Appeals Court Affirms Weak Federal
Privacy Rule, But Opens Door to Stronger State Privacy Laws
On October 31 the U.S. Court of Appeals
for the Third Circuit held that the federal medical privacy
rule does not violate federal constitutional rights because
it only permits, but does not require, the sharing of health
information without patient consent. However, the ruling affirmed
that states can pass tougher privacy laws.
The Court of Appeals in Citizens for Health v. Leavitt affirmed the trial
court's earlier conclusion that the rule is constitutional because
"(1) neither the First Amendment nor the Fifth Amendment places
an affirmative obligation on the State to protect individuals'
rights from harm by [private] third parties and (2) the Amended
Rule is wholly permissive as to whether covered entities seek
consent from an individual before using or disclosing personal
health information for routine uses...." As the Court of Appeals explained, although
the right to medical privacy is legally cognizable under the
U.S. Constitution, the boundaries of that right have not been
delineated and, further, that any violation must be "ascribed
to the government" rather than "the hands of private entities."
Besides finding that the rule permits
but does not compel disclosures without a patient's consent,
the Court of Appeals based its affirmance on two other important
legal interpretations: (1) patients have a right to request
restrictions on uses and disclosures of their health information,
although doctors and other covered entities do not have to comply
[thus the rule does not
guarantee patients true confidentiality] and (2) the rule does
not preempt more stringent state privacy laws.
Citizens for Health filed its lawsuit
in April 2003 and after a hearing in December 2003, the District
Court ruled in favor of the secretary of the U.S. Department
of Health and Human Services (HHS). Following that decision, an appeal was filed
in the U.S. Court of Appeals for the Third Circuit and a hearing
was held last March.
Court Claims Lawsuit Did Not Challenge Specific Disclosures by HHS or Federal
Is it constitutional for HHS-the country's
largest payer for health care-to disclose or compel private
physicians to disclose patients' health information against
their wishes? That
question remains unanswered.
The Court wrote, "The Constitution
protects against state
interference with fundamental rights. It only applies to restrict private behavior
in limited circumstances.. As explained in DeShaney, the Due Process Clauses of the Fifth and
Fourteenth Amendments were intended to prevent federal and state
governments 'from abusing [their] power, or employing it as
an instrument of oppression.'.Their 'purpose was to protect
the people from the State, not to ensure that the State protected
them from each other.'"
At the same time, the opinion pointed out that "'[A]
State is responsible for [the act] of a private party when the
State, by its law, has compelled the act' or when the State
has 'commanded' a particular result."
The Court asserts: ".Citizens [for
Health] here challenge the [HHS] Secretary's promulgation of
the Privacy Rule, not specific disclosures by HHS or any of
the federal agency 'health plans' [such as Medicare] that it
supervises. Whether a challenge to such specific disclosures
would satisfy the Constitution's state action requirement thus
remains outside the scope of this appeal."
Citizens Should Work to Strengthen State Medical Privacy
Jim Pyles, the attorney representing
Citizens for Health, pointed out that the Court acknowledged
the plaintiffs' sworn allegations regarding medical privacy
breaches and that people and organizations covered by the federal
rule may be ignoring state medical privacy laws. "The Court agreed with Plaintiffs' argument
that it must assume that.all sworn allegations by the Plaintiffs
in affidavits, exhibits and the verified amended complaint must
be taken as true.," Pyles said in an analysis posted on the
Internet. "Thus, all allegations of privacy violations described
in nearly 30 affidavits and hundreds of exhibits are assumed
to be true for the purposes of this case because none were disputed
by the government. Those affidavits and exhibits show that on
April 14, 2003, the implementation
date of the Amended Rule, covered entities and their business
associates changed their past practices and began to routinely
violate the medical privacy of the Plaintiffs."
The Court opined, "The fact that covered
entities are construing the 'may use' language as constituting
a new federal seal of approval, and may be ignoring state laws
regarding protections to be afforded to such information, is
regrettable and disquieting. That routine requests for privacy
are apparently being ignored by covered entities is even more
unfortunate. But our task here is to determine the constitutionality
of the Amended Rule, not the propriety of covered entities'
actions under state or common law."
Given the Court's view that more stringent
state medical-privacy laws would not be preempted by the federal
rule, citizens across the country have an important opportunity
to make sure their state laws are more protective of privacy
than the weak federal rule.
