Monday, May 05, 2008

Mandatory Registries for Diabetes Patients Aren't Worthwhile

In 2005, I wrote about the blatant invasion of privacy of with patients with diabetes' health records happening in New York City. Yours truly represented (see p. 49) the interests of people with diabetes at the 2005 public hearing on what was then a proposed registry, and I have remained outspoken on this issue. But thanks to a complete lack of representation from the representatives at the American Diabetes Association, and the American Civil Liberties Union who were handling the case until internal turmoil at the ACLU New York chapter resulted in a resignation of the woman handling the case, there has been little challenge or even media attention about the issue. Even fellow New Yorkers, never a group that keeps their opinions to themselves, expressed an inexplicable non-interest in the subject. In fact, there has been far more media interest in Google's plans for electronic health records. Canadian television interviewed me on the subject (see the interview below):

I also spoke to a newspaper in the U.K., but for whatever reason, the U.S. media continues to remain silent on the issue -- I guess they'd rather talk about Britney Spears' latest stupidity than report news.

It may come as a surprise, but people cannot opt out of this registry, although they may choose not to receive any correspondence consisting of weight loss and diet tips from the NYC Department of Health and Mental Hygiene. But their HbA1c records are still being seized even after opting out of that. There IS a legal basis for challenging the registry, based largely on New York State privacy laws which were passed in the 1980's to protect people who tested positive for HIV, but the same laws nevertheless require the Health Department to provide disclosure that their health information is being seized, something which is not currently happening today.

Since I work in the suburbs, I just have my bloodwork done there, which exempts me from having my results seized, but suburban residents -- even residents of other states like New Jersey and Connecticut who have labwork done in the city are being included, even though the law does not apply to them, a clear HIPAA violation if anyone wants to file a lawsuit! BTW, most of the major labs (Quest Diagnostics, LabCorp) which do the testing are physically based outside of New York (in New Jersey, as a matter-of-fact), and are therefore really under no legal obligation to comply with the NYC law, but they have decided to play nice and comply to keep the Department of Health off their backs.

Anyway, I had pretty much given up much hope on this issue until last week. Then, the April 28, 2008 edition of the medical journal Archives of Internal Medicine featured a barely-noticed submission which was written by two upstate New Yorkers, Paula Trief and Richard Ellison, who oppose mandated, involuntary and non-disclosed diabetes registries. The authors wrote that the involuntary (and non-disclosed) NYC registry won't work and could undermine the relationship between doctors and patients.

Their article, entitled "Mandated Diabetes Registries Will Not Benefit Persons With Diabetes" made some fairly convincing arguments about why such registries are unlikely to yield success. Naturally, NYC Health Commissioner Tom Frieden's personal friend, Benjamin Littenberg wrote a rebuttal in favor of the registry, conveniently overlooking the fact that the Vermont trial funded by the NIH which he headed required an opt-out provision, but the defense seems especially weak considering the registry has accomplished absolutely none of the objectives promised since being implemented 2 years ago.

The Wall Street Journal's health blog featured a post on this matter last week. I submitted my comments (naturally), and to my surprise, virtually all of the comments were in agreement with ME, not the NYC Department of Health and Mental Hygiene.

Interestingly, today's New York Times had an article about a continuing decline in the number of neighborhood supermarkets in NYC has made it harder for millions of New Yorkers to find fresh and affordable food within walking distance of their homes, according to a recent city study. Why, then, isn't the Department of Health and Mental Hygiene jumping all over that issue? I think perhaps its time to revisit this issue since its once again being debated in the public domain.


Anonymous said...

Over the past thirty or forty years, New York City has evolved into the archetype of the Nanny State, in which the government asserts control over all aspects of a person's life -- even his personal life. While this transformation started as early as the Dinkins administration -- possibly even as early as the Beame administration -- the pace seems to have accelerated dramatically during both the Giuliani and Bloomberg administrations.

From a public health standpoint, having a compilation of persons with a particular condition, subgrouped by treatment options and the development of their health over long periods of time, makes it easier to quantify the efficacy of treatment methods and to nudge research into previously hidden areas of the condition and its effects. Allowing an "opt out" would conceivably skew the data, as certain groups would be more likely to opt out than others.

HIPAA regulations aside, the existence of this compiled and correlated information, and its accessibility by any individual or group also allows for its abuse in terms of discrimination against those with the condition, up to and including refusal of care towards those with a certain progression of the condition. This is, of course, a bit of a paradox in the city that prides itself on its legislative inclusiveness.

