T.P. Caruso & Associates

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Regarding Metadata Standards to Support Nationwide Electronic Health Information Exchange

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Comments provided on RIN 0991–AB78: http://ow.ly/6vj4w

Regarding Metadata Standards to Support Nationwide Electronic Health Information Exchange

In this response, we do not address the specific questions posed in the metadata ruling proposal, but rather we argue that these metadata standards solve nothing while creating major security risks for patients.  The PCAST Report argues for tagged data elements for many important reasons:

The best way to manage and store data for advanced data-analytical techniques is to break data down into the smallest individual pieces that make sense to exchange or aggregate. These individual pieces are called “tagged data elements” (TDEs), because each unit of data is accompanied by a mandatory “metadata tag” that describes the attributes, provenance, and required security protections of the data. Universal exchange languages for metadata-tagged data, called “extensible markup languages” are widely and successfully used.

One important feature of such a universal exchange language (UEL) is that they can securely hide associations among the data, since the TDEs can be disassociated from other TDEs making them impossible to be aggregated again without adequate authorization which provides the tools for rebuilding the linkages among the TDEs which adds an additional level of security above and beyond that provided by encryption alone.  Putting metadata tags at the document level simply makes the information easier to find, but it also makes it easier to identify who the information describes since once the document is located, decryption alone gives full access to a set of information about the individual.  If the metadata is the actual patient identifier information, how can this data be maintained as deidentified?

Filed under Comments, New Exchange Architecture, ONC
Sep 15, 2011

Let’s Think Different

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I wonder whether the author of the Healthcare Technology News blog post called “Think Differently – the sequel” thinks that the ONC and their PCAST Workgroup is actually “Thinking Differently”?  Though it was a good summary of the PCAST HIT Report and the PCAST Workgroup Report released in mid-April, the blog suggested this was thinking differently.  Would Steve Jobs (Mr. Think Differently) say that they are thinking differently?  I think not.  Certainly PCAST thought differently when they published their treatise about health information exchange; however, the ONC and its delegates in the HIT Policy Committee are constrained by legacy thinking.  How do we best go from where we are now to there?  That’s legacy thinking and that’s what ONC is doing with the PCAST Health IT Report.

The Biomedical Informatics Think Tank™ thinks differently: that knowing where we are going does not require knowledge of where we are, but only what we want to be able to do with this new exchange architecture.  We are conceiving a technology that will create a Health Data Cloud (see my latest blogs: Why Build a Health Data Cloud and A Health Data Cloud is a Powerful Tool for Health Research), which will attain the objectives set out in the PCAST Health IT Report: Realizing the Full Potential of Health Information Technology to Improve Healthcare for Americans: The Path Forward:

  1. “Every American will have electronic health records and will have the ability to exercise privacy preferences for how those records are accessed, consistent with law and policy.
  2. Subject to privacy and security rules, a clinician will be able to view all patient data that is available and necessary for treatment. The data will be available across organizational boundaries.
  3. Subject to privacy and security rules, authorized researchers and public health officials will be able to leverage patient data in order to perform multi-patient, multi-entity analyses.”

The technology will be based in the latest thinking with a mathematical foundation for medical semantics, privacy and security in a cloud, social networks that empower individuals, and health ontology.  We start our thinking with what we want and think about the best way to meet those needs with technology that will serve us for a long time into the future.  That thinking is not constrained by current ideas about EHRs and time frames to get new technology standards implemented, a clear constraint of the Health IT Policy Committee’s PCAST Workgroup.  We will be part of a transformation health information exchange through our efforts, just as Apple has been part of the transformation of personal computing since the 70′s.  We think differently, and we invite you to think differently with us.

Here’s some different thinking: ONC should invest in a major effort, exceeding the scale of The Human Genome Project (HGP), to define a New Exchange Architecture with a Universal Exchange Language, and then they can actually build and manage the Health Data Cloud that will be required.  This is just as important as the HGP, and in fact, a continuation of the personalized medicine movement that is partially driven by the results of the HGP.  The HGP cost taxpayers $2.7 billion (HGP Frequently Asked Questions, Oct 2010) and much more was contributed by international government agencies from the UK and other countries, as well as by private and non-profit organizations towards this same goal.  HITECH put ten times this amount, $27 billion into motivating healthcare providers to move into the 21st century of health IT and electronic health record technology.  Only 10% of this funding could transform with a New Exchange Architecture.

Let’s think differently!

Filed under CER, New Exchange Architecture, ONC, PCORI, Think Tanks
Jun 30, 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.

Filed under Biomedical IT, CER, New Exchange Architecture, ONC, Think Tanks
Jun 26, 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

Why isn’t a New Exchange Architecture part of the CER discussion?

