Public Comments

02/25/2011

FasterCures submits comments on Stage 2 of meaningful use

David Blumenthal, M.D., M.P.P.
U.S. Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Mary Switzer Building
330 C Street, SW, Suite 1200
Washington, DC 20201

Attention: Joshua Seidman

Dear Dr. Blumenthal:

Thank you for the opportunity for FasterCures to comment on the preliminary recommendations for Stage 2 of Meaningful Use. FasterCures is a nonprofit, non-partisan center of the Milken Institute dedicated to accelerating the progress of discovery and development of new medical solutions for deadly and debilitating diseases. Through our programmatic activities, we work with dozens of patient advocacy and medical research organizations – from cancer to Parkinson's to diabetes – across the disease spectrum.

We are pleased to see the Office of the National Coordinator for Health Information Technology's (ONC) commitment to advancing electronic health record (EHR) adoption and functionality in clinical care. However, we believe that a key element of comprehensive health information exchange – the ability to support clinical research through electronic data exchange – is still missing. As the healthcare system addresses the challenges of widespread adoption of electronic patient records, clinical research capacity should also be included as part of the architecture.

The real, long-term savings of EHR systems – both in terms of reducing healthcare costs and, more importantly, eliminating human suffering – will come from research that leads to earlier and better diagnosis, more effective cures, and enhanced clinical decision support.

We submit these comments to highlight clinical research as a necessary component of a robust health information exchange in the healthcare system and to emphasize the importance of clinical trials as a significant, and sometimes only, option for patients. New drugs, diagnostics, devices, and interventions all result from clinical research.

In 2005, FasterCures released the paper "Think Research: Using Electronic Health Records to Bridge Patient Care and Research," identifying areas where health information technology could accelerate medical discovery, drug and diagnostic development, and improve care. Since then, enactment of the HITECH Act has catalyzed a more widespread adoption of electronic healthcare systems by hospitals and care providers. And yet, the clinical research community remains isolated from the adoption of these technological advances. With 11,000 registered clinical trials actively recruiting nearly 3 million patients,1 our national clinical research environment plays a considerable role in the overall care infrastructure, and must be integrated into the national electronic health information exchange.

We believe that to fully maximize clinical care, ONC should use this opportunity to introduce clinical research within the matrix of meaningful use measures in the next stages, effectively connecting the bench to the bedside. After all, the ultimate goal of health information exchange should be to ensure that every clinical encounter is safely and effectively leveraged as an opportunity to improve and optimize the universe of treatments and interventions available to patients.

Filling the Void: Integrating Cures and Care
To clarify, when we talk about ?research we are not referring to outcomes research (e.g., population health, health services, or comparative effectiveness research) which, while critical, is already being incorporated into the health IT infrastructure and can be aggregated and evaluated in an observational manner. Rather, we are referring to clinical research – matching patients to an appropriate clinical trial, providing this option to every eligible patient, and driving toward a therapeutic development process that delivers effective and accessible options.

A successful clinical research system requires and appropriately incentivizes physicians to be an active part of the process. Physicians are key to accelerating patient participation into trials and facilitating real-time, transparent data exchange between the research and care communities.

As well, we need to provide clinical researchers responsible access to the growing volume of electronic patient data in our healthcare system. Access to these existing data holds great potential to unlock connections between genes, proteins, diagnostics, and drugs that will accelerate biomedical discovery in ways previously unimaginable.

The seamless transition of patient information from the bench to the bedside, and back to the bench will allow us to turn scientific and technological advances into effective medical solutions. This is the hallmark of a true learning healthcare system.

Building Clinical Research Capacity into Electronic Health Systems
To address these obstacles, FasterCures recommends the following:

  • To streamline clinical research and clinical practice, and accelerate discovery, development, and the uptake of the most current evidence-based treatment options, we recommend to the ONC that Stage 2 meaningful use requirements provide incentives and measures for physicians and clinical researchers to participate in a national electronic health information exchange. Such incentives and measures may include patient screening and clinical trials matching, and will pave the way for broader clinical research capabilities in Stage 3. We also recommend that any minimal standards developed for a national health information exchange network support the inclusion of clinical research elements and genomic/molecular elements within the mapping infrastructure.
  • FasterCures supports the model proposed by the President's Council of Advisors on Science and Technology (PCAST)2 for a tagged data element environment that would allow for higher levels of research-quality data to be included in health information exchange.
  1. Tagged data elements allow for discrete data fields to be managed, stored, exchanged, and aggregated while preserving the integrity of the data – a significant issue with research-quality data. As we transition towards Stages 2 and 3 of meaningful use, tagged elements for clinical research would allow core data from EHRs to be safely aggregated with research data, connecting both within the health information network.
  2. Clinical research interoperability specifications and details already exist from the Health IT Standards Panel (IS158) to provide a model for mapping research data elements within an exchange network.
  • Additionally, to encourage a more robust information exchange, we support PCAST's recommendation that "the Federal Government should push ambitiously toward a national health data infrastructure in which patient data can be accessed in de-identified form by both clinical researchers and public health agencies."

FasterCures also urges the Health IT Policy Committee and its Privacy & Security Tiger Team to consider modifying existing privacy rules and consent procedures to enable patient engagement in electronic data exchange for research purposes. We eagerly await their recommendations for ensuring adequate protections for personal health information.

We have long advocated that one of the highest and best uses of an interoperable health information infrastructure—and one of its most underappreciated—is its ability to reduce healthcare costs and eliminate human suffering. Patients and science both stand to benefit tremendously.

Thank you again for the opportunity to offer these comments. FasterCures looks forward to helping in any way we can.

Sincerely,

Margaret Anderson                              Adam M. Clark, Ph.D.
Executive Director                               Director of Scientific and Federal Affairs
FasterCures                                        FasterCures

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