A recent post by Dr. Wes Fisher, a cardiologist-electrophysiologist and med-blogger in Illinois, caught my attention. It’s on HIPPA, the Health Insurance Portability and Accountability Act of 1996, and how patient privacy regulations might impede dissemination of new information and physicians’ education.
What he considers is a case report published in the Annals of Emergency Medicine. The authors describe a complicated cardiac procedure performed in a 42 year old woman who was brought to the emergency department of a hospital in Coon Rapids, Minnesota. The study is not HIPPA-compliant, Dr. Wes notes, and I agree.
The report exemplifies the “small cell problem,” an issue of privacy mentioned by some IRBs but (I found) hard to find published information on. Wes describes it succinctly:
Clinicians should be sensitive to the “small cell problem”: the existence of individuals with such unique or unusual diagnoses or illnesses, that it might be possible for others (or patients and families themselves) to identify the individuals in case reports or medical text books based upon limited information, such as state or city of residence, age and diagnosis.
Excessive regulations can be harmful because detailed case reports can save lives, he writes.
But I think that a patient’s right to privacy almost always overrides the potential value of publishing a case study or small series. Although most IRBs don’t require that individual patients sign informed consent if their case is described in an article, perhaps those policies should change.
If, for example, a physician were to write up a patient’s unusual case record, before submitting it to a journal he or she might ask the patient, if alive, for consent to publish their particular medical history with relevant details. If the patient’s no longer alive, they might ask the next of kin, as a courtesy. (In the U.S., there are few protections of privacy regarding people who are dead.) Perhaps journal editors should insist on a patient’s consent prior to publication of a case in a small community or with unique identifiers.
This “small cell problem” hits close to home. Even in NYC, how many female hematologists-oncologists had breast cancer and scoliosis surgery and needed to stop working? Not many. People talk.
The NIH details 18 rules for compliance regarding privacy in medical research. These are valuable rules.
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Hi Dr. S — I’m having trouble even getting my brain wrapped around this scenario. Are you saying that doctors are NOT currently already asking their patients or next-of-kin for permission to write about these cases for publication?
Even if “most IRBs don’t require that individual patients sign informed consent”, my question is why the hell WOULDN’T docs get this done as a routine matter of simple human courtesy, and particularly when writing about easily identifiable medical conditions?
I am utterly gobsmacked that otherwise intelligent, educated physicians anywhere — yes, even those practicing in Coon Rapids, Minnesota — have to actually be TOLD to exercise plain old common sense like this.
Hi Carolyn, No, there’s no consent required for most kinds of academic case reports.
Elaine, thank you for pointing me to this post — this is a very important issue. Even though I analyze mostly large databases, sometimes I run into this problem, usually when there are fewer than 10 cases per cell. I do not know what the right balance is, taking into account privacy concerns and the need to report. This may be a bit less opaque when the condition in question may pose a contagion risk, where public health concerns may outweigh individual privacy. But really not at all sure what the right answer is. Thanks again.