21st Century Cures Act Compliance – Part One: Understanding the Delay

Last week, the Office of the National Coordinator (ONC) announced a delay in compliance deadlines for the information blocking and health IT certification requirements in the 21st Century Cures Act. Now, April 5, 2021 will mark a big milestone in the world of health data compliance. For many, it’s been dubbed “Compliance Day,” in acknowledgement of efforts by the ONC for Health Information Technology, and by the Centers for Medicare and Medicaid Services’ (CMS) to develop and implement final rules on interoperability and information blocking.

Put simply, the ONC’s: “Interoperability, Information Blocking, and the ONC Health IT Certification Program,” and CMS’s “Interoperability and Patient Access” Final Rules stand to affect every healthcare organization with access to electronic health information (EHI).

The day also puts into motion a fundamental shift in empowering patients and caregivers with greater access to – and control over – their health information. A broad and sweeping piece of legislation, the Rules are intended to modernize the U.S. healthcare system in the areas of medical research and development, medical device innovation, mental health research and care, opioid addiction treatment and prevention, and of course, health information technology.

To say it is a transformative day in healthcare data exchange is an understatement. But we’ve got your back and plan to publish relevant information in the months to come before Compliance Day to help better understand and navigate these changes.

What Will Change: Empowering the Next Generation of Care

These final rules establish many things, including long-awaited definitions of activities that do and do not constitute information blocking, rules regarding the adoption and implementation of APIs, standards required for the United States Core Data for Interoperability (“USCDI”) and APIs, and timelines for compliance with the legislation.

Like PointClickCare – a certified health technology platform – our healthcare provider customers will be bound by the Information Blocking provisions of the ONC Final Rule. In plain English, if a patient requests access to their EHI, providers are required by law to grant it, subject to certain exclusions. The goal is to make health information more easily transferable for patients – an objective that will require its own set of security protocols and implies changes to come across the entire healthcare ecosystem.

What’s Next

• Stick with us – in the coming months we’ll provide tools and resources to help you and your network partners better understand and interpret the rules for effective compliance across the healthcare ecosystem.
• Connect with your legal advisors – given the complexities of these new provisions, we also recommend that you work closely with your legal experts to determine and operationalize the best action plan for your organization.

In the meantime, visit these additional resources to learn more about the Cures Act:

• ONC Final Rule
  • Overview
  • The Office of the National Coordinator for Health Information Technology
  • Information Blocking & Exceptions
    • Example: Epic’s resistance to information blocking received significant media attention, so this is a good opportunity to highlight how we’re approaching this differently and more efficiently.
  • Information Blocking Actors
  • Federal Register
  • Statements from HHS
  • Enforcement Discretion
  • HHS Press Release, OIG proposes rule for civil money penalties for information blocking
    
    
• CMS – Final Interoperability Rule
  • CMS Interoperability and Patient Access final rule
  • Interoperability and Patient Access Fact Sheet
  • Whitepaper from Damo Consulting: Interoperability and Patient Access
  • Federal Register