Introduction to Public Health Law for Bioterrorism Preparedness and Response

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. 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)

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 Secretary’s 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 investigate contacts? • Can we examine and test people? • Can we share information? • Can we treat and vaccinate? • Can we isolate and quarantine? Can we declare a public health emergency? • 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 secretaryshall 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) (cont’d) • 3) The secretarymay 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. 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

22. Legal Issues in a Public Health Emergency • Can we investigate contacts, examine and test? Yes Federal Authority 42 U.S.C.§§ 264, 266 • 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

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 mayrequire 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 • 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)

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. 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

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 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

36. Legal Issues in a Public Health Emergency • Can we use non-governmental personnel? Yes State Law (Maryland) 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)

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 ––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)

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 organization’s personnel or facilities to distribute supplies and restore, rehabilitate or reconstruct services, housing or essential facilities when necessary * 42U.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 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.