Law Students

As discussed in this post, HHS has issued two new rules: the first pertains to health information technology (HIT) standards (see PDF); and the second to meaningful use (see PDF). These are interim final rules. They are now open for public comment over the next sixty days.

This post provides a forest from the trees overview of the first rule and a subsequent post will do the same regarding the second rule.

Title 45 CFR Additions

The "mind map" below contains HHS' additions to 45 CFR. Sections 160, 162, and 164 are the HIPAA Regulations that we have all come to "know and love." The section added (i.e. Section 170) represents something radically new, the codification of health information technology standards.

The expanded version of this mind map can be accessed here. The new rules will be available on the HIPAA Survival Guide in a fully "clickable" format in the next week or so. For now the respective subparts and sections are listed below.

The HITECH Act's regulatory landscape regarding HIT Standards continues to expand rapidly. We will have a lot more commentary on specific sections in subsequent posts. HHS introduce Section 170 as follows:

The standards, implementation specifications, and certification criteria adopted in this part apply to Complete EHRs and EHR Modules and the testing and certification of such Complete EHRs and EHR Modules.

Subpart A General Provisions

170.100 Statutory basis and purpose.
170.101 Applicability.
170.102 Definitions.

Subpart B ? Standards and Implementation Specifications for Health Information Technology

170.200 Applicability.
170.202 Transport standards for exchanging electronic health information.
170.205 Content exchange and vocabulary standards for exchanging electronic health information.
170.210 Standards for health information technology to protect electronic health information created, maintained, and exchanged.
170.299 Incorporation by reference.

Subpart C ? Certification Criteria for Health Information Technology

170.300 Applicability.
170.302 General certification criteria for Complete EHRs or EHR Modules.
170.304 Specific certification criteria for Complete EHRs or EHR Modules designed for an ambulatory setting.
170.306 Specific certification criteria for Complete EHRs or EHR Modules designed for an inpatient setting.

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