The following is a list of Federal Laws that we feel are relevant for this time.
Remember: when you complete your Letter of Intent – only include the violations that are relevant for your situation.
Abuse of Power: Color of Law or Color of Office: Section 1983 provides redress for constitutional violations committed “under color of” state law.2 In Monroe v. Pape, 3 the Court interpreted this phrase to include deprivations of constitutional rights caused by state officers acting either without authority or, what is much the same, in violation of state law.
Harmful-to-minors laws SB 17: prevents elementary and secondary schools and non- college/university libraries from raising a defense to the law-making at a felony to expose minors to “harmful” material. It also strips away protections for material that is disseminated for educational purposes. It lets parents sue to enforce this criminal statute, and would also allow parents to use it if they object to any part of the school curriculum or material available in a school library.
The Equal Employment Opportunity Commission (EEOC) guidance on mandates. Regardless of whether these products are under EUA, or move into full licensure, anti-discrimination laws, both State and Federal, still apply regardless of mandates or product authorization. Even the EEOC stated that “EUA recognized protections that must be afforded to employees seeking exemption from vaccination [or other] requirements, due to medical conditions or sincerely-held religious beliefs.”
Expanded the definition of terrorism to cover “”domestic,”” as opposed to international, terrorism. A person engages in domestic terrorism if they do an act “dangerous to human life” that is a violation of the criminal laws of a state or the United States, if the act appears to be intended to: (i) intimidate or coerce a civilian population; (ii) influence the policy of a government by intimidation or coercion.
Bio-Chemical Warfare – Geneva Protocol A treaty prohibiting the use of chemical and biological weapons in international conflicts. This protocol prohibits the use of bacteriological methods of warfare, asphyxiating, poisonous or other gases, analogous liquids, materials or devices during wartime. This is understood to be a general prohibition on chemical weapons and biological weapons.
U.S.C. 1st Amendment clearly states: Congress shall make no law respecting an establishment of religion or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances.
U.S.C. 5th Amendment…Deprivation of life, liberty, or property, without due process of law; nor shall private property be taken for public use, without just compensation.
16 Am Jur 2d §71 Effect of Emergency. It is sometimes argued that the existence of an emergency allows the existence and operation of powers, national or state, which violate the inhibitions of the Federal Constitution. The rule is quite otherwise. No emergency justifies the violation of any of the provisions of the United States Constitution.
16 Am Jur 2d Sec 177 late 2d, Sec 256: The general misconception is that any statute passed by legislators bearing the appearance of law constitutes the law of the land. The U.S. Constitution is the supreme law of the land, and any statute, to be valid, must be in agreement. It is impossible for both the Constitution and a law violating it to be valid; one must prevail. An unconstitutional law cannot operate to supersede any existing valid law. Indeed, insofar as a statute runs counter to the fundamental law of the land, it is superseded thereby. No one Is bound to obey an unconstitutional law and no courts are bound to enforce it
18 U.S. Code § 1470 – Transfer of obscene material to minors: Whoever, using the mail or any facility or means of interstate or foreign commerce, knowingly transfers obscene matter to another individual who has not attained the age of 16 years, knowing that such other individual has not attained the age of 16 years, or attempts to do so, shall be fined under this title, imprisoned not more than 10 years, or both.
(a) In General.-Whoever- (1) forcibly assaults, resists, opposes, impedes, intimidates, or interferes with any person designated in section 1114 of this title while engaged in or on account of the performance of official duties; or (2) forcibly assaults or intimidates any person who formerly served as a person designated in section 1114 on account of the performance of official duties during such person’s term of service.
(a) Whoever, with the intent to defraud-
(1) draws, prints, processes, produces, publishes, or otherwise makes, or attempts or causes the same, within the United States;
(2) passes, utters, presents, offers, brokers, issues, sells, or attempts or causes the same, or with like intent possesses, within the United States; or
(3) utilizes interstate or foreign commerce, including the use of the mails or wire, radio, or other electronic communication, to transmit, transport, ship, move, transfer, or attempts or causes the same, to, from, or through the United States
(1) any person because he is or has been, or in order to intimidate such person or any other person or any class of persons from-
(A) voting or qualifying to vote, qualifying or campaigning as a candidate for elective office, or qualifying or acting as a poll watcher, or any legally authorized election official, in any primary, special, or general election;
(B) participating in or enjoying any benefit, service, privilege, program, facility, or activity provided or administered by the United States;
(C) applying for or enjoying employment, or any perquisite thereof, by any agency of the United States;
(D) serving, or attending upon any court in connection with possible service, as a grand or petit juror in any court of the United States;
(E) participating in or enjoying the benefits of any program or activity receiving Federal financial assistance; or
(2) any person because of his race, color, religion or national origin and because he is or has been-
(A) enrolling in or attending any public school or public college;
Whoever directly or indirectly deprives, attempts to deprive, or threatens to deprive any person of any employment, position, work, compensation, or other benefit provided for or made possible in whole or in part by any Act of Congress appropriating funds for work relief or relief purposes, on account of political affiliation, race, color, sex, religion, or national origin, shall be fined under this title, or imprisoned not more than one year, or both.
If two or more persons conspire to injure, oppress, threaten, or intimidate any person in any State, Territory, Commonwealth, Possession, or District in the free exercise or enjoyment of any right or privilege secured to him by the Constitution or laws of the United States, or because of his having so exercised the same.
No person in the United States shall, on the basis of sex, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any education program or activity receiving Federal financial assistance, except that.
Every person who, under color of any statute, ordinance, regulation, custom, or usage, of any State or Territory or the District of Columbia, subjects, or causes to be subjected, any citizen of the United States or other person within the jurisdiction thereof to the deprivation of any rights, privileges, or immunities secured by the Constitution and laws, shall be liable to the party injured in an action at law, suit in equity, or other proper proceeding for redress, except that in any action brought against a judicial officer for an act or omission taken in such officer’s judicial capacity, injunctive relief shall not be granted unless a declaratory decree was violated or declaratory relief was unavailable. For the purposes of this section, any Act of Congress applicable exclusively to the District of Columbia shall be considered to be a statute of the District of Columbia.
If two or more persons in any State or Territory conspire to prevent, by force, intimidation, or threat, any person from accepting or holding any office, trust, or place of confidence under the United States, or from discharging any duties thereof; or to induce by like means any officer of the United States to leave any State, district, or place, where his duties as an officer are required to be performed, or to injure him in his person or property on account of his lawful discharge of the duties of his office, or while engaged in the lawful discharge thereof, or to injure his property so as to molest, interrupt, hinder, or impede him in the discharge of his official duties.
(1) “Fiduciary” means an agent, trustee, partner, corporate officer or director, or other representative owing a fiduciary duty with respect to an instrument.
(2) “Represented person” means the principal, beneficiary, partnership, corporation, or other person to whom the duty stated in paragraph (1) is owed.
Emergency dispensing – The requirements of subsections (b) and (f) of section 353, section 354, and section 360j(e) of this title shall not apply to an eligible product, and the product shall not be considered an unapproved product (as defined in section 360bbb–3(a)(2)(A) of this title) and shall not be deemed adulterated or misbranded under this chapter because it is dispensed without an individual prescription.
To enforce the constitutional right to vote, to confer jurisdiction upon the district courts of the United States to provide injunctive relief against discrimination in public accommodations, to authorize the attorney General to institute suits to protect constitutional rights in public facilities and public education, to extend the Commission on Civil Rights, to prevent discrimination in federally assisted programs, to establish a Commission on Equal Employment Opportunity, and for other purposes.
Every child is entitled to a free and appropriate public education (FAPE).When a school professional believes that a student between the ages of 3 and 21 may have a disability that has substantial impact on the student’s learning or behavior, the student is entitled to an evaluation in all areas related to the suspected disability. Creation of an Individualized Education Plan (IEP)
Whoever, under color of any law, statute, ordinance, regulation, or custom, willfully subjects any person in any State, Territory, Commonwealth, Possession, or District to the deprivation of any rights, privileges, or immunities secured or protected by the Constitution or laws of the United States, or to different punishments, pains, or penalties, on account of such person being an alien, or by reason of his color, or race, than are prescribed for the punishment of citizens, shall be fined under this title or imprisoned not more than one year, or both; and if bodily injury results from the acts committed in violation of this section or if such acts include the use, attempted use, or threatened use of a dangerous weapon, explosives, or fire, shall be fined under this title or imprisoned not more than ten years, or both; and if death results from the acts committed in violation of this section or if such acts include kidnapping or an attempt to kidnap, aggravated sexual abuse, or an attempt to commit aggravated sexual abuse, or an attempt to kill, shall be fined under this title, or imprisoned for any term of years or for life, or both, or may be sentenced to death.
Child Endangerment refers to an act or omission that renders a child to psychological, emotional or physical abuse. Child abuse based on the offense of child endangerment is normally a misdemeanor, but endangerment that results in mental illness or serious physical illness or injury is a felony. The child who is subjected to child endangerment is called an abused child or a neglected child.
An act, or a neglect to perform an act, that causes a child to suffer physical, emotional, or psychological abuse.
An adult caring for a child has a legal responsibility to ensure that child is free from unreasonably dangerous situations. When an adult caregiver fails to adequately protect a child, states often punish this as a crime known as “child endangerment.”
