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Health Law Research Guide

INTRODUCTION

This is a guide to researching health law at the federal level. Although the resources discussed will aid with most research in the broad area of health law, this guide will focus on resources in the areas of drug development and approval, regulation of hospitals (including Medicare and Medicaid), and regulation of managed care. Accordingly, the guide deals largely with two federal agencies: the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS), which is part of the Department of Health and Human Services (and was formerly known as HCFA or the Health Care Financing Administration).

General Tips for Researching Regulation of the Health Care Industry

A very useful service that both Westlaw and Lexis provide is their coverage by topic, called Topical Practice Areas on Westlaw (click on “Directory,” then “Topical Practice Areas,” and then “Health and Medicine”) and Area of Law by Topic on Lexis (click on “Area of Law by Topic” and then on “HealthCare”). These directories provide links to databases that specifically cover health law. Because these databases are smaller, searches tend to return more relevant results, and fewer false hits. Many of the databases discussed in this guide can be found through the topic pages. However, be aware that what is considered health-related is a subjective decision. Also, the Lexis HealthCare page is a little easier to navigate because it separates materials into categories (such as Statutes and Legislative Materials, and Administrative Materials and Regulations). However, database coverage varies between Lexis and Westlaw, so make sure to check the information screens and choose the providers with coverage appropriate to your needs.

NOTE: In general, always be sure to check the currency, coverage, and status (official or unofficial) of all sources.

Below is an outline of the materials covered in this guide:

I. Secondary Sources
      A. Encyclopedias
      B. Treatises and Hornbooks
      C. Medical Reference Sources
      D. HOLLIS Subject Headings
      E. Periodicals
      F. Current Awareness
II. Looseleaf Services
III. Primary Sources
     A. Statutes
     B. Legislative Histories
     C. Cases
     D. Administrative Materials
IV. Other Resources, Agencies, Organizations, and Useful Web Resources
     A. Federal Government
     B. Organizations
     C. Other Research Guides and Pathfinders

 

I. SECONDARY SOURCES

A. Encyclopedias

The two encyclopedias listed below are general legal encyclopedias. It is often useful to consult these sources to obtain background information on a topic. In addition, at the end of the articles, the encyclopedias provide citations to relevant cases, which can be very useful. Health law topics also are covered in state encyclopedias. For a list of state encyclopedias available in print and online see the ALR and Legal Encyclopedias Research Guide (and scroll down to the State Legal Encyclopedias section).

1.CJS: Corpus Juris Secundum KF 154 .C56 (Also available on Westlaw (CJS)). – This set has 152 volumes and a four-volume index. Some of the major topics relevant to regulation of the health care industry are:

For information on using the electronic version of CJS, see Tips for Using Legal Encyclopedias on Westlaw and Lexis.

2. Am Jur 2d: American Jurisprudence 2d KF 154 .A4 (Also available on Westlaw (AMJUR) and Lexis (2NDARY; AMJUR)).- This set has a six-volume index with topical indexes in the last volume that covers each topic. Some of the major topics relevant to health law are:

For information on using the electronic versions of AmJur, see Tips for Using Legal Encyclopedias on Westlaw and Lexis.

B. Treatises and Hornbooks

These sources explain the law and can be great resources for finding background information or for researching specific provisions of different topics in the law. They usually provide references to primary materials, which can be a great help. Below is a list of some health care related treatises and hornbooks.

C. Medical Reference Sources

Research in health law can lead to medical questions, and therefore, it may be necessary to consult some medical reference sources to clarify medical terms and concepts. A few of these sources are listed below:

D. HOLLIS Subject Headings

To find additional secondary sources on the regulation of the healthcare industry, the following are select HOLLIS subject headings that may be useful:

E. Periodicals

1. Periodical Indexes

There are several periodical indexes that are useful in searching for law review, non-law scholarly journal, medical, and other articles on regulation of the health care industry. The following is a list of useful indexes. Harvard's subscriptions to these indexes are available for scholarly research only, and not for commercial use.

PubMed/MEDLINE

PubMed is a service of the National Library of Medicine and it includes over 15 million citations for biomedical articles back to the 1950's. These citations are from MEDLINE and additional life science journals. PubMed includes links to many sites providing full text articles and other related resources. Free and unrestricted access is available, and Harvard also offers another version that requires a Harvard ID and PIN. Coverage is the same in both versions, but methods of searching are a little different. Also, the Harvard version will provide links ("Find it at Harvard") to full text if available in Harvard databases. MEDLINE is also available on Westlaw in MEDLINE 1966 to Present (MEDLINE) and in MEDLINE 1990 to Present (MEDLINE90).

Lexis - All Full-Text Medical Journals Database

Lexis- All Full-Text Medical Journals (GENMED; ALLJNL) provides access to many medical journals with varying dates of coverage. However, note that the coverage leans more toward legal journals that deal with medical issues, rather than medical journals with articles that affect legal issues (i.e. The New England Journal of Medicine and The Journal of the American Medical Association are not part of this database).

