Please help with the 3 questions below, thanks! EHR Applications, Inc., has deve
ID: 430991 • Letter: P
Question
Please help with the 3 questions below, thanks!
EHR Applications, Inc., has developed a new ambulatory EGR. It has decided to obtain the Office of the National Coordinator (ONC) for Health Information Technology’s certification for this new product. This is a new company and this is its first attempt to obtain certification. You have been given the responsibility of researching the requirements of the ONC’s certification program.
1) Summarize the requirements to obtain certification.
2) Summarize the testing methods used.
3) For a healthcare facility that purchases and uses an ONC Certified electronic health record (EHR), what impact, if any, could the product have on the facility defining their legal record and the legal record components? When answering this question, consider stakeholders, EHR functionality from the legal process perspective, etc.
Explanation / Answer
1-The ONC certification process include the following steps
a- It issues guideline for the model which each organization should follow while applying for certification.
b- The health IT module should meet the standards specified by the HHS in regulation.
c- Test lab is conducted to test the standards of the module as per the guideline.
d- ONC publish the tested module in its list
2- The testing method currently used has been enforced since 2015. It includes that the program must conform to the full scope of the products required capabilities, regulatory/conformance expectation clarifications and interpretations set forth in the applicable Certification Companion Guides. Test tools are designed by the body so that expected results can be produced from defined functions.
3-The product will be treated on par with other products and procedure used by the healthcare facility. When the HER got certified and deliver below standard result any part can sue the product and the manufacturer just like any other product. In a nutshell we can say that the legal sanctity of the product remains similar.