§ 170.401 Information Blocking

Clarifications:

• The Condition of Certification prohibits any health IT developer who has at least one health IT product certified under the ONC Health IT Certification Program (Certification Program) from taking any action that constitutes information blocking as defined by section 3022(a) of the Public Health Service Act (PHSA) and in 45 CFR 171.103.
• The Condition of Certification is not limited only to certified health IT.
  • For the Information Blocking and Assurances Conditions and Maintenance of Certification requirements, a health IT developer is also responsible to ensure that all of its health IT and related actions and behaviors do not constitute information blocking as defined in PHSA section 3022 and 45 CFR 171.103, or inhibit the appropriate access, exchange, and use of EHI.  (Sections 170.401 and 170.402 implement, consistent with other requirements in Title XXX, PHSA section 3001(c)(5)(D)(i) and (ii) as added by the 21st Century Cures Act.)
  • A developer’s health IT product suite that a hospital, clinician office practice, or other healthcare provider uses (and colloquially references) as its “EHR system” will typically include a wide variety of functions, services, components, and combinations thereof. Even where such a health IT product suite meets the definition of “Certified EHR Technology” for purposes of participation in the Promoting Interoperability Programs, there is no guarantee that every part of the overall product suite will meet the requirements of at least one certification criterion adopted by the Secretary of the Department of Health and Human Services (Secretary). In fact, typically only a subset of the functions, services, components, and combinations thereof within the overall product suite will meet the requirements of at least one certification criterion adopted by the Secretary and be Health IT Modules certified under the Certification Program. The Condition of Certification will apply to all of the Certified Health IT Modules within a developer’s product suite(s) so long as at least one Health IT Module is certified under the Certification Program at the time the developer engages in a practice that is the subject of an information blocking claim. (85 FR 25796)
• The Condition of Certification references the “information blocking” definition in 45 CFR 171.103. Information blocking exceptions can be found in subparts B, C, and D of 45 CFR part 171. Certain terms, such as “actor” and “practice,” have been defined for purposes of the information blocking regulations (45 CFR part 171) in § 171.102.
• Actors are encouraged to review their current, anticipated, or potential practices against the full text of relevant sections within 45 CFR part 171. Additional information specific to definitions, exceptions, and other provisions codified in 45 CFR part 171 is available in the ONC final rules that have established and, as applicable, revised them.
• Actors who wish to avail themselves of any of the voluntary exceptions to the information blocking definition that are set forth in subparts B, C, and D of 45 CFR part 171 should specifically review the full text of each such exception.
• ONC publishes on HealthIT.gov information resources specific to information blocking, including Information Blocking Frequently Asked Questions (FAQs), that also may be helpful in understanding the information blocking regulations in 45 CFR part 171. Questions and informal feedback about information blocking policy can be submitted to ONC through the Health IT Feedback and Inquiry Portal on ONC’s website, HealthIT.gov.