May 03, 2016 | FAH Policy Blog Team
The Federation of American Hospitals submitted a comment letter about the regulation proposed by the Office of the National Coordinator (ONC) for Health Information Technology to establish processes for ONC to directly review health IT certified under the ONC Health IT Certification Program and take action when necessary. Those actions include:
- Requiring the correction of non-conformities found in health IT certified under the Program and suspending and terminating certifications issued to Complete EHRs and Health IT Modules
- Establishing processes for ONC to authorize and oversee accredited testing laboratories under the Program
- Providing for greater transparency and availability of surveillance results
While FAH supports the goals of interoperability, this proposed rule unduly burdens providers and vendors.
The Federation is concerned by the very broad scope of authority that ONC proposes to give itself and by the undefined nature of many aspects of the proposals. It's unclear what ONC could review, the criteria it would use to assess nonconformities, or the standards the agency would apply to developers.
FAH is also concerned about the duplicative nature of the review authority.
When it comes to proposed enforcement actions, FAH believes that ONC should never view termination or suspension of the certification of a health IT product as an option absent the most egregious behavior on the part of a developer or vendor and a nonconformity of a very serious nature.
You can read the entire letter by clicking here.
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