Law and Ethics Final Revision PDF

Law and ethics Class 1: Class one's aims **Understand the general role of law in achieving public health aims.** [What are social determinants of health?] Social determinants of health are the resources and conditions in our social and physical environments that influence exposure, vulnerabilit...

Law and ethics Class 1: Class one's aims **Understand the general role of law in achieving public health aims.** [What are social determinants of health?] Social determinants of health are the resources and conditions in our social and physical environments that influence exposure, vulnerability, and immunity to causes of disease and injury. Basically, most characteristics influence health except health characteristics. [What is Law?] Laws are rules issued and enforced by government entities [Where do Laws or rules come from?] 1. Federal government 2. State government 3. Local government [Law on the books vs Law on the streets what is the difference?] Law on the books forbids "jaywalking" however law on the street has peopled do it anyway, without consequence. A green and black chart with text and images Description automatically generated with medium confidence [How does Law influence health?] 1. It can encourage safe behaviours and discourage unsafe ones. (vapes, minimum unit pricing) - Illicit drug use = punishment - Taxation - Subsidies - Punishment - (fines, tort litigation, imprisonment) 2. Change the physical environment where people live. (side walks) - Zoning rules - Clean air laws - Regulation on toxins 3. Shape the social environment. (Tik tok meta, afterschool activities, anti-bullying inichatives) - Smoking prohibition - Nutrition labeling 4. Influence social determinates of health. (curriculum for health, enrolled in school for certain time period, food stamps, medicade). - Tax Laws - Education Laws - Employment law 5. Structures the health system. (funding, lack of law, vaccine clinic). - ACA - Health facilities regulation - Insurance regulation [What are the criteria for identifying critical opportunities for public health law?] [(Opportunities to use law more)] 1)Address a problem of public health significance. 2\) The mechanisms underlying the public health problem are sufficiently well understood. 3\) A plausible/ feasible legal intervention has been identified. [Address a problem of public health significance] - Prevalence of health condition (motor viechal dealths) - Severity of harm (morbidity or mortality) -- (high mortality e.g. drug overdose) - Distributional effects (e.g. disparities) [The mechanisms underlying the public health problem are sufficiently well understood] The mechanisms underlying the public health problem are sufficiently well understood to support a conclusion that is plausibly amenable to change through law. - To understand how law works to make health better. Health problem is causally related to behaviours, conditions, or other determinants that could plausibly be affected by law. [A plausible/ feasible legal intervention has been identified] - Intervention is likely to be effective. - Intervention does not face insurmountable legal barriers (eg gun control laws, firearms to much) - Any political opposition could probably be overcome in time. (need enough votes feasibility). [Examples of legal interventions] 1. State laws that restrict operation of motor vehicles (eg GDL) 2. Increase sales tax (e.g. alcoholic beverages) 3. Federal Food and Drug Administration standards of nutrient content in food (e.g. sodium) 4. Reform state law to remove barriers or provide legal immunity to helpers (e.g. opioid overdose) 5. State law requirements of collages and universities (e.g. college mental health) [Class 2] [Class 2 aims] 1. Understand the basic structure of the public health system and the differing roles of federal, state and local actors. 2. Identify sources of structural racism in health and care policy. [What does the "public health system" do?] - Ensure food and water safety - Reduce exposure to environmental toxins - Protect against infectious disease - Prepare for and respond to public health emergencies - Encourage health behaviours; discourage unhealthy behaviour - Collect public health data - Conduct research. "The set of community-wide prevention and protection programs that are needed to ensure the conditions people need to live healthy lives" [What are the three categories of the Ten Essential Health services?] 1. Assessment 2. Policy development 3. Assurance **[The ten essential health services -- produced by the CDC in 1994]**  [Public health is organized through government entities, what are the 3 government entities?] 1. Federal 2. State 3. Local [What are the three branches of government?] 1. **Legislative Branch**: creates laws (ie statutes), passes budgets and monitors programs 2. **Executive Branch**: Enforces laws, implements programs, adopt rules and regulations. 3. **Judicial Branch**: Interprets laws, regulations and other rules, resolves conflicts. In general, the legislative branch gives power to the executive branch. Federal: Legislative branch = Congress Executive branch = President and cabinet (agencies ect) Judicial branch = supreme court [US Congress gave power to the executive branch through the 1944 Public health services Act. ] - This allowed the department of health and human services to have authority over and use funding for public health efforts. **The Secretary for health and human services then runs federal agencies (eg CDC, VA, FAA)** Example list of agencies: A group of logos on a white background Description automatically generated Structure of the Department of Health and Human Services:  [What does the department of health and human services budget look like?] - 33% Medicaid - 50% Medicare - 9% Discretionary programs - 5% other mandatory programs - 2% Children entement programs - 1% TANF - Most of the federal public health funding tends to give money to individual healthcare. - The federal budget was \$1.7 tillion. [Do these federal health agencies and experts have influence?] Yes. - The CDC guidelines influence laws at the federal, state, and local levels. - U.S. Preventative Services Task Force recommendations on clinical preventative services (screening, vaccines ect) - They help create guidelines. [Who is the secretary of Health and Human services in the U.S?] Xavier Beccerra - This is usually a political position. [What are the comparative advantages of the federal government (versus state and local) in promoting public health?] 1. More authority/power 2. They can insensitive Medicare/ companies. 3. Stafford Act - Use the power of government in emergencies. What is the Stafford Act? Authorise the president to issue two types of declarations that could provide federal assistance to jurisdictions in response to a public health incident. What are the two types of declarations? 1. Emergency declaration 2. Major disaster declaration State: PA legislator (Legislative branch) gave power to the PA health department (Executive branch) through the Act of Apr. 27, 1905. -- creating the PA health department This gives the PA health department the power and authority to fund and support public health efforts. [What do state public health departments do?] - Collect public health data. - Disease investigations - Training public health workers. - Addressing health equity - "Pass-through" funding from federal government (take funds from federal governments and they can pass money onto other state funding stud and NGO etc) - Regulations and licences. [What does the state budget look like?] A pie chart with different colored circles Description automatically generated - Large proportion on: MA community health couices, M-assist capilation and county child welfare. - Might trust state more then federal - States have different landscapes, populations so the state might be able to cater to the population better then federal - State has more power and resources then local. Local: - Local health departments are on the "front lines" - Local health departments vary state to state, it could mean city, county etc. State legislator (legislative branch) gives power to the PHL department of public health through the Local Health Administration Law. (State legislature gives power to the local government) Philadelphia department of health (state) has the power to create and give power to the local. [What does the local do?] - Check air quality - Vaccines - Child tested for led - Report health and safety concerns - Provide medical care at health centres - Prevent spread of illness and disease - Protect against environmental hazards Local Public Health Agencies: - **Monitor disease outbreaks** - **Conduct inspections** - **Education and counselling** - **Testing and other preventative services** Funded by health insurance, local taxes, fees, state and federal government State and Local have overlap, so it depends how the state chooses to do things as to weather local has more or less power (centralised or decentralised) [How is local funded?]  Generally funded through a variety of sources, including federal and state taxes. 1. Health insurance 2. Local taxes 3. State taxes 4. Fees 5. State and federal government [Where do the money go in local?] 