21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification
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How should a pediatric practice respond to the new Information Blocking rules in the 21st Century Cures Act? Watch this video to learn about Information Blocking and how the new regulations may impact your practice. You’ll get an overview of the legal details, see some real-world examples, and understand what a pediatric practice can do to prepare for the new rules.
Presentation Slides: https://wp.me/a8UHhr-auQ
Links from last slide:
Final Rule: https://www.federalregister.gov/documents/2020/05/01/2020-07419/21st-century-cures-act-interoperability-information-blocking-and-the-onc-health-it-certification
Interim Final Rule: https://www.federalregister.gov/documents/2020/11/04/2020-24376/information-blocking-and-the-onc-health-it-certification-program-extension-of-compliance-dates-and
OIG Proposed Rule: https://www.federalregister.gov/documents/2020/04/24/2020-08451/grants-contracts-and-other-agreements-fraud-and-abuse-information-blocking-office-of-inspector
ONC Cures Site: https://www.healthit.gov/curesrule/
ONC Cures Rule FAQs: https://www.healthit.gov/curesrule/resources/information-blocking-faqs
ONC Cures Rule Fact Sheets: https://www.healthit.gov/curesrule/resources/fact-sheets
The Cures Act Final Rule introduced by the ONC on May 1 2020 provides HIT technology developers with much-needed clarity on Information Blocking. Check out the vide to learn more.
The ONC’s Information Blocking Rule and the CMS’s Interoperability and Patient Access Rules are set to introduce a sea of change to the very nature of patient health information recording and exchange. From FHIR APIs to the establishment of a ‘consent to share’, radically new technology frameworks will set a precedent for seamless access to patient health. Some of these contemporary frameworks are mandatory requirements for providers, payers, and HIT vendors. Learn how you can plan the best approach for your organization and meet compliance requirements.
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MCG’s Managing Editor of Ambulatory Care, Stacey Popko, MD, MBA, discusses the 21st Century Cures Act and what impact it may have on drug development. Learn more about our ambulatory guidance content here: https://www.mcg.com/care-guidelines/ambulatory-care/.
The passage of the 21st Century Cures Act has drawn both applause and criticism. A sweeping bipartisan effort with multiple components, the law dramatically boosts funding for medical research, particularly in areas such as cancer and brain disease. The law also relaxes regulatory processes for pharmaceuticals and medical devices. In doing so, the law’s supporters point to the potential for faster treatments benefiting from a streamlined approval process. Critics raise concerns that safety and efficacy might be compromised, with potentially devastating consequences. And the law also has been questioned for failing to explicitly address high drug prices, a growing public issue. These debates are unfolding as the Trump administration is expected to imminently announce its choice for a new FDA commissioner, who will head an agency directly impacted by the Cures act. In this Forum, experts will explore the implications of the law for biomedicine, regulation, pharmaceuticals and patient advocacy.
This Forum event was presented jointly with STAT on February 27, 2017.
Watch the entire series at ForumHSPH.org.
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