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Compliance with the Information Blocking provisions of the ONC Final Rule for all Actors (Developers of Certified Health IT, HIEs/HINs, and Providers) was required as of April 5, 2021. The timing of enforcement is less clear. The HHS Office of the Inspector General (OIG) will not finalize its enforcement timetable for Civil Monetary Penalties (CMPs) for Developers and HIEs/HINs pending a forthcoming Final Rule (based on an April 24, 2020 Proposed Rule). This Final Rule is scheduled for Spring 2023 release according to the latest federal government Unified Agenda of Regulatory and Deregulatory Actions. HHS is also expected to publish a proposed rule on provider disincentives in 2023.
The first window for health IT developers of certified heath IT to attest to compliance with the Information Blocking Condition of Certification Requirement opened on April 1, 2022 and closed on April 30, 2022. For more information, see the ONC’s Attestations Fact Sheet.
The second window opens October 1, 2022.
Enforcement timing will depend on forthcoming (but not yet scheduled) rulemaking that will address additional information blocking “disincentives” for Providers as well as the federal agencies to which OIG will refer Provider-focused information blocking complaints.
In the face of this uncertainty, and with recognition of the complexity of implementation and compliance planning, rapidly approaching enforcement rules, and the acute need for wide data access, The Sequoia Project believes it prudent for organizations subject to the information blocking regulation to prepare for enforcement by developing an ongoing, organization-wide information blocking compliance strategy.
ONC’s Cures Act Final Rule Policy: Information Blocking
Health IT Feedback and Inquiry Portal
October 29, 2020 News Release – HHS Extends Compliance Dates for Information Blocking and Health IT Certification Requirements in 21st Century Cures Act Final Rule
Information Blocking resources and insight from the digital health law firm, Gravely Group
Exception 1: Preventing Harm (June 2020)
Exception 2: Privacy (June 2020)
Exception 3: Security (June 2020)
Exception 4: Infeasibility (June 2020)
Exception 5: Health IT Performance (June 2020)
Exception 6: Content and Manner (June 2020)
Exception 7: Fees (June 2020)
Exception 8: Licensing (June 2020)
Information Blocking Exceptions Companion Guide (June 2020)
Key ONC Interoperability and Information Blocking Timelines (May 2020)
ONC Rule Definitions Cheat Sheet
High-level cheat sheet on the CMS and ONC interoperability final rules (Updated July 2020)