1. State run local health agencies 2. Locally run public health agencies 3. Nonprofit health organizations 4. State health department [Who is the Philadelphia health commissioner?] Frank A Franklin (interim commoner) [What are the comparative advantages of the Local government (verses federal and state) in promoting public health?] - Trust more at local level. - Cities/ local areas can be very different across the state or country and so when using local then they can understand the local problems and make more of an impact (Philly and opioids). [Sum up/ Important points in this section] Congress (legislative) enacts statues to give power to the federal government (executive branch). Federal government can only get power from congress. [Public health system for Native Americans] - Patchwork: Indian health service, state, us public health agencies - Governed in part by tribal law. Areas of structural racism - CDC does not have anyone to represent them and understand their needs. - Health care person bias. [Structural racism] "Operates through laws and policies that allocate resources in ways that disempower and devalue members of racial and ethnic minority groups, resulting in inequitable access to high-quality care." (Yerby R (2022) - ACA - Coverage gap **Identify sources of structural racism in health law & policy** **Social Determinants of Health:** Resources and conditions in our social and physical environments that influence exposure, vulnerability and immunity to causes of disease and injury. **Be familiar with ethics in public health; Apply ethical principles to public health challenges** - PH ethics draw from research, clinical and bioethics  - Influential documents that influence research ethics - Nuremberg Code: Balancing risks & benefits to research subjects/Informed Consent - Declaration of Helsinki: Doing medical research on human subjects - Common Rule: If you receive federal funding, you will need to get your research approved by the IRB  State government advantages: - States have different needs and the federal gov't can address them all - Trusting state officials might be easier than trusting fed gov't  - More insight about more prominent factors in state vs federal  - More ability to gauge political values Local government advantages: - At the frontline, have the direct contact with the community - Local gov't can respond to local problems  - Trust in local agencies because they likely have connections with local community organizations/groups Federal advantages: - More influence in reaching people nationwide  - Emergency power to enforce legislature - More money to incentivize federal programs (e.g, Medicare & Medicaid) to support the PH efforts Class 3: Class three objectives/ aims: 1. Be familiar with ethics in public health 2. Apply ethical principles to public health challenges [Health Ethics] 1. Research Ethics 2. Clinical Ethics 3. Bioethics These are more established in health ethics than public health ethics. However, Public Health Ethics does draw from these. A diagram of a circle with text Description automatically generated [Research Ethics: Influential Documents] 1. Nuremburg Code 2. Declaration of Helsinki 3. Common Rule [Research Ethics: Background] Nuremburg Code (1947) WW2 greenside of nazi Germany (war crimes) experiments in WW2. What came from it: - The importance of balancing risk and benefits to research subjects, - Informed consent [Common rule:] - It is based on the three ethical principles of the Belmont Report: Beneficence, Justice and Respect for Persons. -- usa [Declaration of Helsinki] Medical research involving human subjects must be conducted only by individuals with the appropriate ethics and scientific education, training and qualifications Under common rule [Clinical Ethics] - Prioritize patients' welfare - Patient autonomy [Bioethics: "Range of meaning"] [What are the four principles of clinical research ethics?] 1. Beneficence (doing good) 2. Nonmaleficence (doing no harm) 3. Justice/ equity 4. Respect for persons/ autonomy [Public health ethics] 1. Beneficence (doing good) 2. Nonmaleficence (doing no harm) 3. Justice/ equity 4. Respect for persons/ autonomy Plus 5. Interdependence/ solidarity/ collective (public health attitions to ethics) A black and white scale with white text Description automatically generated  A black and white scale Description automatically generated  A group of people on a computer Description automatically generated  A brochure of a group of people Description automatically generated  A screenshot of a computer Description automatically generated What are the benefits of an ethical analysis framework? Why should we use one to make ethical decisions? Applying the Ethical Framework 1. Read the introduction, background, case Description 2. Talk through each question of the Ethical Analysis Framework as applies to your case. They may all not apply. 3. Make notes as indicated in the group case submission sheet. Not all of your discussion will be turned in. 4. Answer the question(s)/call for action in the case description (using the information from the analysis) 5. Consider and talk through the scenario shift Public Health Values and Related Obligations: Another Framework for Public Health Ethics a. Professionalism and Trust b. Health and Safety c. Health Justice and Equity d. Independence and Solidarity e. Human Rights and Civil Liberties f. Inclusivity and Engagement Class 4: Objectives: Know basic constitutional principles and apply them. Understand principles related to pre-emption Understand how the US Constitution allocates power between the federal and state government Apply 2 methods of Constitutional Interpretation. Certain types of people made the constitution - They had certain views that don't necessary represent the U.S now. [U.S Constitution: What does it do?] 1. Structures government 2. Empowers federal government by granting specific and general powers 3. Limits government power and activity (e.g. through the bill of rights) The constitution is the source of all law. [The U.S Constitution Articles] 1. Article 1: The powers and role of the legislative branch (ie congress) 2. Article 2L The powers and role of the executive branch (ie the president) 3. Article 3: The powers and role of the courts **[Powers and roles of the federal government: Legislative branch ]** Powers listed in Article 1, Section 8 include: - Tax and spend - To regulate interstate commerce - To make "necessary and proper" laws for implementing other enumerate powers. Primary role: To create laws and fund government through budget laws. **[Powers and roles of the federal government: Executive Branch ]** Powers listed in Article 2, Section 2 & 3 include: - To "take care that the laws be faithfully executed" - To "Nominate, and by and with the advice and consent of the senate... appoint ambassadors,.... Judges of the supreme courts, and all other officers..." Primary role: to enforce the law. **[Powers and Roles of the Federal government: Judicial Branch]** Powers listed in Article 3, Section 2 include: - To hear all cases "arising under this Constitution, the laws of the United States, \[treaties\]..." - "In all cases affecting ambassadors, and... those in which a state shall be party, the Supreme Court shall have **original jurisdiction**. In all the other cases... \[SCOTUS\] shall have **appellate jurisdiction**, both as to law and fact" Primary role: to interpret ambiguous laws and the constitution and resolve conflicts. [What is Judicial review?] Marbury vs madison Federalist papers (Hamilton) Reviews laws to see if they conflict with the constitution. Powers and Roles of the Federal **Judicial Branch** (ie, SCOTUS) - **Marbury v. Madison (1803): United States federal courts have the authority to judicially review the statutes enacted by Congress, and declare a statute invalid if it violates the Constitution.** The courts cannot issue advisory options on the law, and they can only consider cases and controversies.  [Bill of rights] Amendment I Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof; or abridging the freedom of speech, or of the press; or the right of the people peaceably to assemble, and to petition the Government for a redress of grievances. [Theories of constitutional interpretation] A close-up of a document Description automatically generated [Federalism what is it?] Federalism: Federal and state (and local) governments share power. [How do we know when federal law pre-empts state law?] Look at the intent of congress (Wyeth v Levine, 2009) [What are the types of pre-emption?] 1. Express pre-emption 2. Implied pre-emption Within implied pre-emption there is (1) conflict, 2) Obstacle and 3) field) [Express pre-emption ] Congress expressly states that a federal law (a law not beyond constitutional power of congress) intends to pre-empt certain types of legislation. - It would be in the statue something about the pre-emption so always look in the statue for express pre-emption. [Implied pre-emption] **Conflict/ obstacle:** **\ **(a) a state law is in conflict with a federal law because it is impossible to comply with both at the same time (physical impossibility); or\ (b) a state law is in conflict with a federal law because it interferes with the objectives of the federal law or is an obstacle to the accomplishment of the federal purpose.  To determine whether this type of implied preemption exists, it is necessary to determine the purpose of the federal law and how that purpose is impacted by the operation of the state law.   **Field:** field preemption: the federal government has fully occupied the field it has chosen to regulate. To demonstrate that field preemption exists, the challenger must show that Congress intended to fully occupy a field and leave no room for even supplemental state regulation. When the Court is uncertain as to whether Congress intended to preempt the field, it will look at the nature of the regulated area. If the area regulated by Congress is an area in which the federal interest is dominant, the Court will be more inclined to presume that Congress intended to occupy the field (as in the areas of immigration or foreign affairs). If the area regulated by Congress is an area that has traditionally been regulated by the states (as in the area of regulating electrical utilities), the Court will be less likely to presume that Congress intended to occupy the field and may require that Congress make its intent to preempt clear and manifest.  