Legal Module

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Introduction to Public
Health Law for Bioterrorism
Preparedness and
Response
Jason W. Sapsin, JD, MPH
Stephen P. Teret, JD, MPH
Sponsored by the Public Health Law
Program, U.S. Centers for Disease Control
and Prevention (CDC)
Course Overview
 Basics of Emergency Health Law
 Legal Issues Arising in a Public
Health Emergency: State and
Federal law
Basics of Emergency Health Law
General Sources of Law
Constitution
Common Law
Statutes
Regulations
Basics of Emergency Health Law
States’ Health Law Power
 Constitution (U.S.)
“Police Powers”
Basics of Emergency Health Law
States’ Health Law Power
 Constitution
“Police Powers”
 Common Law
Jacobson v. Massachusetts
Basics of Emergency Health Law
Jacobson v. Massachusetts
“The liberty secured by the Constitution
of the United States to every person
within its jurisdiction does not import an
absolute right in each person to be, at all
times and in all circumstances, wholly
freed from restraint. There are manifold
restraints to which every person is
necessarily subject for the common
good.”
Jacobson v. Massachusetts, 197 U.S. 11 (1904)
Basics of Emergency Health Law
States’ Health Law Power
 Constitution
“Police Powers”
 Common Law
Jacobson v. Massachusetts
 State Statutes & Regulations
Basics of Emergency Health Law
States’ Health Law Power
 Constitution
“Police Powers”
 Common Law
Jacobson v. Massachusetts
 State Statutes & Regulations
 Local Boards
Basics of Emergency Health Law
States’ Health Law Power
 Constitution
“Police Powers”
 Common Law
Jacobson v. Massachusetts
 State Statutes & Regulations
 Local Boards
 Relationship to federal powers
Basics of Emergency Health Law
Federal Emergency Health
Powers
 Constitutional
 Statutory
Special legislation
 Regulatory
Secretary’s quarantine authority
The Unfolding Story
 A case appears in a hospital
emergency department
– A 30 year old man presents with fever and
pustules
– He has waited in ED for a few hours before being
seen by a physician
– Patients and staff in ED have come and gone in
the interval
– When seen, the physician suspects smallpox
Legal Issues in a
Public Health
Emergency: State and
Federal law
9 Practical Questions
Legal Issues in a Public Health
Emergency
Can we declare a public health emergency?
Can we investigate contacts?
Can we examine and test people?
Can we share information?
Can we treat and vaccinate?
Can we isolate and quarantine?
Can we obtain facilities and supplies?
Can we use non-governmental personnel?
Are we liable?
The Unfolding Story
 A case appears in a hospital emergency
department
 Public health officials are notified
– They close the ED, telling those present that
they may not leave
– Preliminary confirmation of the diagnosis of
smallpox is made
– The media pick up the story of a local case of
smallpox and widely report it
– The public begins to show signs of panic, and
the local health resources are stressed
The Unfolding Story
 A case appears in a hospital emergency
department
 Public health officials are notified
 Given the nature of smallpox, health
officials urge the Governor to
declare an emergency
– Anxiety among the public increases
– People begin to demand more information.
Some demand vaccine
Legal Issues in a Public Health
Emergency
 Can we declare a public health
emergency?
State Law (Maryland)
Yes
Md. Code Ann., Public Safety §143A-02
If the Governor determines that exposure to a deadly
agent presents an imminent threat of extensive loss of
life or of serious disability, the Governor may issue an
executive order proclaiming the existence of a
catastrophic health emergency.
Legal Issues in a Public Health
Emergency
 Can we declare a public health
emergency?
Federal Authority
Yes
1) Constitutional
Action to preserve life, property, public order,
protect federal property and functions.
2) Statutory
Insurrection statutes: 10 U.S.C. §§331-333
Disaster Relief: Stafford Act 42 U.S.C. §5121 et seq.
The Unfolding Story
 A case appears in a hospital emergency
department
 Public health officials are notified
 Health officials urge the Governor to declare
emergency
 Laboratory tests confirm the
diagnosis of smallpox for the first
patient. More patients begin to
appear in EDs, throughout the city,
with signs of smallpox
– Public health personnel want to learn
the identities of the persons with whom
the cases had contact
– Public health personnel want to examine
those persons
Legal Issues in a Public Health
Emergency
 Can we investigate the contacts?
State Law (Maryland)
Yes
1) The secretary shall investigate diseases that he has
reason to believe are infectious or contagious and
endanger public health. Md. Code Ann., Health -
General §18-102
2) The secretary has authority to continuously evaluate
and monitor existing disease surveillance
procedures to detect a catastrophic health
emergency; investigate actual or potential
exposures to a deadly agent; and treat, prevent or
reduce the spread of the disease or outbreak.
Md. Code Ann., Health - General §18-902
Legal Issues in a Public Health
Emergency
 Can we investigate the contacts?
State Law (Maryland)
(cont’d)
Yes
3) The secretary may require reporting, by any person,
of information needed to conduct contact tracing for
exposed individuals. Md. Code Ann., Health - General
§18-904
Legal Issues in a Public Health
Emergency
 Can we examine and test people?
State Law (Maryland)
Yes
Md. Code Ann., Governor – Executive
& Admin. Dept’s §14-3A-03
Governor, following declaration of catastrophic
health emergency, may order the Secretary of
Health or other designated official to require
individuals to submit to medical examination or
testing when medically necessary and reasonable
Legal Issues in a Public Health
Emergency
 Can we investigate contacts,
examine and test?
Federal Authority
42 U.S.C. §§ 264, 266
1) Secretary’s Authority: Peacetime
42 U.S.C. §264
Apprehension and examination
2) Secretary’s Authority: War time. 42
U.S.C. §266
Apprehension and examination
Yes
The Unfolding Story
 A case appears in a hospital emergency
department
 Public health officials are notified
 Health officials urge the Governor to declare
emergency
 Laboratory tests confirm; more patients appear
 Agencies within the State and
Federal governments, including
public health and safety agencies,
want information regarding persons
who are ill
Legal Issues in a Public Health
Emergency
 Can we share information?
State Law (Maryland)
Yes
Md. Code Ann., Health – General §18-904
The secretary may require reporting of information to the
department by any person and require or authorize a
health care provider to disclose information to a federal,
state or local government agency or another health care
provider
Legal Issues in a Public Health
Emergency
 Can we share information?
Federal Law
Health Information Privacy
The Health Insurance Portability and
Accountability Act of 1996
Health plans
Health providers
Health care clearinghouses
“Public Health” Exception to Anti-disclosure
Rule: research, prevention of serious public
threats, state law reporting requirements
protected
The Unfolding Story
 A case appears in a hospital emergency




