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Consenting Technologies

Yesterday, ONC held a fine gathering at the Grand Hyatt in Washington DC. There were experts, ONC Tiger team members and cutting edge technology vendors displaying and discussing platforms and software for providing patients the opportunity to define granular consent to the sharing of their electronic medical records down to a data element level.

Somewhere in the midst of watching that fabulous and very complex technology, it occurred to me that I don’t quite understand why we are discussing all these things. Obviously, we all agree that patients have a right to privacy, and as HIPAA outlines, our medical records ought to be protected from wanton disclosure without our permission. However, the showcased products and the ensuing conversations at the Grand Hyatt were on a completely different level of sophistication.

Physicians have been exchanging patient records since medical records were invented. Today, patients are signing the obligatory HIPAA forms giving health care providers permission for these exchanges, and most doctors use fax, phone, courier (usually the patient) and occasionally secure email to exchange medical records. A typical scenario would be a PCP making a referral – a letter summarizing the problem is usually written, some test results could be attached, a big yellow envelope with some film may be handed to the patient to bring to their specialist appointment. Physicians equipped with EHRs are doing pretty much the same, in a more automated fashion. We do not consider this an invasion of privacy.

It seems that things are about to change. Data, as we all know, yearns to be free, and once computerized, all data will finally become free (literally and figuratively). Instead of having the doctor select the pertinent information to be released based on circumstances and need to know, all our medical data will be available for access by all interested parties. So in our referral example, the specialist would request, or be granted, access to our entire electronic medical record. For most folks, this would be unacceptable. This is where consent comes in.

Newly empowered patients, or consumers, will need to go through their medical records and choose who can see what and under which circumstances they can see it. First we need to locate our medical records, which could be scattered amongst the various providers we see, or according to the best Toyota principles, will be all aggregated in a PHR that we control. So either we log into various Patient Portals, at various institutions, to give our informed consents, or log into our PHR which magically contains our entire medical record. In the latter case, it is not clear what the exact purpose of the consent would be since each provider would retain their own “unconsented” copy of the records.

Assuming I have a computer, and assuming I have access to the internet, and assuming my English is pretty good, and assuming my health care literacy is decent and I don’t have a disability preventing me from working with a computer, and ignoring these minute details, which are surely going to be resolved soon, let’s proceed with consenting. Since we have a specialist appointment coming up, we should decide what the specialist should see. Probably only stuff associated with the reason we’re going to see her for. We can safely check everything else off. Our PCP ordered an MRI, but we would really like the specialist to do her own tests, so let’s check off the MRI too. On second thought the blood tests looked a bit peculiar the first time around, let’s have some new ones, or let’s see what the specialist decides to order on her own. Checked off.

Now we need some general consent policies too. Who should be able to see our genetic information regarding increased risk for breast cancer? Nobody, that’s our own private business and if the insurers find out, we’re toast. Checked off. How about that little episode of depression? Oh, no, that’s nobody’s business either and we’re fine now. Checked off. At this point, all an unauthorized person can see is that we blocked all access to genetic information regarding breast cancer and mental health information. Hopefully it works better than invoking the Fifth Amendment in a court of law.

I understand Electronic Medical Records and wholeheartedly support their adoption. I understand that physicians need to exchange medical data in order to provide care. I understand per incident data exchange and I understand NHIN Direct. I completely understand a patient’s right to obtain a copy of all his/her records and I definitely understand the imperative to protect medical data from profiteering, legal or otherwise.

However, I do not understand the logic of opening up access to the entire medical record just so that patients can go back in and block same access, data element by data element. I also don’t understand the clinical value of a medical record that can be redacted at will without physician knowledge. And most of all, I don’t understand how small rural and underserved clinics, and their equally underserved patients, get to participate in this exquisite technology plan. Will this exercise improve quality of care? Will it reduce costs? Will it reduce disparities?

Margalit Gur-Arie blogs frequently at her website, On Healthcare Technology. She was COO at GenesysMD (Purkinje), an HIT company focusing on web based EHR/PMS and billing services for physicians. Prior to GenesysMD, Margalit was Director of Product Management at Essence/Purkinje and HIT Consultant for SSM Healthcare, a large non-profit hospital organization.

