T.P. Caruso & Associates

Envisioning a digital infrastructure for a Learning Health System

Tag Archives: Clinical Research

Why Build a Health Data Cloud?

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According to Sharon Begley in a July 2011 Scientific American article titled “The Best Medicine”, Kaiser Permanente can do research studies of data from 8.6 million patients and the VA can do studies on 6 million patients.  Other health care provider organizations are coming together to do research, such as the consortium that includes Cleveland Clinic, Mayo Clinic and four other provider organizations with 10 million records.  A Health Data Cloud in which all health information is stored in one place, the Internet, for easy access by all health researchers, not just those at these particularly large institutions or consortiums, would not only have data from 24.6 million patients from Kaiser Permanente, the VA, and the Cleveland Clinic-Mayo Clinic consortium, it would have records from 100′s of millions of others.  Only in this context could clinical decision support systems be designed to really ask the question: What is the best treatment for each individual, unique patient.

To give this patient the best advice, his doctor needs to be able to know how others like this patient have been advised and how they have fared as a result.  Maximizing the number of patients that doctor can find who are like this particular patient, with similar blood pressure, blood test results, medical history, compliance likelihood (based on various environmental factors like education, values, etc.) and other similar attributes that effect health requires maximizing the number of patients to whom the provider can compare his patient.

Jun 27, 2011

A Health Data Cloud is Powerful Tool for Health Research

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The current effort to bring electronic health record use to healthcare providers, presently funded by the HITECH Act at a level of $27 billion will create hundreds of thousands of silos, one for each provider organization.  Some similarities and substantial compatibility will be seen by those who share one of the hundreds of possible electronic health record systems.  Each of these silos will use their own standards, as long as they have the standard functionality to meet requirements set by the Office of the National Coordinator (ONC) of Health Information Technology in the Meaningful Use Stage 1 through Stage 3 specifications.  One of these requirements will be to provide interoperability with the Nationwide Health Information Network (NwHIN) specifically for providing “Transition of Care” functionality.  Efforts will also be made to create requirements that increase the ability to do research on the healthcare information across the silos.

This strategy is likely to enhance the sharing of information among providers, but not without large challenges.  Certainly research will also be enhanced once data sharing agreements can be established for use of the healthcare information in the network, and more importantly, once language standards are established so, for instance, an MI in one system is understood as a Myocardial Infarction in all systems.  Implementation of language standards has not even been discussed by the ONC’s Health Standards Committee except to say, with the urging of Chris Chute, a leading proponent of this standardization effort, that a language will be a component of the requirements of Meaningful Use.


The President’s Council of Advisers for Science and Technology (PCAST) in their Health IT Report titled “Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward” released in December 2010, recommended a novel approach to health information exchange which would require metadata tagging of atomic data elements that they called a Universal Exchange Language.  The Biomedical Informatics Think Tank(tm)(BITT(tm)) interprets this approach as a Health Data Cloud where all healthcare providers and individuals can store their health information.  Key to this proposal is that only those individuals, providers and researchers authorized to see this information can aggregate it for their use.  The Health Data Cloud could enforce the use of standards since when information is put into the cloud, it the information could be checked to ensure that it meets standard requirements.  Such a New Exchange Architecture would make access to the health information less costly and more able to provide results that could allow an effective implementation of comparative effectiveness research and personalized medicine.  Furthermore critical public health information could be easily monitored for disease outbreaks.  This access could be provided while maintaining the privacy of individual health information.

The BITT has a demonstration of just such technology, which it plans to license as open source.  Some of the interesting characteristics of this technology include:

  1. Individual identifiers can not be downloaded from the system in association with any data (i.e. no identifiers are available external to the code of the system).
  2. Access is provided to proxies, providers or researchers through online authorization (consenting) mechanisms (and thus, individual identifiers are not necessary).
  3. Researchers can do research on any of the information as long as the results they see are only aggregates.
  4. Researchers can only see individual deidentified data (and never identified data) for research purposes only if the providing individual (or their proxy) has given consent for that purpose.
  5. Researchers can notify an individual’s care provider about a healthcare opportunity resulting from a research effort (such as an opportunity to participate in a clinical trial or to follow a particular regime or get a particular procedure done) only through an notification service that keeps the patient identification information unknown to the researcher.

Stay tuned for the latest updates about this proposal for a Health Data Cloud.  If you would like to have a copy of the code, please contact me and we will provide you with this as soon as we can make it available because we want your help in the development of this code as open source.

The Biomedical Informatics Think Tank(tm) and BITT(tm) are trademarks of T.P. Caruso & Associates, LLC.

Jun 26, 2011

Why Change Healthcare One BITT at a Time?

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Healthcare systems in the USA and in many other countries around the world, are not working, and the members the Biomedical Informatics Think Tank(c) also called BITT(c) want to do our part to provide real solutions.  With extensive experience in biomedical informatics including health informatics and analytics, clinical research informatics, and bioinformatics, we think that many of these solutions are based in improvements in the health IT infrastructure.  I envision a digital infrastructure that supports the Learning Health System concepts as defined by the Institute of Medicine.

“…a learning healthcare system in which each patient care experience naturally reflects the best available evidence, and, in turn, adds seamlessly to learning what works best in different circumstances.”

(Also see their report Digital Infrastructure for the Learning Health System: The Foundation for Continuous Improvement in Health and Healthcare: Workshop Series Summary and their Series on the Learning Health System).

Envision a health system that is personalized (i.e. individual-centric vs. patient-centric) with a focus on prevention and health information privacy.  Envision a health system which minimizes the number of people who need to see a doctor, show up at an emergency room, need admission for surgery, or even require medication.  Envision an individual having various touch points through which they can learn to become healthier individuals, through their churches and other community organizations, as well as through mobile phone apps, social networking, and, of course, their family and primary care provider.  Consider that BITT pursues interests in health social networking and their use by a broad set of stakeholders in providing health to the individual in various settings.

