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MDDS and AAMI SW87 -- Quality System for MDDS?

3.21.2012 | 0 Comments

Day 1 of the 22nd Annual AAMI/FDA International Conference on Medical Device Standards and Regulation in Herndon, VA is concluded and a lot of good material to report on. Key first item is the  AAMI SW87 document which aims to focus the FDA Quality System Regulations (QSR) on the  development of MDDS. A training webinar is scheduled for April 12th, 2012. For particulars, visit the AAMI web site.

The SW87 document was produced in 1 year and is focused on MDDS development. The SW87 defines MDDS as follows:

Per 21 CFR 880.6310, “a medical device data system (MDDS) is a device intended to providde one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices

(i) The electronic transfer of medical device data

(ii) The electronic storage of medical device data

(iii) The electronic conversion of medical device data from one format to another format in aaccordance with a preset specification; or

(iv) The electronic display of medical device data

An MDDS may include software, electronic or eletrical hardware such as a physical communnications medium (including wireless hardware), modems, interfaces, and a commmunications protocol. This identifiation does not include devicess intended to be used in connection with ‘active patient monitoring.’”

I intend to cover other aspects of the meeting, including a medical device interoperability taxonomy, in tomorrow’s blog entry.

 

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Twitter Weekly Updates for 2012-03-18

3.18.2012 | 0 Comments

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Durable Medical Device Data and Clinical Decisions

3.16.2012 | 0 Comments

EMBS - Zaleski - 1998

Page from EMBS publication on modeling post-operative respiratory state

Back in 1998 I wrote my first scholarly article on the topic of modeling as it relates to human body systems. The focus of the article was to demonstrate how data collected from bedside medical devices could be used to model specific behaviors and trends that could then be used for predicting future state in critical care patients. This paper was published in IEEE’s EMBS magazine.

Throughout the years I have kept a close eye on the subject of data and clinical decisions based upon data. This is what led to the writing of my second book.

As electronic medical record (EMR) systems have advanced and evolved, the subject of data and clinical decisions has evolved as well, and for good reason. Many illnesses can be better managed or even detected through the collection and management of data, both form durable medical devices and laboratory instruments. A key illness among them is sepsis. Going back to 2008, Health Data Management described the use of bedside data that fed physiologic monitor based models for detecting sepsis in near real time.

Sepsis, or septicemia, is a leading cause of death in ICUs, especially among the elderly. The CDC reported in 2008 that the cost of sepsis management alone broached $14.6B (source: HealthLeaders Media). According to the same source, “[h]ospitalizations for … sepsis as a [primary] diagnosis grew from 326,000 in the [year] 2000 to 727,000 in 2008.” The number is not declining in 2012.

A key element in the management of sepsis is data. Data and clinical decisions surrounding changes in body temperature, heart rate, elevated white blood cell count OR lower-than-average temperature are also signs. Elevated pulse, highe respiratory rate in combination with these and other parameters such as end tidal CO2 changes are all measurable quantities. When combined these data are instructive as to cause. Many elements can be retrieved from the physiologic monitoring equipment, laboratory information systems and other devices (mechanical ventilators) that reside at the bedside of the patient.

It is important to realize that the completeness of the electronic medical record is not just in the notes that are recorded by the clinician at the bedside of the patient, but also in terms of the availability of all information recorded on the patient. Together, this information provides a powerfully instructive set that, when properly mined and properly analyzed, can lead to prospective assessments and early diagnoses of potentially life-threatening ailments…and the source of this rich information is data.

 

 

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Where is Healthcare's Information Appliance?

3.12.2012 | 0 Comments

In Donald Norman’s book, “The Invisible Computer”, written back in the late ’90s, he describes the features and functions of “information appliances” — technologies that are tailored towards solving specific problems in everyday lives. A key benefit of information appliances is that they are singular in purpose. For example, a garage door opener could be considered to be an information appliance.

One might argue that the fact that such devices exist is obvious and unremarkable in everyday use. However, the argument made around having such devices singular-of-purpose is just that: they are easy to use, require very little “training,” have few failure modes and are self-intuitive.

