Electronichealth records are records that contain the data of a patient in adigitalized form that includes all healthcare encounters. Theincreased use of EHR and its incorporation in most of the clinicalresearch and documentation will form a more patient/subject medicalrecord with the aims of fully complying with both the medical recordsregulations and the research.
Inthe latest guidance document, the FDA addressed the rise in the useof the electronic source data which was defined as “data initiallyrecorded electronically”. There has been an increase in the use ofmedical devices such as the electrocardiograph machine and the EHR.FDA saw the need of providing guidance to the clinicians so that toensure the data used in the EHR was being taken from the rightsources (USDepartment of Health and Human Services). Inaccurate data could bemisleading and end up giving false results and even administer thewrong diagnosis to the patients. The EHR can be regarded as a dataoriginator and the data pulled can be considered for referencedocumentation.
Healthcare facilities are in the process of adopting the EHR so as toattain meaningful objectives and also receive incentives that havebeen outlined by the CMS. The goals for a meaningful use of the EHRare to provide efficient and safer care, and also improve the carecoordination and the outcomes of the patients(Summary_Article.pdf).
Electronichealth record implementation creates a better avenue for the exchangeof the health information while enhancing the quality of the carethat the health facilities provide. The secure sharing of the healthrecords of a patient with other healthcare providers creates asubstantial measure of a meaningful use success attained due to theuse of EHR.
USDepartment of Health and Human Services. Investigationalnewdrug application.21 CFR
x312.http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:220.127.116.11.3.4.Revised April 30, 2012. Effective March 19,1987. Accessed July 26,2014