Health Law

Download PDF copy of guide for printing

I. Introduction

The phrase "health law" encompasses a wide range of discrete legal topics, including health insurance, disability, medical malpractice, food and drugs, public health, and the management of medical care institutions. Most of the legal areas that make up “health law” in the United States are the subject of legislation and regulation at both the national and the state levels. This research guide provides an overview of resources where one can find general information on a wide range of health law topics. For more in-depth research into a particular health law topic, please consult the online catalog and/or one of the Goodson Law Library Reference Librarians.

II. Searching the Duke Catalog

Searching by subject heading is one way to pinpoint materials within the Duke Libraries catalog on particular topics within the "health law" field. There are numerous health law related subject headings which can be used to find materials on a specific sub-topic, including:

  • Health care reform -- United States
  • Health insurance
  • Health policy -- United States
  • Medical ethics
  • Medicaid
  • Medicare -- law and legislation
  • Medical records -- law and legislation
  • Drugs -- law and legislation
  • Medical informatics -- law and legislation
  • Reproductive rights

Back to top

III. Secondary Sources and Overview Materials

Health care law is currently the subject of intense political debate, and there are numerous pending bills that would modify everything from the health insurance mandate to the taxes imposed on medical devices under the Patient Protection and Affordable Care Act. Researchers should select a source that is updated regularly, although some of the older materials offer an excellent overview of foundational health care statutes that are still in force today, such as the ADA (Americans with Disabilities Act) and HIPAA (Health Insurance Portability and Accountability Act).

In addition to the resources below, Bloomberg BNA’s Health Law Resource Center includes treatises on pharmaceutical law, managed care, health care fraud, and other health-related topics, with materials subject to regular updates and current awareness resources.

A. Treatises and Hornbooks


Fundamentals of Health Law, American Health Lawyers Association (KF3827.H37 2008). This volume covers basic medical terminology, medicare, medical malpractice and ethics, hospital regulation and antitrust, and home providers/ long-term care.

Health Care Law and Ethics in a Nutshell, West Pub. Co. (Reserves KF3821.Z9 H35 2011).  Small paperback volume that gives an overview of health care finance and delivery, treatment relationships, insurance, facility and insurance regulation, life support, organ donation, and reproductive technologies.

Health Care Law Sourcebook, Matthew Bender & Co., available on Lexis Advance. Includes sections on Medicare and Medicaid, HIPAA and the ADA, drug and device approval, antitrust and trade issues related to health care providers, disease control, ERISA, and other health laws.

Health Law, West Pub. Co. (KF3821 .H4343 2000). Good overview hornbook that covers health law as it affects health care deliverers and institutions, including tax status, regulation and licensure, health care business associations, ERISA, Medicare and Medicaid, antitrust, and ethical decision-making on issues such as death and dying, human research subjects, and reproductive rights.

Legal Medicine, Mosby Co. (KF3821 L45 2004). Covers numerous medical topics of direct interest to patient care providers and gives examples. Cross-listed with the medical center, it covers such topics as medical education and licensure, peer-review, complementary and alternative medicine, health insurance and professional liability insurance, health information privacy, access to medical care, end of life issues, and other legal topics surrounding patient care.

Treatise on Health Care Law, Matthew Bender & Co., available on Lexis Advance (no longer updated in print at KF3821 .T74), 4 v. Comprehensive treatise covering a myriad of legal health topics, including health care management, health care payment systems, litigation, antitrust, medical waste disposal, access to health care, HIPAA/HITECH privacy requirements, informed consent, end of life issues, and other topics.

Back to top

  • B. Articles and Current Awareness


    There are numerous private organizations and law firms that put out informative newsletters and blogs on particular issues in health law. While these sources can be very helpful in keeping researchers abreast of recent developments, the information they provide must be verified and any issue raised should be carefully examined using traditional legal research sources. The information may be accurate and timely, but additional information critical to thoroughly understand the issue may be omitted or truncated. The following resources are credible places to search for information on current legal issues in the health care field.