Child endangerment laws are designed to punish behavior that might lead to a child becoming harmed, but they do not require that children actually suffer an injury or physical harm. State laws often categorize child endangerment as placing a child in a situation that might endanger the child’s life, health, welfare, morals, or emotional well-being. However, child endangerment may still be charged in cases where the actions of the caregiver did eventually result in the child being physically injured or harmed.
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.
Article 1
All human beings are born free and equal in dignity and rights. They are endowed with reason and conscience and should act towards one another in a spirit of brotherhood.
Article 2
Everyone is entitled to all the rights and freedoms set forth in this Declaration, without distinction of any kind, such as race, colour, sex, language, religion, political or other opinion, national or social origin, property, birth or other status. Furthermore, no distinction shall be made on the basis of the political, jurisdictional or international status of the country or territory to which a person belongs, whether it be independent, trust, non-self-governing or under any other limitation of sovereignty.
Article 3
Everyone has the right to life, liberty and security of person.
Article 4
No one shall be held in slavery or servitude; slavery and the slave trade shall be prohibited in all their forms.
Article 5
No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.
Article 6
Everyone has the right to recognition everywhere as a person before the law.
Article 7
All are equal before the law and are entitled without any discrimination to equal protection of the law. All are entitled to equal protection against any discrimination in violation of this Declaration and against any incitement to such discrimination.
Article 8
Everyone has the right to an effective remedy by the competent national tribunals for acts violating the fundamental rights granted him by the constitution or by law.
Article 9
No one shall be subjected to arbitrary arrest, detention or exile.
Article 10
Everyone is entitled in full equality to a fair and public hearing by an independent and impartial tribunal, in the determination of his rights and obligations and of any criminal charge against him.
Article 11
Everyone charged with a penal offence has the right to be presumed innocent until proved guilty according to law in a public trial at which he has had all the guarantees necessary for his defence.
No one shall be held guilty of any penal offence on account of any act or omission which did not constitute a penal offence, under national or international law, at the time when it was committed. Nor shall a heavier penalty be imposed than the one that was applicable at the time the penal offence was committed.
Article 12
No one shall be subjected to arbitrary interference with his privacy, family, home or correspondence, nor to attacks upon his honour and reputation. Everyone has the right to the protection of the law against such interference or attacks.
Article 13
Everyone has the right to freedom of movement and residence within the borders of each state.
Everyone has the right to leave any country, including his own, and to return to his country.
Article 14
Everyone has the right to seek and to enjoy in other countries asylum from persecution.
This right may not be invoked in the case of prosecutions genuinely arising from non-political crimes or from acts contrary to the purposes and principles of the United Nations.
Article 15
Everyone has the right to a nationality.
No one shall be arbitrarily deprived of his nationality nor denied the right to change his nationality.
Article 16
Men and women of full age, without any limitation due to race, nationality or religion, have the right to marry and to found a family. They are entitled to equal rights as to marriage, during marriage and at its dissolution.
Marriage shall be entered into only with the free and full consent of the intending spouses.
The family is the natural and fundamental group unit of society and is entitled to protection by society and the State.
Article 17
Everyone has the right to own property alone as well as in association with others.
No one shall be arbitrarily deprived of his property.
Article 18
Everyone has the right to freedom of thought, conscience and religion; this right includes freedom to change his religion or belief, and freedom, either alone or in community with others and in public or private, to manifest his religion or belief in teaching, practice, worship and observance.
Article 19
Everyone has the right to freedom of opinion and expression; this right includes freedom to hold opinions without interference and to seek, receive and impart information and ideas through any media and regardless of frontiers.
Article 20
Everyone has the right to freedom of peaceful assembly and association.
No one may be compelled to belong to an association.
Article 21
Everyone has the right to take part in the government of his country, directly or through freely chosen representatives.
Everyone has the right of equal access to public service in his country.
The will of the people shall be the basis of the authority of government; this will shall be expressed in periodic and genuine elections which shall be by universal and equal suffrage and shall be held by secret vote or by equivalent free voting procedures.
Article 22
Everyone, as a member of society, has the right to social security and is entitled to realization, through national effort and international co-operation and in accordance with the organization and resources of each State, of the economic, social and cultural rights indispensable for his dignity and the free development of his personality.
Article 23
Everyone has the right to work, to free choice of employment, to just and favourable conditions of work and to protection against unemployment.
Everyone, without any discrimination, has the right to equal pay for equal work.
Everyone who works has the right to just and favourable remuneration ensuring for himself and his family an existence worthy of human dignity, and supplemented, if necessary, by other means of social protection.
Everyone has the right to form and to join trade unions for the protection of his interests.
Article 24
Everyone has the right to rest and leisure, including reasonable limitation of working hours and periodic holidays with pay.
Article 25
Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, widowhood, old age or other lack of livelihood in circumstances beyond his control.
Motherhood and childhood are entitled to special care and assistance. All children, whether born in or out of wedlock, shall enjoy the same social protection.
Article 26
Everyone has the right to education. Education shall be free, at least in the elementary and fundamental stages. Elementary education shall be compulsory. Technical and professional education shall be made generally available and higher education shall be equally accessible to all on the basis of merit.
Education shall be directed to the full development of the human personality and to the strengthening of respect for human rights and fundamental freedoms. It shall promote understanding, tolerance and friendship among all nations, racial or religious groups, and shall further the activities of the United Nations for the maintenance of peace.
Parents have a prior right to choose the kind of education that shall be given to their children.
Article 27
Everyone has the right freely to participate in the cultural life of the community, to enjoy the arts and to share in scientific advancement and its benefits.
Everyone has the right to the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he is the author.
Article 28
Everyone is entitled to a social and international order in which the rights and freedoms set forth in this Declaration can be fully realized.
Article 29
Everyone has duties to the community in which alone the free and full development of his personality is possible.
In the exercise of his rights and freedoms, everyone shall be subject only to such limitations as are determined by law solely for the purpose of securing due recognition and respect for the rights and freedoms of others and of meeting the just requirements of morality, public order and the general welfare in a democratic society.
These rights and freedoms may in no case be exercised contrary to the purposes and principles of the United Nations.
Article 30
Nothing in this Declaration may be interpreted as implying for any State, group or person any right to engage in any activity or to perform any act aimed at the destruction of any of the rights and freedoms set forth herein.
Any goods marked or labeled in contravention of the provisions of this section shall not be imported into the United States or admitted to entry at any customhouse of the United States. The owner, importer, or consignee of goods refused entry at any customhouse under this section may have any recourse by protest or appeal that is given under the customs revenue laws or may have the remedy given by this chapter in cases involving goods refused entry or seized.
Subject to the principles of equity, the owner of a famous mark that is distinctive, inherently or through acquired distinctiveness, shall be entitled to an injunction against another person who, at any time after the owner’s mark has become famous, commences use of a mark or trade name in commerce that is likely to cause dilution by blurring or dilution by tarnishment of the famous mark, regardless of the presence or absence of actual or likely confusion, of competition, or of actual economic injury.
As used in this chapter—
(a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:
(1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.
(2) Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject.
(3) Time is not sufficient to obtain consent from the subject’s legal representative.
(4) There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.
(b) If immediate use of the test article is, in the investigator‘s opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.
(c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.
(d)
(1) Under 10 U.S.C. 1107(f) the President may waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member’s participation in a particular military operation. The statute specifies that only the President may waive informed consent in this connection and the President may grant such a waiver only if the President determines in writing that obtaining consent: Is not feasible; is contrary to the best interests of the military member; or is not in the interests of national security. The statute further provides that in making a determination to waive prior informed consent on the ground that it is not feasible or the ground that it is contrary to the best interests of the military members involved, the President shall apply the standards and criteria that are set forth in the relevant FDA regulations for a waiver of the prior informed consent requirements of section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)). Before such a determination may be made that obtaining informed consent from military personnel prior to the use of an investigational drug (including an antibiotic or biological product) in a specific protocol under an investigational new drug application (IND) sponsored by the Department of Defense (DOD) and limited to specific military personnel involved in a particular military operation is not feasible or is contrary to the best interests of the military members involved the Secretary of Defense must first request such a determination from the President, and certify and document to the President that the following standards and criteria contained in paragraphs (d)(1) through (d)(4) of this section have been met.
(i) The extent and strength of evidence of the safety and effectiveness of the investigational new drug in relation to the medical risk that could be encountered during the military operation supports the drug’s administration under an IND.
(ii) The military operation presents a substantial risk that military personnel may be subject to a chemical, biological, nuclear, or other exposure likely to produce death or serious or life-threatening injury or illness.
(iii) There is no available satisfactory alternative therapeutic or preventive treatment in relation to the intended use of the investigational new drug.
(iv) Conditioning use of the investigational new drug on the voluntary participation of each member could significantly risk the safety and health of any individual member who would decline its use, the safety of other military personnel, and the accomplishment of the military mission.
(v) A duly constituted institutional review board (IRB) established and operated in accordance with the requirements of paragraphs (d)(2) and (d)(3) of this section, responsible for review of the study, has reviewed and approved the investigational new drug protocol and the administration of the investigational new drug without informed consent. DOD’s request is to include the documentation required by § 56.115(a)(2) of this chapter.
(vi) DOD has explained:
(A) The context in which the investigational drug will be administered, e.g., the setting or whether it will be self-administered or it will be administered by a health professional;
(B) The nature of the disease or condition for which the preventive or therapeutic treatment is intended; and
(C) To the extent there are existing data or information available, information on conditions that could alter the effects of the investigational drug.
