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Health Level Seven (HL7) provided its remarks on the utilization of Electronic Health Record (EHR) data in the medical investigations. It strongly supports the Food and Drug Administration’s goals to facilitate the utilization of EHR information to enhance the interoperability of the electronic system and EHRs enhancing the medical inquiry (HL7, 2018). It considers that its Fast Healthcare interoperability Resources (FHIR) standards offer an unexpected opportunity for accomplishing its goals. In this regard, it believes that key EHR vendors in the country will reinforce the FHIR interface. Moreover, it would facilitate consistent and easier access of digital records for various Pharmacovigilance and survey-oriented activities. Noteworthy, it anticipates that program would enhance reliability, validity, and quality as well as data integrity from EHRs enabling more appropriate utilization of secondary research. Furthermore, the FHIR application programming interface (API) also provide the chance of offering a chance in the records of the patient that can be applied as a robust reserve to FDA health reviewers examining safety of clinical trials (HL7, 2018).
Interoperability refers to the capacity to communicate and connect freely via information technology. Extensive interoperability across different systems can be accomplished via dependence on the standard technology interfaces, which set open regulations for communication. Open standards guarantees high interoperability levels (HL7, 2018). Furthermore, open standards ensures that any business of communications services or equipment can execute all values required to interoperate with others. Subsequently, consumers of such products can select the products that satisfy their needs and change at will deprived of fear associated with losing data control or functionality.
HL7.org. (2018). HL7 Response to FDA EHR Guidance. Retrieved from http://www.hl7.org/documentcenter/public_temp_50E59650-1C23-BA17-0CDC0B1665689075/newsroom/HL7%20Response%20to%20FDA%20EHR%20Guidance.pdf
HL7.org. (2018). New Standards. Retrieved from http://www.hl7.org/documentcenter/public_temp_530AE0AF-1C23-BA17-0C06F3313B55FA96/newsroom/new.standards.august.2017.pdf