Notes

Outline

Legal Issues in Public Health Emergencies: An Overview for Maine

Learning Objectives Upon completion of this presentation, participants should be able to: Name the four sources of law (and be able to describe the differences between them) Identify public health legal authorities at the federal, state and local levels

Learning Objectives, continued

Learning Objectives, continued

Learning Objectives, continued

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law 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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General Legal Considerations Balance between individual rights & the protection of the health of the population Responsibilities Relationships Liability Due Process Reasonableness Enforcement

Sources of Law Constitution (U.S. and each state) Statutes (Legislative enactments) Regulations (Administrative agency rules) Common Law (Judicial decisions)

Standards of Proof Beyond a Reasonable Doubt Clear and Convincing Preponderance of the Evidence

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations

Federal Authority U.S. Constitution Commerce Clause (Article 1, Sec. 8) Public Health Service Act (42 U.S.C. 264) Homeland Security Act of 2002 U.S. Dept. of Health & Human Services (USDHHS) Health Resources Services Administration (HRSA) Centers for Disease Control and Prevention (CDC) Centers for Medicare & Medicaid Services (CMS)

State Authority Powers not relegated to the federal government are retained by the states Police Power Parens Patriae

Police Power “…such reasonable regulations established directly by legislative enactment as will protect the public health and the public safety.” Jacobson v. Massachusetts, 197 U.S. 11 (1905)

Police Power Safety belts Smoking Helmets Immunization Quarantine & Isolation

State Law 22 M.R.S.A. § 801 et seq. 37-B M.R.S.A. §§ 742, 821 10-144 CMR Ch. 258

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Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations

Legal Issues during a Public Health Emergency Declaration of emergency Coordination of federal, state, and local authority Coordination between jurisdictions Disease reporting & surveillance Privacy & confidentiality Quarantine & isolation Control and protection of property

Declaration of an Extreme Public Health Emergency “occurrence or imminent threat of widespread exposure to a highly infectious or toxic agent that poses an imminent threat of substantial harm to the population of the state.” 22 M.R.S.A. §801 (4-A)

Public Health Threat “any condition or behavior which can reasonably be expected to place others at significant risk or exposure to infection with a communicable disease” 22 M.R.S.A. §801 (10)

Coordination between Jurisdictions State Federal  international and interstate Among states Emergency Management Assistance Compact (EMAC) Intl Emergency Management Assistance Compact (IEMAC) Among state agencies

Privacy & Confidentiality Federal law HIPAA (Health Insurance Portability and Accountability Act of 1996) HIPAA Privacy Rule (45 CFR 164.512(b)(1)(I)

Privacy & Confidentiality State Law Control of Communicable Diseases, 22 M.R.S.A. § §801-825 Rules for Control of Notifiable Conditions, 10-144 C.M.R. Ch. 258

Quarantine & Isolation Investigation Examination Emergency temporary custody Court procedures Public health measures Review

Management of Persons “Step-wise prescribed care measures” Face-to-face counseling Prescribed care measures Cease and Desist order Court-ordered confinement, isolation & treatment Civil commitment

…in an Extreme Public Health Emergency Identification of exposed persons Tracking and follow-up of infected or exposed persons Mandatory medical examination of infected or exposed persons Mandatory medical treatment Isolation and quarantine 10-144 CMR Ch. 258

EMTALA Emergency Medical Treatment and Active Labor Act 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. http://www.cms.hhs.gov/medicaid/survey-cert/110801.asp

Control of Property – Eminent Domain for the protection and welfare of the State and its inhabitants… [required] as a matter of public necessity or convenience…may take possession of any real or personal property located within the State for public uses… reasonable compensation to the owners… owner may appeal in Superior Court within 6 years of the taking. 37-B M.R.S.A. §821

…in an Extreme Public Health Emergency “the Department shall assure that necessary steps are taken to protect the public health and safety by exercising the following powers as necessary”: Accessing suspicious premises Closure of facilities Temporary use of health care facilities and ability to transfer patients Temporary use of hotel and motel rooms and other facilities

…in an Extreme Public Health Emergency Procurement of medicine and vaccines, supplies and equipment Decontamination of buildings Seizure and destruction of contaminated articles Disposal of human and animal remains 10-144 CMR Ch. 258

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations

Duties and Obligations of Providers Standard of conduct Statutes, regulations, guidelines, custom “Reasonableness” Reasonable provider Reasonable care Similarly situated Negligence Duty Breach Causation Harm

Immunity from Civil Liability An Act to Protect Health Care Practitioners Responding to Public Health Threats (24 M.R.S.A. §2904; effective September 13, 2003) For health care practitioners: voluntarily, without the expectation or receipt of monetary or other compensation acting within the scope of licensure for harm not caused by willful, wanton, reckless, or negligent acts

Immunity from Civil Liability An Act to Protect Health Care Practitioners Responding to Public Health Threats (22 M.R.S.A. §816, sub-§1; eff. Sept. 13, 2003) For private institutions: “…in support of the State’s response to a declared extreme public health emergency…”

CDC Advisory on Liability in Smallpox Vaccination Program

Smallpox Vaccine Injury Compensation Program Established pursuant to USDHHS Secretary authority under the Smallpox Emergency Personnel Protection Act of 2003 (SEPPA).  Provides “benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures.” [boldness added]

Compensation for Work-Related Injuries General principles of workers compensation State and private In the event of an emergency…

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations

Seeking Legal Advice Know whom to consult BEFORE you need them Flag a potential (or actual) conflict with the law Gather relevant facts Don’t delay

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations

Limitations of the Law The law is very fact-specific The law is constantly evolving The law is often catching up… …with advances in scientific knowledge …with changes in society …with unanticipated events and circumstances The law requires interpretation

Fundamental Components of Public Health Law Identify key legal authorities in statute, regulation, or common law Recognize situations in which legal issues may arise Know your professional responsibilities Know when to seek legal advice Understand that the law has limitations