department
Public health officials are notified
Health officials urge the Governor to declare
emergency
Laboratory tests confirm; more patients appear
Agencies within the State and Federal
governments, including public health and safety
agencies, want information regarding persons who
are ill
 There are now 10 confirmed cases in the
city and another 5 cases in other areas of
the state
– More people are demanding vaccination
– Some people, who appear to be ill, are refusing
treatment
– Some people who are believed to have been
exposed to smallpox are refusing vaccination
Legal Issues in a Public Health
Emergency
 Can we treat/vaccinate people?
State Law (Maryland)
Depends
Md. Code Ann., Public Safety §14-3A-03
1) When medically necessary and reasonable to treat,
prevent or reduce the spread of the disease, the
Secretary or other designated official may require
vaccination or treatment
2) Vaccination or treatment may not be likely to cause
serious harm
The Unfolding Story
 A case appears in a hospital emergency





department
Public health officials are notified
Health officials urge the Governor to declare
emergency
Laboratory tests confirm; more patients appear
Agencies within the State and Federal
governments, including public health and safety
agencies, want information regarding persons who
are ill
10 confirmed cases in city; 5 in other areas
 Public health officials recommend the use
of isolation and quarantine
– Some object to being isolated or quarantined
– Family members do not want to be separated
– People fear that their needs will not be met in
isolation or quarantine
Legal Issues in a Public Health
Emergency
 Can we isolate/quarantine people?
State Law (Maryland)
Yes
Md. Code Ann., Public Safety §14-3A-03
1) Governor may order Secretary or other official to
establish places of treatment, isolation and
quarantine and require individuals to go there
2) Release when individuals no longer pose a substantial
risk of transmitting the disease or condition
3) May order people to stay indoors and refrain from
congregating to “save lives or prevent exposure”
Legal Issues in a Public Health
Emergency
 Can we isolate/quarantine people?
Federal Authority
Yes
1) Secretary’s Authority: 42 U.S.C. §§ 264, 266
2) Public Health Service to cooperate with and aid State
and local authorities in the enforcement of their
quarantine and other health regulations. 42 U.S.C. §243
3) Director of CDC may take “reasonably necessary
measures” to prevent spread between States if local
efforts are “insufficient”. 42 C.F.R. §70.2 (2002)
4) Secretary may require permits for interstate travel;
individuals with specified diseases may be detained. 42
C.F.R. §§ 70.5, 70.6 (2002)
The Unfolding Story
 A case appears in a hospital emergency






department
Public health officials are notified
Health officials urge the Governor to declare
emergency
Laboratory tests confirm; more patients appear
Agencies within the State and Federal
governments, including public health and safety
agencies, want information regarding persons who
are ill
10 confirmed cases in city; 5 in other areas
Isolation and quarantine recommended by public
health
 Facilities and supplies become scarce
Legal Issues in a Public Health
Emergency
 Can we obtain facilities and supplies?
State Law (Maryland)
Yes
Md. Code Ann., Governor - Executive &
Admin. Dept’s §14-3A-03
1) Governor may order Sect’y or other official to seize
anything necessary for response and “work
collaboratively, to the extent feasible” with health
care providers to gain access to necessary
facilities
2) Governor may order Sect’y to control, restrict or
regulate necessary medical materials
3) Failure of practitioners or facilities to implement
emergency health plans or disclose information,
when directed, can result in fines or licensure
suspension/revocation §18-906
Legal Issues in a Public Health
Emergency
 Can we obtain facilities and
supplies?
Federal Law
Yes
1) 10 U.S.C. §2538: Wartime ability to order
necessary products or materials from any
person or industry
2) 50 U.S.C. §98f(a)(2): Access to stockpiles after
declaration of war or general national defense
emergency
3) 50 U.S.C. App. §2072,2073: President may declare
materials “scarce” to control supply/price
4) 42 U.S.C. §5196(i): FEMA Director may condemn or
purchase materials or facilities with immediate
possession
The Unfolding Story
 A case appears in a hospital emergency







