A physician's organization spearheading a lawsuit charging that federal medical privacy rules are unconstitutional says it will appeal a court's decision to throw out the suit.
According to Andrew Schlafly, general counsel for the Association of American Physicians and Surgeons, Judge Sim Lake of the U.S. district court in Houston dismissed the suit because "plaintiffs have not yet suffered any injury from enforcement" of the regulations.
The AAPS, along with Rep. Ron Paul, R-Texas, a physician by profession, and three individual patients filed the suit last August challenging privacy regulations enacted under the Health Insurance and Portability Act of 1996.
The group, in a statement, said the law gives government gatekeepers "virtually unrestricted access to patient medical records" while it forces "physicians to comply or risk jail and/or fines up to $250,000."
Lake, in his ruling, said that since the regulations were not yet in full force, the legal issues were not "ripe" for litigation. He also ruled that the plaintiffs had no standing to sue because they "have not yet suffered any injury from enforcement of the Privacy Rule" contained in the HIPAA legislation.
"Defendants also argue that chances are extremely remote that plaintiffs will ever by affected by the rule. The court agrees," Lake wrote.
However, AAPS officials said because Congress passed the law, the rules eventually will apply to everyone.
"We find it difficult to understand a conclusion that our chances of being affected are 'remote' when the privacy rules must be followed by every physician in the country," said Jane Orient, M.D., the group's executive director.
Schlafly argued that HIPAA privacy rules permit the creation of a government-controlled database of medical records, in violation of the Constitution's Fourth Amendment privacy protections. He said the rule requires physicians to hand over to the federal government medical records "in which patients and physicians have a reasonable expectation of privacy."
Such mandatory disclosures to the government are unwarranted and unnecessary, he argued.
Nevertheless, Lake found that "because these 'unwarranted disclosures' have not occurred and plaintiffs have suffered no actual injury, the court concludes that plaintiffs lack standing to pursue this claim."
The claim "is not ripe for review," Lake wrote, finding also that the extension of the government's regulations to include paper – as well as electronic – records was also proper.
"The judge dismissed this case because these particular plaintiffs haven't been hurt yet," Orient said. "So we'll have to wait until after someone is hurt" by them, "in which case we can't undo the damage already done."
In the meantime, she said, "it's malpractice when a doctor fails to act to prevent harm to the patients. Unfortunately, government isn't held to the same standard to 'do no harm.'"
AAPS officials said the group would appeal the ruling.
"The judge merely said our constitutional claims were not yet 'ripe.' When they are ripe, we'll assert them again," said the group's spokeswoman, Kathryn Serkes.
She also said AAPS disagrees with Lake's "narrow view of the Paperwork Reduction Act" – a 1995 law that requires federal agencies to reduce the amount of "paperwork burden on the public."
"As to our statutory claim, the judge gave the federal government too much power over our paper medical records," she said.
The group did, however, manage a small victory. AAPS officials said Lake agreed with them "on the issue of prompt patient access to medical records as defined by state law" – a ruling the group said "is important for patients to go outside their HMOs and [insurance] networks."
The Department of Health and Human Services, which has been tasked by Congress to write the final privacy rules, stopped accepting public comment regarding the issue in April. One official said the response had been "in the thousands."
In past statements, HHS officials have said changes to the rule will keep medical records safe "while improving access to care."
"We have laws in this country to protect the personal information contained in bank, credit card and other financial records. Our citizens must not wait any longer for protection of the most personal of all information – their health records," HHS Secretary Tommy Thompson said.
Health privacy advocates say the changes suggested by the Bush administration would actually reduce a patient's ability to decide who can view medical records by removing consent forms for treatment, payment and health-care operations.
"Under the new rule, doctors and hospitals will be required to open up their records to HHS and other government agents without so much as a court order," said an analysis by the National Consumer Coalition Privacy Group. "The rules also override private contractual arrangements between patient and doctor with a bureaucratic mandate."
Aspects of the privacy rule have their genesis in the Clinton administration, when Hillary Clinton, as first lady, attempted to force through legislation that could have put most all of the nation's health care under the purview of the federal government.
"Some language from Hillary's plan is almost identical to HIPAA," says Robin Kaigh, a New York lawyer who has tracked medical privacy since the bill's passage more than six years ago.
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