It is well known that the goal of the Health Insurance
Portability and Accountability Act of 1996 (HIPAA) was to simplify
the flow of electronic information. But the Court makes it clear that it should
not supersede more stringent state laws. That's why citizens who want true medical
privacy should work with their state lawmakers to strengthen
their state laws.
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Bill Introduced to Stop FDA's Censorship
On November 9, Rep. Ron Paul (R-Tex.)
and seven other members of Congress introduced the Health Freedom
Protection Act (H.R. 4282) to prevent the Food and Drug Administration
(FDA) and Federal Trade Commission (FTC) from censoring information
about dietary supplements.
According to The Liberty Committee,
"In 1994, the U.S. Congress ordered the FDA to let the public
have access to scientific articles and publications on the role
of nutrients in disease by passing the Dietary Supplement Health
and Education Act (DSHEA)....Yet, censorship by the FDA goes
on!" That is why
H.R. 4282 was introduced and is being pushed by a coalition
of some 50 companies and organizations.
Congressman Paul explains that the
Health Freedom Protection Act specifically will: (1) stop the
FDA from censoring truthful claims about dietary supplements;
(2) stop the FDA from prohibiting the distribution of scientific
articles and publications regarding the role of nutrients in
protecting against disease; and (3) address the FTC's violations
of the First Amendment.
In a related matter, Emord & Associates,
a law firm specializing in constitutional and administrative
law, has started a national petition campaign to end the FDA's
and FTC's violations of the First Amendment. The FDA and FTC violate free speech by trying
to control what is communicated about nutrient-disease associations,
according to the firm.
It has drafted a petition to protest suppression of this
health information and hopes to present Congress more than a
million signatures by January 1, 2006.
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NVIC Says Federal Bird Flu Protection
Legislation is Unconstitutional
A behind-the-scenes plan is reportedly
taking shape in Congress to attach language to an unspecified
conference report giving drug companies blanket immunity from
liability for vaccine injuries and deaths. The National Vaccine
Information Center (NVIC), a watchdog consumer advocacy group
critical of provisions in "The Biodefense and Pandemic Vaccine
and Drug Development Act of 2005" (S. 1873) sponsored by Senator
Richard Burr (R-NC) and a similar bill in the House (H.R. 3970),
calls the reported plan "an end-run by Pharma's friends in Congress
to take away the civil rights of the American people."
the past few weeks, public criticism about the proposed bail-out
of drug companies has been mounting as Americans are being told
that a pandemic bird flu is coming and drug companies are asking
Congress to bar citizen access to the civil justice system when
they are harmed by vaccines. Because the bird flu virus has
not mutated into a form that is transmissible from human to
human, questions have been raised as to whether irrational fear
about bird flu is being generated in an attempt to stampede
Congress into passing liability protections the pharmaceutical
industry has been seeking for 40 years.
that there are twice as many drug companies marketing vaccines
in the U.S. today as there
were in 1982 when NVIC was founded, NVIC President Barbara Loe
Fisher said, "It is a big lie that drug companies have been
driven out of business by lawsuits in the past two decades.
The National Childhood Vaccine Injury Act of 1986 protected
drug companies and doctors from almost all lawsuits. There are
only a handful of vaccine injury lawsuits pending in civil courts
but Pharma is on the brink of conning Congress into destroying
Americans' Seventh Amendment Constitutional right to seek redress
in a civil court in front of a jury of their peers. Apparently drug companies [and government
don't want to be accountable] when Americans die or are injured
by experimental and poorly tested biodefense and pandemic flu
vaccines they can be forced to take whenever the Secretary of
Health and Human Services declares a public health emergency
and state officials follow suit."
In a November 15th
letter to Senator Burr's staff director, U.S. Senate Subcommittee
on Bioterrorism and Public Health Preparedness, NVIC President
Barbara Loe Fisher describes S. 1873 as "arguably unconstitutional"
because it (1) lacks transparency into the research, development,
licensure and post-licensure surveillance of vaccines and drugs
used in public health emergencies; (2) lacks accountability
for either manufacturers of these products or government health
officials who mandate their use without informed consent; and
(3) lacks justice for those who will inevitably die or suffer
chronic illnesses after being compelled to take these products.
proposed law will also create a new agency within the Department
of Health and Human Services that will secretly develop experimental
drugs and vaccines to be used by civilian and military populations
whenever the Secretary declares "a potential or actual" public
health emergency. The agency may deny Freedom of Information
Act requests by citizens and is not subject to review of its
actions by the judicial branch of government.
