MEDICAL PRIVACY: Senate Compromises on Private Research
The U.S. Senate Health, Education, Labor and Pensions Committee made significant headway toward a compromise medical records privacy bill yesterday, with Sen. Edward Kennedy (D-MA) agreeing to language regulating use of information for privately funded research -- "the largest issue not resolved" in the bipartisan measure. CongressDaily/A.M. reports that under the provision developed by Sen. Bill Frist (R-TN), private researchers could obtain medical records in one of three ways: obtaining patients' informed consent, applying to the federally regulated Institutional Review Board or "win[ning] the consent of a newly created 'information protections officer' employed by the holder of the records." This official would be designated at all health care provider and research organizations, and would be guided by what is known as the Common Rule: research must not create "more than minimal risk to confidentiality of protected health information ... adversely affect the rights and welfare of the patient" or "be practicably carried out without the waiver." The Common Rule currently governs all federally funded research, as well as research on drugs whose manufacturers are seeking FDA approval.
More on the Way
Other provisions in the compromise measure include "language allowing patients to keep out of their portfolio any medical records of treatments that they paid out-of-pocket without help from an insurer," and a clause codifying "a recent Supreme Court decision protecting records of mental health treatments." In addition, CongressDaily/A.M. reports that Kennedy plans to offer several amendments to the bill "that would raise legal hurdles for law enforcement officers to obtain medical records, and that would allow individual patients to obtain a private right-of-action to sue for the improper use and release of their medical records." Kennedy is also negotiating with HELP Chair Jim Jeffords (R-VT) -- co-sponsor of the compromise measure along with Sen. Christopher Dodd (D-CT) -- over the bill's preemption of state regulations.
HELP member Sen. Paul Wellstone (D-MN) plans to offer amendments that would permit patients to "segregate" sensitive medical information, "extend privacy protections to the deceased ... allow family to control the release of that information," and "add medical records related to worker compensation cases to the bill's list of protected records" (Morrissey, 5/25).