Public comments


FasterCures Comments on ONC's EHR Standards and Certification Criteria Proposed Rule (2014 Edition)

To: Farzad Mostashari, MD, ScM
National Coordinator for Health Information Technology

At: Department of Health and Human Services
Office of the National Coordinator for Health Information Technology
Humbert H. Humphrey Building, Suite 729 D
200 Independence Avenue, SW
Washington, D.C. 20201

Re: 2014 Edition EHR Standards and Certification Criteria Proposed Rule
[RIN 0991-AB82]

Thank you for the opportunity to comment on the proposed rule for the Electronic Health Record Incentive Program—Stage 2. FasterCures is a nonprofit, non-partisan center of the Milken Institute dedicated to accelerating the process of discovering and developing new medical solutions for deadly and debilitating diseases. Through our programmatic activities, we work with dozens of patient advocacy and medical research organizations across the disease spectrum.

We appreciate ONC's focus on enhancing care coordination requirements and ensuring the security, safety, and efficiency of electronic health record technology. And we applaud the agency's continued emphasis on more directly engaging patients in their care. However, we still believe that a key element of comprehensive health information exchange is missing—the ability to support clinical research through electronic health record data. In particular, we still lack the ability to screen and match patients for clinical trials using the information available in EHR systems.

The complexity of issues that affect human health—from the genomic and proteomic levels to the culture and locale of the institutions that provide healthcare services—requires that there be a more comprehensive and collaborative approach to connecting the worlds of science and the clinic. Advancing health information exchange, public health objectives, and patient engagement are all vital to improving care and reducing medical errors, but in order to realize the savings in cost, time, and lives for which we all hope from a digitized health system, emphasis must be placed on curing disease and limiting its damage.

Encouraging Stakeholders to "Think 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, but the ability of our national health IT infrastructure to increase understanding of disease progression and advance biomedical innovation is still falling fall short of its potential.

In 2011, FasterCures released a second report on this issue, "Still Thinking Research: Strategies to Advance the Use of Electronic Health Records to Bridge Patient Care and Research," which examines the extent to which agencies, organizations, and healthcare stakeholders are using digital patient data to advance clinical research today, and puts forth specific recommendations for better harnessing health IT for learning and research purposes.

We submit these recommendations, also outlined in the 2011 report, in the hopes that ONC will seek opportunities to create a policy framework within and beyond meaningful use to address secondary uses of electronic data—such as clinical research—that speed medical progress and accelerate the development of innovative new drugs, devices, diagnostics, and interventions.

I. Use clinically relevant information stored in an EHR to screen and match for clinical trials
Recruiting patients to clinical trials is costly, time consuming, and often restricted to the site participating in the research study. There are currently approximately 11,000 clinical trials recruiting and enrolling 3 million patients, but fewer than one-third of clinical trial sites are able to recruit their original target population within the time specified. In fact, a review of cancer clinical trials sponsored by the National Cancer Institute of the National Institutes of Health (NIH) showed that nearly 40 percent of these trials failed to accrue enough patients and, thus, closed without completing the study.

Integrating a recruitment function into electronic health systems via Meaningful Use will significantly speed and simplify the process of finding patients who match specific trial criteria and expedite patient accrual into trials. This will ultimately accelerate the submission of trial data to the FDA—in the format needed for review—while providing a system that will monitor a patient's care while enrolled in a trial. It will also allow researchers and trial sponsors to shift resources previously dedicated to recruitment strategies to other critically important efforts.

II. Develop an ONC-hosted pilot initiative to create medical research IT modules
One of the barriers standing in the way of research being integrated into an EHR system is the need for high-quality data that are annotated with patient outcomes and can be used for research purposes. However, a number of organizations are testing innovative models that link research and care through imaging records, biospecimens, and genomic databases with patients' EHRs.