Westlaw - Health and Wellness Database

Westlaw - Health and Wellness Database (HWD) includes consumer health magazines, professional medical journals, consumer health pamphlets, medical reference books, topical overviews of diseases and medical conditions, and referral information. It also includes health- related articles from more than 4,000 other business and general interest publications.

In addition, these general indexes to legal periodicals may be helpful.

Index to Legal Periodicals and Books

Index to Legal Periodicals & Books (ILP) provides citations to articles in over 800 legal periodicals such as law reviews, bar association journals, yearbooks, institutes, and government publications from August 1981 to the present. In 1994, ILP began indexing legal books and now includes approximately 2,000 per year. Geographical coverage includes the United States, Australia, Canada, and Great Britain.

Index to Legal Periodicals Retrospective: 1918-1981

This retrospective database indexes over 750 legal periodicals published in the U.S., Canada, Great Britain, Ireland, Australia and New Zealand, including book reviews and case citations.

  • HLS Electronic Resource
  • Print (The Index to Legal Periodicals, which covers 1908 - current, is available in print) Reference K 33 .I54 and ILS RR K 33 .I54

LegalTrac

LegalTrac provides citations to articles in over 1,000 legal periodicals published since 1980. Geographical coverage includes the U.S., Australia, Canada, Ireland, New Zealand and the United Kingdom.

HeinOnline Law Journal Library

HeinOnline Law Journal Library provides online, full-text access to a rapidly growing collection of law reviews and journals. (Harvard University ID and PIN numbers required.)

 

2. Individual Law Journals

There are numerous law journals that cover regulation of the health care industry at the federal level. Listed below are some law journals that relate to health law in general, with coverage of such issues as drug development and approval, regulation of hospitals (Medicare and Medicaid), and regulation of managed care. Call numbers are in Langdell unless otherwise noted.

3. Individual Medical and Pharmaceutical Journals - call numbers are in Langdell unless otherwise noted.

F. Current Awareness

Current awareness sources help by reporting on new developments, trends, and news in particular areas. Below is a list of some current awareness sources that cover regulation of the health care industry. Note that if you are interested in a very narrow or specific topic of health law, there may be a current awareness source (other than those listed below) devoted to the area, or there may be coverage in some of the more general sources.

II. LOOSELEAF SERVICES

Looseleaf services can come in several different forms, but they generally cover a specific area of the law. One of the characteristics that makes them so useful is that they tend to bring primary and secondary sources together in one source. One note of caution: some looseleaf services list paragraph numbers (rather than page numbers) in their indexes and in cross-referencing. When using these looseleaf sources, make sure to look at the paragraph rather than the page number when trying to locate information in the text. For general information on looseleaf services and how to use them, see the Georgetown University Law Library Using Looseleaf Services Guide. Below is a list of some looseleaf services that cover different aspects of federal regulation of the health care industry.

III. PRIMARY SOURCES

A. Statutes

1. Important Statutes

There are many statutes that cover health law in general, and even many that cover the more specific areas of drug development and approval, regulation of hospitals (including Medicare and Medicaid), and regulation of managed care. Below is a list of some of the major statutes in those areas; however you may find it necessary to research additional statutes. Note that not all amendments to these acts are included in the list below. In addition, the summaries of the Acts are very brief and therefore do not cover every provision.

2. Finding Laws

There are many sources for the text of health-related statutes. Some of these sources apply to any statute on any topic, while others only apply to health statutes. For additional information on the sources for statutes in general (including the U.S.C. and Statutes at Large), see the Harvard Law School Library Guide on Researching Federal and State Statutes. The sources listed below focus on health law.

a. Lexis Databases

b. Westlaw Databases

c. Web

d. Looseleafs

Many of the sources listed in the Looseleaf Services section of this guide contain text of statutes, particularly the:

B. Legislative Histories

Documents that compose the legislative histories of federal laws include committee reports, committee prints, hearing transcripts and other information legislators used in the process of passing a law. These documents can help courts determine legislative intent. There are compiled legislative histories for several of the major health care related federal laws. Some of these are listed below. For information on locating sources of legislative history, please see the Harvard Law School Library Researching Legislative History Guide.

1. Print Compiled Legislative Histories

2. CIS Legislative Histories

Some of the legislative histories compiled by the Congressional Information Service (CIS) are listed below. You also may want to consult the CIS Indexes [Reference KF 49 .C62] or LexisNexis Congressional (Harvard ID and PIN required), which has CIS Legislative Histories, to see if there are other legislative histories of relevant laws. Note: These legislative histories provide a list of relevant documents, and indicate where to retrieve the full text of the documents in microfiche.

