Secondary use of EMR

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                                         Secondary Use of EHR for Clinical Research


The Electronic Health Record (EHR) is the primary point of data capture for patient care. In addition to its primary purpose, EHRs can serve as data capture points for secondary uses such as clinical research. Secondary use of health data applies personal health information (PHI) for uses outside of direct health care delivery(1). EHR holds a great potential for supporting clinical research through improving efficiency, quality and reducing the cost of clinical trials. An optimal EHR can be developed to support research related activities including: clinical trials; comparative effectiveness quality measurement; and public health and safety monitoring, including post-marketing surveillance.

Advantages of   secondary use health data for research purposes include but not limited to 

1.Observational and case series can be conducted quickly facilitating new research hypothesis for potential intervention. 2. Without the assistance of Information technology , recruitment is extremely slow, expensive, and low-yield. EHR can also aid in expediting the clinical trials by allowing the available database to be used for screening potential subjects . 3.Through data mining of data set the drug responses and potential toxicities, response to treatment long term sequeale and survival can be monitored for individual patients enrolled in the trials . Trough real time data collection clinical research , patient care and safety can be enhanced.

Challenges for secondary use of health data for clinical research.

1.Confidentiality, privacy, security, and data access The most important concern is protecting the information from inappropriate use . This can be addressed through appropriate regulatory processes such as HIPPA and IRB approval/privacy board approval and modern security techniques such as access control encryption etc . 2.Standardizaton EHR data for Research purposes.

Standardization of data increase data accuracy, availability and  enable data integration. 

Several initiatives such as (RCRIM) Regulated clinical research Information Model through HL7 and non profit initiative through Clinical data Interchangable standards Consortium (CDISC) are now colaborating together to develop final model of data standardization to meet the needs of clinical research .

3. Improving the quality of data research . As mentioned above data standardization is critical for improving quality of research. In addition to standardization, data collected in realtime at the point of care by the primary care provider will ensure accurate and consistant data collection as opposed to retrospective reviews


 As noted in HIT Policy Committee report (2) the following three areas were projected to have a positive impact on meaningfull use of EHR for clinical research.


Supporting Opportunities for Patient Participation by :

Enabled interface can increasing patient interest and queries recarding the clinical trials thus doubling the enrollemnet in 3 years.

Incentives can reduce costs and recruitment time for federally sponsored trials.


Reducing Barriers for Provider Participation in Clinical Research.

By providing incentives for meaningful use of EHR greater provider participation in clinical research can be assured.

Use of Standards-based EHR Data for Clinical Research.

Use of standardized data can enhance efficiency and accuracy of data collected thus improving the quality of research .


Thus by developing an optimal EHR capable of addressing the needs of clinical research with due consideration to privacy protection and data standardization will accelerate research and improve health care effectiveness , efficiency , reduce health care expenditure and enhance patient safety.. References:

1. Toward a National Framework for the Secondary Use of Health Data: An American Medical Informatics Association White Paper J Am Med Inform Assoc. 2007 Jan–Feb; 14(1): 1–9. Charles Safran, MD, MS, Meryl Bloomrosen, MBA, W. Edward Hammond, PHD, Steven Labkoff, MD, Suzanne Markel-Fox, PHD, Paul C. Tang, MD, Don E. Detmer, MD, MA,

2. Designation of Clinical Research Information Integration as an Objective of“Meaningful Use” of Electronic Health Record Systems Presentation to the HIT Policy Committee Gregory Downing.

Link title Secondary Use of EHR for Clinical Research