Even if field preemption exists, there may still be a dispute as to the scope of the field that Congress intends to preempt. [Degrees of preemption] 1. Floor 2. Ceiling **Floor:** - Minium set of requirements **Ceiling:** - Maximum set of requirements - Prohibits lower levels of government for requiring anything more. [Constitutional interpretation ] They need to think about "what the question is" " what do they need to consider" [How do you interpret amendments?] [1.Textualism] [2.Originalism] [3.Constitutional Principles] [4.Pragmatism] [5.Precedent/tradition] [Class 5:] Objectives/aims: 1. Understand and apply the constitutional basis for federal power 2. Describe how the commerce clause has evolved 3. Analyze facts under the Commerce Clause and Tax and Spend powers of the federal government 4. Be familiar with the requirements of the Administrative Procedures Act [The three benches of government ]  [U.S Constitution ] [Section 8:] - The Congress shall have Power To lay and collect Taxes, Duties, Imposts and Excises, to pay the Debts and provide for the common Defence and general Welfare of the United States; but all Duties, Imposts and Excises shall be uniform throughout the United States (tax and spend) - To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes. (commerce clasue) - To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof. [Commerce clause] The Congress shall have Power to regulate Commerce among the several States. (commerce comes down to ideology -- changes (theory)) [Examples of commerce]**:** **Regulate unions under the National Labor Relations Act** (NLRB v. Jones & Laughlin Steel Corp (1937)) **Set minimum wages and hours under the Fair Labor Standards Act** (United States v. Darby (1941)) **Restrict the amount of land used for wheat under the Agricultural Adjudgment Act** (Wickard v. Filburn (1942)) [What is regulation of commerce between the several states? P. 131 of the reading] 1. Any one thing that has a "substantial effect" on interstate commerce 2. Any action that would substantially affect interstate commerce if many people engaged in that action Anything that has a "substantial effect" on interstate commerce Gonzalez v Raich: The Commerce clause give Congress the power to regulate purely local activities that are part of a \"class of activities\" with a substantial effect on interstate commerce. Congress could ban local marijuana use because it was part of such a \"class of activities\": the national marijuana market. Local use affected supply and demand in the national marijuana market, making the regulation of intrastate use \"essential\" to regulating the drug\'s national market **[Example: Is this regulation of commerce among several states?]** Schedule I drugs are those that have the following characteristic according to the United States Drug Enforcement Agency (DEA): - The drug or other substance has a high potential for abuse. - The drug or other substance has no currently accepted medical treatment use in the U.S. - It has a lack of accepted safety for use under medical supervision. Does Congress have the power under the Commerce Clause to criminalize marijuana? Criminalization of marijuana regulation of commerce among the several states? *What the court said:* - Congress\' commerce clause gives it the power to regulate purely local activities that are part of a \"class of activities\" with a substantial effect on interstate commerce. - Congress could ban local marijuana use because it was part of such a \"class of activities\": the national marijuana market. ["Substantial effects" cases] - In Heart of Atlanta Motel v. United States, the Supreme Court upheld the Civil Rights Act of 1964, finding that **racial discrimination in hotels and motels substantially affected interstate commerce by discouraging travel and limiting the supply of accommodations** - Hodel v. Virginia Surface Mining involved a challenge to the Surface Mining Control and Reclamation Act, which the Court upheld, finding that **surface coal mining had substantial effects on interstate commerce through its impact on the coal market and the environment** - Gonzales v. Raich concerned the regulation of medical marijuana under the Controlled Substances Act, with the Court holding that **Congress could regulate local cultivation and possession of marijuana due to its potential impact on the national drug market** 2\. Any action that would substantially affect interstate commerce if many people engaged in that action Congress may regulate activity that occurs solely within state lines, like a single farmer growing wheat, so long as the cumulative effect of such activity could have substantial effects on interstate commerce. ["Aggregate Effects Cases" ] - NLRB v. Jones (1937) While the manufacturing process or relationships between labor and management may not have a direct impact on the flow of goods, they have an aggregate impact on commerce. - The Courts apply a four-part test to see whether there is an aggregate impact on commerce [Federal government uses it's power -- to tax and spend (congress)] 1. Enact taxes to raise funds for public health efforts, to discourage unhealthy behavior, or encourage health conduct 2. Appropriate funds for health-related purposes or subsidize private conduct 3. Attach conditions to federal grants ***[Example:1984 National Minimum Drinking Age Act (NMDAA)]*** \[23 U.S.C. § 158\] Requires that States prohibit persons under 21 years of age from purchasing or publicly possessing alcoholic beverages as a condition of receiving 5-10% of highway funds. Conclution: - The legislation was in pursuit of \"the general welfare,\" and that - the means chosen to do so were reasonable. - The five percent loss of highway funds was not unduly coercive. [The Patient Protection and Affordable Care Act (ACA) has 3 main objectives: ] 1. to reform the private insurance market---especially for individuals and small-group purchasers 2. to expand Medicaid to the working poor with income up to 133% of the federal poverty level, and 3. to change the way that medical decisions are made **[In National federation of independent business v Sebelius ]** The plaintiffs argued that: 1. the individual mandate exceeded Congress\' enumerated powers under the Commerce Clause; 2. the Medicaid expansions were unconstitutionally coercive;. Q: Is the individual mandate regulation of an activity that substantially affects interstate commerce? A: No because it requires individual to become active in commerce when they otherwise would not. **NFIB vs Sebelius Medicaid Expansion: Does the federal government have the power under the spending clause** A: No. This is coercive - Government can use tax and spend a lot but cannot make it coercive A white text with black text Description automatically generated [Agencies] - Legislatures create statutes that authorize programs and create agencies to implement those programs. Statutes are almost always broadly worded. Why? Administrative Procedures Act (1946) 5 U.S. Code § 553 - Rule making  A close up of a document Description automatically generated  [Rules ] - Notice and comment is required for new rules - Notice and comment is NOT required for interpretation of rules [Concluding considerations ] - Why does the legislature delegate power? - Why would the agency want to avoid the notice and comment process? - Why didn't congress require notice and comment for every Agency action? [Side note: from questions I asked.] - Congress -- each state has counties and they each send a member (house of representatives) - Senate -- 2 people of each state - President only has the power that is given to them by congress. Congress gives the agencies power to create rules - regulation) -- rules have the same power as a law. Congress makes the laws and then power to the agencies. They carry out law and this is through making rules. rules have just as much enforcement as the law. - It can be unclear what the states have power to do/ federal has power/ congress has power. But congress has power to tax and spend -- this can be ambiguous though so hard to know whether state or congress has power sometimes. - Or do the government (president) purpose ideas to congress of what they want passed and then congress decides? No, only congress can do stuff, but the president can use their power to try get stuff done. - Supreme court appointed by president but senate has to confirm this - Only federal law can pre-met state law. Not vise versa. Class 6: Objectives: 1. Understand and apply the concept of police power. 