Introduction to Healthcare and Public Health in the US: Regulating Healthcare
Discussion Questions with Expected Outcomes
Discussion questions (for individual assignments or small group discussion):
1. What are some similarities and differences between the Joint Commission (JC)
and the Food and Drug Administration (FDA)?
Expected Outcomes:
The JC is a non-profit organization; the FDA is a regulatory agency of the federal
government. Accreditation is a process in which an impartial organization reviews
another organization’s operations to make sure they are consistent with national
standards. A regulatory agency is established by law to enforce standards in a specific
field (in the FDA’s case, the field of healthcare). Besides food and drugs, the familiar
products that the FDA regulates include medical devices, vaccines, blood for
transfusions, veterinary drugs, cosmetics, and tobacco.
The JC accredits entire healthcare organizations, using the Integrated Survey Process
(on-site visits) and ORYX (a system for having hospitals report performance data about
patients with certain conditions). In addition to accreditation, the JC certifies specific
programs and services, such as programs for managing chronic diseases, as long as
they are run by organizations that have JC accreditation.
The JC is mature accreditation organization and continues to provide safety initiatives it.
The most notable of these are the:
National Patient Safety Goals—lists of tips for healthcare professionals to follow to
prevent errors
Universal Protocol—a standard procedure for surgery teams to follow to avoid using the
wrong procedure, operating on the wrong site, or even operating on the wrong person
Speak Up program—encourages patients to help prevent medical errors by asking
questions, educating themselves, and actively participating in their care
Sentinel Event Policy—calls for healthcare organizations to report how they respond to
an unexpected death, unexpected serious physical or psychological injury, or the risk of
such an event
The FDA also is concerned about the public’s safety through the regulations of many
areas as noted above.
In healthcare we will see both federally regulated and non-federally regulated agencies
that provide ways to protect and improve patient safety.
Objective(s): Describe the role of accreditation, regulatory bodies, and professional
organizations in healthcare in the US.
Health IT Workforce Curriculum
Version 3.0 / Spring 2012
Introduction to Health and Public Health in the US
Regulating Healthcare
1
This material (Comp1_Unit6) was developed by Oregon Health and Science University, funded by the Department of Health and Human
Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.
Lecture(s)/Slide(s): a3-9, 13-15
2. Besides the organizations discussed in question 1, what are some of the ways
that the medical profession, legal system, and government protect patient safety?
How does the US protect patient privacy and confidentiality?
Expected Outcomes:
Likely responses about safety:
 State medical boards set standards for physicians and discipline physicians who are
incompetent.
 The medical profession develops standards of care, and these are considered
during malpractice lawsuits.
 Healthcare providers are expected to help patients give informed consent, and this is
also considered during malpractice lawsuits.
 The Agency for Healthcare Research and Quality issues an annual National
Healthcare Quality Report, which includes patient safety data, among other topics.
The agency provides many other resources to healthcare organizations and the
public about improving patient safety.
Other correct answers about safety:
 One of the purposes of tort law is to dissuade healthcare providers from committing
malpractice.
 Regulatory agencies write rules, regulations, and policies (administrative law), and in
the case of the FDA, many of these relate to patient safety.
 Compliance programs will improve safety while reducing fraud and abuse
 Some students may consider access to care to be a safety issue; if so, HIPAA is
relevant, because it helps patients keep their medical insurance.
Likely responses about privacy and confidentiality:
 The Privacy Rule and Security Rule of HIPAA specify what health information must
be protected and the minimum security standards to be used.
 The American Medical Association’s “Declaration of Professional Responsibility” and
the Consumer Bill of Rights and Responsibilities of 1998 (“Patient’s Bill of Rights”)
also address patient privacy and confidentiality, although they do not have the force
of law.
Objective(s): All objectives from this Unit and slides from unit can be used to answer
this question.
3. Do you know anyone who has felt that they have experienced medical
malpractice or had concerns about fraudulent behavior on the part of the
healthcare organization that they use?
 Did they attempt a lawsuit or report their concern to a federal agency (e.g.
Office of Civil Rights?)
Health IT Workforce Curriculum
Version 3.0 / Spring 2012
Introduction to Health and Public Health in the US
Regulating Healthcare
2
This material (Comp1_Unit6) was developed by Oregon Health and Science University, funded by the Department of Health and Human
Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.
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What was the outcome?
What do you think influences people to sue or not sue a healthcare
provider/organization?
Do you think people are less likely to sue a healthcare provider they like?
Think of one of your healthcare providers—what aspects of the relationship do
you like and not like? Do you think that if you experienced medical
malpractice or suspected fraud, you would be less likely to sue if your health
provider disclosed the error and offered you some compensation upfront?
Expected Outcomes:
The comments will vary. This is a good opportunity to review the elements of a
malpractice, some of the ideas for tort law reform, and informed consent.
Objective(s):
Describe the basic concepts of law in the US: the legal system, sources of law,
classification of laws, the court system, and the trial process.
Lecture b all slides
Describe the legal aspects of medicine involving the Affordable Care Act, professional
standards in healthcare, medical malpractice, Tort reform, and Medicare and Medicaid.
Fraud and Abuse
Lecture(s)/Slide(s): c, all
Health IT Workforce Curriculum
Version 3.0 / Spring 2012
Introduction to Health and Public Health in the US
Regulating Healthcare
3
This material (Comp1_Unit6) was developed by Oregon Health and Science University, funded by the Department of Health and Human
Services, Office of the National Coordinator for Health Information Technology under Award Number IU24OC000015.