Regarding the existence of supermarkets... the last time I was in midtown Manhattan, there were greengrocer/gourmet grocery stores two or three to a block. This, of course, is where the more affluent population works, and where it is possible to sell an $8.00 plate of iceberg lettuce. On the flip side, the dearth of fresh produce in poorer neighborhoods is hardly new to NYC. (Please check out a documentary from around 1969 or 1970 called "The Poor Pay More".) I think the prevailing attitude is, "if you can't earn enough money to afford to live in an affluent area where you can eat healthy, you don't deserve to live -- at least, not in New York City".

Kassie said...

Thanks for this info - I've been curious about how the registry has worked out.

Kathryn said...

:) I'm a wee bit south of you down here in SC. Still, reading this does not surprise me.sigh... After yesterdays headlines on what will happen in a "pandemic circumstance." We're all being tagged in some way to let it be known when "they" will choose to let us die.
survival of the fittest... and when is the world coming to an end? Grin and bear it.. keep on living and fighting.

Scott K. Johnson said...

I was finally able to watch the interview - very nice job Scott! Pretty cool to see you on TV!

Anonymous said...

scott, individuals do not have the right to sue under HIPAA (this was clarified in 2003 by the Department of Health and has been constantly upheld by the courts); however there are cases going through the courts right now that will determine if a patient can use HIPAA as a minimal benchmark of health privacy. Also, state law can supersede HIPAA as long as it provides stricter standards of privacy. There are also large exemptions for government use of this information. Just an FYI. Ping me if you want specific case history; it is a topic I've had to dig into quite a bit for my company.

Changing tacks, who at the ADA was heading up the legal representation of this issue? They have a policy action group and a legal advocacy group (among others), and the two have different motives and operate quite differently (I'm stating the obvious ;) ). I would be curious to learn more! I'll be digging through your blog a bit more.

Thanks for the great post.

Scott S said...

Adam, You're right about HIPAA not guaranteeing the right to sue, the best we can due is file a complaint and hope that it will be considered. I should have specified this, but my central point was that its a clear violation of even HIPAA's loose guidelines to include people who reside outside the NYC legal jurisdiction in the registry, a point that even the ACLA argued in its comments -- since they knew they could not guarantee out-of-state residents would not be included in their submissions.

We did not have anyone from the ADA representing us (no one was surprised about this, the ADA is for all practical purposes a subsidiary of big Pharma), only the ACLU was interested, and only after I pulled some strings; Elisabeth Benjamin was the attorney who I worked with there.

Anonymous said...

hey scott,
I *wish* I kept the reference page, but I ran across a lawyers comments in court pointing out that in the 7+ years HIPAA has been in legal effect, not one of the few thousand complaints has been followed up by the government. It is a law with no teeth, which, in my opinion, makes it more dangerous than not having the law at all. It gives many a false sense of security and encourages lax privacy policies.

I'm *really* surprised it hasn't received more press; the precedent it sets is scary. Diabetes is an epidemic in NYC for sure, but I'm personally not convinced in the slightest that such a registry can help (so thank you for the link to the medical journal in this post!).

Scott, I would love to chat with you more about your involvement in the NYC registry, if you are willing (you have my email address). I don't quite understand the comment about the ADA's close relationship with big pharma being a cause for them not being involved. I can see why big pharma wouldn't want to be involved (their involvement could be construed as an unnecessary risk with no financial upside), but I miss the connection on why that would (or more importantly, should) prevent the ADA from being involved.

Scott, I'm not trying to egg you on... I ask out of curiosity, and with more than a healthy dose of naivete. Thanks for your patience ;)

Scott S said...

Adam, I may have the reference you're referring to: the Washington Post featured an article published on June 5, 2006 ("Medical Privacy Law Nets No Fines") which found that of the 19,420 grievances lodged as of that date, more than 73% of the cases -- more than 14,000 -- either ruled that there was no violation, or allowed health plans, hospitals, doctors' offices or other entities simply to promise to fix whatever they had done wrong, thereby escaping any penalty. As of the date of that article, the Bush administration had received thousands of complaints alleging HIPAA violations but had not imposed a single civil fine, and prosecuted just two (2!) criminal cases.

What's the point in having these laws if we don't even bother to enforce them? I think HIPAA needs to be revisited and re-written!