3. Westlaw Databases of Legislative Histories

4. Lexis Databases of Legislative Histories

5. Web Sources of Legislative Histories

 

C. Cases

Federal health law-related decisions, like other court decisions, are reported in the Federal Supplement Series, the Federal Reporter Series, and the United States Reports Series. (For general information on how to conduct case law research, see the Effective Case Law Research Guide.) Specifically for health care-related cases, the following sources may be helpful:

1. Westlaw Databases

2. Lexis Databases

3. Looseleafs

Many of the sources listed in the Looseleaf Services section of this guide contain excerpts or discussions of cases, as well as tables of cases. In addition, Mealey's Emerging Drugs & Devices (available on Lexis (MEALEY; MEADMD)) covers cases involving prescription drugs, implants, and devices.

Note that there are Westlaw Key Numbers and Lexis Search Advisor categories specific to health law. For help finding these, see a reference librarian.

D. Administrative Materials

1. General Agency Information

This research guide focuses mainly on agency materials related to the FDA and the CMS (part of HHS). For more information on these agencies or any federal agencies, including information about the types of materials they publish, the following sources are very helpful:

2. Regulations

The Federal Register is the official daily publication where federal agencies first publish proposed regulations for comment, adopted final regulations, explanations of actions taken, and announcements of significant interpretations of the law. For information on locating the Federal Register, please see the Summer Guide to Federal Administrative Law Research.

After publication in the Federal Register, final regulations are then arranged by subject into the 50 titles of the Code of Federal Regulations (CFR). CFR titles are divided into chapters, each containing the regulations of a specific agency. Health related rules can be found in Title 15 - Commerce and Foreign Trade; Title 20 - Employee's Benefits; Title 21 – Food and Drug; Title 29 – Labor; Title 42 – Public Health; Title 45 – Public Welfare; and possibly in other Titles since they are administered by many agencies. Chapters are divided into parts, which cover particular topics. Parts are divided into sections, the basic unit of the CFR. For information on locating the CFR, please see the Summer Guide to Federal Administrative Law Research.

The sources listed below assist specifically in finding health law regulations.

a. Westlaw Databases

b. Lexis Databases

c. Web

  • FDA Federal Register Documents – On this page, users can view the current day’s or recent days’ FDA Federal Register Documents. Users also can search by docket number, and use an advanced search function. Documents on this site date back to 1999, and the site is updated daily.
  • FDA Dockets Management – According to this website, The Division of Dockets Management, "serves as the official repository for the administrative proceedings and rule-making documents" for the FDA. Users also can submit electronic comments and receive information about public meetings. The “rulemaking documents” link brings you to a chronological listing of documents related to recent rulemaking activities.

d. Looseleafs

Many of the sources listed in the Looseleaf Services section of this guide contain text of regulations and information on proposed regulations, particularly the:

  • Food, Drug and Cosmetics Law Reporter, and the electronic version (Non-commercial use only; Harvard ID and pin required.) After clicking on the link above, click on "CCH Health and Human Services Research Network," then on "Enter" and then click on the "Food and Drug" tab.
  • Medical Devices Reporter, and the electronic version (Non-commercial use only; Harvard ID and pin required.) After clicking on the link above, click on "CCH Health and Human Services Research Network," then on "Enter" and then click on the "Food and Drug" tab.
  • Medicare and Medicaid Guide, and the electronic version (Non-commercial use only; Harvard ID and pin required.) After clicking on the link above, click on "CCH Health and Human Services Research Network," then on "Enter" and then click on the "Health Care Reimbursement " tab.
  • CCH Health Care Compliance (including the Hospital Law Manual) - (Non-commercial use only; Harvard ID and pin required.) After clicking on the link above, click on "CCH Health and Human Services Research Network," then on "Enter" and then click on the "Health Care Compliance" tab.

3. Other Administrative Materials

In addition to regulations, federal administrative agencies issue other publications, including guidance materials, enforcement reports, and documents related to their quasi-judicial proceedings (these include agency rulings and decisions of administrative law judges). The sources listed for different types of administrative materials do not necessarily contain all of a particular type of material; many of these sources provide only select materials in each category, and some provide only summaries. The lists below are lists of suggestions of where to look, but you may need to consult other sources for some materials.

 

IV. OTHER RESOURCES – AGENCIES, ORGANIZATIONS, AND USEFUL WEB RESOURCES

A. Federal Government

1. Main Websites

Government agency web sites vary by how frequently they are updated and the currency of the documents. The same site may have one section that includes the most recent version of one document but a very old version of another document. It is important to check the currency of all documents, databases, and other web resources. In addition, many of the websites only include select documents of a certain type; therefore, just because a document is not there, does not mean it does not exist.

2. Sub-Pages

B. Organizations

Organizations with a focus on health law issues are a great resource, particularly for hard-to-find information. Perusing the organization web sites may yield extremely helpful information, but possibly the most helpful feature of organization websites is the contact information available. Because the contacts listed on the site focus on health law, it may be very useful to call or email one of these contacts if you reach a dead end in your research.

C. Other Research Guides and Pathfinders