21st Century Cures Act - Information Blocking and CMS Interoperability Compliance

Sep 16, 2026

Uploaded by Stanford

21st Century Cures Act guidance explains how the 2016 law and the ONC and CMS final rules reshape electronic health information (EHI) disclosure expectations by April 5, 2021. It defines information blocking, outlines patient right of access, and details how providers must make EHI available to patients, other providers, and third parties. The material covers eight approved exceptions, public reporting via annual attestation, preferred data formats, USCDI timelines, and the case-by-case review of potentially blocking practices.

LanguageEnglish

CategoryPresentations

FormatPDF

Pages27

Reading Time9 min

AccessFree to download

Overview of the 21st Century Cures Act

Background: ONC Rule and CMS Rule

HIPAA paradigm shift and new disclosure presumption

Information Blocking

Definition and scope (EHI only)

Patient’s right of access

Eight approved exceptions and public reporting

Access to Patient Data

How to make data available without unnecessary delay

Minimum USCDI by April 5, 2021; expanded catalog by October 6, 2022

Preferred formats and vendor/API expectations (FHIR)

Information Blocking in Practice

Case-by-case review and factors

Practices that may prevent access, increase cost, or reduce EHI value

21 st Century Cures Act: Information Blocking and CMS Interoperability Compliance by April 5, 2021 Agenda ▪ Overview of the 21st Century Cures Act and the Final Rules from ONC and CMS ▪ Providing access to patient data & Information Blocking ▪ Patient data access ▪ What is Information Blocking? ▪ Eight approved exceptions ▪ Public reporting – annual attestation ▪ Digital contact information ▪ Admission, discharge, and transfer event notifications Overview How did we get here? ▪ The 21st Century Cures Act (2016) ▪ Codified at 42 U.S.C. 300jj-52 et seq. ▪ Response to limitations on data sharing in health care ▪ Congressional report uncovered data silosand barriers to access patient EHI ▪ ONC Rule ▪ CMS Rule This is a HIPAA paradigm shift. The new presumption is EHI disclosure unless otherwise required bylaw or an exception to the Information Blocking rule. Information Blocking Access to Patient Data Providers are required to make patient data available, to: ▪ Patients ▪ Other providers ▪ Third parties (e.g. apps) Information Blocking Definition Information Blocking A practice that, except as required by law or covered by exception, is likely to interfere with access, exchange, or use of electronic health information (EHI) 45 C.F.R . 171.103(a)(1) Re: EHI The Information Blocking rule only applies to electronic health information (EHI); not paper charts or records Information Blocking Patient’s Right of Access Focus on Patient’s Right of Access ▪ Right to access/direct EHI under HIPAA ▪ Facilitate authorization/consent ▪ Note recent and repeated OCR Announcements of HIPAA enforcement ▪ Patient education about privacy and security risks of 3rd party apps they choose to use to access EHI ▪ Information Blocking speeds up timeline to deliver EHI ▪ “Without unnecessary delay” Information Blocking How to make data available ▪ Broad scope – rules favor broad access, exchange, and use of EHI ▪ Prepare for multiple types of requests and requesters ▪ Make and document plans regarding: ▪ How you will respond to requests “without unnecessary delay” ▪ What you will share – minimum is USCDI ▪ The format in which you will share the data ▪ When you won’t be able to make data available Information Blocking US Core Data for Interoperability (USCDI) Know what data should be available for access ▪ By April 5, 2021, minimum is USCDI ▪ By October 6, 2022, expanded data catalog Information Blocking Preferred formats & your health IT vendors ▪ Share EHI in the format patients specify ▪ ONC’s goal is that FHIR APIs be among the options ▪ Health IT developers (e.g. EHR vendors) will be required to make APIs available in their products to support exchange of EHI, enforcement begins August 2022 ▫ Providers should then make these APIs available for data access ▪ Talk to your vendors now, get in queue for upgrades Information Blocking In Practice Case-by-Case Review Each practice that implicates Information Blocking analyzed on a case-by-case basis Facts and circumstances analysis includes practices that: ▪ Prevent access ▪ Increase cost of access ▪ Add difficulty or burden to access ▪ Limit utility, efficacy, or value of EHI by decreasing integrity, quality, completeness, or timeliness of EHI 85 Fed Reg at 25841 (May 1, 2020) Practice Focus on practices that may implicate the Information Blocking Rule Examples Interference with: ▪ Patients’ access to their own EHI ▪ Treatment and care coordination between providers ▪ Payers seeking to assess clinical value ▪ Quality Improvement/Population Health management by providers ▪ Patient safety and public health

FAQs

What is information blocking under the 21st Century Cures Act rules?

Information blocking is a practice, except when required by law or covered by a covered exception, that is likely to interfere with access, exchange, or use of electronic health information (EHI).

Who must be able to access patient EHI, and what does “without unnecessary delay” mean?

Providers are required to make patient data available to patients, other providers, and third parties such as apps. The rules emphasize responding “without unnecessary delay,” supported by documented plans and authorization/consent facilitation.

What data and formats must be supported for interoperability compliance?

By April 5, 2021, the minimum available content is USCDI, with an expanded data catalog by October 6, 2022. EHI should be shared in the format patients specify, with a goal that FHIR APIs be among the options and that vendors provide APIs to support exchange.

Sep 16, 2026

Uploaded by Stanford