Beverly Woodward

Medical Record Confidentiality and Data Collection: Current Dilemmas

Author discusses current data collection and data disclosure practices that threaten medical record confidentiality. She raises concerns about the reidentification of ostensibly deidentified patient information and discusses measures for protecting confidentiality in a research setting.

Confidentiality, consent and autonomy in the physician-patient relationship.

In the practice of medicine there has long been a conflict between patient management and respect for patient autonomy. In recent years this conflict has taken on a new form as patient management has increasingly been shifted from physicians to insurers, employers, and health care bureaucracies. The consequence has been a diminshment of both physician and patient autonomy and a parallel diminishment of medical record confidentiality. Although the new managers pay lip service to the rights of patients to confidentiality of their records, in fact they advocate very liberal medical records access policies. They argue that a wide range of parties has a need to know the contents of individually identifiable medical records in order to control costs, promote quality of care, and undertake research in the public interest. Broad interpretations of the need to know, however, are at odds with strict interpretations of the right to confidentiality. Strict confidentiality policies require that, with few exceptions, patient consent be obtained whenever a patients record is used outside the treatment context. The traditional criterion for overriding the consent requirement has been that without the override some harm would directly result. This rule is now challenged by the claim that patients have a duty to make their records available for a wide range of research and public health purposes. The longstanding tension between physician responsibility for patient welfare and respect for patient autonomy is being replaced by a debatable requirement that both physician and patient autonomy be subordinated to the goals of data collection and analysis.

Federal Privacy Legislation

Murray’s fear that doctors will use overly aggressive procedures is also overstated. Because success rates are already important to couples, physicians already have the incentive to use aggressive procedures. Moreover, relative aggressiveness is not particularly significant. The important question is whether shared-risk programs will increase the frequency of mismatches between couples who are willing to incur only low risks to become pregnant and doctors who employ procedures that carry high risks. Murray offers no reason to believe the rate of such mismatches or their severity will increase if shared-risk programs are widely available. It also seems unlikely that sharedrisk programs will be structured in a way that gives rise to the abortion-relatcd concerns Murray raised. We think it likely that both parties to a sharedrisk program will favor terms that make each responsible for the issues under their control. We predict that if a couple decided on an abortion, the contract would require the payment of the standard IVF fee, and not count that cycle against the shared-risk program. This arrangement would create incentives identical to those that exist under FFS. Murray’s concern that couples participating in a shared-risk program will not know “when to say when” is also exaggerated. Although there may well be issues relating to the disclosure of information about shared-risk programs, false, deceptive, and misleading advertising is already unlawful. In other markets, such problems are addressed without resorting to an outright prohibition, to the general satisfaction of all concerned. Similarly, although financial considerations afso. fect the decision of “how much” assisted reproduction is “too much,” it is precisely those couples who do not end up pregnant after repeated cycles that benefit from shared-risk programs, and who will be worse off if such programs are not available. Finally, Murray’s arguments regarding commodification and the destruction of physician-patient relationships seem contrived. First, although he does not suggest that couples (or doctors) should be indifferent to the rate at which IVF succeeds, he objects to a payment system that recognizes the value couples place on becoming pregnant. Rut if it is permissible, and even good, that couples and doctors care about success rates, why must they pretend they do not care when it comes to payment plans? Second, no one is proposing the legalization of baby selling. The only issue is whether to allow couples to pay for an existing medical service in a new way. Because IVF services are already bought and sold in markets, they have already been commodified. We fail to see how a new payment option will make IVF services more commodified. Third, contingent compensation agreements are allowed in other settings that involve intimate or fiduciary relationships, without apparent damage to those involved. Indeed, contingent compensation is common within the family, such as where a child’s allowance is contingent on chores being done, or college tuition is paid only if a specified grade point average is maintained. In the future, analysis of these issues should focus on the real problem, which is arriving at compensation systems to encourage physicians to make good judgments and to act skillfully and cost effectively. Murray’s response is that “we are better off when physicians remain focused on our welfare, rather than when they become entrepreneurs peddling insurance.”z This is a good sound bite, but it is little more. One could say, with equal force, that we are better off when physicians remain focused on our welfare than when they get paid whether we live or die. Neither caricature can answer what is at bottom an empirical question: Do different incentive arrangements cause doctors to act in different ways with different consequences for their patients’ well-being and health? In some contexts, fixed fees may create better incentives than contingent fees; in other settings, doctors may perform equally well under both arrangements; and in still other situations, contingent fees (of whic:h sharedrisk programs are an example) may work best. The growth of alternatives to FFS and the markets which operate in all other service industries and professions suggest that Murray’s belief in the necessary and inevitable superiority of FFS medicine is wrong. His unsubstantiated fears are too slim a basis on which to forbid the use of a market mechanism that may enable thousands of additional couples to afford IVF each year. David A. Hyman, M.D., J.D. Associate Professor Univ. of Maryland Schl. of Law Baltimore, Maryland Charles Silver, J.D., M.A. Cecil D. Redford Professor of Law Univ. of Texas Schl. of Law Austin, Texas

Requiring Consent vs. Waiving Consent for Medical Records Research: A Minnesota Law vs. the U.S. (HIPAA) Privacy Rule

The use of medical records in research can yield information that is difficult to obtain by other means. When such records are released to investigators in identifiable form, however, substantial privacy and confidentiality risks may be created. These risks become more common and more serious as medical records move to an electronic format. In 1996, the state of Minnesota enacted legislation with respect to consent requirements for the use of medical records in research. This legislation has been widely criticized because—it is claimed—it creates an unnecessary impediment to research. In this article, we show that these arguments rest upon misinterpretation and/or misrepresentation of the 1996 legislation. A consent requirement had actually been present in Minnesota since 1976 (though codified in a patient rights statute rather than a privacy statute). The 1996 law does not require specific consent, as often claimed, but rather only a general authorization. The campaign against the Minnesota legislation appears to have been motivated by concern with respect to the then impending federal privacy rule. The HIPAA rule, as enacted, is in fact less stringent with respect to consent than the Minnesota consent law. On the other hand, the Minnesota consent law has not been effectively applied or enforced. As we change the way we manage sensitive medical information, new efforts are needed to provide protection against the confidentiality risks in research. Patient consent is an important tool in this regard. New instrumentalities are needed to solicit and document consent.

A reminiscence of Myrtle Solomon

Myrtle Solomon, chair of the War Resisters International (WRI), 1975–1986, was a woman of many talents, widely cherished and loved (even by those with whom she had had political disagreements), and a major force in keeping alive the ideal that war must be abolished— however unfeasible that goal might appear. In devoting herself to the international pacifist movement, Myrtle applied a broad range of gifts: Myrde the eminently fair administrator and mediator, Myrtle the actress, Myrtle the warm and witty friend, Myrtle the accomplished cook, Myrtle the versatile office worker—all played a role in Myrtles substantial contribution to our movement. Myrtle viewed herself more modestly. “Not an intellectual. Not a leader.” So she said. But even though Myrtle admired the “brilliance” of some of her acquaintances and colleagues, she had a sharp eye for everyones foibles and an understanding that it was probably not brilliance that was needed to keep the international pacifist movement from collapsing or fragment...

Human rights and the new Eastern Europe

The dramatically changed circumstances in Eastern Europe call for a new agenda, for those who monitor human rights activities in the region.