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Today I attended the Institute of Medicine (IOM) Meeting titled “Next Steps: Implementation Workshop on Standards for Systematic Reviews and Clinical Practice Guidelines” to understand better the key steps in going from clinical research to practice.  The entire day was spent with experts, primarily academic, discussing two recent IOM reports about standards for systematic reviews (SR) of comparative effectiveness research (CER) and clinical practice guidelines (CPG), respectively.  I asked several questions with the intention of understanding the current linkage between the panelists’ thinking and health IT standardization and interoperability efforts driven by the Office of the National Coordinator (ONC) for Health IT.  Close to the end, I made a comment that I think they needed to hear about the role of health IT in the future of CER, SR and CPG.

The majority of the attention for the day was on implementing the standards proposed, particularly conflict of interest standards necessary to establish trust in the results of the SR or CPG committees, and study thoroughness requirements which directs SR protocols not only to review the best published material, but also to consider “grey” literature such as unpublished source data from the published authors, conference abstracts. etc.  The IOM will be publishing final conclusions from this workshop that will discuss many of the important points made at this session, and a survey of 38 attendees and committee members to determine the likelihood of standard implementation, the timing of the implementation, and the barriers to full implementation.

In asking the first of my questions probing this issue I was told that informatics was out of the scope of the charge from Congress, so they had not considered these issues in the definition of SR and CPG standards.  No one dared to think about what kind of information might be helpful for more powerful SR, nor did they venture to define how the output from the SR could make it easier for the CPG process.  After my question a response did mention the importance of this effort for clinical decision support, only strengthening my confusion about why the standards for CPG would not include a definition that would be understood by a computer for easy automation in a clinical practice setting.

After summary presentations of the reports and the survey, I asked my second question about how the efforts of various organizations would be impacted and coordinated:

  • The newly created Patient-Centered Outcomes Research Institute (PCORI) which will be funding CER and the SR studies which evaluate the CER,
  • The Agency for Healthcare Research and Quality (AHRQ), which was funding the IOM report and workshop and has been the primary source of funding for the majority of the SR studies,
  • The National Institutes of Health (NIH) which also funds SR studies, particularly at the larger institutes like the National Heart, Blood and Lung Institute (NHLBI) and the National Cancer Institute (NCI); and
  • The ONC which is defining a health IT standards and interoperability infrastructure, as well as a new exchange architecture including a universal exchange language (UEL) as proposed by the President’s Council of Advisors on Science and Technology (PCAST) which could serve as a major enhancement for CER, and thus, SR.

In asking this second question, I quickly learned that CER must be kept separate from SR which in turn must be kept separate from both CPG.  So I had to restate that what I was interested in here was the coordination of funding, in particular.  I was told that the Affordable Care Act that established PCORI had a Board of Governors with representation from both AHRQ and NIH.  So that left ONC on the sidelines, though they could have a major impact on the ability of CER to produce standardized results that would make SR and CPG more straight forward.

I sat through the entire afternoon of talks about SR wanting to say something about the changing context in which SR was being standardized by this IOM effort.  Each of four hours was painstakingly used to discuss every important detail of the steps in SR from study design to reporting.  In the last hour focused on reporting I took the microphone and said something like this, or should I say, I wish I had said it like this:

“I’m Tom Caruso from the Biomedical Informatics Think Tank ™ an organization made up of 21 leaders in biomedical informatics and related areas mostly located at major academic medical centers around the country; however, the comments that I am about to make are mine only and do not represent the opinions of BITT ™ or any of its members.  Because a chasm exists between my frame of reference and the frame of reference of all but a few people in this meeting, I am concerned that what I have to say will be dismissed as either not relevant or about a far too distant future.  With that statement, I hope I have partially breached that chasm and you can hear what I have to say.

Everyone in this room would agree that the management of health information is changing rapidly.  We can at least agree on that point.  Now consider how dramatically these changes will change healthcare, and consider how the practicing clinician will soon be using aids to help him or her make personalized clinical decisions.  CPGs will be incorporated into clinical decision support systems and they will guide the physician through every particular case.  You therefore must be thinking about SR reports that include statements of the probability that some outcome, B will result given a set of particular conditions, A.

If you doubt my resolve about the future, which is not so far away, think about how Watson beat two of the all-time winners of Jeopardy.  IBM is taking this technology into the clinic, and it is only the beginning of where healthcare information exchange opportunities will lead us.  We must be thinking about the health IT needs for CER, how CER produces information for optimum SR, and how SR generates information that can be used in these clinical decision support systems that are coming very soon.”

 

Filed under AHRQ, Biomedical IT, CER, NIH, New Exchange Architecture, ONC, PCORI
May 10, 2011

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