We turn now to healthcare and the concept of an information appliance in this field. When Norman wrote his book back in the late ’90s there were no iPhones, no Androids, no iPods (at least those we are familiar with today), and certainly no iPads. Yet, a theme that is often used in describing the ultimately usable device(s) for physicians and nurses, we hear that usability is chief among them. In last week’s Healthcare IT Newsweek piece “12 Integration Capabilities EHRs will need to have” we learn of features and functions that need to be deployed to support single sign on, integration of patient context and awareness, publishing functions to consuming widgets. But, these are all quoted with respect to the assumed rendering device: the personal computer. The personal computer is a generalist’s appliance, not a specialist’s. It is designed to be used for multiple purposes. Hence, when applied toward the specialization of any one problem, it does so only with clunkiness. We are all undoubtedly familiar with problems in upgrading computers; in applying patches; in the intricacies of software installation and configuration. These “generalist appliances” can oftentimes get in the way of the specialist’s purpose because we (all of us) oftentimes spend our time simply figuring out how to use the appliance rather than using the appliance to solve a particular problem for us.

As I was reading Donald Norman’s book, I was thinking about what could be considered to be today’s “information appliances” and how they could be applied to healthcare. My iPhone or iPad immediately came to mind. Albeit, generalist-devices, they have downloadable applications that can make them specialist devices for particular purposes. Then I thought about whether they were really applicable to the healthcare environment: from a clinical perspective, if used by a physician in his or her office or at home that might be the case. But, if use were to be considered at the bedside, there are other issues to deal with: cleaning, dropping, ability to use with a gloved hand, etc. Could the iPhone truly be considered a clinical information appliance at the bedside? I’m not sure it could.

In the 14 or so years since the publication of Norman’s book, much has evolved in terms of technology. Furthermore, the acceptance of technology for clinical practice has certainly evolved enormously. Yet, what has seemingly evolved in a limited way is the usability of technology for clinical practice. Physicians and nurses are all-too-often required to learn to work with, through, or around the quirks of information technology and their requisite appliances rather than having technology that will work with, for and conform to the requirements of the clinical user. This has caused me to think about where is the true clinical information appliance? I do not think it (yet) truly exists.

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Twitter Weekly Updates for 2012-03-11

3.11.2012 | 0 Comments

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3.11.2012 | 0 Comments

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Twitter Weekly Updates for 2012-03-04

3.04.2012 | 0 Comments

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Informatics: the science and my own vision

3.04.2012 | 0 Comments

I am an Informatician. There are several definitions of this that are, generally, supportive of one another. Albeit, the definition of biomedical informatics is rather unique, as can be seen below.

For example, Wikipedia defines Informatics (not biomedical informatics) as follows:

…the science of information, the practice of information processing, and the engineering of information systems. Informatics studies the structure, algorithms, behavior, and interactions of natural and artificial systems that store, process, access and communicate information. It also develops its own conceptual and theoretical foundations and utilizes foundations developed in other fields.

The general study of algorithms, structure, behavior and interactions of natural and artificial systems that store, process, access and communication information are all aspects of biomedical informatics, too.

The Free Dictionary provides the following definitions:

…computerized automated delivery and manipulation of information to and by users of computer systems.

…the management of information and knowledge by computers.

…information management; the technology of information storage, retrieval and transmission. Includes on-line access to and editing of data bases, facsimile transmission, optical reading and word processing.

The American Medical Informatics Association has developed a formal definition of Biomedical Informatics:

…Biomedical informatics (BMI) is the interdisciplinary field that studies and pursues the effective uses of biomedical data, information, and knowledge for scientific inquiry, problem solving and decision making, motivated by efforts to improve human health.

The list goes on, but I think the point is made: the use of biomedical data for knowledge and scientific inquiry, problem solving and decision making. These are definitely aspects and attributes of the definition that apply to me and my background.

I am a member of AMIA, a member of HIMSS (Health Information Management Systems Society), and other organizations that aim to use health information to foster improved care at the bedside. However, when I started my involvement in this whole arena or field of study I knew of neither and some of the societies that are now in full swing were not even born (IHE, for instance).

My involvement in healthcare informatics began in 1990, and the decision to migrate into this field formally occurred after rather a personal tragedy: my mother’s diagnosis with, and ultimate death from, breast cancer. We all have our stories and reasons why we do things in life. This was one that changed my complete direction. I had been working in the aerospace industry for a major defense contractor (later acquired by yet another defense contractor) and had no intention of changing my field. However, mom’s rather sudden diagnosis with a very virulent form of breast cancer combined with the utter helplessness I felt during her illness and the lack of answers I could obtain from her oncologist, caused me to begin to ask the questions about how such seeming inability to assess and forecast was not a major news story. Furthermore, the inability to locate and access data was, to me, unbelievable. After all, weren’t we dealing with people’s lives here? I compared the relative “order” in my field of aerospace engineering–the existence of standards; the ability to link and integrate disparate systems; the ability to collect data and access multiple sources of information, even sources developed by competing contractors, and could not understand why medicine or healthcare in general was “allowed” to continue this way!