2. Understand the source of local public health authority and the difference between "Dillon's Rule" and "home rule" jurisdictions 3. Describe the health implications of state preemption of local decision [Power to address Public health] Federal = Tax and spend and the commerce clause (Enumerated powers) = Plenary (as long as not pre-empted by federal [Plenary definition:] - unqualified; absolute. \"the disciplinary committee will have plenary powers\" [U.S. Constitution ] **Tenth Amendment** The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people. In simple terms states get all the power other than the federal powers in the constitution "tax and spend" "commerce" [State police power] - promote the public health, morals, or safety, and the general well-being of the community; - enact and enforce laws for the promotion of the general welfare; - regulate private rights in the public interest; and - extend measures to all great public needs Police power = nothing to do with police but another way of saying state power. [Jacobson v. Massachusetts (1905)] - Classic case that says states can do stuff for public welfare within limits MA law requires everyone to be vaccinated against smallpox or pay a fine Reverand Henning Jacobson challenges the mandatory vaccine requirement \[The Court\] has distantly recognized the authority of a state to enact... "health laws of every description" [State police power] State police power can do a lot of things like vaccine mandates, driving licenses, seatbelt requirements, mask mandates and smoking ban. However these police powers only go so far: They cannot go against the constitution, or state individuals rights. States cannot infringe "any right granted or secured by the Constitution." So states can use police power as long as it is a reasonable exercise of state authority to secure general comfort, health, and prosperity of the state. (The Legislature could have found that the Act bears a real and substantial relation to the health, safety, good order, comfort, and general welfare of the community...) However, when courts ask is this reasonable. The answer is normally yes. Why? -- this is because laws normally need justification so normally it is seen as reasonable by the court. **Bill of rights provides counter-majoritarian constraints on government power.** - We don't want the legislator to run over the rights so the bill of rights protects minority interests (minority interests said in the broad sense here) [Power to address public health] Federal = Tax and spend and the commerce clause (Enumerated powers) State = Plenary/police power (10^th^ amendment) (as long as not pre-empted by federal) Local = Local gets power from state. "Convenient entities" established to manage and affairs and preserve order at the local level (Hunter v. City of Pittsburgh, 1907) [Local (Municipal) power to address public health] - Dillon Rule - Home Rule - Or Both **[Dillon Rule (per Justice Dillon in 1868 case)]** The state gives power to the local government in specific areas Local government only exercises powers 1. Expressly granted by the state 2. Necessarily and fairly implied from the grant of power 3. Crucial to the existence of local government **[Home rule]** The state gives the local government power broadly. Local government has broad autonomy, so long as it does not conflict with the state (via State Constitution or statute) **[Both?]** A lot of states have a mix and even under home rule dillions rule still applies and can be challenged. However, home rule does make it harder to challenge. **[Why might you want home rule or dillion rule?]** Dillons rule: - Small - Lack of resources - Lack of people for government Home rule: - Bigger population - More resources - Want to control certain things - Have people wanting to do the job/ [Constitution of Pennsylvania] **§ 2. Home rule.** Municipalities shall have the right and power to frame and adopt home rule charters. Adoption, amendment or repeal of a home rule charter shall be by referendum. The General Assembly shall provide the procedure by which a home rule charter may be framed and its adoption, amendment or repeal presented to the electors. A purple rectangle with black text Description automatically generated Any municipality may frame and adopt or amend a charter for its government and may, subject to the provisions of section 3 of this article, exercise thereunder all powers of local self-government. [Example: Nevada] Ongoing dispute to try get rid of dillions rule as people want to change and control their own school, housing etc. Trying to switch to home -- school funding is not received so they want that. [State vs Municipality (local)] State always wins -- they can pass laws to win. [What are some reasons that State governments preempt local governments in public health areas?] - Corporate lobbyist - More homogeny Don't want disconnection throughout the state -- cooperations may find it hard to do different stuff in different areas. - Help public health Some states help promotion of health stuff through pre-emption. If local officials can find a constitutional right -- they can challenge the desition -- other then that the state always wins against local. Class 7: Challenges to health authority, emergency powers (+ challenge to emergency powers) Class objectives: 1. Explain legal bases for decreasing power of public health authorities. 2. Describe the legal bases for public health emergencies. Standing Doctrine: In order to be heard before a court, a party must be affected by the law or regulation, and has suffered or will suffer harm as a result. (limits who can sue as a result) Administrative challenges: 1. Hard to define what the statue is 2. Agencies has to be within that statue is. Administrative procedures act = federal and state act -- heart of aminstative law Chevron Deference: Courts should defer to agency interpretations of statutes related to the agency's work unless the interpretation is clearly unreasonable. (1984 -- 2024) -- the chevron deference was overruled in 2024. However it was slowly being eroded before (CDC) example. Example of courts going against the chevron defense comes form CDC in 2020 on the issue of Eviction moratorium. Congress gave power to the CDC through the public health and service Act (1940). The CDC then used the public health service ACT (1940) through the wording of "other measures" to have a no eviction thing. **[Public Health Service Act (1940)]** \[CDC\] is authorized to make and enforce such regulations as...are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession. For purposes of carrying out and enforcing such regulations, the \[CDC\] may provide for such inspection, fumigation, disinfection, sanitation, pest extermination, destruction of animals or articles found to be so infected or contaminated as to be sources of dangerous infection to human beings, **and other measures**, as in his judgment may be necessary. **[Eviction moratorium:]** Prohibits evictions for nonpayment of rent for all renters who meet income criteria and live in counties experience substantial or high rates of community transmission of COVID-19. Renters must meet eligibility criteria that include efforts to obtain government rental assistance and being at risk of homelessness. However, the court said that the CDC read the statue wrong and that other measures did not mean eviction moratorium. Therefore, the CDC moratorium was invalidated and no chevron deference. **What does the end of the chevron deference mean?** - Agencies have much less power and courts have much more power. Major Questions Doctrine: "If Congress wanted to do something of vast economic and political significance, it would have explicitly state so." Courts used the major questions doctrine to strike down biden plan on student debit. On a substantive cannon of construction that bars agencies from resolving questions of "vast economic and political significance" without clear statutory authorization. Trends In agency action to address public health, Supreme court has shown: - Chevron Deference overturned - Decreasing deference to agencies under the major questions doctrine - Increasing accommodation for religious entities **Emergency declaration = power to the executive branch** [Legal authority to act during an emergency] **FEDERAL** 1. Disaster and emergency declarations under the Stafford Act 2. Public Health Emergency Declarations under the Public Health Services Act 3. Defense production Act **STATE AND LOCAL** May covers Vaccination, isolation & quarantine, school closures, licensing and appointment of healthcare personnel, use of health care facilities, suspension of regulations **[Stafford Act (1988)]** - Via Presidential declaration - Trigger federal relief for the states - Upon request of the state (generally) - Major disaster or emergency President may direct any federal agency to use its existing authorities and resources to coordinate disaster relief and assist state and local governments **[FEDERAL AUTHORITY: Public Health Services Act]** - Via Secretary of Health and Human Services - Disease or disorder presents a public health emergency - Public health emergency (including infectious disease or bioterrorist attack) - Triggers HHS to make grants, finance expenses, conduct investigations, provide financial assistance from the Public Health Emergency Fund - HHS can waive federal law (HIPAA, EMTALA) - Allows FDA to issue an Emergency Use Authorization **[FEDERAL AUTHORITY: Defense Production Act]** - to direct private companies to prioritize orders from the federal government. - to "allocate materials, services, and facilities" for national defense purposes - take actions to restrict hoarding of needed supplies.   Stafford Act (covid-19) Could send military to do stuff Public health and service Act (covid-19) - Vaccine trials - Emergency use authorization for covid vaccine - Grants for covid-19 - Trials exulcerated (a lot quicker) Deference production Act (covid-19) - Companies instructed to make masks etc. **[The model State Emergency Health Powers Act]** A document with text on it Description automatically generated - Ideal state law for health emergencies prepared by Georgetown for the CDC. - Says what laws and statues should be in place for health emergencies. - A lot of states used parts of it after 9/11 to make sure they were prepared - The states choose some of it and use that so the states basically choose bits they want and make their own laws and acts. MSEHPA: Articles   As **2006**, MSEHPA has been introduced in whole or part through  - **171** bills or resolutions in **44** states, the District of Columbia, and the Northern Mariannas Islands. - **38** states \[AL, AK, AZ, CA, CT, DE, FL, GA, HI, ID, IL, IN, IA, LA, ME, MD,MN, MO, MT, NV, NH, NJ, NM, NC, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WI, and WY\] and DC have passed a total of **66** bills or resolutions that include provisions from or closely related to the Act.  **[PA Act 227 of 2002 vs MSEHPA]** PA A black text on a white background Description automatically generated MSEHPA  **[What does PA not have that MSEHPA DOES?]** - Lack of talk about recovery - No medical examinations - Access to and disclosure to health info (pa does not have mention of privacy or health info). [Backlash to emergency powers what is the root of this backlash?] - Fear that there is abuse of power - Fear of loss of control - Individual rights (autonomy) may be being controlled - Political climate -- elections upcoming may have their own agenda. [Pennsylvania and emergency powers] A white background with black text Description automatically generated [§ 20. Disaster emergency declaration and management.] [(a) A disaster emergency declaration may be declared by executive order or proclamation of the governor upon finding that a disaster has occurred or that the occurrence or threat of a disaster is imminent that threatens the health, safety or welfare of this commonwealth.] [(b) Each disaster emergency declaration issued by the governor under subsection (a) shall indicate the nature, each area threatened and the conditions of the disaster, including whether the disaster is a natural disaster, military emergency, public health emergency, technological disaster or other general emergency, as defined by statute. The general assembly shall, by statute, provide for the manner in which each type of disaster enumerated under this subsection shall be managed.] [(c) A disaster emergency declaration under subsection (a) shall be in effect for no more than twenty-one (21) days, unless otherwise extended in whole or part by concurrent resolution of the general assembly.] [(d) Upon the expiration of a disaster emergency declaration under subsection (a), the governor may not issue a new disaster emergency declaration based upon the same or substantially similar facts and circumstances without the passage of a concurrent resolution of the general assembly expressly approving the new disaster emergency declaration.][^\[8\]^](https://ballotpedia.org/Pennsylvania_Question_2,_Emergency_Declarations_Amendment_(May_2021)) Pennsylvania enacted a law that puts 21 day limit on emergencies and an extension mist be put through legislator -- legislator has to approve it. **[Legal Challenges to use of emergency powers]** - Individual rights: Free exercise of religion, equal protection, 1st Amendment - "Major questions doctrine" - Procedural grounds (Procedural grounds = like if the governor did not follow the order the litgation could get involved and challenge.) Class 9 Constitutional rights and limitations 1\. Apply the concepts of substantive and procedural due process. 2\. Understand the history of the Fourteenth Amendment's Equal Protection Clause 3\. Be familiar with classes and levels of scrutiny. 4\. Understand the evolution of the principles of fundamental rights and stare decisis. **[5^th^ Amendment (1789)- applies to federal]** - No person shall be deprived of life, liberty, or property, without due proses of law. - The 5^th^ amendment applies to the federal law. **[14^th^ Amendment (1789)- applies to states]** - No state.... deprive any person of life, liberty or property, without due process of the law. - Protects individuals rights against the states - Most rules/things were developed through the 14^th^ amendment -- due to how the U.S developed and the states powers. BUT all things that apply/ are part of the 14^th^ amendment also apply to the federal government (through the 5^th^ amendment). **[5^th^ and 14^th^ amendment ]** Due process and equal protection under the 5^th^ and 14^th^ amendments use the same analysis. - **Protection against Federal Government = 5^th^ Amendment** - **Protection against State Government = 14^th^ Amendment** [Due process and equal protection and intertwined -- often work together] **How do Due process and equal protection under the 5^th^ and 14^th^ effect public health?** Examples of how they effect public health: 1. Abortion 2. Marriage 3. Civil rights 4. Education **[Due process (as applied to State and Federal action): Questions for the court.]** There are two types of due process these being: 1. Procedural due process 2. Substantive due process **[Procedural due process:]** - How is the law being applied? - Have necessary procedures been established or followed? When life, liberty, or property has been affected by a governments action (If the government does something to affect your liberty 3 things need to happen -- as government is infringing on due process) What are these three things an individual must have? 1. Advance notice 2. Opportunity for a hearing 3. Right to appeal a decision But these three things can be disregarded sometimes -- if the governments interest outweighs individuals' interests. When might the governments interest outweigh the individuals? - Vaccines - Breathalyser -- they can take license away if refuse breathalyser. - Isolation/ quarantine-- property interest restraint Example : Mackey v. Montrym, 443 U.S. 1 (1979) - MA law mandates 90-day suspensionof a driver's license for refusing to take a breathalyzer test - Donald Montrym was arrested for DUI, refused to take a breathalyzer test, license was suspended. The argument was that Donald montrym did not have the three things: Advance notice, opportunity for a hearing and right to appeal the decision. (he said: I had no hearing. Massachusetts violated my procedural due process rights under the14th Amendment). The Supreme Court said: MA has a strong safety justification in removing intoxicated drivers from the road, which would be undermined by a pre-suspension hearing. So procedural due process rights outweighed for safety in drink driving. So individuals have the right to the 3 things but not if the governments interest (in highway safety) outweighs the individual interest. Second example: Quarantine (Hickox v. Christie, 2016) Nurse in west Africa was treating ebola -- she comes back to the U.S and was quarantined due to irrational fear around ebola -- people where afraid around ebola. In quartine she was cold, and could not shower. All while being asymptomatic. The quarantine meant she did not have advance notice (emergency situation). Governments and courts can behave irrationally when scared even when not a massive problem (asymptomatic). Courts may find government interest is stronger/ outweighs more than individuals interests/ rights in/during an emergency.  **[Substantive due process:]** - Is this an unenumerated fundamental right? An unenumerated fundamental due process rights -- rights that are not mentioned in the constitution. Examples of unenumerated fundamental due process rights: 1. Right to travel within the U.S 2. Right to marry 3. Right to raise one's own children 4. Right to an abortion (this has kind of gone away) 5. Right to procreate. Unenumerated rights = Fundamental rights = Due process rights. ***Tiers of scrutiny and Substantive due process*** - If a fundamental right has been infringed courts apply strict scrutiny - If a fundamental right has not been infringed, then the courts apply rational basis So they must look at whether is it a fundamental right and then if that fundamental right has been infringed -- if it is not a fundamental right then what they want to do can be done. However if it is a fundamental right that is being infringed then doing stuff can be very difficult for the government. **[Tiers of scrutiny ]** - Rational basis (lowest) - Intermediate - Strict (Highest) What is Strict scrutiny? 1. Government must show the law is necessary to advance a compelling interest. 2. The Law must be narrowly tailored to infringe as little rights as possible. Strict scrutiny -- high bar if subject to strict scrutiny. What is Intermediate scrutiny? 1. Government must show the law furthers an important government interest... 2. Through means that are substantially related to that interest What is Rational basis? 1. Government must show a legitimate purpose for the law. 2. The law must be rationally related to that purpose Courts normally say yes ok you can do that. **[Stare Decisis/ Precedent]** - A principle or rule established in a previous legal case relevant to a court when deciding subsequent cases with similar issues or facts. - Binding or persuasive in US law. If it is a fundamental right, then courts are expected to always see it as a fundamental right. **[The evolution of fundamental right to reproductive privacy]** A diagram of a diagram Description automatically generated **Griswold v. Connecticut (1965)** - CT 'Comstock' Act banned contraception - Estelle Griswold challenged the law by openly operating a birth control clinic which served married women. - Was arrested and convicted Supreme Court: Marital privacy Right to reproprivacy is implied by the Bill of Rights The foregoing cases suggest that specific guarantees in the Bill of Rights have **penumbras**, formed by **emanations** from those guarantees that help give them life and substance. Various guarantees create zones of privacy. **Eisenstadt v Baird (1972)** - MA law: Contraceptives could only be distributed by doctors or pharmacists to married women. - William Baird was convicted for distributing contraceptive foam to unmarried women Supreme Court: - Married people and unmarried people have the same due process right to privacy under the 14th Amendment. \"If the right of privacy means anything, it Is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.