(vii) DOD’s recordkeeping system is capable of tracking and will be used to track the proposed treatment from supplier to the individual recipient.
(viii) Each member involved in the military operation will be given, prior to the administration of the investigational new drug, a specific written information sheet (including information required by 10 U.S.C. 1107(d)) concerning the investigational new drug, the risks and benefits of its use, potential side effects, and other pertinent information about the appropriate use of the product.
(ix) Medical records of members involved in the military operation will accurately document the receipt by members of the notification required by paragraph (d)(1)(viii) of this section.
(x) Medical records of members involved in the military operation will accurately document the receipt by members of any investigational new drugs in accordance with FDA regulations including part 312 of this chapter.
(xi) DOD will provide adequate followup to assess whether there are beneficial or adverse health consequences that result from the use of the investigational product.
(xii) DOD is pursuing drug development, including a time line, and marketing approval with due diligence.
(xiii) FDA has concluded that the investigational new drug protocol may proceed subject to a decision by the President on the informed consent waiver request.
(xiv) DOD will provide training to the appropriate medical personnel and potential recipients on the specific investigational new drug to be administered prior to its use.
(xv) DOD has stated and justified the time period for which the waiver is needed, not to exceed one year, unless separately renewed under these standards and criteria.
(xvi) DOD shall have a continuing obligation to report to the FDA and to the President any changed circumstances relating to these standards and criteria (including the time period referred to in paragraph (d)(1)(xv) of this section) or that otherwise might affect the determination to use an investigational new drug without informed consent.
(xvii) DOD is to provide public notice as soon as practicable and consistent with classification requirements through notice in the Federal Register describing each waiver of informed consent determination, a summary of the most updated scientific information on the products used, and other pertinent information.
(xviii) Use of the investigational drug without informed consent otherwise conforms with applicable law.
(2) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must include at least 3 nonaffiliated members who shall not be employees or officers of the Federal Government (other than for purposes of membership on the IRB) and shall be required to obtain any necessary security clearances. This IRB shall review the proposed IND protocol at a convened meeting at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas and, if feasible, including a majority of the nonaffiliated members. The information required by § 56.115(a)(2) of this chapter is to be provided to the Secretary of Defense for further review.
(3) The duly constituted institutional review board, described in paragraph (d)(1)(v) of this section, must review and approve:
(i) The required information sheet;
(ii) The adequacy of the plan to disseminate information, including distribution of the information sheet to potential recipients, on the investigational product (e.g., in forms other than written);
(iii) The adequacy of the information and plans for its dissemination to health care providers, including potential side effects, contraindications, potential interactions, and other pertinent considerations; and
(iv) An informed consent form as required by part 50 of this chapter, in those circumstances in which DOD determines that informed consent may be obtained from some or all personnel involved.
(4) DOD is to submit to FDA summaries of institutional review board meetings at which the proposed protocol has been reviewed.
(5) Nothing in these criteria or standards is intended to preempt or limit FDA’s and DOD’s authority or obligations under applicable statutes and regulations.
(e)
(1) Obtaining informed consent for investigational in vitro diagnostic devices used to identify chemical, biological, radiological, or nuclear agents will be deemed feasible unless, before use of the test article, both the investigator (e.g., clinical laboratory director or other responsible individual) and a physician who is not otherwise participating in the clinical investigation make the determinations and later certify in writing all of the following:
(i) The human subject is confronted by a life-threatening situation necessitating the use of the investigational in vitro diagnostic device to identify a chemical, biological, radiological, or nuclear agent that would suggest a terrorism event or other public health emergency.
(ii) Informed consent cannot be obtained from the subject because:
(A) There was no reasonable way for the person directing that the specimen be collected to know, at the time the specimen was collected, that there would be a need to use the investigational in vitro diagnostic device on that subject’s specimen; and
(B) Time is not sufficient to obtain consent from the subject without risking the life of the subject.
(iii) Time is not sufficient to obtain consent from the subject’s legally authorized representative.
(iv) There is no cleared or approved available alternative method of diagnosis, to identify the chemical, biological, radiological, or nuclear agent that provides an equal or greater likelihood of saving the life of the subject.
(2) If use of the investigational device is, in the opinion of the investigator (e.g., clinical laboratory director or other responsible person), required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (e)(1) of this section in advance of using the investigational device, the determinations of the investigator shall be made and, within 5 working days after the use of the device, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.
(3) The investigator must submit the written certification of the determinations made by the investigator and an independent physician required in paragraph (e)(1) or (e)(2) of this section to the IRB and FDA within 5 working days after the use of the device.
(4) An investigator must disclose the investigational status of the in vitro diagnostic device and what is known about the performance characteristics of the device in the report to the subject’s health care provider and in any report to public health authorities. The investigator must provide the IRB with the information required in § 50.25 (except for the information described in § 50.25(a)(8)) and the procedures that will be used to provide this information to each subject or the subject’s legally authorized representative at the time the test results are provided to the subject’s health care provider and public health authorities.
(5) The IRB is responsible for ensuring the adequacy of the information required in section 50.25 (except for the information described in § 50.25(a)(8)) and for ensuring that procedures are in place to provide this information to each subject or the subject’s legally authorized representative.
(6) No State or political subdivision of a State may establish or continue in effect any law, rule, regulation or other requirement that informed consent be obtained before an investigational in vitro diagnostic device may be used to identify chemical, biological, radiological, or nuclear agent in suspected terrorism events and other potential public health emergencies that is different from, or in addition to, the requirements of this regulation.
A commission is created and established, to be known as the Federal Trade Commission (hereinafter referred to as the Commission), which shall be composed of five Commissioners, who shall be appointed by the President, by and with the advice and consent of the Senate. Not more than three of the Commissioners shall be members of the same political party. The first Commissioners appointed shall continue in office for terms of three, four, five, six, and seven years, respectively, from September 26, 1914, the term of each to be designated by the President, but their successors shall be appointed for terms of seven years, except that any person chosen to fill a vacancy shall be appointed only for the unexpired term of the Commissioner whom he shall succeed: Provided, however, That upon the expiration of his term of office a Commissioner shall continue to serve until his successor shall have been appointed and shall have qualified..1 The President shall choose a chairman from the Commission’s membership. No Commissioner shall engage in any other business, vocation, or employment. Any Commissioner may be removed by the President for inefficiency, neglect of duty, or malfeasance in office. A vacancy in the Commission shall not impair the right of the remaining Commissioners to exercise all the powers of the Commission.
The Commission shall have an official seal, which shall be judicially noticed.
(Added by Stats. 1978, Ch. 360.)
The Legislature further finds and declares that:
(a) The Nuremberg Code of Ethics in Medical Research was developed after the trial of Nazi war criminals for unethical use of persons in medical experiments; subsequently, the Declaration of Helsinki additionally established recommendations guiding doctors in experimentation involving human subjects.
(b) Neither the Nuremberg Code nor the Declaration of Helsinki are codified under law and are, therefore, unenforceable.
(c) It is necessary that medical experimentation be done in such a way as to protect the rights of the human subjects involved.
(d) There is, and will continue to be, a growing need for protection for citizens of the state from unauthorized, needless, hazardous, or negligently performed medical experiments on human beings.
It is, therefore, the intent of the Legislature, in the enacting of this chapter, to provide minimum statutory protection for the citizens of this state with regard to human experimentation and to provide penalties for those who violate such provisions.
(Added by Stats. 1978, Ch. 360.)
(a) Be informed of the nature and purpose of the experiment.
(b) Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
(c) Be given a description of any attendant discomforts and risks reasonably to be expected from the experiment.
(d) Be given an explanation of any benefits to the subject reasonably to be expected from the experiment, if applicable.
(e) Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.
(f) Be informed of the avenues of medical treatment, if any, available to the subject after the experiment if complications should arise.
(g) Be given an opportunity to ask any questions concerning the experiment or the procedures involved.
(h) Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation in the medical experiment without prejudice.
(i) Be given a copy of the signed and dated written consent form as provided for by Section 24173 or 24178.
(j) Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject’s decision.
(Added by Stats. 1978, Ch. 360.)
As used in this chapter, “informed consent” means the authorization given pursuant to Section 24175 to have a medical experiment performed after each of the following conditions have been satisfied:
(a) The subject or subject’s conservator or guardian, or other representative, as specified in Section 24175, is provided with a copy of the experimental subject’s bill of rights, prior to consenting to participate in any medical experiment, containing all the information required by Section 24172, and the copy is signed and dated by the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175.
(b) A written consent form is signed and dated by the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175.
(c) The subject or subject’s conservator or guardian, or other representative, as specified in Section 24175, is informed both verbally and within the written consent form, in nontechnical terms and in a language in which the subject or the subject’s conservator or guardian, or other representative, as specified in Section 24175, is fluent, of the following facts of the proposed medical experiment, which might influence the decision to undergo the experiment, including, but not limited to:
(1) An explanation of the procedures to be followed in the medical experiment and any drug or device to be utilized, including the purposes of the procedures, drugs, or devices. If a placebo is to be administered or dispensed to a portion of the subjects involved in a medical experiment, all subjects of the experiment shall be informed of that fact; however, they need not be informed as to whether they will actually be administered or dispensed a placebo.
(2) A description of any attendant discomfort and risks to the subject reasonably to be expected.
(3) An explanation of any benefits to the subject reasonably to be expected, if applicable.
