The temporary rule has been published as updates to 45 CFR Part 170 (HEALTH INFORMATION TECHNOLOGY STANDARDS, IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY) Robin Raiford bookmarked the Federal Register version.
The speakers were:
Carol Beam, Director of Certification and Testing, ONC
Steve Posnack, Director of Policy, ONC
The rules serve two purposes:
- Established the process for the National Coordinator to select ONC's Authorized Testing and Certification Body (ATCB)
- Set some of the parameters around the testing itself.
This rule paves the way for vendors to get their products tested and certified.
Some of the parameters around testing include:
Section 170.420 - the Principals of Proper Conduct
ATCBs must support testing of both developed and deployed solutions
170.445 & 450
ATCBs must also support testing of both complete EHRs and EHR modules.
The following were questions posed by the audience.
- What is a new version? (ie does a bug release constitute a new version)
- If an EHR developers defines it as a new release, then they will require a new certificate.
- The Certified Health IT Product list will be managed by ONC and that website will be the source of truth. For Meaningful Use reporting, a unique identifier will be assigned to each bundle of products that in combination achieve Meaningful Use requirements.
- There will be unique identifiers for each (bundled and un-bundled). ONC will not be testing whether they are actually being used - that's a function of the audit (CMS).
- in the temporary program, ONC will provide oversight of ATCB (adhere to the Principals of Proper Conduct)
- in the permanent program, vendors will be subject to a post-market surveillance program
- CCHIT had presented potential pricing ranges - we generally used those as our estimates. We're hoping that the competitive environment that we hope we've created will reduce those costs.
- We require that the ATCBs tell the developers to convey to prospective purchasers and customers: product name, date of certification, certification number, etc. We don't specify a particular image.
- When a product is ready to be certified, the measures will have to have been published.... Stay tuned.
- The additional software will have to be identified and listed.