\"  ***Roe v. Wade* (1973)** - Texas law banned abortion - Norma McCorvey wanted an abortion *Stairdecis: Says you can expand based on the past* "This right of privacy, whether it be founded in the Fourteenth Amendment\'s concept of personal liberty and restrictions upon state action, as we feel it is, or, as the District Court determined, in the Ninth Amendment\'s reservation of rights to the people, is broad enough to encompass a woman\'s decision whether to terminate her pregnancy." ***Planned Parenthood v. Casey* (1992)** - Undue burden analysis - Made the right to reproductive privacy a bit smaller. (As roe v wade had trimester framework and casy got rid of this and said up to viability.) "\[W\]e will employ the undue burden analysis as explained in this opinion. An undue burden exists, and therefore a provision of law is invalid, if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability." Because neither the factual underpinnings of Roe\'s central holding nor our understanding of it has changed (and because no other indication of weakened precedent has been shown), the Court could not pretend to be reexamining the prior law with any justification beyond a present doctrinal disposition to come out differently from the Court of 1973. - Undue burden -- opened door to restrictions. - Casy put restrictions on abortion (he did not ban it but made it hard for people to get one) - States could not ban abortion but this made it so difficult to get one (as states could add restrictions) -- they made up undue burden. **[Equal protection ]** **[14^th^ amendment ]** - "No state shall... deny to any person within its jurisdiction to equal protection of the laws" - Equal protection also applies to the federal government under the 5^th^ amendment. Someone claiming a violation of equal protection may claim... - The law treats people like me differently OR - The law is applied differently to people like me (It can be law on the streets or law on the books) Equal protection: Invidious discrimination What is Invidious discrimination? - Suspect classification is likely invidious - (Race, national orgin and gender ("quasi-suspect)) **But are there circumstances in which the law should treat people differently based on their characteristics?** - Age -- medicare/ medicade (don't know which one) - Ahe -- treatment -- vaccines - Drinking -- under 21 Its ok to treat people differently but not want indivious distrimination **[Tiers of scrutiny and equal protection:]** **[Strict scuniey:]** If the law categorizes people into suspect classes (race, national origin) Example: Affermative action struck down mased on strict scruniny. Intermediate scruniny: If the law categorizes people into quasi-suspect classes (gender, "illegitimacy") Rational basis: If the law categorizes people into any other Category. **[Jacobson Massachusetts (1905)]** MA law Requires smallpox vaccination for everyone, except "children who present a certificate, signed by a registered physician, that they are unfit subjects for vaccination." Jacobson: This is a violation of the equal protection clause! [Rational basis was used] **[Jew Ho V. Williamson(1900)]** San Francisco issued a quarantine Quarantine was only enforced against individuals of Chinese dissent Strict scrutiny was applied. **[Equal protection + Substantive Due Process in Action]** (Sexual rights and the right to marry) **[Loving v. Virginia (1967)]** - VA's Racial Integrity Act of 1927 criminalized inter-racial marriages. - Mildred & Richard Loving were sentenced to a year in prison for marrying each other. Supreme court: Violates the Equal Protection Clause of the 14th A because of classifications based on race (VA argued the Statute is the same for every race) **[US v Virginia (1996)]** Supreme Court: Virginia Military Academy's male-only admissions policy unconstitutionally discriminates based on sex. (intermediate scrutiny) **[Bowers v Hardwick (1986)]** - Georgia Law prohibited Sodomy - Officer entered Hardwick's home (for a different reason) and observed him having consensual sex with a man Supreme Court: The right to privacy does not extend to men who have sex with men. **[Lawrence v Texas (2003)]** - Texas Law prohibited Sodomy - Officer entered Lawrence's home (for a different reason) and observed him having consensual sex with a man Supreme Court: Their right to liberty under the Due Process Clause gives them the full right to engage in their conduct without intervention of the government. \"It is a promise of the Constitution that there is a realm of personal liberty which the government may not enter.\" **[Obergefell v Hodges (2015)]** - Ohio law does not recognize same-sex marriage. - Ohioans Jim Obergefell and John Arthur want to marry. (Arthur is sick with ALS and Obergefell wants to be recognized as a surviving spouse) Supreme Court: Fundamental rights found in the Fourteenth Amendment\'s Due Process Clause \"extend to certain personal choices central to individual dignity and autonomy, including intimate choices that define personal identity and beliefs." The fundamental due process right to marry extends to same sex couples under the equal protection clause. **[Dobbs v Jackson Women's Health Organization (2022)]** The Due Process Clause of the 14th Amendment guarantees some unenumerated rights, but only those that are deeply rooted in this Nation's history and tradition and implicit in the concept of ordered liberty. **[L.W. v. Skrmetti, 6th Circuit (Sept 2023)]** (Texas & Kentucky bans on Gender-Affirming Care for minors are upheld) The Due Process Clause...protection encompasses two categories of substantive rights: rights guaranteed by the first eight Amendments and a select list of fundamental rights that are not mentioned anywhere in the Constitution In deciding whether a right falls into either of these categories, the Court has long asked whether the right is 'deeply rooted in \[our\] history and tradition' and whether it is essential to our Nation's scheme of ordered liberty. (Dobbs) Texas & Kentucky bans on Gender-Affirming Care for minors are upheld Equal Protection: The bans do not discriminate based on sex. By limiting access to sex-transition treatments to "all" children, the bans do not "constitute a denial of 'the equal protection of the laws.'" **[Email explaining stuff with red being parts patty added:]** have been trying to understand equal protection and due process, as I was very confused about it in class and have been struggling to get my head around it. I think I may understand it now, but I was wondering if my understanding is correct?   Both due process and equal protection are from the 5th amendment if federal and 14th if state and ensure people's rights are protected.   Due process has two parts: 1) substantive and 2) procedural   Procedural is the idea that individuals have the right to (a) advance notice, b) opportunity for a hearing, and c) the right to appeal a diction.) if the government takes/deprives a person of their life, liberty, or property. Procedural due process is broken if the government does not do this -- but there are cases where the government can break/infringe upon the right to procedural due process, and this is when their (government) interest outweighs that of an individual. But overall procedural due process is the process of ensuring rights kind of. Correct!   Then, substantive due process is about an individual\'s fundamental unenumerated rights. Substantive due process is broken if these are infringed on by the government.    Then due process is subject to the tier of scrutiny: Strick if fundamental right is infringed on and rational basis if there is not a fundamental right.    Is procedural due process a fundamental right? And does the intermediate level apply to due process at all? Answer: there are no specific tiers of scrutiny that apply to procedural due process. It's not really considered a fundamental right.   Then, stare decisis is the idea that the court will rule in the same way it had previously -- if the court finds something is a fundamental right in an earlier decision, the court is expected to rule in the same way. Stare decisis also allows for the expansion of what has been seen in the past. Correct!   Equal protection -- the idea that law cannot treat an individual differently or a group of people differently, and has to be related to invidious discrimination? Right!   Then equal protection also uses the different levels of scrutiny. Right!   And equal protection and due process can be intertwined and work together? Yes! The right to marriage is a substantive due process right. And equal protection requires the government to extend this right to everyone, including the case of same-sex marriage. **[Class 10]** Guest lecturer part: **[HIPAA 101 and the Reproductive Health Rule]** **[Legal Privacy Protections for Healthcare Records]** Federal: **HIPAA** protects health information generally; ("Protected Health Information") created or held by providers, health plans, and healthcare clearinghouses. State: State laws may provide additional protections regarding, for example: Mental health records, SUD records ect. **HIPPAA -- Privacy rule** **Privacy Rule:** It details conditions under which Protected Health Information (PHI) may be used or disclosed with and without express patient consent. Gives patients\' rights over the sharing of health information. **Who does HIPAA apply to?