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To calm some fears about the new Department of Health and Human Services patient privacy protections, scheduled to go into effect April 2003, the agency recently issued the first in a planned series of guidance documents. The guidance is intended to clarify the HHS’s intent and dispel some criticism that the rules create some unwieldy conflicts in the real world.
The HHS patient privacy protections were issued in December 2000 after Congress failed to enact legislative protections that it required of itself under a self-imposed three-year deadline. That deadline agreement was incorporated into the Health Insurance Portability and Accountability Act of 1996, requiring HHS to propose patient protections via regulation if Congress failed to pass legislative protections by December 1999.
Health care providers’ misgivings became apparent when HHS received more than 11,000 separate questions on topics ranging from parental rights to medical research before the guidelines were even released. So when HHS issued the final rule in April, the agency said it would issue a series of guidance documents designed to clarify the rules before the rules take full effect on April 14, 2003. (The rules technically took effect in April 2001, but most covered entities were given until April 2003 to comply with the majority of the provisions.)
In releasing the guidance document, HHS Secretary Tommy Thompson said it was "an opening step in helping physicians, health care providers, and health plans understand their obligations to patients under the rule." The guidance clarifies that hospitals will not be required under the regulations to build private, soundproof rooms to prevent conversations between doctors and patients from being overheard, he said. The guidance also clarifies that friends and family members still will be allowed to pick up a patient’s prescription, as often already occurs, Thompson said.
Those were real-world concerns raised by providers and critics of the new rules. Thompson has previously said that he would propose modifications to ensure that pharmacists can fill a phoned-in prescription for a new patient, even when the pharmacist does not have the patient’s signed consent on file.
However, the clarification may not be enough to stop the criticism. A national physician group recently announced that it is suing the Bush administration’s top health official to halt the new medical privacy regulations, calling them unconstitu- tional. The Association of American Physicians and Surgeons (AAPS) contends the rules would violate patient confidentiality and place burdensome new requirements on physicians.
The action follows a recent complaint filed by the South Carolina Medical Association, which contends that HHS created the patient rules "without any guidance whatsoever from Congress." In a complaint filed in U.S. District Court in Houston, AAPS claims the rules violate the Fourth Amendment by requiring physicians to allow government access to personal records without a warrant. They also illegally authorize the government to create a centralized medical records database containing personal information, says Kathryn Serkes, JD, public affairs counsel to the AAPS.
Serkes says forcing patients to surrender information to the federal government constitutes "an illegal search and seizure by the federal government." Doctors can be fined for withholding those records and the federal government can order physicians to refuse treatment to patients who won’t consent to government disclosure, she says. AAPS also contends that the rules place on physicians an overwhelming burden for recordkeeping, particularly for doctors in small offices.
A full copy of the first HHS guidance document is available on the HHS web site, www.hhs.gov/ocr/hipaa.