Introduction to Public Health Law for Bioterrorism Preparedness and Response Sponsored by the Public Health Law Program, U.S. Centers for Disease Control.

Introduction to Public Health Introduction to Public Health Law for Bioterrorism Law for Bioterrorism Preparedness and ResponsePreparedness and Response

The Center for Law & the Public’s Healthat Georgetown& Johns Hopkins UniversitiesCDC Collaborating Center Promoting Public Health through Law


Sponsored by the Public Health Law Program, U.S. Centers for Disease Control and Prevention (CDC)

Jason W. Sapsin, JD, MPHJason W. Sapsin, JD, MPHStephen P. Teret, JD, MPHStephen P. Teret, JD, MPH

Course Overview

Basics of Emergency Health LawBasics of Emergency Health Law

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

Basics of Emergency Health Law

ConstitutionConstitution

General Sources of LawGeneral Sources of Law

Common Law Common Law

Statutes Statutes

RegulationsRegulations

Constitution (U.S.)Constitution (U.S.)


States’ Health Law PowerStates’ Health Law Power

““Police Powers”Police Powers”




Common LawCommon Law


Jacobson v. MassachusettsJacobson v. Massachusetts


““The liberty secured by the Constitution of the The liberty secured by the Constitution of the United States to every person within its United States to every person within its jurisdiction does not import an absolute right jurisdiction does not import an absolute right in each person to be, at all times and in all in each person to be, at all times and in all circumstances, wholly freed from restraint. circumstances, wholly freed from restraint. There are manifold restraints to which every There are manifold restraints to which every person is necessarily subject for the common person is necessarily subject for the common good.”good.”


Jacobson v. MassachusettsJacobson v. Massachusetts, 197 U.S. 11 (1904), 197 U.S. 11 (1904)






State Statutes & RegulationsState Statutes & Regulations









Local BoardsLocal Boards








Local BoardsLocal Boards Relationship to federal powersRelationship to federal powers

Special legislationSpecial legislation

Secretary’s quarantine authoritySecretary’s quarantine authority


Federal Emergency Health Federal Emergency Health PowersPowers

ConstitutionalConstitutional

StatutoryStatutory

RegulatoryRegulatory

The Unfolding StoryThe Unfolding Story

A case appears in a hospital emergency A case appears in a hospital emergency departmentdepartment– A 30 year old man presents with fever and pustulesA 30 year old man presents with fever and pustules– He has waited in ED for a few hours before being He has waited in ED for a few hours before being

seen by a physicianseen by a physician– Patients and staff in ED have come and gone in the Patients and staff in ED have come and gone in the

intervalinterval– When seen, the physician suspects smallpoxWhen seen, the physician suspects smallpox

Legal Issues in a Public Legal Issues in a Public Health Emergency: Health Emergency: State and Federal lawState and Federal law

9 Practical Questions9 Practical Questions

Can we declare a public health emergency?Can we declare a public health emergency?

Can we examine and test people?Can we examine and test people?

Can we investigate contacts?Can we investigate contacts?

Can we share information?Can we share information?Can we treat and vaccinate?Can we treat and vaccinate?Can we isolate and quarantine?Can we isolate and quarantine?Can we obtain facilities and supplies?Can we obtain facilities and supplies?Can we use non-governmental personnel?Can we use non-governmental personnel?Are we liable?Are we liable?

Legal Issues in a Public Health Emergency


A case appears in a hospital emergency department

Public health officials are notifiedPublic health officials are notified– They close the ED, telling those present that they They close the ED, telling those present that they

may not leavemay not leave– Preliminary confirmation of the diagnosis of smallpox Preliminary confirmation of the diagnosis of smallpox

is madeis made– The media pick up the story of a local case of The media pick up the story of a local case of

smallpox and widely report itsmallpox and widely report it– The public begins to show signs of panic, and the The public begins to show signs of panic, and the

local health resources are stressedlocal health resources are stressed


A case appears in a hospital emergency department Public health officials are notified