Also, Fisher points out that in 1982
there were four drug companies marketing vaccines in the U.S.: Wyeth, Lederle,
Merck and Connaught; but today there are eight: Wyeth, Merck,
Sanofi Pasteur, GlaxoSmithKline, MedImmune, Chiron, Bioport,
and VaxGen. She also notes that there are ten vaccine injury
lawsuits currently pending in U.S. civil courts, with
the majority involving a highly reactive whole cell version
of DPT vaccine no longer distributed in the U.S.
- NVIC Press Release, November 15, 2005: www.nvic.org
- NVIC Letter to Senator Richard Burr's subcommittee staff
director, Col. Robert P. Kadlec, M.D. (USAF-ret.), November
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Cut Federal Spending and Put Medicare
Prescription Drugs on Hold
By Richard E. Ralston
Republicans in Congress are now struggling
to carve some spending cuts out of their recent vast increases
in the federal budget.
Democrats, while critical of deficit spending, are helpfully
suggesting even more spending increases. The best quick fix would be to delay the
single largest increase in federal spending in forty years:
Congress should put implementation of the new Medicare prescription
drug program scheduled to begin in 2006 on indefinite hold.
In 2003 the Bush Administration told
us, and Congress pretended to believe, that the program would
cost $400 billions dollars over the first ten years, and much
more thereafter. There
was no explanation of how the government would pay for that
much spending. Now we are informed that it will be triple the
original estimate-$1.2 trillion-before it starts to get really
expensive later. That would pay for recovery from dozens of
hurricanes and a handful of wars like Iraq. It is a financial disaster, and we need to
stop the bleeding before it starts.
Some prefer to pay for it by rolling
back tax cuts on the "wealthy."
That's not nearly enough money. Others would pay for it by rolling back all
of the Bush tax cuts.
They don't say how those who cannot afford their prescription
drugs can afford higher taxes instead. Unfortunately any tax increases are simultaneously
committed many times over to proposed new spending by their
advocates. Those who propose more taxes advocated more generous
prescription drug benefits in the original bill: $1.2 trillion
would not have been enough.
They want new taxes to pay for hurricane recovery efforts
and the wars in Iraq and Afghanistan. Huge shortfalls in Medicaid, Medicare and
Social Security are also supposedly to be met by rolling back
the tax cuts, as are the large increases in subsidies by the
Others want these taxes to further increase the huge
Bush increase in spending on education. Ad infinitum. Tax increases would just be a tidbit
swallowed up in the maw of the Leviathan.
The prescription drug program should
be suspended until Congress designates specific spending cuts
to finance it. Anything else is a flight from reality with ruinous
consequences for our economy and our health. Even if Congress can find offsetting cuts
for this monstrosity, the case could be made that it is just
not worth it.
What are retirees then to do? At least they will be
spared the "surprise" of rising premiums, rising deductibles,
larger "holes" in the middle, and restrictive formularies as
costs go into orbit. Only
the federal government can so effortlessly combine escalating
costs and decreasing benefits.
It certainly can be a struggle to
pay for prescription drugs in the last years of life, including
the new expensive drugs that provide optimum benefits. Many retirees are covered
by their former employers' retirement plans and private Medicare
supplemental policies-in many cases superior to the new government
least able have access to Medicaid-as the rapid increases in
spending for that program testify.
Other options for retirees should
immediately be opened up that would cost a tiny fraction of
the new program in forgone revenue. Those who have already been researching prescription
drug policies for the new program should be allowed to purchase
similar polices free of tax, or by freeing up for that purpose
Health Savings Accounts-the use of which is now highly restricted
for those on Medicare.
Retirees, taxpayers, and pharmacists will also be spared
the "cost of cost control" which the present bill entails, including
the cost of 1,300 pages of new Medicare regulations (added to
the 130,000 already in print), paperwork, and the salaries of
new administrators, regulators and enforcers.
Perhaps one side benefit
of delaying this confusing mess of a prescription program would
be to provide funds for hurricane recovery. The federal government could easily blow
through these savings on other new spending. But at least while recovering from natural
catastrophes we would not be starting down the road to another
Richard E. Ralston is executive
director of Americans for Free Choice in Medicine (www.afcm.org).
Send comments to firstname.lastname@example.org. Copyright 2009 Americans for
Free Choice in Medicine.
Reprinted with permission.
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Health Freedom Watch is published by the Insitute for Health Freedom. Editor: Sue Blevins; Assistant Editor: Deborah Grady. Copyright 2005 Institute for Health Freedom.