    Bloomberg BNA is a subscription database that includes an extensive health care legal resource library. Separate topical pages cover insurance, health care policy, medical devices, medical research, medicare, pharmaceutical law, and other health law areas of interest. Each page includes links to breaking news, summaries called "BNA Insights," hot topics, law firms that practice in that area, and links to news at the state level (with links to individual states). Users can also sign up for weekly email alerts of health care news.

    PubMed is a publicly available search interface that includes the Medline database (also accessible through the Ovid search platform) in addition to life science journals and online books (not to be confused with PubMed Central, which is a digital repository of publicly accessible biomedical and life sciences journal articles). Access PubMed through Duke Libraries in order to get links to those articles available through Duke subscriptions. Articles accessible through PubMed include a wide range of topics, from highly technical clinical trial reports to health policy and regulatory compliance articles.

    Justia is a free website that provides daily and weekly opinion summaries by topic, includes a Health Care Law topical link which provides access to current news, articles, blogs, legislation, regulations, and featured cases.

    FindLaw Newsletters includes the bi-weekly free newsletter Health Law Pulse. A free FindLaw account is required to set up the subscription.

Back to top

C. Dictionaries, Encyclopedias and Indexes
 
  • Attorneys' Dictionary of Medicine, available in Lexis Advance, includes medical term definitions with examples and practical analogies.
  • MedLine Plus is a consumer-friendly resource from the National Institutes of Health that includes a medical encyclopedia and a medical dictionary.
  • The Sloane-Dorland Annotated Medical-legal Dictionary (Ref. RA1017 .S56 1987 & Supp. 1992), integrates legal concepts into medical definitions, and includes expert witness testimony and excerpts from legal briefs.
  • Stedman’s Medical Dictionary includes medical, pharmaceutical, and bioscience terms. Available online through WestlawNext (Secondary Sources > Health Law Texts and Treatises > Stedman’s Medical Dictionary). Free version available through MediLexicon. An older edition is also available in Superseded Ref. R121 .S83 1995.
  • Taber’s Cyclopedic Medical Dictionary (Ref R121.T33 2013) includes comprehensive health science dictionary with color illustrations in reader-friendly language.

Back to top

D. Health Statistics
 
  • National Center for Health Statistics is a portal that includes links to numerous collections of health data and statistical reports.
  • CDC Wonder provides a single point of access to a wide variety of public health reports and data systems, both local and external, categorized by topic.
  • Statehealthfacts.org, sponsored by the Kaiser Family foundation, includes a map with clickable links to health statistics by state. Users can also search for health statistics by topic.
  • Health Statistics, maintained by the National Library of Medicine and the National Institutes of Health, includes links to health statistics by topic, including CDC’s "Faststats A-Z"
  • The Dartmouth Atlas of Health Care uses Medicare data to provide information and analysis about national, regional, and local markets, as well as hospitals and their affiliated physicians. Search by topic, hospital, or region.
  • National Institutes of Health/National Library of Medicine, Databases, Resources & APIs is a portal to numerous free databases and includes a search template that allows selection of data by subject and type of data from list of resources.

Back to top

IV. Primary Sources of Federal Health Law

There are many federal laws that have an impact on health law, either directly (for example, the Patient Protection and Affordable Care Act) or indirectly (for example, sections of the tax code allowing for health-cost related exemptions). The following laws are some of the primary sources of legislative authority that U.S. shape health care law.

A. Statutes and Legislative Histories
 

ADA (Americans With Disabilities Act of 1990), Public Law No. 101-336, 104 Stat. 327, codified at 42 U.S.C. § 12101 et. seq. Prohibits discrimination against people with disabilities in employment, transportation, public accommodation, communications, and governmental activities.