Given the nature of smallpox, health Given the nature of smallpox, health officials urge the Governor to declare an officials urge the Governor to declare an emergencyemergency– Anxiety among the public increasesAnxiety among the public increases– People begin to demand more information. Some People begin to demand more information. Some

demand vaccinedemand vaccine


Can we declare a public health Can we declare a public health emergency?emergency?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Public Safety §14-Md. Code Ann., Public Safety §14-3A-023A-02

If the Governor determines that exposure to a If the Governor determines that exposure to a deadly agentdeadly agent presents an imminent threat of extensive loss of life or of presents an imminent threat of extensive loss of life or of serious disability, the Governor may issue an executive serious disability, the Governor may issue an executive order proclaiming the existence of a order proclaiming the existence of a catastrophic health catastrophic health emergencyemergency..

YesYes


Can we declare a public health Can we declare a public health emergency?emergency?

Federal AuthorityFederal Authority

1) Constitutional1) Constitutional

YesYes

Action to preserve life, property, public order, protect Action to preserve life, property, public order, protect federal property and functions.federal property and functions.

2) Statutory2) Statutory

Insurrection statutes: Insurrection statutes: 10 U.S.C. §§331-33310 U.S.C. §§331-333

Disaster Relief: Disaster Relief: Stafford Act 42 U.S.C. §5121 et seq.Stafford Act 42 U.S.C. §5121 et seq.

The Unfolding StoryThe 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 Laboratory tests confirm the diagnosis of smallpox for the first patient. More of smallpox for the first patient. More patients begin to appear in EDs, patients begin to appear in EDs, throughout the city, with signs of throughout the city, with signs of smallpoxsmallpox– Public health personnel want to learn the Public health personnel want to learn the

identities of the persons with whom the identities of the persons with whom the cases had contactcases had contact

– Public health personnel want to examine Public health personnel want to examine those personsthose persons


Can we investigate the contacts?Can we investigate the contacts?

State Law (Maryland)State Law (Maryland)YesYes

1)1) The secretaryThe secretary shall investigate diseases that he has reason shall investigate diseases that he has reason to believe are infectious or contagious and endanger to believe are infectious or contagious and endanger public health. public health. Md. Code Ann., Health - General §18-102Md. Code Ann., Health - General §18-102

2)2) The secretary has authority to continuously evaluate and The secretary has authority to continuously evaluate and monitor existing disease surveillance procedures to monitor existing disease surveillance procedures to detect a catastrophic health emergency; investigate detect a catastrophic health emergency; investigate actual or potential exposures to a deadly agent; and actual or potential exposures to a deadly agent; and treat, prevent or reduce the spread of the disease or treat, prevent or reduce the spread of the disease or outbreak.outbreak.

Md. Code Ann., Health - General §18-902Md. Code Ann., Health - General §18-902


Can we investigate the contacts?Can we investigate the contacts?

State Law (Maryland) State Law (Maryland) (cont’d)(cont’d)YesYes

3)3) The secretaryThe secretary may require reporting, by any person, of may require reporting, by any person, of information needed to conduct contact tracing for exposed information needed to conduct contact tracing for exposed individuals. individuals. Md. Code Ann., Health - General §18-904Md. Code Ann., Health - General §18-904


Can we examine and test people?Can we examine and test people?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Governor – Executive & Md. Code Ann., Governor – Executive & Admin. Dept’s §14-3A-03Admin. Dept’s §14-3A-03

Governor, following declaration of catastrophic health Governor, following declaration of catastrophic health emergency, may order the Secretary of Health or other emergency, may order the Secretary of Health or other designated official to require individuals to submit to designated official to require individuals to submit to medical examination or testing when medically medical examination or testing when medically necessary and reasonablenecessary and reasonable

YesYes


Can we investigate contacts, examine Can we investigate contacts, examine and test?and test?

