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Welcome to the Maine Train-the-Trainer program.
This presentation has been prepared by the Harvard School of Public Health Center for Public Health Preparedness to provide an overview of the legal issues relevant to public health emergencies in Maine. As you may already know, public health law is a matter primarily of state law, not federal, and while the principles generally are consistent, the provisions of specific laws may vary greatly from state to state. This presentation is intended for use by individuals for personal education, or by educators and trainers to present to a class of students.
The content has been developed for public health professionals, but should prove beneficial to hospital personnel, first line-responders, and the general public interested in learning more about public health law.
The information in this presentation is provided for educational purposes only and should not be construed as legal advice. Participation in this presentation does not create a lawyer-client relationship.
Also, keep in mind that this presentation is an OVERVIEW, and includes discussion of legal issues generally, with specific provisions of only a sample of relevant Maine law. There is a multitude of laws that may apply in a public health emergency, related to any one of the issues that we raise in this discussion.
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•Upon completion of this presentation, we hope to accompany the following seven learning objectives
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Public health law can be broken down into 5 fundamental components, the 5 progressive steps you must take in order to understand the key issues of law relevant to a public health emergency. These 5 steps are the framework for this presentation:
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•Identify key legal authorities in statute, regulation, or common law
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•Recognize situations in which legal issues may arise
•Know your professional responsibilities
•Know when to seek legal advice
•Understand that the law has limitations
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•Before we further explore the 5 Fundamental Components of Public Health Law in greater depth, it is first important to understand the roles of the three branches of government
•The framers of the Constitution wanted to form a strong, decentralized government that did not allow one person to have too much authority or control. With this in mind the framers wrote the Constitution to provide for a separation of powers, or three separate branches of government. Each has its own responsibilities and at the same time they work together to assure that the rights of individuals are not ignored or disallowed. This is done through checks and balances. A branch may use its powers to check the powers of the other two in order to maintain a balance of power among the three branches of government. The three branches of the U.S. Government are the legislative, executive, and judicial.
•The legislative branch of government is made up of the Congress, or the House of Representatives and the Senate at the federal level, and the legislature of each state. The legislative branch enacts laws that are referred to as “statutes.”
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•The executive branch of Government is responsible for implementing and enforcing the law. The President of the United States is the head of the executive branch at the federal level, and the Governors of each state head the Executive Branch of state government. This branch also includes federal and state agencies.
•The judicial branch of government is made up of the court system. The Supreme Court is the highest court in the United States. There is a federal court system consisting of district (or trial) courts and appellate (or circuit) courts throughout the country. Each state has trial and appellate courts too. Maine, with Massachusetts and Puerto Rico, is part of the 1st Circuit Court of Appeals of the U.S., and the highest state court in Maine is called the Supreme Judicial Court. Each court has a jurisdiction in which its decision is binding.
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As we first look broadly at how the law works, moving to specific provisions of Maine law as applied in public health emergency situations, we should keep in mind some general considerations of what the law “does.”
•The law, particularly in the area of public health, is applied in a context of the balance between the rights of the individual and the protection of the health of the population.
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•The law defines the responsibilities or duties of parties.
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•The law defines those responsibilities in relationships between parties.
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•The law also creates and defines the liability of parties in particular situations.
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•Following from the requirements set forth as in the U.S. Constitution, the law contains due process protections, or procedures that seek to ensure that laws are applied fairly.
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•Laws are based not only on the principle of fairness, but also on reasonableness.
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•And, the law provides for enforcement– by imposing penalties for noncompliance.
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The term “law” is often used to refer to the statutes that are enacted by the legislative branch, but in fact there are four sources of “law”:
1.The Constitution– the United States Constitution and that of each state.
2.Statutes- the legislative branch (the Maine Legislature and the U.S. Congress) enacts laws that become part of the code of the state, and of the United States, respectively. In Maine, the statutes are compiled into the state code that is the Maine Revised Statutes.
3.Regulations are the rules that are promulgated by executive branch agencies, under the statutory authority granted to them by the legislative branch. The Maine Department of Human Services makes rules under its duties for the “general supervision of the interests of health and life of the citizens of the State.” (22 M.R.S.A. 1 §3)
4.Common Law refers to the law made by judges in courts. Remember the relative roles of the three branches of government– the legislature enacts laws, the executive branch implements and enforces them, and the judicial branch interprets them. The interpretation of these laws and regulations contribute to a common law.
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Similarly, the ordinances that are enacted on the local level also have the force of law.
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•The standard of proof required by law varies depending on the type of legal proceeding, and logically corresponds to the level of liberty or other interest that is at stake.
•The highest standard - beyond a reasonable doubt – is applied during criminal cases, where the penalty is greatest.