Of course, I was naive. I  understood that there were major challenges in medicine that remained and still remain unsolved (cancer being one of them). Yet, I was coming at this “problem” from the perspective of an engineer’s brain: diagnose the problem, seek the data, formulate a solution approach, execute the solution.

What I saw in this case (so close to me as it was) was the ability to diagnose the problem, collect some of the causal data, but the processes of formulating an effective solution and executing on that solution were completely beyond the capabilities of everyone involved. At the time, at least, there was “guessing”; there were pockets or sources of incomplete data; not all information could be collected and made available to any given clinical end user, etc. Now, to be fair, had my mother been diagnosed in this day & age I believe she may still be around–some very fundamental advances have been made in the field that would have given her more of a fighting chance. However, back then the key approach was “poisoning” the system (note: I had read Dr. Susan Love’s book on breast cancer at that time). Furthermore, the tools at hand for her oncological team were stored in “silos.” There was not much sharing of information outside of the major medical journals. In addition, the oncological team’s ability to seek independent studies or new research to be able to evaluate or even model or statistically assess the effectiveness of experimental treatments was almost impossible to do.

However, the experience placed a focus like a laser beam in my consciousness in terms of providing the tools and access to data to improve the care and prospects of the patient that has not diminished in me since that time. In the aerospace field, collecting information from multiple sources in order to seek better overall knowledge of the “target” was and is done regularly. Often called “multi sensor data fusion”, I carry this term forward from my former field to comparable use in medicine and healthcare as a metaphor for describing the process of collecting data that may paint a picture of “different sides of the elephant” in order to assemble a more complete view of what is actually happening–in other words, to improve situational awareness around the patient. This aspect of informatics is one that, for me, also motivated the need for better and more complete data (medical device connectivity being one source for this type of information).

During my days in research at PENN, collecting data from multiple sources was key to establishing the situational awareness and conditions around the predictive models I had developed for assessing likelihood to wean from post-operative mechanical ventilation. To accomplish this, rich and complete source data from laboratory to medical device information as well as patient demographics and history were necessary. The conditions that establish the usability of the data, its importance and applicability to the environment are, in a microcosm, what was missing from my mother’s experience and that of her oncological team. The ability to source data–even experimental data–from multiple sources and to have the ability to combine and integrate it effectively for the use in “what-if” analysis was completely missing. However, again, going back to the aerospace engineering analogy, this is frequently done as a method for validating design or determining the best approach or possible effects for dealing with unknown situations.

In summary, medicine is much more complex than “rocket science,” but only because of the unknowns. The field of informatics seeks to place the best possible information in the hands of those who are operating on the front lines of battle–the physicians, principally–who are charged with guiding the treatment. If, in this process, I can assist or make a difference to win the battle for the patient, my life will have been well lived.

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The subjective and economic costs of chronic pain

3.02.2012 | 0 Comments

In one recent article on Kevin Pho, a Danish physician, Kim Kristiansen, chronicles the economic costs of chronic pain. Based on my own personal experiences with chronic pain, I pay attention to such articles and the impacts they have on the human condition. In this article, Dr. Kristiansen sites a Swedish and Irish study on the economic costs associated with chronic pain and discusses the economic impact “diagnosis related to pain” can not only have on the individual, but on society in general.

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Pain a significant problem in patients with COPD

2.29.2012 | 0 Comments

An interesting article was reported in Dove Press on a study of 100 Norwegian patients with COPD and the effects of COPD on subjective and objective assessment of these patients relative to pain. The study title, “Differences in subjective and objective respiratory parameters in patients with [COPD] with and without pain” evaluated both objective pulmonary state in the form of forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) as well as subjective assessment of pain in these patients. Top items reported in St George’s Respiratory Questionnaire (SGRQ) identified painful cough, exhaustion related to cough, breathlessness, and sleep disturbance.

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Stage 2 MU Released

2.27.2012 | 0 Comments

Stage 2 MU announcement was made at HIMSS 2012 last week in Las Vegas. Healthcare IT News has a write-up:

The rule proposes to delay implementation of higher standards in Stage 2 of the $27 billion meaningful use program by one year for eligible hospitals and physicians who adopted EHRs in 2011. These new standards incrementally increase requirements and add new functions health providers must meet to qualify for taxpayer incentives in Medicare and Medicaid.