Federal AuthorityFederal Authority42 U.S.C.42 U.S.C. §§ 264, 266 §§ 264, 266

1)1) Secretary’s Authority: PeacetimeSecretary’s Authority: Peacetime 42 U.S.C. §26442 U.S.C. §264

Apprehension and examinationApprehension and examination

YesYes

2)2) Secretary’s Authority: War time. Secretary’s Authority: War time. 42 U.S.C. 42 U.S.C. §266§266

Apprehension and examinationApprehension and examination


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 Agencies within the State and Federal governments, including public health governments, including public health and safety agencies, want information and safety agencies, want information regarding persons who are illregarding persons who are ill


Can we share information?Can we share information?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Health – General §18-904Md. Code Ann., Health – General §18-904

The secretary mayThe secretary may require reporting of information to the require reporting of information to the department by any person and require or authorize a health department by any person and require or authorize a health care provider to disclose information to a federal, state or local care provider to disclose information to a federal, state or local government agency or another health care providergovernment agency or another health care provider

YesYes


Can we share information?Can we share information?

Federal LawFederal LawHealth Information PrivacyHealth Information Privacy

The Health Insurance Portability and The Health Insurance Portability and Accountability Act of 1996Accountability Act of 1996Health plansHealth plansHealth providersHealth providersHealth care clearinghousesHealth care clearinghouses

““Public Health” Exception to Anti-disclosure Public Health” Exception to Anti-disclosure Rule: research, prevention of serious public Rule: research, prevention of serious public threats, state law reporting requirements threats, state law reporting requirements protectedprotected


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 There are now 10 confirmed cases in the city and another 5 cases in other areas of the and another 5 cases in other areas of the statestate– More people are demanding vaccinationMore people are demanding vaccination– Some people, who appear to be ill, are refusing Some people, who appear to be ill, are refusing

treatmenttreatment– Some people who are believed to have been Some people who are believed to have been

exposed to smallpox are refusing vaccinationexposed to smallpox are refusing vaccination


Can we treat/vaccinate people?Can we treat/vaccinate people?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Public Safety §14-3A-03Md. Code Ann., Public Safety §14-3A-03

DependsDepends

1) When medically necessary and reasonable to treat, 1) When medically necessary and reasonable to treat, prevent or reduce the spread of the disease, the prevent or reduce the spread of the disease, the Secretary or other designated official may require Secretary or other designated official may require vaccination or treatmentvaccination or treatment

2) Vaccination or treatment may not be likely to cause 2) Vaccination or treatment may not be likely to cause serious harmserious harm


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,


10 confirmed cases in city; 5 in other areas Public health officials recommend the use of Public health officials recommend the use of

isolation and quarantineisolation and quarantine– Some object to being isolated or quarantinedSome object to being isolated or quarantined– Family members do not want to be separatedFamily members do not want to be separated– People fear that their needs will not be met in People fear that their needs will not be met in

isolation or quarantineisolation or quarantine


Can we isolate/quarantine people?Can we isolate/quarantine people?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Public Safety §14-3A-03Md. Code Ann., Public Safety §14-3A-03

YesYes

1) Governor may order Secretary or other official to 1) Governor may order Secretary or other official to establish places of treatment, isolation and establish places of treatment, isolation and quarantine quarantine and require individuals to go there and require individuals to go there

2) Release when individuals no longer pose a substantial 2) Release when individuals no longer pose a substantial risk of transmitting the disease or conditionrisk of transmitting the disease or condition

3) May order people to stay indoors and refrain from 3) May order people to stay indoors and refrain from congregating to “save lives or prevent exposure”congregating to “save lives or prevent exposure”


Can we isolate/quarantine people?Can we isolate/quarantine people?

Federal AuthorityFederal Authority1)1) Secretary’s Authority: Secretary’s Authority: 42 U.S.C. §§ 264, 26642 U.S.C. §§ 264, 266

YesYes

2)2) Public Health Service to cooperate with and aid State and Public Health Service to cooperate with and aid State and local authorities in the enforcement of their quarantine and local authorities in the enforcement of their quarantine and other health regulations. other health regulations. 42 U.S.C. §24342 U.S.C. §243

3)3) Director of CDC may take “reasonably necessary measures” Director of CDC may take “reasonably necessary measures” to prevent spread between States if local efforts are to prevent spread between States if local efforts are “insufficient”. “insufficient”. 42 C.F.R. §70.2 (2002) 42 C.F.R. §70.2 (2002)