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Michelle W20 MuleTeam DriverCaptain Jack SparrowMedInformaticsMDJ.S. Recent comment authors
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Michelle W
Guest

I’ll second the thoughts on most patients: I really don’t believe as many people are as interested in becoming masters of health care as some would have us believe. Just like most people trust a mechanic to look after their cars (even though they could do simple repairs/preventive work), most people want a doctor they can trust to handle their health. As for the redaction issue, I can certainly see how that would be a problem. What is I’m in a car accident in another state? If I’m unconcious, I’m not able to suddenly decide that my trauma care team… Read more »

20 MuleTeam Driver
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20 MuleTeam Driver

I saw the numbers above and wondered what the real amount of the appropriation was. I looked again and tried to calculate how many friends I would need to carry out the 8.9 million dollars then how many more I would need to carry off the 20 Billions of Dollars under ARRA. Ok, forget U-Haul trucks or Tom Cruise busting open a Bank Vault. You need frickin Superman to stop this non-sense. You can’t get that much cash delivered overnight without the help of the government. Conclusion: Mussolini is in charge and he has a lot of friends. What good… Read more »

Captain Jack Sparrow
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Captain Jack Sparrow

“Sen. Charles Grassley (R, Iowa) started the high-level discussion about the FDA’s role in health IT in the context of meaningful use of EMRs and the push to get physicians to adopt technology. He sent a letter on Feb. 24 to Health and Human Services Secretary Kathleen Sebelius asking what her agency intended to do to ensure the safety of EMRs, and the role the FDA should play in monitoring them. The next day, an FDA director stated flatly: ‘Under the Federal Food, Drug and Cosmetic Act, HIT software is a medical device.'” http://www.ama-assn.org/amednews/2010/05/24/bica0524.htm So why are we even discussing… Read more »

Margalit Gur-Arie
Guest

Dr. Smith, we had quite a lively discussion here on the subject you mentioned and I’m sure we will have more… https://thehealthcareblog.com/the_health_care_blog/2010/06/do-ehrs-kill-people.html Dr. S., glad to see you here. I guess I never thought about the “consent” you have in mind. Do you seriously think that patients need to consent to usage of specific “devices” in the course of their care? I can see patients having the right to name the “device” manufacturer in a malpractice suit, but I’m not sure about consent. As to security of electronic information, as opposed to paper records, that is also an altogether different… Read more »

MedInformaticsMD
Guest
MedInformaticsMD

Consenting technologies? Interesting title.
Here’s thoughts about informed consent to use of EHR medical devices that govern care:
“Draft Patient Rights Statement and Informed Consent on Use of HIT”
http://hcrenewal.blogspot.com/2009/03/draft-patient-rights-statement-and.html
Here’s about prospects for confidentiality:
“Concern About Medical Records Is Not Misplaced”
Wall Street Journal
April 3, 2010
http://online.wsj.com/article/SB10001424052702304252704575156092885171262.html
and
Operation Aurora And a Widespread Reluctance to Discuss IT Flaws: Is Universal Healthcare IT Really a Good Idea in 2010?http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=aurora

J.S.
Guest
J.S.

REALITY
” .. The cart is waaaay before the horse! Until with have a unified and easy-to-use healthcare data privacy regime, technology needs to be held at bay ..”
Yes. The public is DAMN ANGRY at unaccountable, incompetent big organizations.
Dream on about technology until the cows come home — most will NOT going to cooperate with EMR/EHR until someone ACCOUNTABLE steps up. Probably will take at least 15 years, at today’s rate.
And blaming Bush, Cheney, Rove, Boehner, Palin, et. al, will not win over the masses. They are so much smarter than that charade, it is not funny.

Andee Ruinee
Guest
Andee Ruinee

Thanks for the heads up on the HHS-App for IPhones- this is one of my favorite tools! I did a preliminary scan on the application and found that it does cost 99 cents but it comes with an opportunity to review the application too which by itself makes the application valuable from that point of view providing feedback is given to the agency and public. On the other hand considering the Quality of people we have in the branch of government known as HHS it will probably not be a good investment even as a reviewer tool. What is needed… Read more »

praetorius
Guest
praetorius

It is a travesty that the HHS Secretary is abusing the taxpayer by wasting money on these greed and control based ideas. It was stated: “The main point was creation of sophisticated policies for access to data and how the policies themselves should, or should not, be attached to the data itself. The patient is of course responsible for setting the access rights.” Most patients can not take their medications correctly and these self appointed “policy wonks”, aka HIMSS insiders, think patients can set access rights? For Sebelius to have authorized such a inappropriate meeting, considering that the current EMR… Read more »

iPhone app?
Guest
iPhone app?