** \"Covered entities\" (\"CE\") - Certain (most) health care providers - Health plans (including government health plans) - Health care clearinghouses » Business Associates of a covered entity. **Certain health care providers:** But only if they transmit information in electronic form in connection with an electronic standard transaction that HHS has adopted a standard. **Protected health information (PHI)** Information, including demographic information: \- In any form: written, electronic or oral \- Relating to past, present or future \- Physical or mental health status or condition; \- Provision of health care; or \- Payment for provision of health care That identifies the individual or for which there is a reasonable basis to believe can be used to identify the individual **Permissible disclosures:** Basic Rule: Covered entities are prohibited from using or disclosing PHI unless required or allowed by HIPAA privacy rule. **Additional Exceptions** » **As required by law** **HIPAA exceptions that allow disclosure to public health departments** "Required by law" -- mandate contained in law that is enforceable in a court of law \- Law includes statutes, administrative rules, executive orders (such as under Emergency Management Law), court-ordered subpoenas, etc. "Public health" -- to public health authorities and their authorized agents for public health purposes, including but not limited to public health surveillance, investigations, and interventions. **Minimum Necessary rule:** Minimum necessary applies to disclosure to public health officials for public health purposes Except for treatment purposes, must limit uses and disclosures of PHI to the minimum amount necessary to accomplish the intended purpose \- Do not disclose more information than required \- Do not access information you don't need **[De-in deification:]** - Van be a key to open doors Methods of de-identification under HIPAA: 1. Expert determination 2. Safe harbour **[Patty's slides and rest of class:]** **[Objectives ]** Describe regulatory frameworks for protecting privacy and security in health care. **What are harms from disclosure of sensitive health information?** - Employment reproductions **[What public health aims may impact informational privacy?]** **Key Definitions** **Public health surveillance:** Monitoring of the distribution and trends of risk factors, injury, and disease in the population. Uses continuous, systematic collection, analysis, and interpretation of health data for the planning, implementation, and evaluation of public health practice. **Public health research:** Systematic investigation designed to contribute to generalizable public health knowledge. **Privacy:** An individual's claim to control access by others to some aspect of her personal life **Informational privacy:** An individual's claim to control access by others to information about herself **Security:** The technological, organization, and administrative practices designed to protect a data system against unwarranted disclosure, modification, or destruction, whether intentional or unintentional **Confidentiality:** The agreement and accompanying trust between two parties engaged in an intimate relationship, such as between a doctor and patient, about how information shared within the confines of that relationship will be handled. **[Prescription Drug Monitoring Programs (Here's WI, but they are in most states)]** What are the privacy risks? - Diagnosis attracted to certain drugs: people can know (stigma) - Who has access to the platform -- who can look it up? Used for research. **[Whalen v. Roe (1977)]** - NYS Statute required the collection and storage of a patient's identifying information in the context of controlled substances. - Right to informational privacy: Within due process clause of the 14^th^ Amendments Invasion of privacy vs Government Interest NYS Statute required physicians to report information about prescriptions for Schedule II controlled substances, stored in a central database A diagram of a balance scale Description automatically generated  **[Oregon Prescription Drug Monitoring Program v. DEA (2014)]** 4^th^ Amendment The right of the people to be secure in their persons, houses, papers, and effects, against unreasonable searches and seizures, shall not be violated, and no Warrants shall issue, but upon probable cause, supported by Oath or affirmation, and particularly describing the place to be searched, and the persons or things to be seized. Other privacy laws (just know they exist) - Family educational rights act - Privacy Act of 1974 - Freedom of information act - State laws **[Federal Policy for the Protection of Human Subjects (The Common Rule)]** - Requires review and approval by an IRB - Must ensure adequate provisions to protect the privacy of subjects - Informed consent of human participants Confidentiality Certificates: Not reliable - Issued by a federal agency - Can allow researchers to withhold information from authorities - Untested in courts **Public health research v public health practice** Public health research- subject to the Common Rule Public health practice -- not **[Class 11]** **[Class 11 Objectives:]** 1. Describe how courts have limited the regulation of commercial speech through application of the First Amendment. 2. Understand standards used by courts to assess the constitutionality of public health laws on religious grounds. 3. Understand Second Amendment limitations to regulation of firearms **[First Amendment Free Speech]** - "Congress shall make no law... abridging the freedom of speech" **[1965: Advertising about the price of alcohol was banned in Rhode Island]** This was not challenged. However: Bigelow v. Commonwealth of Virginia (1975) *VA bans on advertising abortion*\ \ Virginia State Pharmacy Board v. VCCC (1976) *VA bans on advertising prescription drug prices* Both Where challenged. Courts said: **Unconstitutional!** First Amendment Protects factually accurate commercial speech. **Court: People will act in their own best interests if they're well enough informed** These (1975) and (1976) cases where the first time seeing this change in rights and advertisement. The first amendment rests on the assumption that people will act in their own best interest. If they have all of the information. First National Bank of Bosten V Belotti (1978) -- also corporations have free speech. - This is because they are all people who come together so that's why they have free speech. **[Central Hudson Test for Commercial Speech]** To decide if limits on commercial speech are constitutional, Courts consider: 1. If the speech is truthful (Zauderer 1985) and related to legal products 2. Government's interest in the restriction is substantial 3. The regulation "directly advances" that interest 4. The regulation is no more extensive than necessary to serve the interest Product labelling regulations were generally upheld. Government want to make it a small infringement if they do infringe and therefore try make it as small as possible. **1996: Advertising about the price of alcohol was banned in Rhode Island** 44 Liquormart, Inc., v. Rhode Island (1996) A diagram of a state of rhode island Description automatically generated Therefore, using the Hudson test the Rhode island thing was struck off? It was about free speech, they decided you could ban alcohol but you cannot ban free speech -- they don't want them to harm free speech. **Tabaco rules** 15 U.S. Code § 1333 -- Labeling **(d) Graphic label statements** Not later than 24 months after June 22, 2009, the[ Secretary ](https://www.law.cornell.edu/definitions/uscode.php?width=840&height=800&iframe=true&def_id=15-USC-1264422296-855009324&term_occur=999&term_src=title:15:chapter:36:section:1333)shall issue regulations that require color graphics depicting the negative health consequences of smoking to accompany the label statements specified in subsection (a)(1). The[ Secretary ](https://www.law.cornell.edu/definitions/uscode.php?width=840&height=800&iframe=true&def_id=15-USC-1264422296-855009324&term_occur=999&term_src=title:15:chapter:36:section:1333)may adjust the type size, text and format of the label statements specified in subsections (a)(2) and (b)(2) as the[ Secretary ](https://www.law.cornell.edu/definitions/uscode.php?width=840&height=800&iframe=true&def_id=15-USC-1264422296-855009324&term_occur=999&term_src=title:15:chapter:36:section:1333)determines appropriate so that both the graphics and the accompanying label statements are clear, conspicuous, legible and appear within the specified area. From 2009 congress wanted to curve smoking. So they got the FDA to make labelling. Congress passed a law allowing the fda to make labelling and rules. So the FDA designed graphic warnings. However Reynolds Tabacco sued the FDA. RJ Reynolds Tabbacco vs FDA (2012). -- they said it is against the first amendment speech In this case: Court looked at the notice and comment stuff around it -- and while the FDA don't need to include or adapt anything based on this notice and comment they are able to be brought up on not doing this. The courts are not afraid at looking at notice and comments and using the lack of change against the fda and they did so in this case. In this case they looked at the notice and comment and used it against the agency. So RJ Reynolds won against the FDA (2012) -- Because it went against the constitutional rights to free speech -- first amendment. **Freedom of speech** - **Right to speak** - **Right to refrain from speaking (from "compelled speech"** **Read RJ Reynolds v. FDA Excerpt and The Central Hudson Test for Commercial speech** Read RJ Reynolds v. FDA Excerpt In pairs groups, discuss: 1. Is the speech truthful and related to legal products? 2. What is government's interest in the restriction? Is it substantial? 3. Do the regulation "directly advance" that interest? 4. Why did the FDA lose? 5. Do you think the Court was correct to evaluate the evidence about the effect of the graphic warnings? RJ Reynolds v. FDA 1. The speech was truthful and related to legal products 2. Government's interest in the restriction was substantial. The regulation DID not "directly advance" that interest because the data did not show the link between labels and decrease in smoking-related death and injury **First Amendment Free Exercise Clause** Congress shall make no law respecting an establishment of religion, or prohibiting the free exercise thereof. **Examples of where governments infringe upon religious rights for public health reasons?