4)4) Secretary may require permits for interstate travel; Secretary may require permits for interstate travel; individuals with specified diseases may be detained. individuals with specified diseases may be detained. 42 42 C.F.R. §§ 70.5, 70.6 (2002)C.F.R. §§ 70.5, 70.6 (2002)




10 confirmed cases in city; 5 in other areas Isolation and quarantine recommended by public health

Facilities and supplies become scarceFacilities and supplies become scarce


Can we obtain facilities and supplies?Can we obtain facilities and supplies?

State Law (Maryland)State Law (Maryland)Md. Code Ann., Governor - Executive & Admin. Md. Code Ann., Governor - Executive & Admin. Dept’s §14-3A-03Dept’s §14-3A-03

YesYes

1) Governor may order Sect’y or other official to seize 1) Governor may order Sect’y or other official to seize anything anything necessary for response and “work necessary for response and “work collaboratively, to the collaboratively, to the extent feasible” with extent feasible” with health care providers to gain access to health care providers to gain access to necessary necessary facilitiesfacilities

2) Governor may order Sect’y to control, restrict or 2) Governor may order Sect’y to control, restrict or regulate necessary medical materialsregulate necessary medical materials

3) Failure of practitioners or facilities to implement 3) Failure of practitioners or facilities to implement emergency health plans or disclose information, emergency health plans or disclose information, when when directed, can result in fines or licensure directed, can result in fines or licensure suspension/revocation suspension/revocation §18-906§18-906


Can we obtain facilities and supplies?Can we obtain facilities and supplies?

Federal LawFederal LawYesYes

1) 1) 10 U.S.C. §253810 U.S.C. §2538: Wartime ability to order : Wartime ability to order necessary necessary products or materials from any products or materials from any person or industryperson or industry

2) 2) 50 U.S.C. §98f(a)(2)50 U.S.C. §98f(a)(2): Access to stockpiles after : Access to stockpiles after declaration of war or general national defense declaration of war or general national defense emergencyemergency

3) 3) 50 U.S.C. App. §2072,207350 U.S.C. App. §2072,2073: President may declare : President may declare materials “scarce” to control supply/pricematerials “scarce” to control supply/price

4) 4) 42 U.S.C. §5196(i)42 U.S.C. §5196(i): FEMA Director may condemn or : FEMA Director may condemn or purchase materials or facilities with immediate purchase materials or facilities with immediate possessionpossession




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 scarceHealth care personnel become scarce


Can we use non-governmental Can we use non-governmental personnel?personnel?

State Law (Maryland)State Law (Maryland)

1) Governor may order any health care provider, who 1) Governor may order any health care provider, who does does not voluntarily participate, to participate in not voluntarily participate, to participate in disease disease surveillance, treatment and suppression surveillance, treatment and suppression efforts or efforts or otherwise comply with the directives of otherwise comply with the directives of the Sect’y or the Sect’y or other designated official. other designated official. Md. Code Md. Code Ann., Public Safety Ann., Public Safety §14-3A-03(c)§14-3A-03(c)

2) Sect’y, in consultation with health care facilities, may 2) Sect’y, in consultation with health care facilities, may require them to develop and implement require them to develop and implement

contingency plans. contingency plans. Md. Code Ann., Health – Md. Code Ann., Health – General §18-General §18-903903

YesYes



YesYes

3) 3) Health care facilities: civil penalty up to Health care facilities: civil penalty up to $3000/offense for failure to comply with Sect’y $3000/offense for failure to comply with Sect’y order under order under 18-903 or 18-904. 18-903 or 18-904. Md. Code Ann., Md. Code Ann., Health-General §18-Health-General §18-907(b)907(b)

4)4) Practitioners: licensing action, including Practitioners: licensing action, including probation, suspension, revocation or $3000 civil probation, suspension, revocation or $3000 civil penalty. penalty. Md. Code Ann., Health – General §18-Md. Code Ann., Health – General §18- 907(c)907(c)

