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Physicians sue to overturn HIPAA privacy rule. (Texas OB.GYN. A Coplaintiff).

The Association of American Physicians and Surgeons has filed a lawsuit asking that a new federal privacy regulation be overturned on the basis that it is unconstitutional.

Rep. Ron Paul (R-Tex.) signed onto the suit as a coplaintiff. The lawsuit has been filed in U.S. District Court for the Southern District of Texas-Houston Division.

The complaint seeks declaratory judgments that the privacy rule is unconstitutional because it allows government access to personal medical records without a warrant, impedes patient-physician communications, and intrudes into the states' maintenance of personal medical records.

"Patients are withholding information, and doctors are lying because of privacy concerns," said Dr. Jane M. Orient, the association's executive director, citing an informal poll of 344 AAPS members. "Physicians' ethics will be further challenged if they're forced to choose government compliance or lying for a patient."

In the poll, 96% of respondents said that the privacy rule would further compromise patient privacy.

The privacy rule, which is part of the Health Insurance Portability and Accountability Act (HIPAA), became effective on April 14.

Most health plans and providers have until 2003 to fully comply; small plans have an extra year.

Before the rule went into effect, Rep. Paul, an ob.gyn. who sees patients regularly at a Houston free clinic, had introduced a joint resolution (H.J. Res. 38) designed to prevent it from taking effect. However, Congress did not take action on the resolution.

AAPS, which is a national association with a mission to protect the physician-patient relationship from the intrusion of third parties, is the first national group to file a lawsuit against HIPAA, according to Kathryn Serkes, who is AAPS public affairs counsel.

The lawsuit says that the privacy rule:

* Violates the Fourth Amendment by allowing government access to personal medical records without a warrant or patient consent.

* Violates the First Amendment by subjecting physician-patient communications to warrantless government review

* Violates the 10th Amendment by intruding on physician-patient affairs that are intrastate in nature (as opposed to interstate) and are beyond the scope of federal power to regulate.

* Violates HIPAA and lacks statutory authority to the extent that it regulates medical records other than electronic transmissions, was not promulgated in the time period expressly required by Congress, and increases administrative costs.

* Violates the Paperwork Reduction Act and the Regulatory Flexibility Act because it imposes an unjustified regulatory burden on small physician practices.

Additional administrative costs imposed by HIPAA include the need to purchase new software in order to comply with the rule, and training staff to be in compliance with the rule.

The rule also requires each covered entity to have a privacy officer who oversees compliance with the rule, Ms. Serkes said.

The complaint also outlines how the rule conflicts with other state laws, such as those in California and Florida, that grant patients specific rights to medical data privacy.

A spokesman for the Department of Health and Human Services had no comment on the lawsuit, citing agency policy not to comment on pending litigation. A representative of the American Hospital Association also had no comment.

According to the lawsuit, one AAPS member estimated that his cost of compliance with the privacy rule the first year alone would total between $16,000 and $23,000 for computer hardware, new software, and seminar fees.

This figure would be "substantially more" if an additional employee or consultant were needed to manage the software.

The changing nature of the privacy rule confuses the issue.

"How can they tell us to be HIPAA-compliant when HHS says there will still be changes?" Ms. Serkes questioned.

HHS recently issued a 57-page "guidance" document aimed at clarifying parts of the privacy rule. The agency said that more of these documents would be forthcoming.

A separate lawsuit filed by the South Carolina Medical Association (SCMA) asks for an injunction while the rules are revised by Congress.

The suit has been filed in the U.S. District Court for the District of South Carolina-Columbia Division.

In its suit, the medical association argues that HHS went beyond what Congress intended to be the scope of the privacy rule. Congress originally wanted the rule to refer only to the electronic transfer of medical records, but the HHS rule applies to electronic, written, and oral communications.

The South Carolina suit also says that the rule is too vague to be enforced, especially through criminal penalties. SCMA is discussing whether and how to back the AAPS suit, SCMA president Dr. J. Capers Hiott said.

"This law is constitutionally flawed," Dr. Hiott said. "We as physicians are totally behind confidentiality ... but they overstepped the bounds."

Rep. Paul's spokesman said he could not speculate on the success of the AAPS lawsuit, but said, "We venture it will be a tough battle."
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Author:Peters, Sally
Publication:OB GYN News
Date:Nov 1, 2001
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