EMTALA (Emergency Medical Treatment and Active Labor Act), Public Law No. 99-272, 100 Stat. 164, codified at 42 U.S.C. § 1395dd, requires hospitals that accept Medicare to provide emergency treatment to anyone regardless of citizenship, legal status, or ability to pay, with no reimbursement provisions. Participating hospitals may not transfer or discharge patients needing emergency treatment without the patient’s informed consent until the patient is stabilized, unless their condition requires transfer to another facility better equipped to treat them.

ERISA (Employee Retirement Income Security Act of 1974, Public Law No. 93-406, 88 Stat. 829, codified in sections of Title 29 of the U.S. Code, short title at 29 U.S.C. § 1001) provided a comprehensive federal scheme for the regulation of employee pension and welfare benefit plans offered by employers.

FDCA (Food, Drug and Cosmetics Act), Public Law No. 75-717, 52 Stat. 1040, codified at 21 U.S.C. § 301 et. seq., gives authority to the Food and Drug Administration to oversee the safety of food, drugs, medical devices, and cosmetics sold in interstate commerce.

  • For explanations and summaries, see the Food and Drug Law Institute’s A Practical Guide to FDA’s Food and Drug Law and Regulation (KF1900.Z9 2012) and Food and Drug Law and Regulation  (KF3869.F659 2011); Protecting America’s Health: The FDA, Business, and One Hundred Years of Regulation, Philip Hilts (RA11.H54 2003). 
  • For legislative history materials, see A Legislative History of the Federal Food, Drug and Cosmetic Act and Its Amendments, (Docs. HE20.4005:F 73/2 & online); David F. Cavers, The Food, Drug and Cosmetic Act of 1938: Its Legislative History and its Substantive Provisions, 6 Law & Contemp. Probs. 2 (1939), available in Duke Law Scholarship Repository; Vincent A. Kleinfeld, Legislative History of the Federal Food, Drug and Cosmetic Act, 1 Food Drug Cosm. L.Q. 532 (1946), available via HeinOnline.

Back to top

HIPAA/HITECH (Health Insurance Portability and Accountability Act of 1996, Public Law No. 104-191, 110 Stat. 1936, codified in Titles 29, 42, 18, and 26 of the U.S. Code, short title at 42 U.S.C. § 201) created national standards to protect the privacy of patients’ medical records and other personal health information. Health Information Technology for Economic and Clinical Health Act, Public Law No. 111-5, 123 Stat. 226, codified in sections of Title 42 of the U.S. Code, short title at 42 U.S.C. § 201, was enacted to promote the adoption of health information technology, and strengthened enforcement of HIPAA privacy and security rules.

Medicare/Medicaid: Medicare was created under Public Law No. 89-97, 79 Stat. 286, under Title 18 of the Social Security Amendments of 1965, and codified at 42 U.S.C. § 1395c et seq. It provided all persons 65 years of age or older who are legal U.S. residents for at least 5 years with insurance benefits covering hospital, medical, and prescription drug costs. Medicaid was created under Title 19 of the Social Security Act, and it is codified at 42 U.S.C. 1396 et. seq.; established a program that pays for medical assistance for low income families.

  • For explanations and summaries, see Brief Summaries of Medicare & Medicaid;  Elicia J. Herz, Medicaid: A Primer, Congressional Research Service Report for Congress, July 18, 2012; Patricia A. Davis, Medicare Primer, Congressional Research Service Report for Congress, January 31, 2013; Basics of Elder Law, NC Bar Association, includes chapters on Medicare and Medicaid (KFN7491.A3 .B37 2011).
  • For legislative history materials, see Kaiser Family Foundation, Medicaid: A Timeline of Key Developments; Social Security Legislative History, includes chronology of related legislation starting with 1935 act, and collection of legislative histories compiled by various governmental agencies; ProQuest Legislative Insight search for PL 89-97, to see the legislative history of enacted bill 89 H.R. 6675, including bills, debates, reports and hearings; Legislative History of the Act of July 30, 1965, PL 89-97, in WestlawNext, U.S. GAO Federal Legislative Histories.