State Law (Maryland)State Law (Maryland)Penalties – Penalties – failure to comply with Secty’s failure to comply with Secty’s order under 18-903, 904order under 18-903, 904



YesYes

5) Violation: misdemeanor with imprisonment (up to 1 year) or $5000, or both. Md. Code Ann., Public Safety §14-3A-08(b)

State Law (Maryland)State Law (Maryland)Penalties – Penalties – Knowing and willful failure to comply with Knowing and willful failure to comply with an order, requirement or directive issued under subtitle 3A ––an order, requirement or directive issued under subtitle 3A ––Governor’s Emergency Health PowersGovernor’s Emergency Health Powers



Federal LawFederal Law YesYes

* * 4242 U.S.C. §5149(a): Federal agencies can accept and U.S.C. §5149(a): Federal agencies can accept and utilize services or facilities of any governmental entity utilize services or facilities of any governmental entity with consentwith consent

1) 1) 42 U.S.C. §5152(a)42 U.S.C. §5152(a): President [through FEMA] may use, with : President [through FEMA] may use, with consent, American Red Cross, Salvation Army, Mennonite consent, American Red Cross, Salvation Army, Mennonite Disaster Service or any other such organization’s personnel Disaster Service or any other such organization’s personnel or facilities to distribute supplies and restore, rehabilitate or or facilities to distribute supplies and restore, rehabilitate or reconstruct services, housing or essential facilities when reconstruct services, housing or essential facilities when necessarynecessary

* * Limited use of military personnelLimited use of military personnel




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 liabilityWorkers and volunteers worry about liability


Are we liable?Are we liable?

State Law (Maryland)State Law (Maryland)

LimitedLimited

1)1) Md. Code Ann., Public Safety §14--3A-06Md. Code Ann., Public Safety §14--3A-06““A health care provider is immune from civil or A health care provider is immune from civil or

criminal liability if the health care provider acts in criminal liability if the health care provider acts in good good faith and under a catastrophic healthfaith and under a catastrophic health emergency emergency proclamation.”proclamation.”

2) 2) Md. Code Ann., Health General §18-907(d) Md. Code Ann., Health General §18-907(d) ““A health care provider acting in good faith and in A health care provider acting in good faith and in accordance with a catastrophic health emergency accordance with a catastrophic health emergency disease surveillance and response program is disease surveillance and response program is immune from immune from civil or criminal liability related to civil or criminal liability related to those actions, unless those actions, unless the health care provider acts the health care provider acts with willful misconduct.” with willful misconduct.”


Are we liable?Are we liable?

Federal LawFederal Law

LimitedLimited

1) 1) 42 U.S.C. §514842 U.S.C. §5148: Federal Government not liable for : Federal Government not liable for claims based on discretionary functions or claims based on discretionary functions or duties of duties of agencies or employeesagencies or employees

2) 2) 42 U.S.C. §5160(b)42 U.S.C. §5160(b): Individuals not liable to U.S. for : Individuals not liable to U.S. for costs costs incurred as a result of action taken or incurred as a result of action taken or omitted in response omitted in response to a major disaster or to a major disaster or emergencyemergency

3) 3) 28 U.S.C. §2680(f)28 U.S.C. §2680(f): Federal Government not liable for : Federal Government not liable for claims based on damages caused by the claims based on damages caused by the

imposition or establishment of a quarantine by imposition or establishment of a quarantine by the United the United States. States.

4) 4) Title III, §304 Homeland Security Act of 2002Title III, §304 Homeland Security Act of 2002: : Smallpox Countermeasures.Smallpox Countermeasures.

Introduction to Public Health Law Introduction to Public Health Law for Bioterrorism Preparedness for Bioterrorism Preparedness and Responseand 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.

Introduction to Public Health Law for Bioterrorism Preparedness and Response Sponsored by the Public Health Law Program, U.S. Centers for Disease Control.

Documents

public health emergency

catastrophic health

public health law program

federal law slide

notified health officials

emergency anxiety

local health resources

state law maryland