Does anybody have the latest news on the LITTLE DICKEY (formerly known as “the Dick-O”, a.k.a. Richard Blumenthal)? The fellow that was reduced in size, appropriate to his false claims of service in Vietnam? You know, brother of David Blumenthal, MD, ONC Coordinator. I wonder which one of them came up with the great idea to charge .99 for the iPhone application: “HHS News Reader”? And whose pocket is this cash going to? As I have not reviewed this application, I wonder if this app provides either a gossip column or a classified section that discloses which HIMSS Insider is… Read more »

Colonel Klink
Guest
Colonel Klink

Thanks to all for the use of the word “REDACTING”. According to Colonel Pat Wise of HIMSS this is not a real word but then HIMSS only deals in make believe, that they know what is right for everyone including what utterances may or may not be words tied to their ideas of safety; its safe if it puts money in the pockets of the vendors. “Is it Safe”, a reminder of the movie Marathon Man– how one man’s military would do anything to achieve world domination. So typical of the maniacal ideologies of the past and easily identified here… Read more »

Penny Smith, MD
Guest
Penny Smith, MD

A waste of taxpayers’ money to have such a program.
One minor problem_in the UK, it was recently determined that the patients do not look at their medical records nor will they opt in or opt out. The percentages were impressive and of no surprise to me.
The default should be opt out, always.
Another problem, the EMRs are often defective, and are currently being sold illegally, in violation of the Federal Food Drug and Cosmetic Act.
For those who drink the kool aid of HIT, including those who attended and spoke at the conference, the following links may cause peristalsis reversus:
http://www.ischool.drexel.edu/faculty/ssilverstein/cases/?loc=cases&sloc=MAUDE
http://google2.fda.gov/search?as_sitesearch=www.accessdata.fda.gov%2Fscripts%2Fcdrh%2Fcfdocs%2Fcfmaude%2Fdetail.cfm&q=cerner+maude+millenium&x=0&y=0&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&ie=UTF-8&ip=98.219.102.123&access=p&sort=date%3AD%3AL%3Ad1&entqr=3&oe=UTF-8&ud=1&start=40
http://blogs.wsj.com/health/2010/07/02/health-blog-qa-electronic-medical-records-and-liability-risk/

Margalit Gur-Arie
Guest

I agree. I particularly like the general disclaimer idea. That way patients can have their privacy and docs can be alerted that they need to take the history from scratch. And I do agree that the vast majority of folks won’t even bother to go through their chart, just like they didn’t in the UK. So really the main question remains whether we start with opt-in or opt-out. That will probably be up to the States. I would prefer opt-out for clinical use and opt-in for “research”, with rock solid protection from data selling.

jd
Guest

“My thinking is that if doctors become aware of this latter possibility, they will place very little value on whatever records they receive.” Exactly, which is why it’s such a terrible idea. On top of that, to the extent that they do take the data as complete, they open themselves up to pursuing treatments that are contra-indicated given the full facts. I’m surprised you say that you see the other side. Why shouldn’t it be enough that someone can opt out for transmission of information; why does the system have to enable them to conceal that fact? Seriously, what is… Read more »

Margalit Gur-Arie
Guest

jd, it is more complicated than just deciding what goes to the HIE and what doesn’t, and the questions are very much still open today. The “cutting edge” presenters showed software that is minimally deployed or just in pilot phase. I don’t know if any State agency is considering purchasing these technologies. The main point was creation of sophisticated policies for access to data and how the policies themselves should, or should not, be attached to the data itself. The patient is of course responsible for setting the access rights. For example, the first presenter showed a federated model of… Read more »

jd
Guest

Margalit, I must not have been clear. When I was closer to this, it was not an open question whether to allow people to remove information from the RHIO without an indicator that the patient didn’t want to disclose that information. There was no debate in 2008. The technology was always there to allow this (in fact, it is harder to allow selective removal with an indicator than without one). So I don’t think it has anything to do with new technologies, but instead shows that at least some people consider this an open issue today, whereas I thought it… Read more »