New York City will require laboratories to report all HbA1c results above normal, along with patient and physician information. Plans are to compile a registry of an estimated half-million diabetics (stories at Bloomberg.com, NY Times, and Newsday, with more details in a Health Department presentation pdf). The Department of Health enthusiastically wants to track increased incidence of Type II diabetes in children, map physical areas within the City where blood sugar control is better or worse, etc. It also wants to target interventions at both patients and physicians, starting a pilot treatment program in the Bronx in 2007. For instance, alerts would be sent to patient and doctor if 90 days passed without a new HbA1c test, and patients with poor HbA1c control would receive letters and educational materials. Clinicians would get a quarterly roster of their patients stratified by glycemic control and best practice recommendations. New York will be the first city to make diabetes a reportable disease.
Although the city says that patients can opt out of the program, procedures are not yet developed for them to do so, even though the program is to begin right away, with current laboratory electronic reporting developed for other required health reporting likely to be easily adapted to add the new value. The health department presentation talks about giving patients the opt-out option when they receive their first letter from the department, which really does not touch the issue of whether they are in the patient database.
Thomas Frieden, the city health commissioner, pooh-poohs privacy concerns, saying that security protections will prevent patient information from being passed along to insurers or others.
I think this goes way too far for a non-infectious disease and an agency that does not actually have any responsibility for the patient’s care, in a country where negative health information can be extremely damaging to an individual wanting insurance or employment. Dr. Frieden, though, compares it to cancer registries or communicable disease reporting.
Quite an empire-builder, is Dr. Frieden. He would also like to track treatment status and lab test results of HIV patients city-wide.
Were I a NYC physician or patient, I'd be furious that the city was sticking its oar in in this fashion, and I’d think my rights violated. Yes, surveillance information can be of value, but given possible ramifications I absolutely wouldn’t be willing to throw information into the bucket, nor have the city contacting me about what to do.
But then, were I in NYC, I wouldn’t be asked.
If NYC were to hire negotiators, take bids, and make a deal with a test strip provider to buy large quantities of strips for residents at low cost and resell them to all NYC residents for less than diabetics could normally buy them for, I’ll wager they could save a lot more lives and the program could pay for itself, without violating anyone’s privacy.
I can supply some relevant comment vis-a-vis my own recent work on diabetes.
ReplyDeleteWe just obtained funding from NIDDK to study diabetic patients' preferences for technological aids in communicating their glycemic control values to their physicians.
NIH turned us down, the first time we submitted, in part because we did not provide privacy protection. We thought it might be exempt. When we fixed that and resubmitted we obtained the funding.
And we are simply asking questions of these patients about how they manage their diabetes. We obtain no actual data on glycemic control, and retain no personal identifying information.
So the question arises. Why does the federal government insist that protections are in place, with full informed consent and IRB approval, simply to put some diabetics in a room with us, when another governmental agency can retain intrusive surveillance data without consent?
Privacy issues are of great concern indeed especially with insurance coverage & employment at risk.
ReplyDeletebut registry will help if it gives providers access to lab results over period of time?
there are always 2 sides of coin, 2 different & often opposing ways to look or interprete things.
risk versus benefits can be one way to look at it.