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Just how open, and thus open to public scrutiny, should medical research be? Part of the push to digitize the doctor's office via Electronic Health Records (EHRs) is to get information out of dead trees and into a space where that data could positively transform the world of medical research. Remember the stats I was able to compile for this blog? Now imagine if researchers could pull the same kind of analytics together for disease populations in real time. Practice Fusion belives that anonymized patient data is the next major advancement in health care.

But are there any danges to this open, web 2.0 concept of medical research? How much does patient privacy (or even safety) factor into this paradigm? What, if any, are the risks? I'd like to look at two news stories from this week to examine the pros and cons of open medical research.

Exhibit One: The Chemical Drug Cycle

One Associated Press story I saw covered in a number of publications was that of Dr. David Nichols, pharmacology chair at Purdue University. Dr. Nichols often studies the effects of psychodelic drugs on his test subjects (rats and other lab animals). You can read about his research in newspapers (like this July 2009 The Times-Picayune article) and medical journsals (see here) alike.

But it's not a medical breakthrough that put Dr. Nichols in the news yesterday. Instead, reporters all wanted to cover an essay he wrote for Nature magazine, admitting the difficulties he finds in publishing results in a field where many may use his work for harm. In his editorial, "Legal highs: the dark side of medicinal chemistry," Dr. Nichols explains how all too often, those most interested in his findings only want to find a recipe for the next big street drug:

I first became aware that unknown amateur chemists were watching my papers more than a decade ago. My laboratory was doing research on 3,4-methylenedioxymethamphetamine (MDMA or ecstasy).... In the process, we studied many molecules that had structures similar to MDMA. One was 4-methylthioamphetamine, or MTA, which could inhibit the enzyme that breaks down serotonin in the body....

Without my knowledge, MTA was synthesized by others and made into tablets called, appropriately enough, 'flatliners'. Some people who took them died. Now, any knowledgeable person who had carefully read our papers might have realized the danger of ingesting MTA. It not only caused the release of serotonin from neurons, but also prevented the breakdown of this neurotransmitter, potentially leading to a dangerous serotonin syndrome that can sometimes prove fatal. My laboratory had shown that rats perceived the effects of MTA as being like those of ecstasy. It seemed that that was the sole motivation for its illicit production and distribution to humans. I was stunned by this revelation, and it left me with a hollow and depressed feeling for some time. By 2002, six deaths had been associated with the use of MTA. It did not help that I knew some of these fatalities were associated with the use of multiple drugs, or had involved very large doses of MTA. I had published information that ultimately led to human death.

For those not familiar with the term, a blog carnival is an organized collection of blog posts from various authors relating to a central theme. I follow and try to contribute to the general medical blog carnival Grand Rounds and the health policy carnival Health Wonk Review. Grand Rounds is hosted by different blogs on a weekly basis, while Health Wonk Review comes out every two weeks. Both have their first editions of the new year up this week:

• Grand Rounds was hosted this week by Pizzazz, themed around the idea of this year's major health "bowl" games.
• Health Wonk Review was hosted by The Apothecary, with a huge sampling of posts relating to the Affordable Care Act (ACA).

Speaking of the ACA, there's a new blog carnival that will surely cover this legislation closely: it's called Benefits Package, and bills itself as "the blogosphere’s first ever blog carnival dedicated to health care and employee benefits." It's inaugural edition was hosted by Evan Falchuk of See First, who I met through an online conversation about predictions for the new year. If you'd like to submit to this carnival, contact InsureBlog.

One thing about blog carnivals is that while you can always learn about new advances and technical information, you also get some amazing stories about patients and providers in the field who are dealing with life and sharing their personal health journeys. As a case in point, this Grand Rounds featured a compassionate article on the gene patent controversy by Dr. Ed Pullen, a Washington state family physician. Gene patents are something I've touched on before, and which I hope to write more about as the current lawsuit progresses. Here's the situation in a nutshell, as described by Dr. Pullen:

The BRCA gene was isolated and cloned at the University of Utah in 1994. The same year Myriad Genetics was formed, a patent filed for the BRCA 1 and subsequently BRCA 2 genes was filed. The first patents were granted in 1997 and 1998. Currently Myriad provides the only available testing for BRCA 1 and BRCA 2 gene mutation testing. The patents for this testing and for the patent on the BRCA 1 and 2 genes held by Myriad have been challenged in court with lawsuits supported by patients, physicians, medical associations and the ACLU.

Dr. Pullen admits he was largely unaware of this issue until his wife was diagnosed with breast cancer, and now his Christmas wish is that these patents will be broken. As he explains, the whole concept of genetic patenting allows Myriad to have an unprecedented monopoly on these patients' health:

The fact that they charge $2975 for this testing adds to the anger by patients and physicians. Myriad has refused to allow use of their testing to assess the accuracy of the test itself. The cost keeps thousands of patients from access to a test that could potentially save their lives or allay their anxiety.

