January/February 2010
the zen of science

by Marc Ringel

Private practice
Patient privacy vs the need to know

As a doctor, people tell you about their pain and their fears. They expose their bodies.
They cry. They trust you. One of the worst ways to abuse that trust is to reveal these intimacies to somebody who doesn’t need to know. Most everybody in healthcare
respects patients’ privacy as a matter of course, especially since Congress passed HIPAA, the Health Insurance Portability and Accountability Act in 1996. The law features extensive definitions of types of medical information, who can reveal what to whom, and when and how they can reveal it. The act is backed up by serious penalties, both civil and criminal, if
you mess up.

When HIPAA was first passed, everybody working in healthcare had to take classes on this stuff; complying with confidentiality provisions took a lot more than common sense around the concept of need-to-know. The law explicitly says it does not intend to get in the way of patient care or of research. However, that’s not how the law has always been interpreted. For example, immediately post-HIPAA, emergency room personnel frequently encountered extra paperwork hoops to jump through before they could get other hospitals to fax documents urgently needed to care for critically ill patients. HIPAAnoia reared its ugly head.

Things are better now. Still, a recent survey of medical researchers showed that a large majority of them believe their work has been impeded by HIPAA rules. Which brings us to an important question. How do you balance the right to privacy of the individual with the need to make information available for important research? There is insight to be gained from looking at approaches that two other countries, Israel and England, have taken in generating medical research data from their populations.

Israel was founded by European expatriots, a large proportion of whom had deep roots in Western civilization and science. Early on, with the best of scientific and humanitarian intentions, writers of Israeli public health policy made autopsies mandatory in many circumstances.

An autopsy is the gold standard for determining cause of death. As an intern, one of the criteria I was rated on, for good reason, was the number of autopsies agreed to by the families of my patients who had died. My medical teammates and I were often
enlightened by the tales that the tissues of our departed charges had to tell. The post-mortem examination has been a hugely valuable tool of modern medical science and medical
education.

Bear in mind that Israel is not simply a Western nation. It is also a Middle Eastern state with an established religion. There exists a complex rabbinical literature, far outside the realm of science, that debates whether autopsies are okay with God or not. Some rabbis say “never.” Others say it’s allowed if there is a real likelihood of helping a living person. And so the argument has gone, ‘round and ‘round, for centuries.

Over the years there has been huge conflict over autopsies between the Israeli orthodox and medical communities. An interesting take on the issue popped up last year in the tragic case of a woman, the wife of a rabbi, who’d been choked to death in the course of a robbery. Although the cause of death was obvious (she was found with the rope that strangled her still around her neck), the authorities felt obligated to follow a law that mandated an autopsy in every violent fatality. The husband refused. A compromise was arrived at when the medical examiner agreed that a magnetic resonance imaging exam (MRI), which would yield a detailed 3-dimensional image of inside the corpse, could satisfy the law. The Talmud is silent about MRIs.

Then there’s the case of England, which keeps pretty compete health information on all its citizens. This information is expected to take a quantum leap in quantity and quality once the universal electronic medical record, backed by the National Health Service, is fully installed. (A daunting project, to be sure. Billions of dollars have been spent so far, and still the
British electronic medical record is five years behind schedule.) What data the Brits do have are being used to great effect to lend important insights into health, illness and patterns of medical practice. They’ve only scratched the surface of what’s possible. Sooner or later, English doctors will have powerful statistical tools that are the equivalent of an MRI of
the public corpus.

That’s the future of research. As we install electronic medical records systems, based on standards that allow information to be aggregated from disparate sites into great big databases, we’ll be able to ask specific questions of the data easily and quickly.

Today, in order to do credible research, scientists have to define a narrow question; hustle thousands or millions of dollars in grants; laboriously strive (as well they ought) to obtain
the approval of a committee that assures subjects are fairly informed about the study and treated ethically; enroll hundreds or thousands of people to serve as subjects and controls; run the study; statistically untangle the data; and then publish results that hopefully will be useful to somebody who is actually practicing medicine. Medical research should get a whole lot quicker and cheaper in the future when there are enough patients generating enough data to answer many questions by simple data-mining techniques. This is called
concurrent research.

It is possible to structure a database to allow access to a large share of its information while fully protecting the actual identity of every individual who has contributed data. Perhaps the
best thing about concurrent research is that it allows you to do a study without needing to obtain permission from human subject research committees, from individual patients - nor
even from their rabbis.

Marc Ringel has spent the majority of his career as a family doctor working in rural communities, including the last 12 years in Brush, Colorado. He has written extensively, for lay and professional audiences, about rural health, medical informatics and healing.