department
Public health officials are notified
Health officials urge the Governor to declare
emergency
Laboratory tests confirm; more patients appear
Agencies within the State and Federal
governments, including public health and safety
agencies, want information regarding persons who
are ill
10 confirmed cases in city; 5 in other areas
Isolation and quarantine recommended by public
health
Facilities and supplies become scarce
 Health care personnel become scarce
Legal Issues in a Public Health
Emergency
 Can we use non-governmental
personnel?
Yes
State Law (Maryland)
1) Governor may order any health care provider, who
does not voluntarily participate, to participate in
disease surveillance, treatment and suppression
efforts or otherwise comply with the directives of
the Sect’y or other designated official. Md. Code
Ann., Public Safety §14-3A-03(c)
2) Sect’y, in consultation with health care facilities, may
require them to develop and implement
contingency plans. Md. Code Ann., Health –
General §18-903
Legal Issues in a Public Health
Emergency
 Can we use non-governmental
personnel?
State Law (Maryland)
Yes
Penalties –
failure to comply with
Secty’s order under 18-903, 904
3)
Health care facilities: civil penalty up to
$3000/offense for failure to comply with Sect’y
order under 18-903 or 18-904. Md. Code Ann.,
Health-General §18-907(b)
4) Practitioners: licensing action, including
probation, suspension, revocation or $3000 civil
penalty. Md. Code Ann., Health – General §18-
907(c)
Legal Issues in a Public Health
Emergency
 Can we use non-governmental
personnel?
State Law (Maryland)
Yes
Penalties –
Knowing and willful failure to comply
with an order, requirement or directive issued under
subtitle 3A ––Governor’s Emergency Health Powers
5)
Violation: misdemeanor with imprisonment
(up to 1 year) or $5000, or both. Md. Code
Ann., Public Safety §14-3A-08(b)
Legal Issues in a Public Health
Emergency
 Can we use non-governmental
personnel?
Federal Law
Yes
1) 42 U.S.C. §5152(a): President [through FEMA] may use,
with consent, American Red Cross, Salvation Army,
Mennonite Disaster Service or any other such
organization’s personnel or facilities to distribute
supplies and restore, rehabilitate or reconstruct
services, housing or essential facilities when
necessary
* 42 U.S.C. §5149(a): Federal agencies can accept and
utilize services or facilities of any governmental
entity with consent
* Limited use of military personnel
The Unfolding Story
 A case appears in a hospital emergency








department
Public health officials are notified
Health officials urge the Governor to declare
emergency
Laboratory tests confirm; more patients appear
Agencies within the State and Federal
governments, including public health and safety
agencies, want information regarding persons who
are ill
10 confirmed cases in city; 5 in other areas
Isolation and quarantine recommended by public
health
Facilities and supplies become scarce
Health care personnel become scarce
 Workers and volunteers worry about
liability
Legal Issues in a Public Health
Emergency
 Are we liable?
Limited
State Law (Maryland)
1) Md. Code Ann., Public Safety §14--3A-06
“A health care provider is immune from civil or
criminal liability if the health care provider acts in
good faith and under a catastrophic health
emergency proclamation.”
2) Md. Code Ann., Health General §18-907(d)
“A health care provider acting in good faith and in
accordance with a catastrophic health emergency
disease surveillance and response program is
immune from civil or criminal liability related to
those actions, unless the health care provider acts
with willful misconduct.”
Legal Issues in a Public Health
Emergency
 Are we liable?
Limited
Federal Law
1) 42 U.S.C. §5148: Federal Government not liable for
claims based on discretionary functions or
duties of agencies or employees
2) 42 U.S.C. §5160(b): Individuals not liable to U.S. for
costs incurred as a result of action taken or
omitted in response to a major disaster or
emergency
3) 28 U.S.C. §2680(f): Federal Government not liable for
claims based on damages caused by the
imposition or establishment of a quarantine by
the United States.
4) Title III, §304 Homeland Security Act of 2002:
Smallpox Countermeasures.
Introduction to Public Health
Law for Bioterrorism
Preparedness and Response
The Center for Law and the Public’s Health would like to
thank CDC’s Public Health Law Program for its
institutional support. Development of portions of this
presentation and related course materials was
sponsored by the CDC’s Public Health Law Program,
under cooperative agreement U50/CCU319118.
Course contents are solely the responsibility of the
Center for Law and the Public’s Health, and do not
necessarily represent the official views of CDC.
This course is within the public domain.
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