Thanks, Dr. Pullen, for adding a human face to this court battle, and here's hoping that this issue continues to be discussed in light of the very real need of these patients.

Yesterday was a big day for the government's Electronic Health Record (EHR) incentive program: it was the first day providers and hospitals could register to become meaningful users, and the final rule on the permanent certification process was released. Remember, all the accredited certification bodies and the certification they've issued to different vendors and products are temporary, set to expire in 2012. After that the permanent certification process is supposed to kick in.

The Department of Health and Human Services (HHS) released the rule on its website yesterday, and will print it through the Government Printing Office this Friday. I've created a bookmarked copy of the PDF for those interested (click here), and blogger Brian Ahier has uploaded the full rule to the open document platform Scribd.

I've only given the rule a cursory glance, but here's what I've gathered so far: under the current, temporary program, the Office of the National Coordinator (ONC) received applications for accredited certification bodies and approved them. Under the permanent process, the ONC will sanction an ONC-Approved Accreditor (ONC-AA) to handle the application process for certification bodies. The application process for an outfit to become the ONC-AA is defined in Section III, Part D (p. 31):

... under this revised § 170.503, the National Coordinator will review all timely requests for ONC-AA status in one batch and choose the best qualified accreditation organization to serve as the ONC-AA. We are revising §170.503(b) to provide a 30-day period during which all interested accreditation organizations may submit requests for ONC-AA status. We will publish a notice in the Federal Register to announce this submission period. We are revising § 170.503(c) to permit the National Coordinator up to 60 days to review all timely submissions and determine which accreditation organization is best qualified to serve as the ONC-AA based on the information provided in the submissions and each organization’s overall accreditation experience.

Once the ONC-AA is established, anyone wanting to be an ONC-Authorized Certification Body (ONC-ACB) or ONC-Authorized Testing and Certification Body (ONC-ATCB) will need to go through that organization. I noticed this little tidbit on certification tucked away in Section III, Part F (p. 43):

We seek to make clear that the primary responsibility of ONC-ACBs under the permanent certification program is to certify Complete EHRs and EHR Modules, and potentially other types of HIT at some point in the future, in accordance with the certification criteria adopted by the Secretary. In consideration of the comments and the preceding discussion, we are adding new provisions ... to make it explicitly clear that an ONC-ACB must offer the option for a Complete EHR or EHR Module to be certified solely to the applicable certification criteria adopted by the Secretary and not to any additional certification criteria.

So if a vendor came to CCHIT and requested to be tested using only the requirements of the ONC (rather than any CCHIT had developed), CCHIT would have to comply. However, CCHIT can still offer its own type of additional certification:

As a matter of its own business practices, however, an ONC-ACB may decide to offer multiple options for the certification of HIT, some of which could potentially impose other requirements for certification or include additional certification criteria beyond what has been adopted by the Secretary. If an ONC-ACB chooses to offer multiple certification options for HIT, we expect it would be done consistent with the requirements of the ONC-ACB’s accreditation.

However, the ONC wants to make sure that these "super certifications" are merely a vendor prerogative and not in any way to be understood as marking a better product in the eyes of HITECH:

Accordingly, we have added as a component of a new principle in the Principles of Proper Conduct for ONC-ACBs ... that any certifications that are based solely on the applicable certification criteria adopted by the Secretary at subpart C must be separate and distinct from any other certification(s) that are based on other criteria or requirements. To further clarify, HIT that meets the definition of a Complete EHR or EHR Module and is certified to the certification criteria adopted by the Secretary as well as to an ONC-ACB’s own additional certification criteria must have its certified status as a Complete EHR or EHR Module noted separately and distinctly from any other certification the ONC-ACB may issue based on its own certification criteria.

That should help people realize that certification under HITECH is not necessarily the same as CCHIT certification. I'll post more once I've had a chance to really dig into the rule.

Here are some Health Information Technology (HIT) headlines to start your new year off.

MU Registration Today

Today is January 3, and the first day eligible providers can register with the Centers for Medicare & Medicaid Services (CMS) to be meaningful users of Electronic Health Records (EHRs). CMS expects that attestation for HITECH will begin in May, with incentive payments beginning in May. Only time will tell if those predictions prove true or not. Also, CMS wants providers to know that they should "Register as soon as possible. You can register before having a system installed." To register, go to the CMS web page here.

Surescripts an Accredited Certification Body

I and other bloggers have speculated before on how many accredited certification bodies (or ATCB) there would be in HITECH. Well, time to add one more to the list: Surescripts, the largest e-prescribing network, has been recognized to certify e-prescribing modules. That makes six certification bodies in all (see here for a complete list). Here's the scoop from Health Data Management:

In a Dec. 23 announcement, the Office for the National Coordinator for Health IT said that Arlington, Va.-based Surescripts can verify that e-prescribing, privacy and security modules meet the standards laid out in the meaningful use requirements. Surescripts is the sixth authorizer to be approved by ONCHIT, but it’s the only one with limited certification abilities—the five others have ONCHIT’s blessing to certify Complete EHRs and EHR modules.