•The intermediate standard – clear and convincing – is applied during civil cases; it requires a “High probability”, or something less than “beyond a reasonable doubt”– this standard is seen most often in the involuntary civil commitment context.
•The lowest standard – preponderance of the evidence – is applied also during civil cases; “More likely than not”
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•Now that we have a basic understanding of the sources and general principles of law, we will examine the first fundamental component of public health law – identifying the key legal authorities in statute, regulation, or common law.
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While in practice protecting the health and welfare of a state’s own residents is usually within the authority of the state, there is relevant federal authority that you are likely to encounter and which you should be able to recognize.
The federal authority over public health matters stems from the Commerce Clause of the U.S. Constitution, which grants the federal government the authority to regulate matters that affect commerce among the states. This has been interpreted over the years by courts to include various areas of public health, including environmental health, food and drug safety and occupational safety.
The Public Health Service Act and the Homeland Security Act of 2002 are examples of federal laws, enacted by Congress, that grant the federal government authority to regulate certain aspects of public health.
For example, the Public Health Service Act, in Title 42 of the United States Code, section 264, describes the authority of the Surgeon General to make and enforce rules to prevent the spread of communicable diseases from a foreign country to the United States, or from one state to another.
Federal administrative agencies, from the Executive Branch, with which you should be familiar, include the U.S. Department of Health and Human Services, and the these agencies within it….HRSA, CDC, and CMS.
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State law is going to provide the rules most of the time in public health preparedness. So, Maine state law will be your primary authority. Under U.S. Constitutional law, powers not relegated to the federal government are retained by the states.
That includes the Police Power – over the years, the U.S. Constitution has been interpreted by courts to reserve for the states the authority to protect the public’s health, safety, welfare or morals.
Parens Patriae refers to the state’s authority to protect minors, and others unable to protect themselves.
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The Jacobson case is perhaps the most familiar reference of the police power by the United States Supreme Court.
This case originated in Cambridge, Massachusetts, at the turn of the 20th century, where smallpox vaccination was being administered by the Cambridge Board of Health during an outbreak.  Mr. Jacobson challenged the town’s compulsory vaccination on grounds that it violated certain of his constitutional rights.
The highest court in Massachusetts, and then the U.S. Supreme Court, in this case upheld compulsory vaccination as an exercise of the state’s police power, as delegated to the local board of health here, citing such elements as its: public health necessity, reasonable means, and proportionality.
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Some examples of the state’s exercise of its police power in public health are:
•Safety belts
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•Smoking
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•Helmets
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•Immunization
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•Quarantine & Isolation
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Selected state laws are cited here…
Title 22, section 801 and following, of the Maine Revised Statutes Annotated, includes provisions that relate to the authority of the Department of Human Services for the control of communicable diseases.
10-144 of the Code of Maine Regulations, Chapter 258 includes the rules made by the Department of Human Services, under the statutory authority granted to it by the state legislature, that apply to the Bureau of Health’s control of notifiable conditions.
You should be familiar with these abbreviations so that you will recognize whether a citation refers to a statute or a regulation.
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This gives you a picture of the context of where the state entities sit, with authority over the matters related to public health emergency in Maine. For example, the state’s Office of Public Health Emergency Preparedness sits in the Bureau of Health, which is one of 5 bureaus contained within the Department of Human Services.
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The second fundamental component of public health law is to recognize situations in which legal issues may arise.
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This slide lists some of the legal issues one may encounter during a public health emergency.
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This slide references the Maine statute that defines an extreme public health emergency.
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This slide references the Maine statute that defines a public health threat.
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We will see great deference given to the state’s authority to protect the health and welfare of the public in a public health emergency, but there are relationships with other jurisdictions that will figure in a public health emergency.
For example, the federal government, perhaps through the US Department of Health and Human Services, Centers for Disease Control and Prevention, or the Department of Homeland Security may exercise authority, particularly in situations between a foreign country and another state, or in matters that cross one state’s border to another’s.
States and foreign countries may also enter into agreements, much like mutual-aid agreements, which may sound familiar, that are called “compacts.” Maine is a signatory of two major compacts:
The Emergency Management Assistance Compact includes nearly every U.S. state.
The International Emergency Management Assistance Compact includes all six of the New England states, as well as the Canadian provinces of New Brunswick, Newfoundland and Labrador, Nova Scotia, Prince Edward Island, and Quebec.
These compacts are codified in the Maine statutes, and basically serve as vehicles through which Maine and other jurisdictions agree to request and receive assistance from each other– in this case, during a public health emergency.
The provisions of the compacts apply to the liability and licensure of one jurisdiction’s professionals or emergency responders acting in another’s. They can also include arrangements between the jurisdictions regarding compensation for services that are provided from one jurisdiction to another.
And, coordination among various agencies within a single state is another aspect of coordination, and the one that is probably most obvious to you as you practice in a public health emergency.