** - Vaccines - Quarantine **Supreme Court. Native Americans have no religious protection against firing for religious use of Peyote (Employment Division, Department of Human Resources of Oregon v. Smith (1990)** Law itself did not discriminate but the native Americans religion was affected as a result. Supreme Court. Native Americans have no religious protection against firing for religious use of Peyote (Employment Division, Department of Human Resources of Oregon v. Smith (1990) Generally, a general law, neutral on religion, that incidentally burdens religious practice is constitutional. **[But Congress wanted more protection for religious freedom:]** \- Religious Freedom Restoration Act (1992): Requires any statute or regulation that substantially limits religion to be narrowly tailored to serve a compelling government interest **COVID Restrictions on religious gatherings** Rules that deemed religious gatherings non-essential are discriminatory (Roman Catholic Diocese of Brooklyn v. Cuomo, 2020; South Bay Pentecostal Church v. Newsom, 2021); (Tandon v. Newsome, 2021) Trend toward stronger protections for religious institutions. Congress said that Religious RIFRA should be under strict scrutiny -- so now basically anything related to religion is under strict scrutiny. Religious freedom and restoration - Congress can only make rights bigger but cannot make them smaller. **Second Amendment  Right to Bear Arms** A well regulated Militia, being necessary to the security of a free State, the right of the people to keep and bear Arms, shall not be infringed **NYS Rifle & Pistol Assn v Bruen (2022)** - NYS Statute: Applicant for an unrestricted license to carry a handgun outside the home for self-defense must establish proper cause (target practice, hunting, or special need because of job, etc) - USSC strikes down the requirement as violative of the 2^nd^ Amendment. "The government must justify its regulation by demonstrating that it is consistent with the Nation's historical tradition of firearms regulation." **United States v. Rahimi (June 21, 2024)** Question: Does 18 U.S.C. § 922(g)(8), which prohibits the possession of firearms by persons subject to domestic-violence restraining orders, violate the Second Amendment? Court: No. The law is constitutional. Look to laws in English and American history, which confirm that when an individual poses a clear threat of violence to another, the threatening individual may be disarmed. Court: We interpret the Second Amendment by looking for a historical analogue, not a historical twin. We do not want a 'law trapped in amber'. **Garland v. Cargill (June 2024)(not 2^nd^ A case)** Q: Is a bump stock device a "machinegun" as defined in 26 U.S.C. § 5845(b)? A: No, semiautomatic weapons with bum stocks are not machine guns under the Statue. Congress can amend the statute if it wants to. Week 13 Objectives 1. Explain the legal authority for vaccination at the federal and state levels 2. Describe the laws regulating vaccination 3. Identify laws and policies that hinder and promote harm reduction efforts Federal Government  (Research development) Vaccines, as with all products regulated by FDA, undergo a rigorous review of laboratory and clinical data to ensure the safety, efficacy, purity and potency of these products. Vaccines approved for marketing may also be required to undergo additional studies to further evaluate the vaccine and often to address specific questions about the vaccine\'s safety, effectiveness or possible side effects. - Basically vaccines are approved by federal government. - The Public health service act in emergency can make vaccines trials go quicker -- this is federal power in vaccines. **[Advisory Committee on Immunization Practices -- Federal government also in change of recommending and giving advice through the advisory committee.]** A screenshot of a computer Description automatically generated What power does the federal government use to ensure every American gets vaccinated according to the schedule? They don't have power -- they can only make recommendations and give advice.. through schools and insurance ect....  **[OSHA -- Vaccine mandate ]** Free Employee COVID-19 Screening Form for OSHA Mandate Federal government has tried to play a bigger role in vaccines OSHA created a vaccine mandate -- has regulatory power -- however it went to supreme court and court said no as it is economically bad "Major questions doctrine" How do immunization schedules get implemented? State school laws -- really mandates vaccines Government do it through schools. State School Vaccination Laws - Have requirements and exemptions What are the two ways the government deals with adverse effects of vaccines? 1. VAERS 2. HRSA - National Vaccine Injury Compensation Program - Surveillance system - Provides early warning for possible safety concerns VAERS -- provides early warning for bad batches ect so they can track. HRSA -- National Vaccine Injury Compensation Program Vaccine companies asked for this as they did not want to keep getting swewd as if this happended they would not be able to have enough money to develop new vaccines. It is funded through each dose -- like per dose of vaccine a small percentage of the cost goes to fund this program. "quai-legal" strategy State enacted from congress Someone who has been harmed cannot just sew -- they cannot just go through state law they have to use this and go through the federal govement  A close-up of a white page Description automatically generated How do immunization schedules get implemented? FDA has drug approval and schedules enchorage State School Vaccination Laws Have requirements and exemptions  A close-up of a white background Description automatically generated The exemptions is PA are pretty big. 1. Choose a state other than PA 2. What exemptions to child/adolescent school vaccines requirements are authorized? Some states have different rules -- some only have medical exemptions -- some have non medical and medical. **Regulation of Illicit Drugs/Harm Reduction** The Controlled Substances Act -- Federal Legal framework for classifying drugs that may pose a risk of abuse and dependance, into Schedules I (most strict) through V (least strict) The Drug Enforcement Administration (DEA) is the federal agency primarily responsible for implementing and enforcing the CSA - Some in statute some in regulations **Federal CSA**: establishes distribution controls to prevent the misuse of substances deemed to pose a potential danger to the public welfare **State Controlled Substances Acts**: establishes distribution controls to prevent the misuse of substances deemed to pose a potential danger to the public welfare Both above are basically the same thin one is federal and one is state but basically say the same thing. Commerce clause -- weed person in cali got erssesed Federal laws were developed in probation Anti-Drug Abuse Act of 1986 - Minimum sentence of 5 years without parole for possession of **5 grams** of crack cocaine or **500 grams** of powder cocaine. - Banned the operation of venues intended for use of illegal drugs, a provision known as the \"Crackhouse Law."  This 100:1 disparity was reduced to 18:1, when crack was increased to 28 grams (1 ounce) by the Fair Sentencing Act of 2010 Drug rules have racist rules and undertones -- crack cocaine vs powder -- different consequences Racially-biased Mandatory Minimums & Enforcement  Shows the number of people in prison after the mandatory jail sentence in 1968 grew massively and had a massive effect on the number of individuals in jail. A graph with numbers and a rectangle Description automatically generated Huge disparity in race and imprisonment Harm Reduction Harm reduction -- very principled -- set of strategies Harm reduction is a set of practical strategies and ideas aimed at reducing negative consequences associated with drug use. Harm Reduction is also a movement for social justice built on a belief in, and respect for, the rights of people who use drugs. Idea that people use drugs anyway and therefore need to focus on reducing harm. **Do public health ethics support harm reduction?** 1. **Beneficence (doing good)** 2. **Nonmaleficence (doing no harm)** 3. **Justice/equity** 4. **Respect for Persons/Autonomy -- Letting them control if they use drugs or not** 5. **Interdependence/Solidarity/ Collective** **Syringe Exchanges: Legal Barriers** \- State laws that prohibit the sale or distribution of drug paraphernalia, including syringes (and their enforcement) \- State laws that prohibit the possession or distribution of drug paraphernalia, including syringes Syringe Exchanges -- help cut down communicable disease like HIV **Naloxone Access: Legal Barriers** State laws that criminalize Naloxone without a prescription (and their enforcement) \- Fear of arrest by assisters who may be in possession of controlled substances **Supervised Consumption/Overdose Prevention Centers: Legal Barriers** \- Federal and state laws that criminalize possession of controlled substances (and their enforcement) \- Federal "crack house" portion of the CSA which makes it illegal to "knowingly open or maintain \[or\] manage or control any place for the purpose of unlawfully using a controlled substance." \- Municipal bans on Safe Injection Sites **If the laws remain, how can local officials promote harm reduction?** 1. Enforcement discretion by police and prosecutors 2. Leadership by elected officials 3. Funding of harm reduction measures **How does Mayor Parkers plan promote or hinder harm reduction**  What can be done to promote harm reduction under Mayor Parkers plan? Consider officials, organizations, individuals.