(4) A disclosure of any appropriate alternative procedures, drugs, or devices that might be advantageous to the subject, and their relative risks and benefits.
(5) An estimate of the expected recovery time of the subject after the experiment.
(6) An offer to answer any inquiries concerning the experiment or the procedures involved.
(7) An instruction to the subject that he or she is free to withdraw his or her prior consent to the medical experiment and discontinue participation in the medical experiment at any time, without prejudice to the subject.
(8) The name, institutional affiliation, if any, and address of the person or persons actually performing and primarily responsible for the conduct of the experiment.
(9) The name of the sponsor or funding source, if any, or manufacturer if the experiment involves a drug or device, and the organization, if any, under whose general aegis the experiment is being conducted.
(10) The name, address, and phone number of an impartial third party, not associated with the experiment, to whom the subject may address complaints about the experiment.
(11) The material financial stake or interest, if any, that the investigator or research institution has in the outcome of the medical experiment. For purposes of this section, “material” means ten thousand dollars ($10,000) or more in securities or other assets valued at the date of disclosure, or in relevant cumulative salary or other income, regardless of when it is earned or expected to be earned.
(d) The written consent form is signed and dated by any person other than the subject or the conservator or guardian, or other representative of the subject, as specified in Section 24175, who can attest that the requirements for informed consent to the medical experiment have been satisfied.
(e) Consent is voluntary and freely given by the human subject or the conservator or guardian, or other representative, as specified by Section 24175, without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence.
(Amended by Stats. 2003, Ch. 397, Sec. 1. Effective January 1, 2004.)
(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.
(Amended by Stats. 1996, Ch. 1023, Sec. 205. Effective September 29, 1996.)
(b) If a person is under a conservatorship of the person or of the person and estate, pursuant to Division 4 (commencing with Section 1400) of the Probate Code, informed consent for a medical experiment involving such person shall be obtained:
(1) As provided in Section 2354 of the Probate Code if the person has not been adjudicated to lack the capacity to give informed consent for medical treatment.
(2) As provided in Section 2355 of the Probate Code if the person has been adjudicated to lack the capacity to give informed consent for medical treatment.
(c) If an adult person is gravely disabled, as defined in subdivision (h) of Section 5008 of the Welfare and Institutions Code, and is under a conservatorship of the person or of the person and estate, pursuant to Chapter 3 (commencing with Section 5350) of Part 1 of Division 5 of the Welfare and Institutions Code, informed consent for a medical experiment involving such person shall be obtained from such person, unless the conservator of such person has the right to consent to medical treatment on behalf of the conservatee, pursuant to subdivisions (c) and (d) of Section 5357 and Section 5358 of the Welfare and Institutions Code.
(d) If an adult person is developmentally disabled, as defined in subdivision (a) of Section 4512 of the Welfare and Institutions Code, and has no conservator and is mentally incapable of giving informed consent, informed consent shall be obtained for a medical experiment involving such person, pursuant to subdivision (c) of Section 4655 of the Welfare and Institutions Code.
(e) Informed consent given by a person other than the human subject pursuant to subdivisions (b) through (d), inclusive, of this section shall only be for medical experiments related to maintaining or improving the health of the human subject or related to obtaining information about a pathological condition of the human subject.
(Amended by Stats. 1979, Ch. 730.)
(a) Any person who is primarily responsible for conduct of a medical experiment and who negligently allows the experiment to be conducted without a subject’s informed consent, as provided in this chapter, shall be liable to the subject in an amount not to exceed ten thousand dollars ($10,000), as determined by the court. The minimum amount of damages awarded shall be five hundred dollars ($500).
(b) Any person who is primarily responsible for the conduct of a medical experiment and who willfully fails to obtain the subject’s informed consent, as provided in this chapter, shall be liable to the subject in an amount not to exceed twenty-five thousand dollars ($25,000) as determined by the court. The minimum amount of damages awarded shall be one thousand dollars ($1,000).
(c) Any person who is primarily responsible for the conduct of a medical experiment and who willfully fails to obtain the subject’s informed consent, as provided in this chapter, and thereby exposes a subject to a known substantial risk of serious injury, either bodily harm or psychological harm, shall be guilty of a misdemeanor punishable by imprisonment in the county jail for a period not to exceed one year or a fine of fifty thousand dollars ($50,000), or both.
(d) Any representative or employee of a pharmaceutical company, who is directly responsible for contracting with another person for the conduct of a medical experiment, and who has knowledge of risks or hazards with respect to the experiment, and who willfully withholds information of the risks and hazards from the person contracting for the conduct of the medical experiment, and thereby exposes a subject to substantial risk of serious injury, either bodily harm or psychological harm, shall be guilty of a misdemeanor punishable by imprisonment in the county jail for a period not to exceed one year or a fine of fifty thousand dollars ($50,000), or both.
(e) Each and every medical experiment performed in violation of any provision of this chapter is a separate and actionable offense.
(f) Any attempted or purported waiver of the rights guaranteed, or requirements prescribed by this chapter, whether by a subject or by a subject’s conservator or guardian, or other representative, as specified in Section 24175, is void.
(g) Nothing in this section shall be construed to limit or expand the right of an injured subject to recover damages under any other applicable law.
(Amended by Stats. 2003, Ch. 397, Sec. 2. Effective January 1, 2004.)
(Amended by Stats. 1996, Ch. 1023, Sec. 206. Effective September 29, 1996.)
(1) Care is provided in accordance with the procedures and the additional protections of the rights and welfare of the patient set forth in Part 50 of Title 21 of, and Part 46 of Title 45 of, the Code of Federal Regulations, in effect on April 1, 2012.
(2) The patient is in a life-threatening emergency necessitating urgent intervention and available treatments are unproven or unsatisfactory.
(3) The patient is unable to give informed consent as a result of the patient’s medical condition.
(4) Obtaining informed consent from the patient’s legally authorized representatives is not feasible before the treatment must be administered. The proposed investigational plan shall define the length of time of the potential therapeutic window based on scientific evidence, and the investigator shall commit to attempting to contact a legally authorized representative for each subject within that length of time and, if feasible, to asking the legally authorized representative contacted for consent within that length of time rather than proceeding without consent.
(5) There is no reasonable way to prospectively identify the individuals likely to become eligible for participation in the clinical investigation.
(6) Valid scientific studies have been conducted that support the potential for the intervention to provide a direct benefit to the patient. Risks associated with the investigation shall be reasonable in relation to what is known about the medical condition of the potential class of subjects, the risks and benefits of standard therapy, if any, and what is known about the risks and benefits of the proposed intervention or activity.
(7) The institutional review board has reviewed and approved the informed consent procedures and these procedures are to be used with subjects or their legally authorized representatives in situations where use of the procedures and documents is feasible.
(8) Additional protections of the rights and welfare of the subjects will be provided, including, but not limited to, all of the following:
(A) Consultation, including, where appropriate, consultation carried out by the institutional review board, with representatives of the communities in which the research will be conducted and from which the subjects will be drawn.
(B) Public disclosure to the communities in which the research will be conducted and from which the subjects will be drawn, prior to the initiation of the research, of plans for the research and its risks and expected benefits.
(C) Public disclosure of sufficient information following the completion of the research to apprise the community and researchers of the study, including demographic characteristics of the research population and the results of the study.
(D) Establishment of an independent data monitoring committee to exercise oversight of the research.
(b) This section does not relieve any party of any other legal duty, including, but not limited to, the duty to act in a nonnegligent manner.
(Amended by Stats. 2013, Ch. 547, Sec. 1. (AB 58) Effective January 1, 2014.)
(b) Subdivisions (c) and (e) shall apply only to medical experiments that relate to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of research participants.
(c) For purposes of obtaining informed consent required for medical experiments in a nonemergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker with reasonable knowledge of the subject, who shall include any of the following persons, in the following descending order of priority:
(1) The person’s agent pursuant to an advance health care directive.
(2) The conservator or guardian of the person having the authority to make health care decisions for the person.
(3) The spouse of the person.
(4) An individual as defined in Section 297 of the Family Code.
(5) An adult son or daughter of the person.
(6) A custodial parent of the person.
(7) Any adult brother or sister of the person.
(8) Any adult grandchild of the person.
(9) An available adult relative with the closest degree of kinship to the person.
(d) (1) When there are two or more available persons who, pursuant to subdivision (c), may give surrogate informed consent and who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the medical experiment, consent shall not be considered as having been given.
(2) When there are two or more available persons who are in different orders of priority pursuant to subdivision (c), refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate.
(e) For purposes of obtaining informed consent required for medical experiments in an emergency room environment, and pursuant to subdivision (a), if a person is unable to consent and does not express dissent or resistance to participation, surrogate informed consent may be obtained from a surrogate decisionmaker who is any of the following persons:
(1) The person’s agent pursuant to an advance health care directive.
(2) The conservator or guardian of the person having the authority to make health care decisions for the person.
(3) The spouse of the person.
(4) An individual defined in Section 297 of the Family Code.
(5) An adult son or daughter of the person.
(6) A custodial parent of the person.
(7) Any adult brother or sister of the person.
(f) When there are two or more available persons described in subdivision (e), refusal to consent by one person shall not be superseded by any other of those persons.