You can see that matters that cross state boundaries and jurisdictions is an area of law that is served by interstate compacts and interagency agreements that clarify individual and institutional roles and responsibilities.
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•On April 14th, 2003, the HIPAA Privacy Rule was implemented. The Maine Department of Human Services, Bureau of Health, Division of Disease Control (DDC) is clarifying the exemptions provided for public health functions under HIPAA restrictions on disclosure of Protected Heath Information (PHI). It is important to emphasize the DDC’s classic public health functions that are not inhibited by the HIPAA Privacy Rule: those of reportable disease surveillance and preventive follow-up; outbreak investigations; preventive outreach education and appropriate preventive follow-up services for contacts of communicable diseases.
•As stated in 45 CFR 164.512 (b)(1)(i), “The [HIPAA] Privacy Rule permits covered entities to disclose protected health information, without authorization, to public health authorities who are legally authorized to receive such reports for the purpose of preventing or controlling disease, injury, or disability. This would include, for example, the reporting of a disease or injury; reporting vital events, such as births and deaths; and conducting public health surveillance, investigations, or interventions.”
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The DDC is legally authorized to receive reports by Maine Statute (22 MSRA, Chapter 250 Control of Communicable Diseases, Sections 801-825) and Maine Rules (Rules for Control of Notifiable Conditions 10-144 C.M.R. Ch. 258) requiring all medical providers to continue to report, and to cooperate with “public health investigations and interventions.” That includes providing supporting information such as relevant laboratory tests. As stated in the HIPAA Privacy Rule, “Effects on State Law” section (42USC § 1320 (d) (7) (b) PUBLIC HEALTH): “Nothing in this part shall be construed to invalidate or limit the authority, power, or procedures established under any law providing for the reporting of disease or injury, child abuse, birth, or death, public health surveillance, or public health investigation or intervention.”
Health care workers who provide names of persons to public health authorities to carry out these above functions are covered under Maine statute 22 M.R.S.A § 1711-C (6) that “allows a health care practitioner or health care facility to disclose confidential health information as follows: to federal, state or local government entities in order to protect the public health and welfare when reporting is required or authorized by law.”
When concern exists regarding a potential public health problem in the community, DDC’s Epidemiologists contact health care providers to alert them to the fact that further epidemiological investigation and interview of patients diagnosed with a notifiable disease or condition is deemed necessary. This contact is done in an attempt to enhance collaborative working relationships with the private medical community. DDC’s interest and concern are directly related to public health surveillance and intervention. If you have any questions you may contact DDC at 800.821.5821.
Source: Maine Epi-Gram, Summer 2003, at http://www.state.me.us/dhs/bohepi/summer03.htm#Skin%20Conditions%20that%20Mean%20You%20Should%20NOT%20be%20Vaccinated
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Again, while the Secretary of the U.S. Dept. of Health and Human Services has statutory responsibility for preventing the introduction, transmission, and spread of communicable diseases from foreign countries into the U.S. and between states, states and their localities have primary responsibility for isolation and quarantine within their borders.
These are titles of the sections in the Maine statute that describe authority of the Department for quarantine (the limitation of movement of individuals who have been exposed to a communicable disease) and isolation (the separation of an infectious person to prevent spread of an infectious agent to others).
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Step-wise, that is increasing in their level of intervention, prescribed care measures are described in regulation to be used when there is non-compliance with infection control measures on the part of a person believed infected or exposed to one of the notifiable conditions listed in the same regulation. This reflects a tempered approach to balancing the treatment of individuals with the protection of the population’s health.
1.Face-to-face counseling by a public health professional for the individual
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2.Prescribed care measures include a range of supportive services, such as direct observation of therapy, transportation, and financial support.
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3.A Cease and Desist order directing the individual to comply with specified disease control measures
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4.Court ordered confinement, isolation and treatment upon information that a Cease and Desist order has been violated.
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5.And finally, the most extreme, civil commitment proceedings, which consist of a set of requirements to ensure the protection of the rights of the individual.
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In an extreme public health emergency, the control measures to protect the public health and safety include the following:
•Identification of exposed persons
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•Tracking and follow-up of infected or exposed persons
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•Mandatory medical examination of infected or exposed persons
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•Mandatory medical treatment
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•Isolation and quarantine
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This cited law is likely familiar to you. The federal Emergency Medical Treatment and Active Labor Act (often referred to as the “patient anti-dumping law,”)  states that there may be cases in which state or local governments have developed community response plans that designate specific entities (hospitals, public health facilities, etc.) with responsibility for handling certain categories of patients in bioterrorism situations. The transfer or referral of these patients in accordance with such a community plan would not violate the hospital’s EMTALA obligations.
