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Home > Special Topics > Health Law and Regulation

 
     
  Health Law and Regulation  
 

Robert I. Field, JD, MPH, PhD
Director, Health Policy Program
Associate Professor of Health Policy
University of the Sciences in Philadelphia
Email: r.field@usip.edu 

The study of health law and regulation is the study of policy in action. The health care industry is regulated in many ways by all levels of government and by private accreditation organizations and specialty societies. Law and regulation shape every aspect of the way health care is financed and delivered.

WHAT IT ENCOMPASSES

Law and regulation are the way that policy is implemented. They translate government decisions into action. Since health care is the most regulated industry in the United States, health laws and regulations effectuate a plethora of different policies.

WHAT IS ITS IMPORTANCE TO HEALTH POLICY

All health policy is designed to address one of three basic goals—improving quality, expanding access, and controlling costs. These objectives, while all essential to a well-functioning system, compete with one another. Enhancing one inevitably diminishes one of the others. The history of health law is a story of regulatory programs that addressed one of the goals only to create problems that engendered new programs to fix them. The conflicts have built over time into a fascinating patchwork that can delight connoisseurs of policy analysis.

BRIEF HISTORY OF RESEARCH ON THIS SPECIAL TOPIC

Health care regulation dates back a hundred years to the first licensure laws for physicians. The academic study of health law and regulation began in earnest in the early 1970s, with the relentless rise of health care costs that began at that time. Today, it is a guide for policy makers throughout the government and private sectors.

CURRENT AREAS OF RESEARCH INTEREST

  • Genetic medicine, which raises fundamental concerns across a range of legal areas, including privacy of information, discrimination based on genetic traits, and patent protection for genetic discoveries.
  • Confidentiality of medical records and the effects of privacy rules recently promulgated by the federal Department of Health and Human Services under the Health Insurance Portability and Accountability Act (HIPAA).
  • Post-market surveillance of drugs and the role of the FDA in the wake of revelations about COX-2 inhibitors.
  • New health insurance mechanisms involving “consumer-driven” health care, including high deductible coverage and medical savings accounts.
  • Reduction of medical errors and ways it can be encouraged through legal reforms that permit information sharing between providers and patients and better teamwork approaches in hospitals.
  • Malpractice reform, both in terms of changes to the tort system and more vigorous regulation of insurance underwriting practices.
  • Regulation of financial arrangements involving payments to providers in return for referring patients and its effects on health care business dealings.

FACULTY MEMBER’S PUBLICATIONS RELATED TO THIS TOPIC

Much of the health law scholarship at USP involves the regulation of pharmaceuticals. Prof. Robert Field writes a regular column for the journal Pharmacy and Therapeutics on drug oversight. He has published articles and lecture on law and policy related to managed care, genomic medicine, and industry structure.

Field, R. and Valdmanis, V.  “The Implementation of Medicare Inpatient Prospective Payment in the United States.”  Annexe 1 to Ministère de la Santé Français, Rapport Final Pour Law Direction de la Recherche, des Etudes, de l'Evaluation et des Statistiques (DREES), 2004.

Field, R., Plager, B., et al.  “Toward a Policy Agenda on Medical Research Funding: Results of a Symposium.”  Health Affairs, vol.22, no.3, May/June 2003.

Field, R.  “Book Review Essay: Managed Care and Monopoly Power: The Antitrust Challenge.”  The Journal of Legal Medicine, vol. 25, p.369-376, 2004.

Field, R.  “Book Review Essay: Holding Health Care Accountable: Law and the New Medical Marketplace.”  The Journal of Legal Medicine, vol.23, p.289-296, 2002.

Field, R.  ‘Support Grows for a Third Class of “Behind-the-Counter’ Drugs.”  Pharmacy and Therapeutics, vol. 30, no. 5, May 2005.

Field, R.  “Do We Need a Second FDA to Prevent Another COX-2 Fiasco?”  Pharmacy and Therapeutics, vol. 30, no. 1, Jan. 2005.

Field, R.  “Advocates Pursue a Public Registry for All Clinical Trials.”  Pharmacy and Therapeutics, vol. 29, no.9, Sept. 2004.

Field, R.  “The New Federal Fetal Protection Law: Implications for Health Policy.”  Pharmacy and Therapeutics, vol. 29, no.5, May 2004.

Field, R.  “Stem Cell Researchers Face an Unsettled Legal Environment.”  Pharmacy and Therapeutics, vol. 29, no.3, March 2004.

Field, R.  “Is the FDA Becoming an Economic Regulator?”  Pharmacy and Therapeutics, vol. 28, no.11, Nov. 2003.

Field, R.  “ Maine’s Plan to Lower Drug Costs for the Uninsured Passes a Major Legal Test.”  Pharmacy and Therapeutics, vol. 28, no.9, Sept. 2003.

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