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Public Comments

FasterCures' Comments on "Meaningful Use" of Health IT, Urges Clinical Research Considerations
Jun 30, 2009

Dr. David Blumenthal
Office of the National Coordinator for Health Information Technology
200 Independence Avenue SW, Suite 729D
Washington, DC 20201

Dear Dr. Blumenthal:

Thank you for the opportunity to comment on the draft description of the term “meaningful use” as it relates to the application of electronic health records (EHRs). We are writing to urge you to ensure that meaningful use requirements for EHRs address support for clinical research at the earliest possible time, i.e. as of 2011.

FasterCures has long advocated that one of the highest and best uses of a nationwide health information infrastructure – and one of its most underappreciated – is in accelerating the search for new and better treatments for disease. To date, the utility of health information networks has been seen as related primarily to reducing healthcare costs, limiting medical errors, and generally improving the standard of care. While these benefits are important, we believe the real savings – in terms of both reducing healthcare costs and, more importantly, in eliminating human suffering – will come from curing disease and limiting its damage. As the healthcare system addresses the challenges of widespread adoption of EHR systems, research capacity must be part of the architecture. Given the simultaneous priority the federal government has placed on comparative effectiveness research, we feel that this imperative cannot be overlooked or delayed.

Medical research simply can no longer be efficiently done without access to large collections of personal medical data. To understand the relationships between molecular information and human health, population-based and clinical studies are needed, entailing the generation, storage, and analysis of enormous quantities of epidemiologic, genotypic, and phenotypic data. To understand the connections between genes, proteins, and the environment, sophisticated comparisons must be conducted, and these comparisons cannot be done by hand or by eye or patient by patient. It is the collective observations of hundreds, even thousands, of patients that will shine a light on these associations.

What would be possible if all our medical records were accessible to researchers? EHR systems could speed data acquisition and searching, allow mass computing and sampling, and provide the research community access to a broader and more diverse patient population.

  • Pointing the way to new treatments. Researchers are using supercomputing technology and applying customized algorithms, data mining, and pattern recognition to uncover correlations between particular proteins, genetic markers, patient outcomes, and other factors that could lead to new diagnostics and treatments. Experts envision a time when computer programs will be developed to note patterns and trends of interest on their own, without humans having to create a query.
  • Conducting post-marketing research. With an EHR system, one could look at entire populations and know the impact of a new drug or device on, for example, diabetics, asthmatics, African-American woman over 65, or whatever population subset was chosen. Impact could be ascertained on a weekly, monthly, or yearly basis. Studies using EHRs have resulted in the withdrawal of products for further safety testing.
  • Making clinical trials cheaper and easier. Many trials rely on information from medical records, primarily to identify potential research subjects. Widespread use of EHRs has the potential to significantly lower the time and expense involved in accruing participants for trials. When asked, more than 95% of patients allow their records and samples to be used for research.

As you know, most clinical EHR systems are designed to support clinical workflow, not research. To serve research needs, EHR systems will have to meet different and somewhat higher standards; among the challenges that must be overcome are:

  • the reliability and completeness of the record;
  • the limits of legacy databases (administrative and transactional);
  • variability in medical practice;
  • the pervasiveness of unstructured text;
  • the lack of specificity of patient data;
  • the ability to look across many records and many databases; and
  • privacy and human subjects protections regulations.

But there are many examples of institutions making successful use of their EHRs for research, and many emerging solutions, such as:

  • integration of practice databases for data mining;
  • more sophisticated abstraction and encryption systems;
  • development of database connection tools;
  • creation of translational systems;
  • online informed consent procedures;
  • evolving data mining and pattern recognition systems;
  • interactive patient query programs;
  • creation of patient databases/warehouses/registries; and
  • directories of clinical databases.

(For more information on the challenges and opportunities of EHRs for research, see “Think Research: Using Electronic Medical Records to Bridge Patient Care and Research” (FasterCures, 2005)

A truly effective nationwide health information network will require that a single set of standards be developed and adopted for the collection and exchange of data across all health communities, including the clinical research community. If a common set of standards for key information is not required from the beginning (in this case 2011), it will be much more difficult to require these downstream.

Many of the essential standards are available now, or will be identified by the end of this year; these should be leveraged and required as of 2011. (We understand that the American National Standards Institute (ANSI) is sharing with you specific standards that could be used to support the objectives you have identified for meaningful use.) EHR vendors are aware of and have been involved in these standards-related activities, and they should be able to implement a key set by 2011. Standards do not have to be difficult to implement and, in fact, can bring significant value in facilitating processes for clinicians.

One of the widely agreed-upon objectives of meaningful use is clearly to provide clinical decision support at the point of care. Clinical decision support is informed by research, and it is therefore important to include an opportunity to support clinical research through EHRs in 2011 (with standards that will be available before 2010). Similarly, if one of the stated objectives of meaningful use is “aggregating clinical summaries from multiple sources available to authorized users,” standards and controlled terminology are essential for such aggregation if it is to be useful. These should be required in 2011 so that this 2015 goal can be realized.

We would very much like to see two items added to the objectives for 2011:

  • a “Core EHR Clinical Research Dataset” – ANSI is leading an effort to define such a dataset, which should be available before 2010; and
  • “Adverse Event Reporting” – there is an IHE Integration profile developed with CDISC, available and in use now to facilitate adverse event reporting.

The frontier of medical science has rarely been as exciting and as full of promise as it is today. As someone who has done research at one of the institutions at the forefront of medical informatics and research data mining, we know you appreciate what patients will sacrifice if we do not build research needs into the healthcare information superhighway. We stand ready to help in whatever we can. Thank you again for the opportunity to offer these comments.

Sincerely,

Margaret Anderson
Chief Operating Officer, FasterCures




 

 

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