(g) Surrogate decisionmakers described in this section shall exercise substituted judgment, and base decisions about participation in accordance with the person’s individual health care instructions, if any, and other wishes, to the extent known to the surrogate decisionmaker. Otherwise, the surrogate decisionmaker shall make the decision in accordance with the person’s best interests. In determining the person’s best interests, the decisionmaker shall consider the person’s personal values and his or her best estimation of what the person would have chosen if he or she were capable of making a decision.
(h) Research conducted pursuant to this section shall adhere to federal regulations governing informed consent pursuant to Section 46.116 of Title 45 of the Code of Federal Regulations.
(i) Any person who provides surrogate consent pursuant to subdivisions (c) and (e) may not receive financial compensation for providing the consent.
(j) Subdivisions (c) and (e) do not apply to any of the following persons, except as otherwise provided by law:
(1) Persons who lack the capacity to give informed consent and who are involuntarily committed pursuant to Part 1 (commencing with Section 5000) of Division 5 of the Welfare and Institutions Code.
(2) Persons who lack the capacity to give informed consent and who have been voluntarily admitted or have been admitted upon the request of a conservator pursuant to Chapter 1 (commencing with Section 6000) of Part 1 of Division 6 of the Welfare and Institutions Code.
(Amended by Stats. 2003, Ch. 397, Sec. 3. Effective January 1, 2004.)
This chapter shall not apply to a pharmacist dispensing drugs upon a prescription.
(Added by Stats. 1978, Ch. 360.)
(Amended by Stats. 1999, Ch. 658, Sec. 8. Effective January 1, 2000. Operative July 1, 2000, by Sec. 43 of Ch. 658.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(a) Notwithstanding Section 146, any person who practices or attempts to practice, or who advertises or holds himself or herself out as practicing, any system or mode of treating the sick or afflicted in this state, or who diagnoses, treats, operates for, or prescribes for any ailment, blemish, deformity, disease, disfigurement, disorder, injury, or other physical or mental condition of any person, without having at the time of so doing a valid, unrevoked, or unsuspended certificate as provided in this chapter or without being authorized to perform the act pursuant to a certificate obtained in accordance with some other provision of law is guilty of a public offense, punishable by a fine not exceeding ten thousand dollars ($10,000), by imprisonment pursuant to subdivision (h) of Section 1170 of the Penal Code, by imprisonment in a county jail not exceeding one year, or by both the fine and either imprisonment.
(b) Any person who conspires with or aids or abets another to commit any act described in subdivision (a) is guilty of a public offense, subject to the punishment described in that subdivision.
(c) The remedy provided in this section shall not preclude any other remedy provided by law.
(Amended by Stats. 2011, Ch. 15, Sec. 11. (AB 109) Effective April 4, 2011. Operative October 1, 2011, by Sec. 636 of Ch. 15, as amended by Stats. 2011, Ch. 39, Sec. 68.)
(1) Conducts surgery or any other procedure on another person that punctures the skin or harmfully invades the body.
(2) Administers or prescribes X-ray radiation to another person.
(3) Prescribes or administers legend drugs or controlled substances to another person.
(4) Recommends the discontinuance of legend drugs or controlled substances prescribed by an appropriately licensed practitioner.
(5) Willfully diagnoses and treats a physical or mental condition of any person under circumstances or conditions that cause or create a risk of great bodily harm, serious physical or mental illness, or death.
(6) Sets fractures.
(7) Treats lacerations or abrasions through electrotherapy.
(8) Holds out, states, indicates, advertises, or implies to a client or prospective client that he or she is a physician, a surgeon, or a physician and surgeon.
(b) A person who advertises any services that are not unlawful under Section 2051 or 2052 pursuant to subdivision (a) shall disclose in the advertisement that he or she is not licensed by the state as a healing arts practitioner.
(Amended by Stats. 2005, Ch. 621, Sec. 24. Effective January 1, 2006.)
a) A person who provides services pursuant to Section 2053.5 that are not unlawful under Section 2051 or 2052 shall, prior to providing those services, do the following:
(1) Disclose to the client in a written statement using plain language the following information:
(A) That he or she is not a licensed physician.
(B) That the treatment is alternative or complementary to healing arts services licensed by the state.
(C) That the services to be provided are not licensed by the state.
(D) The nature of the services to be provided.
(E) The theory of treatment upon which the services are based.
(F) His or her educational, training, experience, and other qualifications regarding the services to be provided.
(2) Obtain a written acknowledgment from the client stating that he or she has been provided with the information described in paragraph (1). The client shall be provided with a copy of the written acknowledgement, which shall be maintained by the person providing the service for three years.
(b) The information required by subdivision (a) shall be provided in a language that the client understands.
(c) Nothing in this section or in Section 2053.5 shall be construed to do the following:
(1) Affect the scope of practice of licensed physicians and surgeons.
(2) Limit the right of any person to seek relief for negligence or any other civil remedy against a person providing services subject to the requirements of this section.
(Amended by Stats. 2005, Ch. 621, Sec. 25. Effective January 1, 2006.)
(b) Notwithstanding subdivision (a), any of the following persons may use the words “doctor” or “physician,” the letters or prefix “Dr.,” or the initials “M.D.”:
(1) A graduate of a medical school approved or recognized by the board while enrolled in a postgraduate training program approved by the board.
(2) A graduate of a medical school who does not have a certificate as a physician and surgeon under this chapter if he or she meets all of the following requirements:
(A) If issued a license to practice medicine in any jurisdiction, has not had that license revoked or suspended by that jurisdiction.
(B) Does not otherwise hold himself or herself out as a physician and surgeon entitled to practice medicine in this state except to the extent authorized by this chapter.
(C) Does not engage in any of the acts prohibited by Section 2060.
(3) A person authorized to practice medicine under Section 2111 or 2113 subject to the limitations set forth in those sections.
(Amended by Stats. 2017, Ch. 775, Sec. 22. (SB 798) Effective January 1, 2018.)
(Amended by Stats. 1989, Ch. 886, Sec. 19.)
(b) It is the public policy of the State of California that a physician and surgeon be encouraged to advocate for medically appropriate health care for his or her patients. For purposes of this section, “to advocate for medically appropriate health care” means to appeal a payor’s decision to deny payment for a service pursuant to the reasonable grievance or appeal procedure established by a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff and governing body, or payer, or to protest a decision, policy, or practice that the physician, consistent with that degree of learning and skill ordinarily possessed by reputable physicians practicing according to the applicable legal standard of care, reasonably believes impairs the physician’s ability to provide medically appropriate health care to his or her patients.
(c) The application and rendering by any person of a decision to terminate an employment or other contractual relationship with, or otherwise penalize, a physician and surgeon principally for advocating for medically appropriate health care consistent with that degree of learning and skill ordinarily possessed by reputable physicians practicing according to the applicable legal standard of care violates the public policy of this state. No person shall terminate, retaliate against, or otherwise penalize a physician and surgeon for that advocacy, nor shall any person prohibit, restrict, or in any way discourage a physician and surgeon from communicating to a patient information in furtherance of medically appropriate health care.
(d) This section shall not be construed to prohibit a payer from making a determination not to pay for a particular medical treatment or service, or to prohibit a medical group, independent practice association, preferred provider organization, foundation, hospital medical staff, hospital governing body acting pursuant to Section 809.05, or payer from enforcing reasonable peer review or utilization review protocols or determining whether a physician has complied with those protocols.
(e) Medically appropriate health care in a hospital licensed pursuant to Section 1250 of the Health and Safety Code shall be defined by the hospital medical staff and approved by the governing body, consistent with that degree of learning and skill ordinarily possessed by reputable physicians practicing according to the applicable legal standard of care.
(f) Nothing in this section shall be construed to prohibit the governing body of a hospital from taking disciplinary actions against a physician and surgeon as authorized by Sections 809.05, 809.4, and 809.5.
(g) Nothing in this section shall be construed to prohibit the Medical Board of California from taking disciplinary actions against a physician and surgeon under Article 12 (commencing with Section 2220).
(h) For purposes of this section, “person” has the same meaning as set forth in Section 2032.
(Amended by Stats. 1996, Ch. 260, Sec. 1. Effective January 1, 1997.)
(b) Health care service plans and their contracting entities shall not include provisions in their contracts that interfere with the ability of a physician and surgeon or other licensed health care provider to communicate with a patient regarding his or her health care, including, but not limited to, communications regarding treatment options, alternative plans, or other coverage arrangements. Nothing in this section shall preclude a contract provision that provides that a physician and surgeon, or other licensed health care provider, may not solicit for alternative coverage arrangements for the primary purpose of securing financial gain.
(c) Any contractual provision inconsistent with this section shall be void and unenforceable.
(d) For purposes of this section, “licensed health care provider” means any person licensed or certified pursuant to this division or licensed pursuant to the Osteopathic Initiative Act or the Chiropractic Initiative Act.
(e) No communication regarding treatment options shall be represented or construed to expand or revise the scope of benefits or covered services under a health care service plan or insurance contract.
(Added by Stats. 1996, Ch. 1089, Sec. 1. Effective January 1, 1997.)
(b) Nothing in this chapter shall be construed to prohibit obtaining a blood specimen by skin puncture for the purpose of performing blood glucose testing for the purposes of monitoring a minor child in accordance with paragraph (6) of subdivision (b) of Section 1241.
(Amended by Stats. 1997, Ch. 550, Sec. 2. Effective January 1, 1998.)