PPACA (Patient Protection and Affordable Care Act, Public Law No. 111-148, 124 Stat. 119, codified in sections of titles 42, 26, and 25 of the U.S. Code, short title at 42 U.S.C. § 18001.) Expanded Medicaid coverage, created health insurance exchanges for individuals without employer-based or public insurance coverage, prohibited coverage denial for pre-existing conditions and lifetime insurance limits, required most individuals to carry health insurance.

Back to top

B. Agencies, Regulations, and Administrative Decisions
 

Executive branch and independent federal agencies have broad responsibilities that impact health law. These federal agencies issue regulations, guidance documents, and sometimes administrative rulings on individual disputes. See the Goodson Law Library’s research guide to Federal Administrative Law for comprehensive information on finding administrative law materials.

Three agencies that play a seminal role in administering health law and creating health law policy are the Food and Drug Administration, the Centers for Medicare and Medicaid Services, and the Social Security Administration.

FDA (Food and Drug Administration)

The FDA is an agency within the US Department of Health and Human Services. FDA and USDA share responsibility for food safety inspection, although the rules that determine which agency is responsible for which food products can be complex. FDA is also responsible for regulating drugs, medical devices, radiation-emitting products, vaccines and biological products, animal and veterinary products, cosmetics, and tobacco products. The FDA also develops and enforces sanitation rules for interstate transport of various products.

  • CFR sections: CFR Title 21, parts 1-1499, searchable by keyword.
  • Letters and Guidance Documents: via FDA enforcement documents website;
    Bloomberg Law > Practice Centers > Health > Regulatory Agencies > FDA (enter keywords to search guidances and interpretations);
    Lexis Advance > Browse Sources > Healthcare Law > Food and Drug Administration (select type of document or apply as filter);
    WestlawNext, Food & Drug Administration database (Administrative Decisions & guidance > Federal Administrative Decisions & Guidance >  Department of Health & Human Services > Food & Drug Administration).

CMS (Centers for Medicare & Medicaid Services)

The CMS is an agency within the US Department of Health and Human Services. It is responsible for administering Medicare, state insurance program for children (SCHIP), and for enforcing HIPAA standards.

  • CFR sections: 42 CFR Ch. IV (Centers for Medicare & Medicaid Services, Department of Health and Human Services)
  • Rulings, decisions, and agency documents: CMS.gov Regulations & Guidance, Review Boards and Administrative Decisions;
    Bloomberg Law > Practice Centers > Health > Regulatory Agencies > CMS (enter keywords to search orders, decisions, and forms);
    Lexis Advance > Browse Topics > Healthcare Law > Regulators > US Centers for Medicare & Medicaid Services > Get Documents (filter by category);
    WestlawNext, HHS Database (Administrative Decisions & guidance > Federal Administrative Decisions & Guidance > Department of Health & Human Services; Includes decisions by the Medicare Appeals Council).

SSA (Social Security Administration)

The SSA is an independent agency within the executive branch that is responsible for administering social security retirement, disability, and survivor benefits.

  • CFR sections: 20 CFR Parts 400-499 (Chapter III- Social Security Administration)
  • Rulings, decisions and agency documents: Cumulative Listing of Current Court Case Decisions Published as Social Security Rulings (1960-2005) (alphabetical listing; includes disputed issue in parenthetical next to title of case);
    WestlawNext, SSA Database (Federal Administrative Decisions & Guidance > Social Security Administration > Social Security Rulings: includes adjudicative decisions reached by the Social Security Administration (SSA) board or a federal court and acquiescence rulings, beginning with 1960);
    Lexis.com FEDAGN database (Federal Legal-US > Federal Agency Decisions, Combined > add “Social Security” in ALJ-Decision segment search): includes Social Security ALJ rulings.

Jane Bahnson
06/2015

Back to top