Health Law Monitor
SHOW ME THE DATA: ONC COMPLIANCE DEADLINE EXTENDED
November 19, 2020
By: Alaina N. Crislip and Lindsay D. Petrosky
The Office of the National Coordinator extended compliance deadlines to its 21st Century Cures Act: Interoperability, Information Blocking, and ONC Health IT Certification Program Final Rule (the “Final Rule”). This extension postpones compliance requirements for the Information Blocking provisions that were set to go into effect November 2, 2020 until April 5, 2021. Clearly this provides “Actors”1 more time to review policies, procedures, agreements, and technology infrastructures to ensure compliance with the Final Rule. Even though the compliance deadline has been extended, Actors should not slow down their efforts to operationalize the Information Blocking provisions. Actors should use this additional time to “test” their policies and procedures and processes for evaluating and responding to requests for access to Electronic Health Information2 (EHI).
An area for Actors to further evaluate is the EHI they will be required to provide. Beginning April 5, 2021 and prior to October 6, 2022, at a minimum, Actors will have to provide EHI as identified within the data elements presented in the United States Core Data for Interoperability (USCDI)3. One of the USCDI Data Elements includes “clinical notes”4, which includes the following eight categories: (1) consultation notes; (2) discharge summary notes; (3) history & physical; (4) imaging narratives; (5) laboratory report narratives; (6) pathology report narratives; (7) procedure notes; and (8) progress notes. EHI, and clinical notes as a subset of EHI, do not include psychotherapy notes or information compiled in reasonable anticipation of, or use in, a civil, criminal or administrative action or proceeding.
Unless an applicable exception applies, the Final Rule requires Actors to provide an individual or a designated third party with access to clinical notes, amongst other USCDI data elements. The Information Blocking compliance deadline is still coming. Take this time to review what EHI your organization has and the various systems where the information is maintained. Should you need assistance in review of Information Blocking or identifying which data meets USCDI data standards, contact your Jackson Kelly health care team.
1 Health care providers, health information exchanges, and health IT developers.
2 Electronic Health Information means electronic protected health information as defined in 45 CFR 160.103 to the extent that it would be included in a designated record set as defined in 45 CFR 164.501, regardless of whether the group of records are maintained by or for a covered entity as defined in 45 CFR 160.103, but EHI shall not include: (1) psycho therapy notes and (2) information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding.
3 This limitation of EHI for purposes of the information blocking definition is not contingent on whether those data elements are recorded or represented using the specific content and vocabulary standards in the USCDI standard at 45 CFR 171.213. On and after October 6, 2022, the information blocking regulation in 45 CFR part 171 pertain to all EHI as defined in 45 CFR 171.102
4 Other data element categories include: Allergies and intolerances, health concerns, procedures, assessment and plan of treatment, immunizations, provenance, care team members, laboratory, smoking status, medications, unique device identified(s) for patient implantable device(s), patient demographics, vital signs, goals, and problems.