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A coalition of privacy advocates and medical professionals filed suit in U.S. District Court in Philadelphia last week to challenge new federal regulations set to go into effect today that, they say, will illegally eliminate the duty to obtain a patient’s consent before disclosing medical records. The suit alleges that the new regulations — promulgated by the U.S. Department of Health and Human Services under the Health Insurance Portability and Accountability Act of 1996 — will give insurance companies, drug companies and police virtually unfettered access to individual medical records. Attorneys Kenneth I. Trujillo, Ira Neil Richards and Peter Winebrake of Trujillo Rodriguez & Richards filed the suit along with attorney James C. Pyles of Powers Pyles Sutter & Verville in Washington, D.C., naming as defendant HHS Secretary Tommy G. Thompson. “Under the secretary’s action, virtually all personal health information about every aspect of an individual’s life can be used and disclosed routinely without the individual’s consent and against his or her will,” the suit says. The suit wages five challenges to attack the new regulations. The first claim is that the process used by HHS to pass the regulations violated the federal Administrative Procedures Act because the agency never explained why it was reversing its prior position, and because the public was not given enough time to comment. In the second, third and fourth claims, the suit alleges that the regulations violate patients’ constitutional privacy and free speech rights, as well as the common-law doctor-patient privilege. Finally, the suit alleges that the regulations violate HIPAA itself since Congress’ intent in passing the law was “to establish a floor of federal privacy protections.” The suit, which was assigned to U.S. District Judge Mary A. McLaughlin, alleges that the new set of regulations “eliminates the right to privacy of individuals for their personal medical records and jeopardizes the privacy of past and future communications between patients and their physicians and practitioners within the context of the patient-physician relationship.” Under HHS’ own findings, the suit says, the new rules affect the medical privacy rights of “virtually every American” and the privacy obligations of more than 600,000 entities. One purpose of HIPAA, the suit says, was to improve the efficiency and effectiveness of the health care system by facilitating the greater use of electronic technology to maintain and transmit health information. But the suit says Congress also recognized that such efficiencies “could not be realized unless strong federal protections were put in place to preserve the public’s trust and confidence that their right to health privacy would not be eroded or eliminated.” As a result, the suit says, Congress authorized HHS to pass regulations that would set a federal “floor” of health information privacy protections. At first, the suit says, HHS seemed to understand. When it passed its original regulations in December 2001, the agency stated: “Unless public fears are allayed, we will be unable to obtain the full benefits of electronic technologies. The absence of national standards for the confidentiality of health information has made the health care industry and the population in general uncomfortable about this primarily financially-driven expansion of the use of electronic data.” The suit says that one of the “key” elements of the original rule was “recognition of the traditional right of individuals to give or withhold consent before their personal health information is used or disclosed for most routine purposes.” But in August 2002, the suit says, HHS issued the “Amended Privacy Rule” that “flatly reversed” its initial interpretation of HIPAA. According to the suit, the new rule repeals the right of individuals to not have their identifiable health information used or disclosed for routine purposes without their consent, and grants blanket “regulatory permission” for thousands of organizations and individuals to use and disclose individuals’ identifiable health information for routine purposes without their knowledge or consent and against their will. As a result, the suit alleges, the new rule effectively “turned the health information ‘privacy’ rule into a health information ‘disclosure’ rule.” Since the new rule was passed, the suit says, HHS has passed additional regulations that set standards for computer security. But while the new privacy rule takes effect today, the new security rules will not go into effect for more than two years. Also missing, the suit says, is any “enforcement” mechanism. The suit alleges that HHS has “stripped citizens of the power to exercise their right to medical privacy” while at the same time expressly authorizing “thousands of entities and their business associates to use and disclose the most personal health information regardless of the individuals’ wishes or expectations.” At the same time, the suit says, HHS “ensured that the confidentiality and integrity of this personal health information will not be protected by failing to put adequate security and enforcement measures into effect on a timely basis.”

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