proposed med-privacy regs: NYT article/AAPS statement

[Peter Marshall <techdiff@ix.netcom.com>]

http://www.nytimes.com/library/politics/103099clinton-privacy.htm
l
> 
> October 30, 1999
> 
> Clinton's Rules on Medical Privacy Fuel Debate Over Patients' Rights
> 
> By ROBERT PEAR
> 
> WASHINGTON -- President Clinton kicked off an intense debate on Friday on
> how to protect the privacy of medical records in an era when doctors can
> test their patients for genetic defects and send the information around the
> world with the click of a computer mouse.
> 
>  In unveiling new rules to safeguard such information, Clinton said, "These
> standards represent an unprecedented step toward putting Americans back in
> control of their own medical records."
> 
>  But doctors said the rules were inadequate and could actually erode some
> protections that patients now have. Several physician groups said they had
> been invited to today's White House ceremony, but stayed away because in
> many cases the proposal does not require that patients give consent before
> their records are shared, only that they be notified. Such a rule, they
> said, does not give patients enough control over the use and disclosure of
> their medical records.
> 
>  The Administration estimated that compliance would cost the health-care
> industry $3.8 billion over five years, but the insurance industry says the
> costs could be 10 times that amount. With both sides saying they support
> the goals of the standards, a central point in the debate will be: What is
> privacy worth in dollars and cents?
> 
>  Health insurance plans object, in particular, to a provision that would
> make them responsible for privacy lapses by companies that collaborate in
> the care of a patient. For example, an H.M.O. that sends a patient to a
> pharmacy could be liable if the pharmacy improperly uses the patient's
> records.
> 
>  Under the proposed rules, patients would gain a new Federal right to
> inspect, copy and suggest corrections in medical records that have been
> kept or transmitted electronically.
> 
>  Federal officials estimated that it would cost doctors, hospitals and
> health maintenance organizations more than $400 million to issue notices
> informing patients of their privacy rights, as required by the rules. In
> addition, the officials predicted, thousands of patients will try to
> correct their medical records, and it will cost the health-care industry
> more than $2 billion to deal with these requests over the next five years.
> 
>  The rules would permit the use and disclosure of medical information
> without a patient's consent for treatment, payment and a wide range of
> loosely defined "health-care operations," including many common business
> practices of H.M.O.'s.
> 
>  Dr. Donald J. Palmisano, a trustee of the American Medical Association,
> said, "The A.M.A. believes that mere notice of a health plan's intended use
> is inadequate."
> 
>  Many doctors contend that health plans and insurance companies should have
> to obtain consent from patients before using information from their files
> to monitor the patients' compliance with recommendations for medical
> treatment and testing. Too often, the doctors say, H.M.O.'s interfere in
> the doctor-patient relationship by suggesting a cheaper drug or a different
> course of treatment.
> 
>  The Clinton Administration would allow health plans to use personal health
> information, without a patient's consent, for the following "health-care
> operations": assessing the quality of care and the performance of doctors
> and nurses; developing clinical guidelines; setting premiums for the
> renewal of insurance contracts, and investigating fraud.
> 
>  Dr. Richard K. Harding, vice president of the American Psychiatric
> Association, said the proposed rules "give the Federal Good Housekeeping
> Seal of Approval to practices that could undermine privacy."
> 
>  Many states allow patients to limit the use of some or all of the
> information in their medical files. In theory, the Federal rules do not
> override state laws that provide more protection for privacy.
> 
>  But William B. Bruno, a lawyer for the psychiatric association, said,
> "Patients could lose some protections they now have. At present -- because
> of state laws, court decisions and canons of medical ethics -- many
> hospitals will not disclose medical records unless the patient gives
> consent. The Federal Government is now weighing in, saying that's not
> required. It's giving a green light for significant changes in current
> practice."
> 
>  Administration officials insisted that the rules would create protections
> in areas where none now exist. Doctors, hospitals and H.M.O.'s would, for
> example, have to keep logs documenting who got access to patients' records
> for various purposes.
> 
>  The rules would greatly expand the role of the Federal Government in
> regulating the practices of the health-care industry. It would set hundreds
> of detailed Federal standards, with civil and criminal penalties for
> violations.
> 
>  Mary Nell Lehnhard, senior vice president of the Blue Cross and Blue
> Shield Association, described the rules as costly, complex and confusing.
> 
>  "We believe that all patients should have the peace of mind that comes
> from knowing their personal records are secure, and we are outraged when
> breaches of this trust occur," Ms. Lehnhard said. "But why do we need 600
> pages of regulations to protect medical records when the Bill of Rights
> takes only one page to provide Americans with all their basic rights? Why
> didn't the Administration just simply spell out what activites are illegal?"
> 
>  Janlori Goldman, director of the health privacy project at Georgetown
> University, said, "This is a historic day. These regulations will be the
> first enforceable Federal rules protecting health privacy."
> 
>  But, Ms. Goldman said, the proposal falls short because "there is no
> requirement that a judge or a magistrate approve or deny access to medical
> records sought by law enforcement agencies."
> 
>  Under the rules, most health-care providers would have to designate
> "privacy officials" to develop privacy policies and procedures. This rule
> would apply even to a small office with three doctors, who could designate
> the office manager as privacy coordinator. Health-care providers would also
> have to designate a "contact person" to handle patients' complaints about
> violations of privacy.
> 
>  Clinton and Donna E. Shalala, the Secretary of Health and Human Services,
> expansively interpreted their authority. The rules make doctors, H.M.O.'s
> and insurance companies responsible for any violation of a patient's
> privacy by their "business partners."
> 
>  Kristin A. Bass, director of legislative affairs at the American
> Association of Health Plans, a trade group, said that an H.M.O. would have
> little power over a drug store that improperly sold information about the
> patient to a drug manufacturer.
> 
>  "They would hold us responsible for the pharmacy's misbehavior," Ms. Bass
> said.
> 
>  Health insurance plans could also be held accountable for the misuse of
> medical records by their other "business partners," including their
> lawyers, auditors, billing firms and consultants.
> 
>  Under the rules, health-care providers and health plans would have to get
> a patient's consent for certain types of disclosures -- if, for example,
> the information was to be used in marketing.
> 
>  Doctors and insurers could not insist that people surrender their privacy
> rights as a condition of obtaining treatment or insurance. In other words,
> they could not coerce patients into giving consent.
> 
>  The Administration acknowledged that the rules would create substantial
> costs for health-care providers and health plans. But, it said, the rules
> are necessary because computer technology makes it possible to "breach the
> security and privacy of health information on a scale that was previously
> inconceivable."
> 
>  In addition, doctors have many new clues to their patients' destiny.
> Scientists have developed more than 450 genetic tests that may help
> identify people with an increased risk of developing breast cancer,
> prostate cancer, cystic fibrosis and other diseases.
> 
>  In a preface to the rules, the Administration said they would have "major
> social benefits" that could not be quantified. Privacy concerns now
> discourage people from being tested for certain types of cancer and for
> some sexually transmitted diseases, the Administration said. The new rules
> will allay these concerns, so more people will receive effective
> treatments, it said.
> 
>  A person who violated the rules could be required to pay a civil penalty
> of $25,000. The rules authorize tougher penalties for criminal violations:
> a $50,000 fine and one year in prison for willful violations; a $250,000
> fine and 10 years in prison if the offender tried to use or sell data for
> "commercial advantage, personal gain or malicious harm."
> 
>  The public will have two months to comment on the proposals, which are to
> be published in the Federal Register on Nov. 3. The Secretary of Health and
> Human Services is supposed to issue final rules, with the force of law, by
> Feb. 21, 2000.
> 
>  Clinton said he was acting because Congress failed to meet its goal of
> adopting comprehensive privacy standards by Aug. 21.
> 
>  "I am taking this action today because Congress has failed to act and
> because, a few years ago, Congress explicitly gave me the authority to step
> in if they were unable to deal with this issue," he said.
> 