Nothing in this chapter applies to any practitioner located outside this state, when in actual consultation, whether within this state or across state lines, with a licensed practitioner of this state, or when an invited guest of the California Medical Association or the California Podiatric Medical Association, or one of their component county societies, or of an approved medical or podiatric medical school or college for the sole purpose of engaging in professional education through lectures, clinics, or demonstrations, if he or she is, at the time of the consultation, lecture, or demonstration a licensed physician and surgeon or a licensed doctor of podiatric medicine in the state or country in which he or she resides. This practitioner shall not open an office, appoint a place to meet patients, receive calls from patients within the limits of this state, give orders, or have ultimate authority over the care or primary diagnosis of a patient who is located within this state.
(Amended by Stats. 2003, Ch. 607, Sec. 2. Effective January 1, 2004.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(b) This section shall become operative on January 1, 2020.
(Repealed (in Sec. 23) and added by Stats. 2017, Ch. 775, Sec. 24. (SB 798) Effective January 1, 2018. Section operative January 1, 2020, by its own provisions.)
(Amended by Stats. 1991, Ch. 359, Sec. 10.)
Any violation of this section or Section 2064.1 may be enjoined in an action brought in the name of the people of the State of California by the district attorney of the county in which the violation occurs, upon receipt of a complaint by an aggrieved student.
(Added by Stats. 1989, Ch. 425, Sec. 1.)
(b) Except for students granted status pursuant to Section 1101(a)(15)(T) or (U) of Title 8 of the United States Code, this section shall not apply to a person excluded from the term “immigrant,” for purposes of the federal Immigration and Nationality Act (8 U.S.C. Sec. 1101), pursuant to paragraph (15) of subdivision (a) of Section 1101 of Title 8 of the United States Code, as that paragraph exists on January 1, 2017.
(Amended by Stats. 2021, Ch. 296, Sec. 2. (AB 1096) Effective January 1, 2022.)
(b) Except for students granted status pursuant to Section 1101(a)(15)(T) or (U) of Title 8 of the United States Code, this section shall not apply to a person excluded from the term “immigrant,” for purposes of the federal Immigration and Nationality Act (8 U.S.C. Section 1101), pursuant to paragraph (15) of subdivision (a) of Section 1101 of Title 8 of the United States Code, as that paragraph exists on January 1, 2017.
(Amended by Stats. 2021, Ch. 296, Sec. 3. (AB 1096) Effective January 1, 2022.)
(a) Within 180 days after enrollment in a board-approved postgraduate training program pursuant to Section 2065, medical school graduates shall obtain a physician’s and surgeon’s postgraduate training license. To be considered for a postgraduate training license, the applicant shall submit the application forms and primary source documents required by the board, shall successfully pass all required licensing examinations, shall pay a nonrefundable application and processing fee, and shall not have committed any act that would be grounds for denial.
(1) Each application submitted pursuant to this section shall be made upon an online electronic form, or another form provided by the board, and each application form shall contain a legal verification by the applicant certifying under penalty of perjury that the information provided by the applicant is true and correct and that any information in supporting documents provided by the applicant is true and correct.
(2) Each application shall include the following:
(A) A diploma issued by a board-approved medical school. The requirements of the school shall not have been less than those required under this chapter at the time the diploma was granted or by any preceding medical practice act at the time that the diploma was granted. In lieu of a diploma, the applicant may submit evidence satisfactory to the board of having possessed the same.
(B) An official transcript or other official evidence satisfactory to the board showing each approved medical school in which a resident course of professional instruction was pursued covering the minimum requirements for certification as a physician and surgeon, and that a diploma and degree were granted by the school.
(C) Other information concerning the professional instruction and preliminary education of the applicant as the board may require.
(D) An affidavit showing to the satisfaction of the board that the applicant is the person named in each diploma and transcript that the applicant submits, that the applicant is the lawful holder thereof, and that the diploma or transcript was procured in the regular course of professional instruction and examination without fraud or misrepresentation.
(E) Either fingerprint cards or a copy of a completed Live Scan form from the applicant in order to establish the identity of the applicant and in order to determine whether the applicant has a record of any criminal convictions in this state or in any other jurisdiction, including foreign countries. The information obtained as a result of the fingerprinting of the applicant shall be used in accordance with Section 11105 of the Penal Code, and to determine whether the applicant is subject to denial of licensure under the provisions of Division 1.5 (commencing with Section 475) and Section 2221 of this code.
(F) If the medical school graduate graduated from a foreign medical school approved by the board pursuant to Section 2084, an official Educational Commission for Foreign Medical Graduates (ECFMG) Certification Status Report confirming the graduate is ECFMG certified.
(b) The physician’s and surgeon’s postgraduate training license shall be valid until 90 days after the holder has received 12 months credit of board-approved postgraduate training for graduates of medical schools in the United States and Canada or 24 months of board-approved postgraduate training for graduates of foreign medical schools approved by the board pursuant to Section 2084 other than Canadian medical schools. The physician’s and surgeon’s postgraduate training licensee may engage in the practice of medicine only in connection with the licensee’s duties as an intern or resident physician in a board-approved program, including its affiliated sites, or under those conditions as are approved in writing and maintained in the postgraduate licensee’s file by the director of the program.
(c) The postgraduate training licensee may engage in the practice of medicine in locations authorized by subdivision (b), and as permitted by the Medical Practice Act and other applicable statutes and regulations, including, but not limited to, the following:
(1) Diagnose and treat patients.
(2) Prescribe medications without a cosigner, including prescriptions for controlled substances, if the licensee has the appropriate Drug Enforcement Agency registration or permit and is registered with the Department of Justice CURES program.
(3) Sign birth certificates without a cosigner.
(4) Sign death certificates without a cosigner.
(5) Sign any other forms a physician and surgeon is authorized to sign.
(d) The postgraduate training licensee may be disciplined by the board at any time for any of the grounds that would subject the holder of a physician’s and surgeon’s certificate to discipline.
(e) If the medical school graduate fails to obtain a postgraduate license within 180 days after enrollment in a board-approved postgraduate training program or if the board denies the graduate’s application for a postgraduate license, all privileges and exemptions under this section shall automatically cease.
(f) Each medical school graduate who was issued a postgraduate training authorization letter by the board prior to January 1, 2020, and is enrolled in a board-approved postgraduate training program by April 30, 2025, will be issued a postgraduate training license automatically by June 30, 2020, or by June 30 of the year following initial enrollment into a board-approved postgraduate training program, whichever is earlier, upon proof of enrollment in the postgraduate training program.
(g) The board shall confidentially destroy the file of each medical school graduate who was issued a postgraduate training authorization letter by the board prior to January 1, 2020, who did not enroll in a postgraduate training program by April 30, 2025.
(Amended by Stats. 2021, Ch. 649, Sec. 6. (SB 806) Effective January 1, 2022.)
(1) Limitations on practice.
(2) Total or partial restrictions on drug prescribing privileges for controlled substances.
(3) Continuing medical or psychiatric treatment.
(4) Ongoing participation in a specified rehabilitation program.
(5) Abstention from the use of alcohol or drugs.
(6) Restrictions against engaging in certain types of medical practice.
(7) Compliance with all provisions of this chapter.
(8) Payment of the cost of probation monitoring.
(b) The decision placing the applicant on probation shall be disclosed to an inquiring member of the public indefinitely and shall be posted on the board’s Internet Web site for the period of probation.
(c) The board may modify or terminate the terms and conditions imposed on the probationary postgraduate training license after one year upon receipt of a petition from the postgraduate training licensee. The board may assign the petition to an administrative law judge designated in Section 11371 of the Government Code. After a hearing on the petition, the administrative law judge shall provide a proposed decision to the board.
(d) The board shall deny a postgraduate training license to an applicant who is required to register pursuant to Section 290 of the Penal Code. This subdivision does not apply to an applicant who is required to register as a sex offender pursuant to Section 290 of the Penal Code solely because of a misdemeanor conviction under Section 314 of the Penal Code.
(e) An applicant shall not be eligible to reapply for a postgraduate training license for a minimum of three years from the effective date of the denial of his or her application, except that the board may, in its discretion and for good cause demonstrated, permit reapplication after not less than one year has elapsed from the effective date of the denial.
(f) This section shall become operative on January 1, 2020.
(Added by Stats. 2017, Ch. 775, Sec. 26. (SB 798) Effective January 1, 2018. Section operative January 1, 2020, by its own provisions.)
(b) A public letter of reprimand issued concurrently with a postgraduate training license shall be purged three years from the date of issuance.
(c) A public letter of reprimand issued pursuant to this section shall be disclosed to an inquiring member of the public and shall be posted on the board’s Internet Web site until purged consistent with this section.
(d) Nothing in this section shall be construed to affect the board’s authority to issue an unrestricted postgraduate training license.
(e) This section shall become operative on January 1, 2020.
(Added by Stats. 2017, Ch. 775, Sec. 27. (SB 798) Effective January 1, 2018. Section operative January 1, 2020, by its own provisions.)
(a) Unless otherwise provided by law, no postgraduate training licensee, intern, resident, postdoctoral fellow, or instructor may engage in the practice of medicine, or receive compensation therefor, or offer to engage in the practice of medicine unless they hold a valid, unrevoked, and unsuspended physician’s and surgeon’s certificate issued by the board. However, a graduate of an approved medical school may engage in the practice of medicine whenever and wherever required as a part of a postgraduate training program under the following conditions:
(1) The medical school graduate has taken and passed the board-approved medical licensing examinations required to qualify the applicant to participate in an approved postgraduate training program.
