02 Nov 21st Century Cures Act and Pediatricians

We have received many questions, and there is much uncertainty in the Health IT industry, regarding the impact of the Information Blocking section of the 21st Century Cures Act. While there are many details that remain unknown, this communication is intended to lay the foundation for continued education and information which will be forthcoming in the months ahead. 

Implementation of the Information Blocking Rule

The implementation of the Information Blocking rule has been delayed. Nothing related to information blocking is happening in November! Initially, you may have heard that the ONC used their discretionary authority to delay imposing the Rule for 3 months (February 2021): On October 29th, the ONC issued a new Interim Final Rule extending the Program compliance dates beyond those identified in the April 21, 2020 enforcement discretion announcement. This establishes a new future applicability date for information blocking provisions and identifies the new applicable date as 4/5/2021. 

The Interim Final Rule also adopts updated standards and makes technical corrections and clarifications to the ONC Cures Act Final Rule. We encourage you to watch a publically available informational ONC webinar: Interim Final Rule with Comment Period.

Enforcement Process

While the ONC has written the regulations, they are not the oversight body charged with enforcement. Currently, there is not an established enforcement process for the Cures Act Final Rule. Enforcement rules will be established and implemented by the Office of the Inspector General (OIG) through the standard federal rule-making process, including a public comment period. 

As of 10/29/2020, this rule-making process has not been completed. No Civil Monetary Penalties will be assessed until the OIG enforcement rules are finalized and an enforcement start date is confirmed in the Federal Register. Information Blocking that occurs prior to the enforcement rules start date will not be penalized retroactively. See the bottom of page 2.

Importantly, the Cures Act does not supersede or alter federal or state laws surrounding patient privacy. However, the Cures Act does empower patients and families to understand their rights to access their electronic health information (EHI). The ONC has resources for patient engagement (updates in process) that we encourage you to review as you plan your practice strategy.  

Our Promise

OP is committed to keeping our practices informed of progress. I am fortunate to be involved in Pediatric Health IT conversations between the ONC and the AAP and will use our collective voice to advocate for improved understanding, protection of pediatric patient privacy and pediatric-focused resources.

Thank you for all you do for the patients and families of your communities. Be on the lookout for additional information in the months ahead. 

Best,

Sue Kressly, MD, FAAP

Medical Director, Office Practicum

While we’ve gathered and studied this information as best we can, we can’t guarantee its accuracy, especially since it is subject to change, and much of how the rules may be applied will depend on your own practices and procedures, or other circumstances. Since we are not permitted to provide legal advice, you should not rely on this information as such. As with any law or regulation, you should access your own professional advisor on any matter you’re not certain about.