“Unfortunately, under the HHS rule, we will lose a year of interoperability,” White said. “Stage 1 required a test of clinical information exchange. HHS has proposed eliminating the test in 2012 and 2013. So there isn’t even a test for that previously required function.”

“In 2014, HHS suggests adopting minimal standards for information exchange related to a patient who transfers from a hospital to a nursing home, or who is referred by an internist to a cardiologist,” White added. “We have to wait two years for that? This is simply not acceptable.”

 

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Twitter Weekly Updates for 2012-02-26

2.26.2012 | 0 Comments

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Triple Negative Breast Cancer and Decision Support

2.26.2012 | 1 Comment

Triple negative breast cancer is a very aggressive, virulent form of breast cancer. The TNBC organization defines triple negative breast cancer as the following:

These subtypes of breast cancer are generally diagnosed based upon the presence, or lack of, three “receptors” known to fuel most breast cancers: estrogen receptors, progesterone receptors and human epidermal growth factor receptor 2 (HER2). The most successful treatments for breast cancer target these receptors.
Unfortunately, none of these receptors are found in women with triple negative breast cancer. In other words, a triple negative breast cancer diagnosis means that the offending tumor is estrogen receptor-negative, progesterone receptor-negative and HER2-negative, thus giving rise to the name “triple negative breast cancer.” On a positive note, this type of breast cancer is typically responsive to chemotherapy. Because of its triple negative status, however, triple negative tumors generally do not respond to receptor targeted treatments. Depending on the stage of its diagnosis, triple negative breast cancer can be particularly aggressive, and more likely to recur than other subtypes of breast cancer.

An important findinf is that approximately 18% of HER2 negative results transform into HER2 positive and have an affinity for spreading metastatically to the central nervous system (CNS). Dr. Sursh Katakkar recently published a finding in Dove Press in an article titled “A triple negative breast caner: what it is not!

In this article he describes a very interesting yet tragic case of a woman with triple negative breast cancer who experienced metastatis to the CNS. It hs been reported that patients with TNBC have poor prognoses and apprximately one third experience CNS metastasis.

As part of Dr. Katakkar’s conclusion, he asserts that TNBC has been shown to have increased vascularity in MRI, possibly indicating increased angiogenesis. If the secretion of increased vascular endothelial growth factor is found in these patients, would molecular analysis be the determinant in establishing the likelihood for increased likelihood of CNS metastasis?

This example indicates one of the potential benefits that personalized medicine can have relative to improving treatment of individuals diagnosed with very virulent forms of the disease.

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Faster migration to market motivates medical device data system (MDDS) compliance?

2.25.2012 | 0 Comments

The HIMSS 2012 Daily Insider on Tuesday, February 21st included an article entitled “Agility Through Regulation,” discussing the incentive the final FDA ruling on Medical Device Data Systems (MDDS) has had on enterprise-wide medical device connectivity. This article by Mary Carr discussed the motivation that the MDDS ruling, made by the FDA in February 2011, had on hospitals to begin their migration away from piecemeal, home-grown connectivity solutions and to align on enterprise-wide solutions. The objective in aligning on system-level integration is to foster homogeneous interoperability and connectivity, both at the durable medical device level and informationally through the various healthcare information systems throughout the hospital.

The MDDS ruling by the FDA reads in part:

“…This regulation classifies as class I MDDS only data systems with specific intended uses and functions. Those device data systems that include any uses beyond, or that are for intended uses different from, those identified for an MDDS will remain class III devices. FDA has determined that MDDSs can be regulated as class I devices because general controls provide a reasonable assurance of safety and effectiveness for this device type. In making this determination, FDA has considered that the risks associated with MDDSs are generally from inadequate software quality and incorrect functioning of the device itself. These failures can lead to inaccurate or incomplete data transfer, storage, conversion according to preset specifications, or display of medical device data, resulting in incorrect treatment or diagnosis of the patient. Based on FDA’s knowledge of, and experience with, MDDSs, FDA has determined that general controls will provide a reasonable assurance of safety and effectiveness of MDDSs, such that special controls and premarket approval are not necessary to provide such assurance.

