If you develop and/or provide health information technology such as Electronic Medical Record or Electronic Health Record software, there is now another item to check off before hiring a certification group or agency to certify your software.
You will need to ask the certification body if they have been accredited by ANSI – the American National Standards Institute.
The ONC (Office of National Coordinator…can you tell this is a government operation from all the acronyms and initials?) has chosen ANSI to accredit bodies that certify health information technology software and to administer the Permanent Certification Program for Health Information Technology (soon to be the PCP-HIT, I suppose? Sounds like drug use slang).
These bodies will have to be following these regs in order to be certified:
- ISO/IEC Guide 65
- IAF Guidance
- ANSI Policy – PL-102
- 45 CFR Part 170
This doesn’t mean you need to check that the certifiers follow these, you just need to know that they hace been accredited by ANSI. If they are not, there is the very real chance that your software will not be allowed into the medical establishment.
As a software company catering to the medical establishment you may already be covered by FDA regulations from a healthcare safety point of view. This is just another item to check off before going to market. ANSI has just “opened for business” this past August on the accreditation process and certifiers will need to apply and be passed, so no telling how long this will take.
Just be ready with that checklist, two aspirin, and the number of a good doctor.
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