Envision that an individual’s personal health information will only be shared with those who the individual wants to see it, and those who see it may not share it with anyone else without that individual’s permission.  Envision that the individual does not need to give protected health information to anyone, not even their primary care provider since they can manage their care without it.  Envision that an individual’s entire history of health information is available to that individual and their assignees at any location, and that any individual can discover easily who has accessed that information and why it has been accessed.  Envision that an individual can even make money by allowing researchers to access their unidentifiable health information, increasing their motivation to support research.   Consider that BITT is creating technology as part of a proposed “universal exchange language” that would allow secure aggregation with that allows for a never identified patient.

Envision researchers, care providers and even individuals easily accessing ALL “consented” health information in a secure health data cloud, not just the “consented” health information available at a particular health institution, and that health information can not give away anyone’s identity.  Envision that access to this information happens so quickly it can be used to assist in making personalized decisions about an individuals care while a patient talks to their care provider about options and their likely and unlikely outcomes, all based on real evidence pulled from the health data cloud.  Consider that BITT has various activities to encourage the development of just such a health data cloud for a “new exchange architecture” (NEArch) that would include a “universal exchange language” (UEL) which would support improved comparative effectiveness research and other types of clinical and translational research (white paper here).

Envision clinical decision support systems (CDSS) apps for individuals as well as physicians that help in accessing and making sense of the information in this health data cloud.  Envision that these tools can provide care plan options with additional sources of information for the individual or provider to pursue.  Envision that these tools estimate the likelihood of specific outcomes based on various input factors which can be personalized for a particular individual possibly through a tie between the CDSS applications and an individual’s personal health record (though not their protected health information).  Envision CDSS applications that model the functions of the human body considering various environmental and genetic factors.  Envision these tools allow physicians to predict the outcomes of various behavioral, drug, or surgical interventions.  Envision that these applications base their advice on the latest Clinical Practice Guidelines.  Consider that BITT pursues opportunities to fund the design and development of such applications as defined in the National Research Council’s report titled Computational Technology for Effective Health Care: Immediate Steps and Strategic Directions.

The Biomedical Informatics Think Tank works towards these goals “changing healthcare one BITT at a time.”

™ Biomedical Informatics Think Tank and BITT are trademarks of Projectivity, Inc.  BITT is a division of Projectivity, Inc.

Jun 4, 2011

Inspire don’t Manipulate

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As the result of a watching a TED talk video about Simon Sinek I purchased Start with Why, Sinek’s book that provides more detail than the talk.  After saying in chapter 1 what he said so eloquently in the TED video, in chapter 2 Sinek writes:

There are only two ways to influence human behavior: you can manipulate it or you can inspire it…Typical manipulations include: dropping price; running a promotion; using fear, peer pressure or aspirational messages; and promising innovation to influence behavior – be it a purchase, a vote or support.

He also writes that those companies that have an unclear idea about the reasons customers buy their product are very likely to use manipulation to make their sales because manipulations to sell products and services.  Companies pay a price for manipulation, usually in product quality and, eventually, competitiveness, sales and profitability.

The alternative is to inspire your customers, as, Sinek says, does Apple for instance.  Inspiring customers requires an understanding of what your potential customers want to buy.  By purchasing an Apple iPhone or computer, an individual reinforces their desire to be perceived as unique and different (1).  The image of a different product that stands out in a world of commodity smart phones and computers Apple uses to inspire its potential customers to buy their products.

As for the business I am currently developing, the Biomedical Informatics Think Tank ™ has, initially, potential customers in government agencies interested in improving healthcare, as well as academics leading in defining a biomedical informatics infrastructure for population studies, clinical effectiveness research, public health research, CDSS design and translational research.  In fact, if the latter group is inspired to join the BITT ™, as 21 individuals have already joined, I’m confident that the resulting think tank will be what attracts the potential customers in government agenices.  Thus, my focus is on attracting a strong team with exciting projects.

 

May 21, 2011

PCORI Would Benefit from HIT Experts on their Board of Governors

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I attended the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors (BOG) meeting today in New York City.  Once again, as with both the Institute of Medicine and Air Force Medical Services/NIH meetings last week, I’m awed by the desire to improve care and the outstanding nature of the professionals in the room.  This meeting may have been the most star-studded with both Francis Collin, Director of NIH and Carolyn Clancy, Director of the Agency for Healthcare Quality and Research sitting on the Board of Governors with many other leaders in comparative (or is it clinical?) effectiveness research (CER).  Clearly members of the BOG want PCORI to do things differently with a greater focus on the needs of the patient.

Once again I stood up in the middle of the meeting, when given the chance to make a comment for the PCORI public record that health IT experts were not represented in this meeting, and for that matter, CER experts were also not represented in meetings of the Office of the National Coordinator (ONC) for Health IT.  In the process I mention my affiliation with the Biomedical Informatics Think Tank™ a division of Projectivity, Inc. giving further information about the membership being made up of 21, mostly academic leaders in biomedical informatics.  I expect that some people who have attended more than one of these events, like I have, know who I am and that the focus of BITT™ is to fill the knowledge gap between ONC and CER to bridge these two important efforts.

Except for that clear branding this effort has certainly achieved among those who are listening, I’m concerned that I am not being heard.  I need a more definitive message where people will understand why they need to involve health IT in CER methodology planning, and why they need to get involved as CER experts in heath IT infrastructure policy and standards development.

I’ll have to work on that message.

 

Filed under AHRQ, Biomedical IT, CER, NIH, ONC, PCORI
May 16, 2011