“…Based on the preamble to the proposed rule, and the comments received in response to the proposed rule, FDA is now finalizing the reclassification of medical device data systems from class III to class I. This classification will be codified at 21 CFR 880.6310. To meet the definition of an MDDS under § 880.6310, a data system must be intended for the ‘‘transfer,’’ ‘‘storage,’’ ‘‘electronic conversion * * * in accordance with a preset specification,’’ or ‘‘electronic display’’ of medical device data, ‘‘without controlling or altering the functions or parameters of any connected devices.’’ This classification excludes any data systems with intended uses outside the scope of this rule …

“…an MDDS only communicates medical device data. For purposes of this rule, data that is manually entered into a medical device is not considered medical device data. However, if manually entered data is subsequently transmitted from a medical device as electronic data it will be considered medical device data. A device that then transmits that data or is intended to provide one of the other MDDS functions with regard to that data may be an MDDS. In response to requests for clarification, the use of ‘‘real time, active, or online patient monitoring’’ in the proposed rule has been replaced to indicate that an MDDS is not ‘‘intended to be used in connection with active patient monitoring.’’

Ms. Carr identified several key and salient points related to the FDA’s position on the integration of durable medical device data:

1) Piecemeal integration leads to silos and organic separation of information. My comment: piecemeal separation is anathema to large enterprises interoperability in which patients need to be transferred around the hospital. This makes for difficulty in sharing of patient information as needed as they roam or are moved from department to department.

2) Silos are often unable to deliver real-time patient data reliably to centralized information systems. My comment: data synchronization to ensure the latest time-aligned data may be absent.

3) Vendor-dependent solutions lead to internal battlegrounds. My comment: this will be a challenge for some time to come. In my opinion, and based on the industry at-large, the right answer is to target enterprise-wide solutions that meet the scalable and flexible needs of the institution and allow for expansion and growth. Eventually, durable medical devices will speak in accordance with common physical and semantic standards, and this problem will go away (see the IHE PCD Wiki).

In both of my books I have written about the need for ubiquitous medical device data integration. It has taken a long time (decades) to reach the point of some commonality in terms of semantics and messaging since I started out in the field. It will take a while longer to achieve will interoperability of medical devices in the physical connection department. The focus will need to shift on the use of the data for clinical decision making. Some medical devices are beginning to make the shift to network connectivity as their primary physical mode of communication and transmitting HL7 transactions from the machine itself. Many medical devices will need to make this shift. Furthermore, the ability of medical devices to accept commands from external systems is an aspect that needs to happen to support higher-order command and control (C3I) type functions that make use of extended situational awareness around the device and the patient. Again, I believe this is beginning to happen and will continue to happen. It is a matter of time and continued proselytization. The era of data collection from durable medical equipment where I began my healthcare career some 20 years ago has changed some in this department and will change further. I believe we as an industry are on the verge of a breakthrough and great acceleration in this department.

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Jailbreak future healthcare

2.20.2012 | 0 Comments

Kent Bottles’ piece “break out of the prison of the American health care delivery system” nails it: just as the 19th century focused on the new idea of identifying pathology of disease, the 21st century needs to be the one that evolves beyond screening for ailments that are already there, to the point  of (in Dr. Susan Love’s words) finding of root cause.

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1 Trillion Gigabytes and counting--big data leading to personalized medicine

2.20.2012 | 0 Comments

According to Lucy Mckeon in her article “The coming medical revolution“, that’s how much medical data are produced yearly. In this article she interviewed Dr. Eric Topol, Chief Academic Officer for Scripps Health.

In this interview, Dr. Topol lists three areas in which data–big data–and the human genome are contributing to the shift toward personalized medicine. I briefly summarize these below and leave to the interested reader the link to the page above:

1) Pharmacogenomics and the ability to assess whether certain patients will respond to certain drugs based upon genotype. The statistics stand at $350B for the amount the US spends annually on prescription drugs. Many drugs do not work on certain individuals (e.g.: Plavix – 1/3 of those taking have no response; Metformin – 1/4 of diabetics unresponsive). The effects of underlying genetics could be better understood with a genotype of individuals, thereby resulting in better targeting of drugs based on individual. Genotyping is a major big data producer.

2) Cancer therapy and tumor genomics in comparison to the germline DNA of the individual. Comparative analysis can lead to better, more directed therapies. Certain cancer treatments, when directed based on the underlying genotype, can lead to better outcomes. Cancer therapy is a major big data consumer.

