MEDICAL PRIVACY: Some Agreement, but a Long Way to Go

      Although consumer-protection/public health groups and the health care industry now agree on many aspects of pending medical privacy legislation, a few key issues still may serve to bog down the process, according to speakers yesterday at a Capitol Hill discussion sponsored by the California Institute for Federal Policy Research: "Balancing Medical Privacy and Confidentiality with Medical Research." Framing the issue, California HealthCare Foundation CEO Dr. Mark Smith noted that everyday paperwork -- for example, between doctors, labs and health plans -- is irreducible for the current system to function properly. Patients' concerns are raised when the information is provided to recipients outside of plans and providers, like pharmaceutical companies and the NCQA. The issue, he said, is how to "reconcile people's skepticism of health care information systems with the needs of" the health care delivery system ( click here for past coverage). As Congress begins to seriously assess medical privacy legislation, nearly all speakers seemed to agree that there now exists much greater agreement on all sides of the debate. Opinion sharply divides, however, over the key issues of federal preemption of state laws and the research uses of medical information.

How Much Oversight?
      Laurie Michel, senior director and counsel for government affairs for Merck & Co., differentiated between what she called consent for obtaining "interventional" information, such as for clinical trials, versus "observational" information, like data studies of existing information. Picking up on this point, Heidi Wagner, director of government affairs for Genentech Inc., supporting a bill to be introduced Monday by Sen. Robert Bennett (R-UT), allowed that while explicit consent should be given for clinical trials, non-identifiable information should be "outside the scope of the law." Also, as the drug industry may examine "hundreds of thousands" of patient data per day in retrospective analyses, it would not be feasible to secure consent for each. Rather, the drug industry supports a provision in the Bennett bill that would provide for its own general accountability in securing the confidentiality of data, without an explicit review of each case. But Janlori Goldman, of the Health Privacy Project at Georgetown University, said two opposing bills -- introduced by Sens. Patrick Leahy (D-VT) and Edward Kennedy (D-MA), and Sens. Jim Jeffords (D-VT) and Chris Dodd (D-CT) -- contain more protective provisions. They would force private organizations to adhere to the same confidentiality standards, determined by an independent review board, as federally funded projects. As many drug companies already have their own IRBs, Goldman suggested that the drug industry's opposition is simply a means to avoid additional external regulation.

State's Rights
      With respect to a federal preemption of existing state laws, Goldman supports provisions in the two Democratic bills that would allow stronger state medical privacy laws to apply beyond the federal law. She said the Bennett bill, which creates a national ceiling for the severity of medical privacy regulations, would "wipe out a body of existing California law." Which is fine with Wagner, who said "any way you look at it," the drug industry seeks "to create greater uniformity." She said allowing stronger state laws to supersede federal law would result in "significant litigation," as courts would be forced to determine in each case which body of law was the "stronger" of the two (Jeff Dufour, California Healthline).

What the Little Guy Can Do
      In related news, this month's Consumer Reports makes suggestions for patients who wish to proactively safeguard their medical privacy. Consumers should obtain a copy of their medical records from their provider; request a copy of their file from the Medical Information Bureau (www.mib.com), which "keeps records of those with serious medical conditions, poor driving records, or other factors that may affect longetivity;" read authorization forms before signing; and protest disclosures which they find inappropriate, in order to help doctors "know what bothers consumers." Consumers Union also reiterated its position that while changes in record-keeping technology are primarily for the better, disclosure of identifiable information should be illegal without the patients' explicit permission. Patients should also "have the right to examine and correct their health records." Any legislation, however, "shouldn't hinder important public- health efforts or research, or pre-empt more-protective state laws" (May 1999 issue).