> Doctors Question President Clinton on Medical Privacy
> To: National Desk, Health Reporter
> Contact: Kathryn Serkes of the Association of American Physicians
> and Surgeons, 202-333-3855;
> E-mail: kaserkes@worldnet.att.net;
> Web site: http://www.aapsonline.org
> 
> WASHINGTON, Oct. 29 /U.S. Newswire/ -- Following is a statement
> by Jane M. Orient, M.D., executive director of the Association
> of American Physicians and Surgeons, in response to President
> Clinton's announcement of forthcoming regulations on medical
> privacy:
> 
> "Trusting President Clinton to protect our medical privacy
> is a bit like asking the Pied Piper to baby-sit our children.
> 
> "Congress had better take a very close look at the details of the
> President's privacy regulations when they come out, as this
> administration's record on privacy is lousy. President Clinton had
> no problem with pushing a national patient i.d. through Congress
> to record all the intimate details of our records on a national
> database, while refusing to make public his own medical file.
> 
> "And wasn't it this administration that pilfered hundreds of FBI
> files for its own use, and leaked Linda Tripp's personnel file? The
> same administration that enacted the federal OASIS program this year
> to collect pages of intrusive personal information, from toilet
> habits to sexual activity, from people getting home health care --
> whether paid for by the federal government or not.
> 
> "This administration has repeatedly abused the privacy of others
> for its own agenda. President Clinton's call for an end to
> abuse of medical records is the ultimate irony."
> 
> -0-
> /U.S. Newswire 202-347-2770/
> 10/29 16:54
> 
> Copyright 1999, U.S. Newswire