corporation for many physicians is that members are protected from losing their individual assets if the corporation is sued.
Education and training
Because of the increasingly complex network of regulations and other legal considerations surrounding the practice of medicine, a number of medical schools in the United States and Canada now offer or require courses in law as part of the course work for the MD degree. In 1999, 11 of the 125 medical schools in the United States required students to take a course in medical jurisprudence, while 96 schools offered the subject as part of an existing required course. Sixty-seven schools offered courses in health law as electives. One law professor states that at the minimum level, all medical students should acquire a familiarity with laws that affect their patients and those that affect their relationships with their patients. In addition, she maintains that courses offered jointly to law and medical students are helpful in helping students in both fields come to a clearer understanding of the patterns of reasoning and analysis used by members of the other profession.
Civil law— The branch of law that deals with matters between two individuals or between an individual and the government that do not concern criminal acts.
Common law— The system of law that originated in England between 1300 and 1500 and is based on custom or court decisions rather than laws enacted by a ruler or legislature. Common law is also known as case law.
Controlled Substances Act (CSA)— A law passed by Congress in 1970 to regulate the manufacture, distribution, and possession of narcotics and certain other drugs. Drugs are divided into five schedules (categories) according to their potential for abuse, potential for addiction, and accepted medical use(s). The classification of drugs is administered jointly by the Department of Justice and the Food and Drug Administration (FDA).
Coroner— An officer who holds inquests regarding violent, sudden, or unexplained deaths. Coroners in the United States may be elected officials who are finders of fact or they may be physicians. In the latter case, they are usually called medical examiners. The name is derived from "crown," because coroners in medieval England were minor officials of the Crown.
Ethics— The rules or principles governing right conduct. The term is also used to refer to the branch of philosophy that studies these rules.
Expert witness— A person called to appear in court in order to explain certain facts or points of information relevant to the case that lie outside the general knowledge of most nonspecialists.
Fee splitting— Accepting payment for referring patients to another physician.
Forensic— Referring to legal or courtroom matters.
Impairment— A condition of incompetence to practice medicine resulting from a physical injury or disease, psychiatric disorder, or substance abuse.
Liability— The state or condition of being legally responsible for an act or event.
Medical malpractice— Intentional abandonment of duty or failure to exercise medical skill on the part of a physician rendering services that results in loss, injury, or damage.
Negligence— Failure to perform one's professional duties according to an accepted standard of care.
Perjury— The making of verifiably false statements under oath in a court of law.
Respondeat superior— The legal principle that holds an employer responsible for the actions of employees performed in the course of employment.
Statutory law— Written law enacted by a legislature, as distinguished from unwritten law or common law.
Tort— A wrongful act against another person or property that results in harm. Torts are considered civil cases and are settled by common law (court decisions) rather than by statutory law.
Advanced education and training
As of the early 2000s, there are a growing number of physicians who take earn a second degree in law. The American College of Legal Medicine (ACLM) was founded in 1960 to meet the growing demand for interprofessional cooperation as well as better understanding of medico-legal issues among attorneys as well as physicians. Seventeen medical schools in the United States and Canada offer joint MD/JD programs as of 2005. These programs typically take six years to complete. The usual pattern for joint degree programs consists of two years of preclinical course work at the medical school, followed by two years of courses in the law school and completed by two years of clinical rotations at the medical school. MD/JD programs are particularly attractive to four groups of students:
- Those interested in a career in government healthcare policy
- Those who wish to serve on the executive board of a hospital
- Those who wish to specialize in forensic medicine
- Those who want to practice law with a focus on medical issues
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American Board of Medical Specialties (ABMS). 1007 Church Street, Suite 404, Evanston, IL 60201-5913. (847) 491-9091. Fax: (847) 328-5956. http://www.abms.org.
American College of Legal Medicine (ACLM). 1111 North Plaza Drive, Suite 550, Schaumburg, IL 60173. (847) 969-0283. Fax: (847) 517-7229. http://www.aclm.org.
American Medical Association (AMA). 515 North State Street, Chicago, IL 60610. (8000) 621-8335. http://www.ama-assn.org.
Federation of State Medical Boards of the United States, Inc. (FSMB). P. O. Box 619850, Dallas, TX 75261-9850. (817) 868-4000. Fax: (817) 868-4099. http://www.fsmb.org.
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