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10 Eur. J. Health L. 11 (2003)
Legal Issues in Quality of Care Oversight in the United States: Recent Developments

handle is hein.journals/eurjhlb10 and id is 19 raw text is: European Journal of Health Law 10: 11-25, 2003.                    11
© 2003 Kluwer Law International. Printed in the Netherlands
Legal Issues in Quality of Care Oversight in the United States:
Recent Developments
The issues of medical error, patient safety, and quality of medical care have since
the beginning of this decade been unusually high on the health policy agenda of
the United States. In 2000, the Institute of Medicine (1OM) of the National Aca-
demy of Sciences (a prestigious federally-chartered society of eminent scholars
that conducts studies to advise the federal government on issues of health care
and policy) issued its much publicized report, To Err is Human.2 This report
reached the shocking conclusion that iatrogenic injuries are the eighth leading cause
of death in the United States, resulting in 44,000 to 98,000 deaths annually, more
than are caused by motor vehicle accidents, breast cancer or AIDS.3 National costs
of preventable medical errors, including lost income, lost household production,
disability and health costs were estimated to be between USD 17 and 29 billion.4
A follow on report by the same committee, Crossing the Quality Chasm, concluded
that fundamental change was needed in the American health care system to sub-
stantially improve the quality of health care over the following 10 years.5
These reports caught not only the attention of the public, but also that of legal
scholars and of law-makers. A torrent of law review articles, including symposia
in several law journals, followed on the initial report.6 Several bills have also
been introduced into Congress to address the issues raised by the IOM.7 The
reports and proposed legal responses to them will be discussed in this article, but
first we will examine traditional legal responses to medical error and quality of
care failures.
Five legal approaches have evolved for addressing medical error and quality
of care lapses in the United States. Chronologically the oldest of these is medical
malpractice litigation, which dates back to the eighteenth century in the United
States, and beyond that to English antecedents as early as the fourteenth century.8
The basic concept of medical malpractice liability is quite straightforward and
parallels that found in most other legal systems - a health care professional whose
diagnosis or treatment of a patient fails to conform to the standard of care (the
required degree of care, skill and diligence) of his or her profession is liable to

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