ONC Proposes to Define Conduct That Is Not Information Blocking under the Cures Act

Overview


The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed rule would have a significant impact on data sharing arrangements and other relationships among health care providers, health IT developers and other stakeholders. In this On the Subject, our experienced team analyzes ONC’s information blocking proposals and suggests practical next steps for the regulated industry.

This On the Subject was co-authored by Rachel Stauffer at McDermott+Consulting

In Depth


Summary

On February 11, 2019, the Office of the National Coordinator for Health Information Technology (ONC) released its long-awaited proposed rule (Proposed Rule) that, among other things, proposes to implement the “information blocking” prohibition of the 21st Century Cures Act (the Cures Act) by identifying conduct that is not information blocking. On the same day, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule on related interoperability issues. We cover the CMS proposed rule in a separate On the Subject. If finalized, ONC’s proposed policies would have a significant impact on data sharing arrangements and other relationships among health care providers, health IT developers and other stakeholders.

More broadly, these two rules emphasize the administration’s focus on ensuring patient access to data and data exchange. As CMS Administrator Seema Verma recently explained, “[t]he days of holding patient data hostage are over…Our proposed rule includes a policy to publicly identify doctors, hospitals, and other healthcare providers who engage in information blocking. Simply put, we’re going to expose the bad actors who are purposely trying to keep patients from their own information. Patient data doesn’t belong to the doctor, hospital, or electronic health record. It belongs to the patient.” ONC’s Proposed Rule reflects a similar sentiment.

The public will have 60 days to submit comments following official publication of the Proposed Rule in the Federal Register, which we expect to occur in the near future.

The following sections of this On the Subject address:

  • The events leading up to the adoption of the Cures Act and the Proposed Rule;
  • Discussion and analysis of the information blocking provisions of the Proposed Rule, including its exceptions describing permissible conduct under the Proposed Rule; and
  • Practical impact and next steps for health care industry stakeholders.

A. Background

Since passage of the Health Information Technology for Economic and Clinical Health Act in 2009, the federal government has invested billions of dollars to encourage the adoption of interoperable technologies in the hope that it will lead to better care and a more efficient health care system. Congress, regulators and health care industry stakeholders, have grown concerned that, despite increased adoption of technology, like electronic health record (EHR) systems, certain economic and market conditions create an incentive for some to inappropriately limit or restrict the flow of electronic health information in ways that undermine the significant investment; this conduct is commonly referred to as “information blocking.”

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