The Office of National Coordinator for Health Information Technology (ONC) has issued a draft of its 2016 Interoperability Standards Advisory. While the standards and implementation specifications included in the advisory may be adopted in regulation (already or in the future), required as part of a testing and certification program, or included as procurement conditions, the advisory is non-binding. It provides ONC’s assessment of the best available standards and implementation specifications for a given interoperability need. The advisory has been re-formatted to list limitations, dependencies, and preconditions in implementing each standard. It is also intended and expected for advisories to be “ahead” of where a regulatory requirement may be, in which case a standard or implementation specification’s reference in an advisory may serve as the basis for industry or government action. According, it highlights issues and standards that ONC might be considering for adoption in regulations, but is providing an additional opportunity for public comment.
The standards and implementation specifications listed in the draft advisory focus explicitly on clinical health IT systems’ interoperability. The advisory’s scope includes electronic health information created in the context of treatment and subsequently used to accomplish a purpose for which interoperability is needed (e.g., a referral to another care provider, public health reporting). The advisory does not include within its scope administrative and payment-oriented interoperability purposes or administrative transaction requirements that are governed by HIPAA and administered by the Centers for Medicare & Medicaid Services (CMS).