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EHR Use May Not be Adequate for Precision Medicine Research

Because of lacking interoperability and data standards, EHR use may not help support precision medicine research.

By Sara Heath

- Precision medicine research may not be making the process it once strive for, and EHR use could be one of the culprits.

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According to a recent viewpoint published in the Journal of the American Medical Association, precision medicine research initially set out to determine gene determinant for certain conditions. This could spur new and personalized treatments for these conditions.

Specifically, efforts for precision medicine research focused on the following six central points:

  • common diseases will be explained largely by a few DNA variants with strong associations to disease
  • this knowledge will lead to improved diagnosis
  • such knowledge will also drive preventive medicine
  • pharmacogenomics will improve therapeutic decision making
  • gene therapy will treat multiple diseases
  • a substantial increase in novel targets for drug development and therapy will ensue

Ideas regarding stem cell research and EHR use for research purposes have become other tenets of precision medicine. EHRs are seen by many as the driving force behind precision medicine research, providing stores of health data and centralizing it for gene research.

According to paper authors Michael J. Joyner, MD, Nigel Paneth, MD, MPH, and John P. A. Ioannidis, MD, DSC, combining all of these measures together could drive healthcare into a revolution, with research-driven treatment methods.

READ MORE: EHR Data Helpful in Identifying Positive Drug Combinations

The authors say that researchers have met many shortcomings in precision medicine research. Due to various barriers such as an abundance of genetic data affecting the investigated conditions, researchers have apparently not been able to make the process initially expected.

Underpinning those shortcomings have been a failure of EHRs. Because of lacking interoperability, poor technology quality, and data accuracy, precision medicine has not been able to progress as it was initially expected. Researchers have also seen pitfalls with health data security over the EHR and massive cost barriers.

“These features make the use of EHRs for research into the origins of disease, as proposed in the Precision Medicine Initiative, highly problematic,” Joyner, Paneth, and Ioannidis wrote. “No clearly specified targets for either improved outcomes or reduced costs have been developed to assess the performance efficiency of EHRs.”

To meditate these issues, the trio suggest a massive overhaul of precision medicine research protocol. While much of these suggested revisions do center on the actual approach to the genomic research, they also argue that EHRs must be revamped for research purposes.

However, they maintain that it is difficult to pinpoint how the technologies must be revised. Ultimately, they suggest a better review and assessment method to improve understanding of EHR use in precision medicine research.

READ MORE: 3 Barriers Limiting EHR Data Use for Patient Safety Research

“Although it is difficult to argue for a return to paper records, any claim of future transformation of the medical record should include well-defined accountability and review mechanisms,” the authors explained. “Otherwise, the health care system may become hostage, wasting increasing resources to continuously upgrade electronic technology without really helping patients.”

Earlier this year, other healthcare professionals questioned the use of EHRs for precision medicine research. In May, the FDA released a set of guidelines for EHR use in precision medicine research, underscoring the importance of good data governance.

However, some industry groups have spoken out against those guidelines, stating that EHR data lacks integrity due to lack of standardization. Following FDA’s guideline release, the American Medical Informatics Association (AMIA) released a public statement about the issue.

According to AMIA president and CEO Douglas Fridsma, MD, Phd, and board chair Thomas Payne, MD, most EHRs are not yet up to the challenge of supporting robust research.

“As a picture of the future state, this guidance provides an important window into how interoperable EHRs and electronic data capture systems or electronic case reporting forms could be leveraged to simplify data collection, reduce errors and provide healthcare professionals new opportunity to treat emerging issues that arise as part of investigations,” wrote the pair.

READ MORE: Senate HELP Committee to Hone EHR Use, Interoperability Laws

“However, we strongly caution FDA from assuming that most EHRs are readily configurable for clinical investigations, even among more advanced institutions.”

Fridsma and Payne pointed to similar problems spelled out in the JAMA article, stating that lacking interoperability and data governance make EHRs not yet ready to support precision medicine research.

These are pain points which plague many other aspects of healthcare and patient care. Therefore, it is critical that EHR vendors and health information professionals continue to develop ways to improve EHR interoperability and EHR use.

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