'The liberty secured by the Constitution of the Unite

1
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)
2
Course Overview

• Basics of Emergency Health Law

• Legal Issues Arising in a Public Health
  Emergency State and Federal law

3
Basics of Emergency Health Law

• General Sources of Law

Constitution
Common Law
Statutes
Regulations
4
Basics of Emergency Health Law
States Health Law Power

• Constitution (U.S.)

Police Powers
5
Basics of Emergency Health Law
States Health Law Power

• Constitution

Police Powers

• Common Law

Jacobson v. Massachusetts
6
Jacobson v. Massachusetts
Basics of Emergency Health Law

• 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)
7
Basics of Emergency Health Law
States Health Law Power

• Constitution

Police Powers

• Common Law

Jacobson v. Massachusetts

• State Statutes Regulations

8
Basics of Emergency Health Law
States Health Law Power

• Constitution

Police Powers

• Common Law

Jacobson v. Massachusetts

• State Statutes Regulations

• Local Boards

9
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

10
Basics of Emergency Health Law
Federal Emergency Health Powers

• Constitutional

• Statutory

Special legislation

• Regulatory

Secretarys quarantine authority
11
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

12
Legal Issues in a Public Health Emergency State
and Federal law

• 9 Practical Questions

13
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?

14
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

15
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

16
Legal Issues in a Public Health Emergency

• Can we declare a public health emergency?

Yes
State Law (Maryland) Md. Code Ann., Public Safety
14-3A-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.
17
Legal Issues in a Public Health Emergency

• Can we declare a public health emergency?

Yes
Federal Authority
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.
18
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

19
Legal Issues in a Public Health Emergency

• Can we investigate the contacts?

Yes
State Law (Maryland)
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
20
Legal Issues in a Public Health Emergency

• Can we investigate the contacts?

Yes
State Law (Maryland) (contd)
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
21
Legal Issues in a Public Health Emergency

• Can we examine and test people?

Yes
State Law (Maryland) Md. Code Ann., Governor
Executive Admin. Depts 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
22
Legal Issues in a Public Health Emergency

• Can we investigate contacts, examine and test?

Yes
Federal Authority 42 U.S.C. 264, 266

• Secretarys Authority Peacetime
• 42 U.S.C. 264
• Apprehension and examination

2) Secretarys Authority War time. 42 U.S.C.
266 Apprehension and examination
23
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

24
Legal Issues in a Public Health Emergency

• Can we share information?

Yes
State Law (Maryland) 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
25
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

26
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

27
Legal Issues in a Public Health Emergency

• Can we treat/vaccinate people?

Depends
State Law (Maryland) 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
28
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

29
Legal Issues in a Public Health Emergency

• Can we isolate/quarantine people?

Yes
State Law (Maryland) 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
30
Legal Issues in a Public Health Emergency

• Can we isolate/quarantine people?

Yes
Federal Authority

• Secretarys 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)
31
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

32
Legal Issues in a Public Health Emergency

• Can we obtain facilities and supplies?

Yes
State Law (Maryland) Md. Code Ann., Governor -
Executive Admin. Depts 14-3A-03
1) Governor may order Secty 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 Secty 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
33
Legal Issues in a Public Health Emergency

• Can we obtain facilities and supplies?

Yes
Federal Law
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
34
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

35
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 Secty or other designated
official. Md. Code Ann., Public Safety
14-3A-03(c)
2) Secty, in consultation with health care
facilities, may require them to develop and
implement contingency plans. Md. Code Ann.,
Health General 18-903
36
Legal Issues in a Public Health Emergency

• Can we use non-governmental personnel?

Yes
State Law (Maryland)
Penalties failure to comply with Sectys order
under 18-903, 904
3) Health care facilities civil penalty up to
3000/offense for failure to comply with Secty
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)
37
Legal Issues in a Public Health Emergency

• Can we use non-governmental personnel?

Yes
State Law (Maryland)
Penalties Knowing and willful failure to comply
with an order, requirement or directive issued
under subtitle 3A Governors 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)
38
Legal Issues in a Public Health Emergency

• Can we use non-governmental personnel?

Yes
Federal Law
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 organizations 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
39
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

40
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.
41
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.
42
Introduction to Public Health Law for
Bioterrorism Preparedness and Response
The Center for Law and the Publics Health would
like to thank CDCs Public Health Law Program for
its institutional support. Development of
portions of this presentation and related course
materials was sponsored by the CDCs Public
Health Law Program, under cooperative agreement
U50/CCU319118. Course contents are solely the
responsibility of the Center for Law and the
Publics Health, and do not necessarily represent
the official views of CDC. This course is
within the public domain.