(2) If the medical school graduate graduated from a foreign medical school approved by the board pursuant to Section 2084, the Educational Commission for Foreign Medical Graduates (ECFMG) has submitted an official ECFMG Certification Status Report directly to the board confirming the graduate is ECFMG certified.
(3) The medical school graduate is enrolled in a postgraduate training program approved by the board.
(4) The board-approved postgraduate training program has submitted the required board-approved form to the board documenting the medical school graduate is enrolled in an approved postgraduate training program.
(5) The medical school graduate obtains a physician’s and surgeon’s postgraduate training license in accordance with Section 2064.5.
(b) A medical school graduate enrolled in an approved first-year postgraduate training program in accordance with this section may engage in the practice of medicine whenever and wherever required as a part of the training program, and may receive compensation for that practice.
(c) A graduate who has completed the first year of postgraduate training may, in an approved residency or fellowship, engage in the practice of medicine whenever and wherever required as part of that residency or fellowship, and may receive compensation for that practice. The resident or fellow shall qualify for, take, and pass the next succeeding written examination for licensure. If the resident or fellow fails to receive a license to practice medicine under this chapter within 27 months from the commencement of the residency or fellowship, except as otherwise allowed under subdivision (g) or (h), or if the board denies their application for licensure, all privileges and exemptions under this section shall automatically cease.
(d) All approved postgraduate training the medical school graduate has successfully completed in the United States or Canada shall count toward the 15-month license exemption for graduates of medical schools in the United States and Canada or 27-month license exemption for graduates of foreign medical schools approved by the board pursuant to Section 2084 other than Canadian medical schools, except as otherwise allowed under subdivision (h).
(e) The program director for an approved postgraduate training program in California shall report to the board, on a form approved by the board, and provide any supporting documents as required by the board, the following actions within 30 days of the action:
(1) A postgraduate training licensee is notified that they have received partial or no credit for a period of postgraduate training, and their postgraduate training period is extended.
(2) A postgraduate training licensee takes a leave of absence or any break from their postgraduate training, and they are notified that their postgraduate training period is extended.
(3) A postgraduate training licensee is terminated from the postgraduate training program.
(4) A postgraduate training licensee resigns, dies, or otherwise leaves the postgraduate training program.
(5) A postgraduate training licensee has completed a one-year contract approved by the postgraduate training program.
(f) Upon review of supporting documentation, the board, in its discretion, may grant an extension beyond 15 months to a postgraduate training licensee who graduated from a medical school in the United States or Canada, or beyond 27 months to a postgraduate training licensee who graduated from a foreign medical school approved by the board pursuant to Section 2084 other than a Canadian medical school, to receive credit for the 12 months of required approved postgraduate training for graduates of medical schools in the United States and Canada and 24 months of required approved postgraduate training for graduates of foreign medical schools other than Canadian medical schools.
(g) An applicant for a physician’s and surgeon’s license who has received credit for 12 months of approved postgraduate training in another state or in Canada and who is accepted into an approved postgraduate training program in California shall obtain their physician’s and surgeon’s license within 90 days after beginning that postgraduate training program or all privileges and exemptions under this section shall automatically cease.
(h) Upon review of supporting documentation, the board, in its discretion, may grant a physician’s and surgeon’s license to an applicant who demonstrates substantial compliance with this section.
(Amended by Stats. 2021, Ch. 649, Sec. 7. (SB 806) Effective January 1, 2022.)
(b) Nothing in this chapter shall be construed to prohibit a foreign medical graduate from engaging in the practice of medicine when required as part of the program authorized by this section.
(c) There is currently a preresidency training program at the University of California, Los Angeles David Geffen School of Medicine, Department of Family Medicine, hereafter referred to as UCLA, for selected international medical graduates (IMGs). Participation in the program authorized by this section shall be at the option of UCLA. This section authorizes those IMGs, through the program authorized by this section, to receive, through the existing program, hands-on clinical instruction. The program, as administered by UCLA, shall include all of the following elements:
(1) Each program participant shall have done all of the following:
(A) Graduated from a medical school recognized by the Medical Board of California at the time of selection.
(B) Taken and passed the United States Medical Licensing Examination Steps 1 and 2 (Clinical Knowledge and Clinical Science).
(C) Submitted an application and materials to the Educational Commission for Foreign Medical Graduates.
(2) A program participant shall receive all clinical instruction at health care facilities operated by the University of California, Los Angeles, or other approved UCLA-designated teaching sites, which shall be hospitals or clinics with either a signed formal affiliation agreement with UCLA or a signed letter of agreement.
(3) Participation of a trainee in clinical instruction offered by the program shall not generally exceed 16 weeks. However, at the discretion of UCLA, an additional eight weeks of clinical instruction may be granted. In no event shall a participant receive more than 24 weeks of clinical instruction under the program.
(4) The clinical instruction shall be supervised by licensed physicians on faculty at UCLA or faculty affiliated with UCLA as specified in an approved affiliation agreement between UCLA and the affiliated entity.
(5) The clinical instruction shall be provided pursuant to written affiliation agreements for clinical instruction of trainees established by UCLA.
(6) The supervising faculty shall evaluate each participant on a regular basis and shall document the completion of each aspect of the clinical instruction portion of the program for each participant.
(d) UCLA shall provide the board with the names of the participants in the program on an annual basis, or more frequently if necessary to maintain accuracy. Upon a reasonable request of the board, UCLA shall provide additional information such as the courses successfully completed by program participants, the dates of instruction, and other relevant information.
(Amended by Stats. 2018, Ch. 144, Sec. 1. (AB 2311) Effective January 1, 2019.)
For purposes of this section the terms “providing nutritional advice or giving advice concerning proper nutrition” means the giving of information as to the use and role of food and food ingredients, including dietary supplements.
Any person in commercial practice providing nutritional advice or giving advice concerning proper nutrition shall post in an easily visible and prominent place the following statement in his or her place of business:
“NOTICE”
“State law allows any person to provide nutritional advice or give advice concerning proper nutrition—which is the giving of advice as to the role of food and food ingredients, including dietary supplements. This state law does NOT confer authority to practice medicine or to undertake the diagnosis, prevention, treatment, or cure of any disease, pain, deformity, injury, or physical or mental condition and specifically does not authorize any person other than one who is a licensed health practitioner to state that any product might cure any disease, disorder, or condition.”
The notice required by this section shall not be smaller than 81/2 inches by 11 inches and shall be legibly printed with lettering no smaller than1/2 inch in length, except the lettering of the word “NOTICE” shall not be smaller than 1 inch in length.
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
(a) (1) Notwithstanding any other law, a medical assistant may administer medication only by intradermal, subcutaneous, or intramuscular injections and perform skin tests and additional technical supportive services upon the specific authorization and supervision of a licensed physician and surgeon or a licensed podiatrist. A medical assistant may also perform all these tasks and services upon the specific authorization of a physician assistant, a nurse practitioner, or a certified nurse-midwife.
(2) The supervising physician and surgeon may, at his or her discretion, in consultation with the nurse practitioner, certified nurse-midwife, or physician assistant, provide written instructions to be followed by a medical assistant in the performance of tasks or supportive services. These written instructions may provide that the supervisory function for the medical assistant for these tasks or supportive services may be delegated to the nurse practitioner, certified nurse-midwife, or physician assistant within the standardized procedures or protocol, and that tasks may be performed when the supervising physician and surgeon is not onsite, if either of the following apply:
(A) The nurse practitioner or certified nurse-midwife is functioning pursuant to standardized procedures, as defined by Section 2725, or protocol. The standardized procedures or protocol, including instructions for specific authorizations, shall be developed and approved by the supervising physician and surgeon and the nurse practitioner or certified nurse-midwife.
(B) The physician assistant is functioning pursuant to regulated services defined in Section 3502, including instructions for specific authorizations, and is approved to do so by the supervising physician and surgeon.
(b) As used in this section and Sections 2070 and 2071, the following definitions apply:
(1) “Medical assistant” means a person who may be unlicensed, who performs basic administrative, clerical, and technical supportive services in compliance with this section and Section 2070 for a licensed physician and surgeon or a licensed podiatrist, or group thereof, for a medical or podiatry corporation, for a physician assistant, a nurse practitioner, or a certified nurse-midwife as provided in subdivision (a), or for a health care service plan, who is at least 18 years of age, and who has had at least the minimum amount of hours of appropriate training pursuant to standards established by the board. The medical assistant shall be issued a certificate by the training institution or instructor indicating satisfactory completion of the required training. A copy of the certificate shall be retained as a record by each employer of the medical assistant.
(2) “Specific authorization” means a specific written order prepared by the supervising physician and surgeon or the supervising podiatrist, or the physician assistant, the nurse practitioner, or the certified nurse-midwife as provided in subdivision (a), authorizing the procedures to be performed on a patient, which shall be placed in the patient’s medical record, or a standing order prepared by the supervising physician and surgeon or the supervising podiatrist, or the physician assistant, the nurse practitioner, or the certified nurse-midwife as provided in subdivision (a), authorizing the procedures to be performed, the duration of which shall be consistent with accepted medical practice. A notation of the standing order shall be placed on the patient’s medical record.
(3) “Supervision” means the supervision of procedures authorized by this section by the following practitioners, within the scope of their respective practices, who shall be physically present in the treatment facility during the performance of those procedures:
(A) A licensed physician and surgeon.
