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Health Law: Statutes and Regulations

About the CFR

The Code of Federal Regulations (CFR) is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations.

The CFR is keyed to and kept up-to-date by the daily Federal Register. These two publications must be used together to determine the latest version of any given rule. When a Federal agency publishes a regulation in the Federal Register, that regulation usually is an amendment to the existing CFR in the form of a change, an addition, or a removal.

A full set of the CFR consists of approximately 200 volumes. The approximately 200 CFR volumes are revised at least once a year on a quarterly basis as follows:

Titles 1 -- 16 as of January 1
Titles 17 -- 27 as of April 1
Titles 28 -- 41 as of July 1
Titles 42 -- 50 as of October 1

The revision date of each volume is printed on the cover, and at the top of every even-numbered page. Each year's cover is a different color for quick reference.

For  more information on searching for regulations view the LibGuide on researching Administrative Law.

Health and Nuclear Regulation

Title 10 of the U.S. Code of Federal Regulations (C.F.R.) deals with Energy.  Chapter I, parts 1–199 are devoted to the Nuclear Regulatory Commission.

While several sections are applicable to those practicing nuclear medicine, parts 20 and 35 are the most often referenced:

10 C.F.R. §§ 20.1001–20.2402 (at NRC site), Standard for Protection against Radiation.

10 C.F.R. §§ 35.1–35.4002Medical Uses of Byproduct Material.

Additionally, the U.S. Department of Transportation regulates the transportation of radioactive materials.  These regulations may be found in:

49 C.F.R. §§ 100–185, Hazardous Materials and Oil Transportation.

The U.S. Nuclear Regulatory Commission maintains a site with all parts of Title 10, Code of Federal Regulations, as well as other helpful regulations and statutes.

For the most up-to-date changes, be sure to consult the Federal Register.

Federal Statutes

U.S.C. Title 21 Food and Drugs covers a wide variety of health topics, the following are some of the more common areas:

U.S.C. Title 24 Hospitals and Asylums covers topics for different healthcare organizations and military healthcare providers:

U.S.C. Title 42 The Pulic Health and Welfare covers specific health regulatory issues and organizations, as well as research on popular sicknesses and child welfare:

Health Regulatory Terms

EMTALA: Emergency Medical Treatment and Active Labor Act
All individuals seeking emergency medical treatment must be provided a medical screening examination to determine if an individual has an emergency medical condition.

HIPAA: Health Insurance Probability and Accountability Act
Establishes national standards for privacy of securing personal information, to improve efficiency and effectiveness, and force safeguards on health care providers.

Antitrust Laws: § 1 Sherman Act, § 2 Sherman Act, § 7 Clayton Act
Protects and promotes competition as the primary method by which the country allocates its economic reserves. Designed to protect consumers in the health regulatory field.

Tax Exemption: IRC 501(c)(3)
Provides exemption for health care organizations organized and operated exclusively for charitable purposes, where no part of the net earnings accustoms to the benefit of any private shareholder or individual.

Stark I, II, III: Physician Self-Referral Law - 42 U.S.C. § 1395nn
Prohibits a physician from ordering designated health services for Medicare patients from entities with which the physician (or an immediate family member) has a "financial relationship."

Anti-Kickback: Medicare and Medicaid Fraud Statutory Prohibition - 42 U.S.C. §§ 1320a-7b(b)
Makes it a felony to knowingly and willfully solicit or receive remuneration in return for referring an individual to a person for furnishing or arranging for furnishing of any item of service or in return for purchasing, leasing, ordering or arranging for or recommending purchasing, leasing, or ordering any good, facility, service or item for which payment may be made in whole or in part under a Federal health care program.

HITECH: Health Information Technology for Clinical Health Act
Promotes electronic communication in heath care and added several new notification requirements for breaches. Gives guidance to protected health information and prohibits the sell of protected health information, and maintains that patient has a right to receive electronic files.

Fraud and Abuse
There are five laws that commonly make up the health care fraud and abuse laws:
False Claims Act - 31 U.S.C. §§ 3729-3733
Anti-Kickback Statute - 42 U.S.C. §§ 1320a-7b(b)
Physician Self-Referral Law - 42 U.S.C. § 1395nn
Exclusion Statute - 42 U.S.C. § 1320a-7
Civil Monetary Penalties - 42 U.S.C. § 1320a-7a

Subject Guide

Statutes and Regulations Research Guides

Two useful research guides on the topic of the Federal Statutes:

  1. Research Guide from Harvard University
  2. Research Guide from NYU.

Two useful research guides on the topic of the Oklahoma Statutes:

  1. Research Guide from the Library of Congress
  2. Research Guide from Georgetown University.

A useful research guide for the Texas Codes:

  • Research Guide from the Library of Congress.

Statutes in Print

The resources containing the Federal Statutes can be located in the Law Library in the reference area. Oklahoma statutes can be located in the Oklahoma Collection (southeast corner of the law library) and Texas statutes can be located in the general collection.

800 N. Harvey Oklahoma City, OK 73102 405.208.5271