According to a November 8, 2001 Centers for Medicare and Medicaid Services (CMS) question and answer, a hospital’s EMTALA obligations are not violated by transferring or referring patients pursuant to a state or local government-developed community response plan.
This is an important source of guidance from this federal agency as community response plans are reconciled with obligations to provide emergency treatment under the federal law, EMTALA.
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The U.S. Constitution, 5th Amendment provides that the government not “take” private property for public use without some compensation to property owners.
Both statute and regulations in Maine mention eminent domain as a tool for the control of property in an extreme public health emergency.
Generally, title 37-B M.R.S.A. §821 sets forth the requirements for when the state may take compensation and appeal (remember: due process)
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In a public health emergency, you can anticipate that such actions may be required.
Maine regulations “Rules for the Control of Notifiable Conditions” at 10-144 CMR Ch. 258 provide that these steps may be taken:
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The third fundamental component of public health law is to know your professional responsibilities
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Generally, there are standards for what is required of providers and of professionals.
Standards of conduct are found in: statutes, regulations, professional association guidelines, and sometimes even in custom.
There is a notion of reasonableness that is contained in the rules for how professionals should act.
For example, the reasonable provider, exercising reasonable care, such as those similarly situated, is likely to depict sounds actions on the part of a health provider, in particular.
The elements of negligence in medical malpractice are listed here, to provide an example:
The four elements of medical malpractice, all of which must be met to find malpractice, are:
Duty – created by the establishment of a doctor-patient relationship
A Breach of that duty
And the Causation of that breach of duty
For harm to the patient
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There is a range of laws, both federal and state, that may apply to the liability of health care practitioners, who volunteer in support of the state’s response to a public health threat or to an extreme public health emergency (both defined terms in Maine statute), and here is an example of a pretty recent one in Maine: In 1993, the legislature enacted “An Act to Protect Health Care Practitioners Responding to Public Health Threats” which amended the Maine Revised Statutes in two different places:
This first one may look to you like a Good Samaritan statute.
Immunity from civil liability may be granted for a licensed health care practitioner who acts in good faith.
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Here, Maine law provides for immunity from civil liability for health care practitioners who are employees in a private institution, as if they were state employees, here specifically for acts in support of the state’s response to a public health emergency.
BOTH of these provisions implicate the notion of “acting in good faith.” A common requirement for the law to grant immunity from liability.
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This is a flow chart that describes the liability scheme under Section 504 of the Homeland Security Act. It is included here for two purposes:
1.It illustrates the role of state law in determining liability, damages, and remedies; and
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2.It is an example of the resources and guidance that the CDC provides to health care providers and public health workers, regarding the smallpox vaccination program.
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The Smallpox Emergency Personnel Protection Act of 2003, Public Law 108-20, 117 Stat. 638, enacted on April 30, 2003, authorized the Secretary of Health and Human Services to establish the Smallpox Vaccine Injury Compensation Program. The program was appropriated $42 million to provide benefits and/or compensation to eligible individuals. An interim final rule was issued by USDHHS in December, published in the Federal Register on December 16, 2003.
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Workers compensation law is probably familiar to you, in your usual course of business.
Common elements of workers compensation include:
Whether one meets the definition of “employee.”
When one was acting within the scope of one’s employment when injured.
Compensation for work-related injuries is governed by several laws, depending on whether you are a private or a state employee.
This represents an area of public health emergency law that is under some change and further development. Some issues to think about here:
In the event of an emergency, it is anticipated that the definition of terms such as employee or employment will require some clarification. Also, whether a private employee converts to a state employee, acting as an agent for the state in an emergency.
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The fourth fundamental component of public health law is to know when to seek legal advice.
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Know whom to consult BEFORE you need them. Know who your agency or organization’s lawyer is. Same idea as being prepared in the case of an emergency.
Learn to flag a potential (or an actual) conflict with the law. Or, when you are not certain what the rule is in a particular situation, get advice from a legal professional.
Gathering relevant facts is important. The application of the law is very fact-specific, and the more you remember or are able to report, generally the clearer the situation will be.
Don’t delay. Memories fade and situations escalate. Some situations may wait, but you may not be able to tell whether you are in the middle of one of them.
Generally, keep in mind: you are a professional with duties and responsibilities, and being aware of laws that apply to you is part of that. There is no substitution, however, for legal advice when you are unsure. You are not expected to be an expert on the law.
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The fifth fundamental component of public health law is to understand that the law has limitations
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One very current illustration that the law is constantly evolving and catching up is the CDC’s Public Health Law Program, which includes an initiative to offer states resources for modernizing their public health laws, some of which are the oldest in the country….for example, a Model State Emergency Health Powers Act was drafted to provide a sort of template for states to apply to their current statutes to identify gaps and areas that may need change. Some states have used this approach.
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•In review, we have covered these 5 fundamental components of public health law