(B) A licensed podiatrist.
(C) A physician assistant, nurse practitioner, or certified nurse-midwife as provided in subdivision (a).
(4) (A) “Technical supportive services” means simple routine medical tasks and procedures that may be safely performed by a medical assistant who has limited training and who functions under the supervision of a licensed physician and surgeon or a licensed podiatrist, or a physician assistant, a nurse practitioner, or a certified nurse-midwife as provided in subdivision (a).
(B) Notwithstanding any other law, in a facility licensed by the California State Board of Pharmacy under Section 4180 or 4190, other than a facility operated by the state, “technical supportive services” also includes handing to a patient a prepackaged prescription drug, excluding a controlled substance, that is labeled in compliance with Section 4170 and all other applicable state and federal laws and ordered by a licensed physician and surgeon, a licensed podiatrist, a physician assistant, a nurse practitioner, or a certified nurse-midwife in accordance with subdivision (a). In every instance, prior to handing the medication to a patient pursuant to this subparagraph, the properly labeled and prepackaged prescription drug shall have the patient’s name affixed to the package and a licensed physician and surgeon, a licensed podiatrist, a physician assistant, a nurse practitioner, or a certified nurse-midwife shall verify that it is the correct medication and dosage for that specific patient and shall provide the appropriate patient consultation regarding use of the drug.
(c) Nothing in this section shall be construed as authorizing any of the following:
(1) The licensure of medical assistants.
(2) The administration of local anesthetic agents by a medical assistant.
(3) The board to adopt any regulations that violate the prohibitions on diagnosis or treatment in Section 2052.
(4) A medical assistant to perform any clinical laboratory test or examination for which he or she is not authorized by Chapter 3 (commencing with Section 1200).
(5) A nurse practitioner, certified nurse-midwife, or physician assistant to be a laboratory director of a clinical laboratory, as those terms are defined in paragraph (8) of subdivision (a) of Section 1206 and subdivision (a) of Section 1209.
(d) A nurse practitioner, certified nurse-midwife, or physician assistant shall not authorize a medical assistant to perform any clinical laboratory test or examination for which the medical assistant is not authorized by Chapter 3 (commencing with Section 1200). A violation of this subdivision constitutes unprofessional conduct.
(e) Notwithstanding any other law, a medical assistant shall not be employed for inpatient care in a licensed general acute care hospital, as defined in subdivision (a) of Section 1250 of the Health and Safety Code.
(Amended by Stats. 2014, Ch. 333, Sec. 1. (AB 1841) Effective January 1, 2015.)
Notwithstanding any other provision of law, a medical assistant may perform venipuncture or skin puncture for the purposes of withdrawing blood upon specific authorization and under the supervision of a licensed physician and surgeon or a licensed podiatrist, or a physician assistant, a nurse practitioner, or a nurse-midwife as provided in subdivision (a) of Section 2069, if prior thereto the medical assistant has had at least the minimum amount of hours of appropriate training pursuant to standards established by the Division of Licensing. The medical assistant shall be issued a certificate by the training institution or instructor indicating satisfactory completion of the training required. A copy of the certificate shall be retained as a record by each employer of the medical assistant.
(Amended by Stats. 2001, Ch. 358, Sec. 3. Effective January 1, 2002.)
(Amended by Stats. 2021, Ch. 630, Sec. 16. (AB 1534) Effective January 1, 2022.)
(Added by Stats. 1980, Ch. 1313, Sec. 2.)
The performance of acupuncture by a certified acupuncturist or other licentiate legally authorized to practice acupuncture within his or her scope of practice or a person licensed or certified in another state to perform acupuncture or other forms of traditional Asian medicine, alone or in conjunction with other forms of traditional Asian medicine, when carried on in a program affiliated with and under the jurisdiction of an approved medical school or approved acupuncture school, for the primary purpose of scientific investigation of acupuncture, shall not be in violation of this chapter, but those procedures shall be carried on only under the supervision of a licensed physician and surgeon.
Any medical school or approved acupuncture school conducting research into acupuncture under this section shall report to the Legislature annually on the fifth legislative day of the regular session of the Legislature concerning the results of that research, the suitability of acupuncture as a therapeutic technique, and performance standards for persons who perform acupuncture.
(Amended by Stats. 2005, Ch. 649, Sec. 2. Effective January 1, 2006.)
(1) The physician and surgeon has an oral or written agreement with a sports team to provide general or emergency medical care to the team members, coaching staff, and families traveling with the team for a specific sporting event to take place in this state.
(2) Except as provided in Section 2058 or 2060, the physician and surgeon may not provide care or consultation to any person residing in this state, other than a person described in paragraph (1).
(b) The exemption shall remain in force while the physician and surgeon is traveling with the team, but shall be no longer than 10 days per individual sporting event.
(c) The executive director may grant a physician and surgeon additional time for exemption, up to 20 additional days per sporting event, upon prior request by the physician and surgeon. The total number of days a physician may be exempt, including additional time granted upon request, may not exceed 30 days per sporting event.
(d) A physician and surgeon who is exempt from licensure requirements under this section is not authorized to practice medicine at a health care clinic or facility, including an acute care facility.
(Added by Stats. 2003, Ch. 78, Sec. 1. Effective January 1, 2004.)
(1) The physician and surgeon has been invited by the United States Olympic Committee to provide medical services at training sites designated by the olympic training center or to provide medical services at an event in this state sanctioned by the committee.
(2) The United States Olympic Committee certifies to the board the name of the physician and surgeon, the state or country of the applicant’s licensure, and the dates within which the applicant has been invited to provide medical services.
(3) The physician and surgeon’s practice is limited to that required by the United States Olympic Committee. Those medical services shall be within the area of the physician’s and surgeon’s competence and shall only be provided to athletes or team personnel registered to train at the olympic training center or registered to compete in an event conducted under the sanction of the United States Olympic Committee.
(b) The exemption provided in this section shall remain in force while the holder is providing medical services at the invitation of the United States Olympic Committee and only during the time certified to the board, but in no event longer than 90 days.
(c) Notwithstanding any other provision of law, the official team manager who is responsible for any team member participating in events at the invitation of the United States Olympic Committee in California may give consent to the furnishing of hospital, medical, and surgical care to a minor who is a team member and that consent shall not be subject to disaffirmance because of minority. The consent of the parent, or parents, of that person shall not be necessary in order to authorize hospital, medical, and surgical care.
(Amended by Stats. 1997, Ch. 654, Sec. 2. Effective January 1, 1998.)
(b) As used in this section, “orthopaedic physician assistant” means an individual who meets all of the following requirements:
(1) Successful completion of training as an orthopaedic physician assistant from an approved California orthopaedic physician assistant’s program in any year between 1971 and 1974, inclusive. As used in this section, “approved California orthopaedic physician assistant’s program” means an orthopaedic physician assistant’s course of training that has been accredited by the American Medical Association Council on Medical Education.
(2) Continuous experience as an orthopaedic physician assistant upon completion of the program described in paragraph (1), which may include experience in the United States Armed Services.
(3) Successful fulfillment of the certification requirements of the National Board for Certification of Orthopaedic Physician Assistants.
(c) Nothing in this section shall authorize any individual to hold himself or herself out as a licensed physician assistant in violation of Section 3503.
(Added by Stats. 1996, Ch. 1030, Sec. 1. Effective January 1, 1997.)
(a) As used in this section, “DMSO” means dimethyl sulfoxide.
(b) A licensed physician and surgeon shall, prior to treating a patient with a DMSO preparation, inform the patient in writing if DMSO has not been approved as a treatment or cure by the Food and Drug Administration for the disorder for which it is being prescribed.
(c) If DMSO is prescribed for any purpose other than for those purposes approved pursuant to Section 111550 of the Health and Safety Code, informed consent shall first be obtained from the patient.
As used in this subdivision, “informed consent” means the authorization given by the patient for treatment with DMSO after each of the following conditions have been satisfied:
(1) The patient is informed verbally, in nontechnical terms, about all of the following:
(A) A description of treatment procedures to be used in administering DMSO.
(B) A description of any attendant discomfort and risks to the patient that can be reasonably expected from treatment with DMSO.
(C) An explanation of any benefits to the patient that can be reasonably expected.
(D) An explanation of any appropriate alternative procedures, drugs, or devices that might be advantageous to the patient, and their relative risks and benefits.
(E) An offer to answer any inquiries concerning the treatment of the procedures involved.
(2) The patient signs and dates a written consent form acknowledging that disclosure has been given pursuant to paragraph (1), and acknowledging consent to treatment with DMSO pursuant to this section. The patient shall be provided with a copy of the signed and dated form.
(d) An organized health care system may require that the administration of DMSO within the organized health care system be performed pursuant to standardized procedures developed by the organized health care system through collaboration among administrators and health professionals.
(Added by Stats. 1996, Ch. 890, Sec. 1. Effective January 1, 1997.)
(b) The Medical Board of California shall review the information submitted and take action as follows:
(1) Inform the Dental Board of California whether the physician and surgeon has a current license in good standing to practice medicine in this state.
(2) Verify whether the applicant has successfully completed a postgraduate residency training program in anesthesiology and whether the program has been recognized by the American Council on Graduate Medical Education.
(3) Inform the Dental Board of California whether the Medical Board of California has determined that the applicant has successfully completed the postgraduate residency training program in anesthesiology recognized by the American Council on Graduate Medicine.