To facilitate these activities and ensure widespread use across a number of EHR platforms, ONC is well-positioned to fund pilot programs that will create research modules that can be "attached" (plug and play) or retrofitted to existing EHR systems that were built without the capacity to accommodate research. These pilot programs would allow connectivity to systems being developed to meet meaningful use requirements and encourage community practitioners to participate in clinical research.

III. Build capacity for incorporating genomic and molecular data into EHRs
The ONC should consider the need to harmonize standards for collecting genomic and molecular data and integrating these into an EHR. Despite the fact that 9 of the top 10 causes of death in the United States have genetic components, there is no uniform and systematic effort to build capacity for incorporating genomic and molecular data into electronic records.

As more individuals undergo genetic analyses and as more clinical information becomes linked to genomics, it will be critical to bridge this genetic information with clinical information collected in an EHR to improve our ability to understand the genetic underpinnings of disease. Combining larger datasets on drug response with genomic data on patients could steer therapies to the people they are most likely to help, reducing the cost and waste involved in trial-and-error medicine.

There are smart, committed pioneers in both the public and private sector who are already thinking about and creating opportunities to link researchers and patients through EHR and digital databases; several working models exist from which ONC can draw best practices. Below are a few brief highlights; additional information about these and other models is available in our "Still Thinking Research" report:

  • The Health Maintenance Organization Research Network (HMORN)—HMORN, a consortium of 16 HMOs funded by NIH, has developed a Virtual Data Warehouse to capture data in patient EHRs and medical claims databases in a standard format and make it available to researchers in the network.
  • The Electronic Medical Records and Genomics Network (eMERGE)—eMERGE is a network of five sites with their own biorepositories that use a common genotyping platform to sequence DNA samples from their specimens. They have demonstrated that data contained in patient EHRs can be used with patients' genetic information in large-scale studies and have identified genetic variants associated with a number of conditions.
  • The Partnership to Advance Clinical Electronic Research (PACeR)—PACeR was launched as an electronic clinical research data network in New York state to more efficiently identify candidates for clinical research studies and manage their care.
  • The Consent to Research Project—This is a standardized, portable, patient-centered informed consent system—created by John Wilbanks of Kauffman Foundation and Stephen Friend of Sage Bionetworks—for anyone who has obtained data relevant to their health and would like to donate that data for research purposes.

As institutions move forward with adoption and implementation of health IT systems, and as systems seek to become certified for this purpose, it is critical that they consider the needs of and seek the advice of the clinical research community. While we appreciate that EHRs do not constitute a "silver bullet" for research, as Dr. Isaac Kohane of Harvard has said: "It is unacceptable and counter-intuitive that we should not be learning more of medicine, and amassing the state of the art of medicine, with every patient encounter."

From immediate opportunities to improve the direct delivery and coordination of healthcare to longer-term opportunities to responsibly unlock and integrate data for analytics in the areas of clinical research, population health, quality improvement, performance measurement, and monitoring and surveillance, EHRs hold great promise to benefit not only the life of an individual patient, but also other patients with the same disease or disorder, and, by extension, the larger research enterprise working on solving that illness. We should be capitalizing on that promise.

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

1 English R., Lebovitz, Y. Giffin, R. 2010. Transforming clinical research in the United States: challenges and opportunities. Washington, D.C.: National Academies Press.
2 Campbell, M.K. et al. 2007. Recruitment to randomised trials: Strategies for trial enrollment and participation study, The STEPS Study, Health Technology Assessment. 
   11(48):iii, ix-105.
3 Cheng, S. et al. 2010. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of Cancer Therapy Evaluation Program
   (NCI-CTEP) sponsored studies, Clinical Cancer Research, 16(22):5557-5562.
5 NIH News. eMERGE network moves closer to tailored treatments based on patients' genomic information NIH-supported project expands into clinic. August 17, 2011.
6 PACeR: Partnership to Advance Clinical electronic Research. Transforming and Improving Clinical Research Capabilities in New York State to Benefit Patients. Phase 1 
   White Paper, Feasibility Assessment, and Phase 2 Plan, 12_pacer_whitepaper.pdf, accessed August 11, 2011
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