3) Reduction in what Topol terms the idiopathic relative to “guessing” at therapies that would / could / should be revealed by the underlying genome that would establish biological basis for disease.

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Twitter Weekly Updates for 2012-02-19

2.19.2012 | 0 Comments

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Healthcare, Trust, and Social Media

2.18.2012 | 1 Comment

Is social media the new way of life? Are we to avoid it as a fad or simply agree to “become one with the Borg?” Is social media a means for improving the communication between we as the patient and we as the physician? There are many reasons to use social media, and many reasons to avoid it…especially if you are a professional. Once something appears on the Web it is effectively there forever (I know…)

I have been maintaining this blog for about 4 years now and have over 120 posts on various topics related to clinical decision making, medical devices, and data as well as links to my books, etc. I maintain this primarily for myself… as a professional diary and as a social tool for professional interaction. By and large this goal has been and is being achieved. Yet, I read something interesting on the use of Google+, with special emphasis on a use case for physicians, primarily, that provides a vehicle for interaction among themselves, possibly with their patients, and as a safe haven that is not quite as revealing as Facebook and not as “minimalist” but yet as open as Twitter.

In the world of medicine, especially in the relationship between physician and patient, it is extremely important to maintain privacy and control of the conversation. One of the key challenges in the health information technology age is ensuring that patient information and the communication between physician and patient remain private with control in the hands of the participants. I emphasize that security and control are key. The next generation of social media may involve more of the security and less of the social. This aspect of communication, once trustworthiness is assured, may represent or reflect the maturing of the technologies that heretofore have been seen as the wild west.

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Automated data collection is a key enabler for comparative effectiveness research

2.14.2012 | 0 Comments

When I began conducting my own research ~20 years ago, I envisioned interaction among large numbers of databases from which I could automatically draw needed information to assemble the models I required to verify performance of one patient in comparison with a population of patients having the same specific characteristics. The comparison of a test patient with a population was not only the basis for my predictive methodology but a basic tenet of Bayes’ Theorem and conditional probability. I envisioned back then a day would come when all the data I was attempting to cobble together by hand and by computer would be readily available… perhaps 10 years down the road.

Fast forward to today.

In the AHRQ’s opening FAQ about what comparative effectiveness research (CER) is, they state that, they state that “Comparative effectiveness research is designed to inform healthcare decisions by providing evidence on the effectiveness, benefits, and harms of different treatment options.”

Physicians rely on evidence, in the form of corroborating (and some contradictory) studies to validate and verify hypotheses related to treatment. Accepted treatments and approaches for care are those most usually associated with corroborating evidence–a great deal of corroborating evidence. Not all data arrive in the form of simple measurements. Data take on the form of studies, published research papers, laboratory results, films, guidelines, textbooks, and from bedside medical devices.

To a degree, the electronic health record (EHR) was seen as a key element in achieving the type of data richness that was necessary to support comparative effectiveness research. The EHR and its adoption are necessary but (yet) insufficient in terms of the CER enterprise. In “Optimizing Health Information Technology’s Role in Enabling Comparative Effectiveness Research“, Navathe and Conway note that “…[f]or CER to be conducted, …EHRs must be connected to data networks enabling access to at least portions of their captured data. It will be challenging to implement EHRs on a large scale and to develop electronic networks substantial enough to produce observational data that alter clinician, patient, and other decisions.”

As Navathe and Conway state, healthcare data is not just personal, it is a strategic asset upon which basic research depends. Despite visions of a unified, singular database “Borg” where all data would go to be mined endlessly by large mainframes, the facts most probably near term and into the future are that data will be federated. They will reside in many different pockets “owned” by many separate and disparate institutions large and small. The key, then, to my mind, is not figuring out how to assemble them into some common structure, but enabling their inter operative interaction, much the way the Internet operates today. When we type in a Google query, we are not interacting with some great big “WOPR” computer (references to the 1983 movie WarGames), we are interacting with millions of computers around the world.

What I did not realize 20 years ago that I have finally come to realize is that I thought then the “hard” problem was solving the predictive model for the patients I was monitoring, when the really hard problem was assembling all of the data together from the many disparate sources. Through all of the standards committees and claims of interoperability, we are really a long way off in terms of enabling the one thing that would allow us to do what I had started out almost 20 years ago doing: automating the data collection, from any source, that would allow us to focus on the real business of health care research, and would enable the vision of comparative effectiveness research.

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Twitter Weekly Updates for 2012-02-12

2.12.2012 | 0 Comments

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