The announcement has brought on mixed reactions. John Lynn asked "Doesn't this scream conflict of interest?" at EMR AND HIPAA, while The Medical Quack wondered "If certifying only modules then what is the cost?" Then there's this anonymous commenter's remarks at HIStalk:

Re: SureScripts as an ATCB just for e-prescribing. How an e-prescribing clearinghouse be an objective judge about a vendor’s functionality? If I don’t use their clearinghouse, where does that put me? I think the certification process is going to get much stranger in the new year.

I certainly think his prediction is correct: strange things will probably happen this year as we move toward real HITECH action. Considering that Surescripts already has a relationship with a large number of practices and hospitals, it makes a certain logical sense for them to be accredited. Here's a good question I haven't seen asked, though: if Surescripts came out with its own e-prescription module, would it have to get a different ATCB to certify it?

Miscellaneous

Google's Android market "has officially launched it's medical category," allowing doctors to quickly locate apps for their (non-Apple) smart phones and tablets (hat tip to EMR Daily News). Speaking of mobile technology, a Japanese company has announced plans to ship its iPad competitor to the US soon.

To close, here are some updates to two stories I reported on previously. First, bionic legs are getting another serious treatment as a doctor attempts to help former NBA player "Massive" Mike Williams to walk again. "The doctor is also trying to persuade Berkeley Bionics to create and donate a set of bionic legs for Williams, who could provide free advertising for their brand," ("Bionic legs may help ex-basketball player walk again," NBC News). Also, the donor in the first successful US organ transplant passed away last week at 79. In a romantic quirk of fate, the man actually married the nurse who supervised his twin brother's surgery back in 1954. You can read more about this medical pioneer at NBC or ABC.

It's the last day of the year 2010, and I'd like to share some information about how our little blog at Occam Practice Management has done this year. I've learned a great deal about blogging and the world of Health Information Technology (HIT) this past year, not just through my own research, but through the help of others who I've followed and who generously took the time to encourage me through comments and tips. Now it's my turn to give back: may this review be helpful to other bloggers, newbie and experienced alike.

First, here's a graph of how many posts I wrote this year, categorized by month:

As you can see, I started out in sporadic bursts but leveled off to a good average as the year went on. When I first started I thought I should wait until I had some real meaty content to post. Gradually I realized that it was better to post more frequently. I could still get in the occasional longer post, but even a short one each day was better than waiting several days or weeks between posting. I've got a good rhythm now of saving some topics for later while posting ones of immediate interest on a near daily basis.

But what about site visitors? Here's a graph of our blog's traffic per week:

Unfortunately, I have no statistics for the first few weeks of blogging due to not having installed an analytics tool yet. Toward the end of February I installed the open source Piwik, which has really helped me see what works and what doesn't in reaching out to site visitors.

We had some real milestones in traffic this year. Here are some examples of what brought people over to the blog:

• March 4: 55 unique visitors in one day

  This burst was mostly due to my creating a bookmarked PDF of the NPRM on Certification, which I emailed out to other bloggers. Dr. John Halamka, among others, was kind enough to link back. Blogging, I've found, is all about bringing something useful (meaningful, if you will) to the conversation.

• June 22: 53 unique visitors in one day

  Here's an example of how reading other blogs can boost your own traffic. I got the idea from David Harlow's HealthBlawg to create word clouds of health care legislation, and then left comments linking back to my post on two other blogs. Not a lot of writing here, but it contributed something different for people to view, compare, and share.

• August 24: 74 unique visitors

  I've also learned that blog carnivals can really help get your name out. On this particular day, the Grand Rounds edition hosted by A Cartoon Guide to Becoming a Doctor brought a lot of visitors over to read my submission.

• September 7: 41 unique visitors

  Also, don't count out older posts bringing in traffic later on. Sometimes I'd post something I thought really clever, like the "Meaningful Use in Under 3 Minutes" video I made, but few to none would show up to watch. Then months later, a stray comment I made over at another blog brought people to view it, and continues to draw traffic each week. I learned to not give up on older articles or be afraid to promote them: sometimes you just need a little while to develop an audience.

What were the top topics of this blog in 2010? Here's a tag cloud of the top words I used, created with the brilliant Tagxedo application:

The top three words were health, information, and EHR, which came as no real surprise. But take a look at this graph, which shows how the use of those words changed over time:

My use of the "EHR" term rose and fell throughout the year, picking back up toward the end, while "information" went south. "Health," though, remained king. I was able to do this in-depth analysis through the Voyeur text analysis tool, which I only found this week in order to perform this year end review. It's a great tool that allows you to submit different pages for comparison of terms, and one that could help me stay on target with posts I want to be about a specific idea or concept.

Well, there you have it: that's the story of Occam PM's blog in its maiden voyage. I hope that the new year brings great new stories, better technology to cover and tools to learn, and even more visitors to share this information with. Thanks for sharing this journey with us far; here's to another great year of blogging in 2011.