Congress to act on privacy law for security of patient data
Some worry ‘research’ term may cloak economic aim
One of the first items on Congress’ agenda this session may be legislation to protect the privacy of an individual’s medical records.
Under a 1996 law, Congress must enact medical privacy
legislation by August 1999, or the Secretary of Health and Human
Services (HHS) will be responsible for adopting privacy regulations
by August 1999. Last fall, HHS submitted recommendations to the
Senate Committee on Labor and Human
Resources and the House Committee on Commerce on Ways and Means.
Concerns have been expressed over the possible misuse and indiscriminate access to patient records stored in centralized electronic data bases and that these records will be open to the scrutiny of insurance companies, law enforcement agencies such as the FBI and governmental agencies including the Internal Revenue Service (IRS). However, the proposed HHS legislation does not apply to law enforcement agencies.
Congress believes legislation for privacy protection is necessary to establish boundaries, security, consumer control and public responsibility. The recommended legislation would provide new rights and define responsibilities for patients who could deny access and impose limitations to medicine, academic researchers and others who need access to patient records for the advancement of science and medicine.
Donald J. Palmisano, MD, a member of the American Medical Association’s (AMA) Board of Trustees, said, "The AMA is very concerned about the general use of the term ëresearch’ (in the proposed legislation) because it has been used as a comprehensive term to cover a spectrum of activities, ranging from purely medical and scientific research, to purely economic analysis."
Further, Dr. Palmisano, who testified before the Senate Committee on Labor and Human Resources last October, said, "There’s a great danger if all of the medical records end up in a common data base and all of those who access [records] claim that they have a need to know for research. That research might not be scientific research, but rather economic research and for the benefit of the requesting entity’s commercial gain.
"I think everybody’s for this [legislation]. But the big question is, ëHow will this get granulated into law?’"
Dr. Palmisano pointed out that "the AMA is generally satisfied that the protections related to the release of identifiable information with authorization when a federally recognized Institutional Review Board (IRB) determines that the need for information outweighs the individual’s right to privacy or care."
Clearly, many researchers believe it is in the best interest of patients and science to monitor incidence and prevalence of disease and conduct outcomes reports. To some degree, researchers are able to do this without formally receiving permission from every patient.
Because orthopaedists have always been at the forefront of advocating for patients and physicians in many arenas, including tort reform, Dr. Palmisano believes they will be "important players in the privacy and confidentiality arena."
Bernard N. Stulberg, MD, chairman of the Academy’s Biomedical Engineering Committee, notes, "The true researcher isn’t affected by any or all of this; he already has rules. But we now are going to be making economic judgments about population-based studies and broad issues that haven’t been protected and some sub-categories where there are some situations where a record might not be released. It’s not feasible. Say you’re going to collect health population information from four states in the Midwest. Are you going to call [patients] and get them to consent? The process of doing that would be time-consuming."
Gary E. Friedlaender, MD, chairman, department of orthopaedics and rehabilitation, Yale University School of Medicine, New Haven, Conn., said, "The physician-patient relationship is built on trust. One can’t develop a credible medical history without this assumption that they have the right to privacy and the physician is their partner in understanding their history and how it applies to their health."