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THE NEW YORK TIMES
August 10, 2002
Bush Rolls Back Rules on Privacy of Medical Data
By ROBERT PEAR
http://www.nytimes.com/2002/08/10/politics/10PRIV.html
WASHINGTON, Aug. 9 — The Bush administration today formally rolled back
some major protections for the privacy of medical records adopted by
President Bill Clinton. But at the same time, it also set new standards for the
use of personal information to market prescription drugs and other health care
products.
The new rules, the first comprehensive federal standards for medical privacy,
will affect virtually every doctor, patient, hospital, drugstore and health
insurance company in the United States. The rules are the final version of
changes proposed in March, embody more than five years of work and have the
force of law. Most health care providers and insurers have to comply by April 14
or face civil and criminal penalties, including a $250,000 fine and 10 years in
prison for the most serious violations.
The administration decided to abandon the core of the Clinton rules, a
requirement that doctors, hospitals and other health care providers obtain
written consent from patients before using or disclosing personal medical
information for treatment or paying claims. Instead, providers will have to
notify patients of their remaining rights and have to make "a good-faith effort
to obtain a written acknowledgment of receipt of the notice."
Administration officials made the change despite opposition from consumer
advocates, patients' rights groups and psychiatrists. The secretary of health
and human services, Tommy G. Thompson, said the rules struck a common-sense
balance.
"The prior regulation, while well intentioned, would have forced sick or injured
patients to run all around town signing consent forms before they could get care
or medicine," Mr. Thompson said.
The rules guarantee patients access to their medical records and limit the
information that can be disclosed for various purposes. The issue of medical
privacy now goes to the political arena. Some Democrats are already making an
issue of the new rules. Senator Edward M. Kennedy, Democrat of Massachusetts,
said the administration was "favoring the interests of powerful corporations
over those of ordinary Americans."
In a recent speech, Terry McAuliffe, chairman of the Democratic National
Committee, said the White House seemed to worry less about the privacy of
medical records than about the secrecy of Vice President Dick Cheney's energy
task force.
Under this administration, Mr. McAuliffe said, "it's O.K. to reveal personal
medical information about the American people, but when the oil companies meet
with policy makers to ask for special favors, that's guarded like a state
secret."
The new rules won praise from the American Hospital Association and the American
Association of Health Plans, which represents health maintenance organizations.
A spokeswoman for the H.M.O. group, Susan M. Pisano, said, "The final rules
represent a balanced, workable approach that protects privacy without
undermining patients' health care."
The rules appear to set strict standards on using personal data from patients
for marketing. They prohibit drugstores from selling personal medical
information to a drug company or other business that wants to sell products or
services.
In the last few years, some drug companies have paid pharmacies for customer
health information and used it to try to sell products to individuals with
conditions like osteoporosis, diabetes or depression. Mary R. Grealy, president
of the Health Care Leadership Council, which represents large health care
corporations, said the new rules were "stronger and tougher" than the Clinton
rules on marketing. Representative Edward J. Markey, Democrat of Massachusetts,
said the Bush administration had made some improvement in the marketing rules,
but left some loopholes.
"The final regulations appear to shut down some of the existing avenues of
commercial exploitation of personal medical data by third parties without the
knowledge or consent of the patient," said Mr. Markey, who is co-chairman of the
Congressional Privacy Caucus. "But the regulations still allow a drug company to
pay a pharmacy to act as its agent and allow the pharmacy to do the marketing
without disclosing the financial arrangement."
Although a drugstore could not sell health information on a patient to a drug
company, Mr. Markey said, the drug company could pay a pharmacist to recommend
that patients switch from one drug to another. The definition of "marketing" in
the new rules excludes communications to a patient by a health care provider who
is promoting goods and services offered by the provider itself. An
administration official confirmed that reading of the rules. Dr. Paul S.
Appelbaum, president of the American Psychiatric Association, criticized the
decision to drop the consent requirement.
"This abolishes the traditional control that patients have had over access to
their medical records," Dr. Appelbaum said. "It may discourage patients from
revealing information to their physicians that's necessary for their treatment,
and it may encourage doctors not to record important but embarrassing
information in the patients' medical charts." Lobbyists for hospitals,
drugstores and insurance companies saw the Clinton rules as unworkable.
Pharmacists had said it would be difficult to obtain written consent from a
patient whose doctor phoned in a prescription that was picked up by a neighbor
or a relative.
The Mayo Foundation of Rochester, Minn., said the consent requirement was an
"affront to patients" and "bad medical practice," because it would force doctors
to secure written consent from patients before even inquiring about their
problems. But Democrats and consumer groups said those standards were needed
because of an explosion in information technology that permitted the
dissemination of medical data with the click of a computer mouse.
The new rules include these provisions:
 | In general, information from a person's medical records cannot be
disclosed to an employer unless the patient specifically authorizes the
disclosure. |
| Patients can review their medical records and request changes to correct
errors. |
| Researchers can use medical records to track an outbreak of disease if
they strip the records of the patients' names, addresses, Social Security
numbers and other "direct identifiers." |
The federal rules establish minimum protections for medical privacy. State
laws providing more protection will still apply.
Under the rules, the "incidental use or disclosure" of personal information is
allowed. For example, doctors can still use sign-in sheets in waiting rooms and
talk to patients in semiprivate hospital rooms without fear of violating the
rules.
Copyright 2002 The New York Times Company
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