Electronic medical records (EMRs) have been considered a panacea for cutting down on medical errors, streamlining recordkeeping,
and delivering quality care to patients by health care providers, medical technology companies, and even the president of
the United States.1 They are also seen as a boon to clinical research by assisting in matching cancer patients with the right clinical trial,2 aiding in cost effective subject recruitment, and rapidly identifying adverse events.3 However, not everyone agrees that EMRs are ready for prime time.
Photography: Getty Images Illustration: Paul A. Belci
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In a recent practice improvement study, researchers looked at 50 primary care centers to evaluate the effect of EMRs on outcomes
for treating diabetes. The study found that primary care centers using EMRs were less effective in treating diabetes than
centers using standard recordkeeping systems. The researchers noted that there were significant differences among commercially
available EMR systems, including the amount of training and technical support available.
The study, published in the Annals of Family Medicine, concluded that "a high level of support for EMR implementation will be required" to meet the federal goal of EMRs for all
Americans by 2014 while preserving and enhancing the quality of medical care. This analysis has promoted a lively discussion
on the journal's Web site, with comments containing alternate viewpoints.4
Issues at handSponsors of clinical research are responsible for monitoring the progress of the investigation.5 In addition, medical device sponsors are responsible for having written procedures for how they will monitor the study.6 When monitors and quality assurance auditors visit clinical sites, they are confronted with a number of concerns about EMRs.
These concerns fall into three broad categories:
- Privacy: How does the Health Insurance Portability and Privacy Act (HIPAA)7 impact a monitor's ability to review EMRs?
- 21 CFR Part 11: How does FDA enforcement of Part 118 impact a sponsor using EMRs as source documents?
- Data integrity: Do EMRs provide the same level of data integrity that a paper record does?
A look at federal laws, regulations, and guidance documents as well as two case studies, provides answers to some of these
questions and establishes a framework for GCP-compliant monitoring and recordkeeping.
Privacy ABCs
With the advent of HIPAA in 1996 and the Privacy Rule regulations of 2002,9 many institutions began limiting access to EMRs. Clinical investigators, however, are required by FDA to maintain "adequate
and accurate case histories."10 The principal GCP guideline, the ICH Guideline for Good Clinical Practice (E6), states that a sponsor specify that the investigator
and institution shall "provide direct access to source data/documents for trial-related monitoring."11
