Wednesday, December 20, 2000

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The Washington Post U.S. Moves To Cloak Medical Records
"The Clinton administration will issue broad new regulations today to safeguard the confidentiality of Americans' medical records, establishing the first federal protections aimed at limiting what information doctors, hospitals and health plans can divulge without patients' consent.

The rules are significantly more far reaching than those proposed by the White House a year ago, covering not only electronic medical records, as was initially outlined, but also paper records and oral communications. They also require patients' written consent for even routine disclosure of information, something not covered in the administration's earlier plan, and close a loophole that would have allowed large self-insured employers access to medical records without patient approval."

"The Clinton administration's move will not come without controversy. Medical industry representatives have argued that limiting how patients' records can be used will boost costs and hamper research that could lead to more advanced treatments."

JOURNAL OF HEALTH, LAW, AND PUBLIC POLICY Health Data in the Information Age: Use, Disclosure, and Privacy.
"Accompanying the current debate over health care reform is an equally important debate about the privacy of medical records. No information is more sensitive or potentially more stigmatizing than personal health records. At the same time, medical data have enormous value to researchers and health care providers, offering insight for the epidemiologist and quantitative assessment of health care effectiveness. Striking this balance is not an easy task. Understandably, the medical profession has followed closely the privacy discussion associated with proposed administrative reforms, but many of these issues are complex, and the policy proposals are often not clear."

The New England Journal of Medicine Privacy and Medical-Records Research
"Researchers, members of institutional review boards (IRBs), and health advocacy groups have acknowledged the fact that we can no longer guarantee privacy and confidentiality in an age of electronic medical records. The logistic hurdles associated with medical- and research-record gatekeeping make errors inevitable. Because of this reality, it is more important than ever to ensure the use of informed-consent procedures that convey this potential loss of privacy as one of the risks of research. And because the misuse of genetic information could be especially damaging, we need public policies that specifically address genetics research.

Although there are greater costs associated with recontacting individual subjects and gaining renewed consent for any additional research uses of tissue samples or medical records, this is a price we must be willing to pay. Much valuable research will still be able to go forward, and society will not be harmed in any meaningful fashion.

As we move to create better public policies in this area, we must retain our tradition of protecting human subjects and their right to consent or to refuse to consent before any use is made of their medical information for research.”

redux [06.15.00]
New England Journal Of Medicine Rules for Research on Human Genetic Variation -- Lessons from Iceland
"DNA molecules are entirely separate from medical records. In the future, however, the DNA molecule and the medical record are likely to merge into one when it becomes possible to sequence a person's entire genome and put that information on a computer chip or disk. This is not deCODE's current project, but we should not wait until this step is taken to explore its implications. The most important questions would then be who has the authority to make such a disk in the first place; who owns the disk; who controls the use of the disk; and whether the disk containing the genome should be treated as specially protected medical information, as is the case for psychiatric and drug-dependency records? In clinical settings, it seems reasonable to treat such a disk as containing particularly private and sensitive medical information. It also seems reasonable to permit patients to agree to have their entire genome scanned without detailing the tens of thousands of tests that would be run. This is akin to consent to a battery of tests during an annual physical examination.

On the other hand, in a research setting, or when a specific genetic disorder is suspected, the creation and use of an individual patient's genome disk should be subject to the informed consent of the patient. And since they can be both separated from the medical record and readily recreated, research subjects should retain the right to have the files containing their genetic information destroyed at any time.

Iceland's experience with deCODE provides a useful catalyst for formulating fair and ethical rules for research on genetic variation. The Icelandic experience demonstrates that people are concerned about how genetic research is done, that medical-records research and DNA-based research are not the same, that community consultation is necessary but not sufficient to justify DNA-based research ethically, that the probable benefits of such research should be spelled out as clearly as possible, and that international standards for consent to and withdrawal from research should apply directly to research on human genetic variation. Rules for such research will retain their relevance even after it becomes possible to transfer all the genetic-sequence information in a DNA molecule to a computer disk."

redux [02.13.00]
The Daily Davos Beyond the Genome
"By the spring of this year, the first draft of the human genome -- the sequence of all the genetic instructions needed to make up a human being -- will be published on the Web. But that is only the end of the beginning. Scientists still have very little idea of what most of the 100,000 or so human genes actually do, and finding out will take them into a very different area of research.

The raw material of the genome program has been anonymous samples of DNA, manipulated by complex laboratory machines that turn out information like a production line turns out widgets. But the new era of post-genome research involves analysing real people and their confidential medical records. The records are needed to match the genes that people carry with the diseases they may develop. Only then will gigabytes of genetic data into new treatments for cancer or heart disease. And that is why socialised healthcare is a vital part of post-genome research.

Countries such as the U.S., which provide healthcare through private enterprise, are useless for this sort of genetic inquiry. Only those countries which have organized the delivery of healthcare to their population in a way that is independent of the marketplace have built up the universal medical records necessary to make sense of the patterns of disease."