The information below highlights what pediatricians need to know about the 21st Century Cures Act Interoperability Final Rule.
- The Information Blocking provisions of the Final Rule apply to all clinicians, practices, and health systems that maintain electronic health information (EHI) about patients.
- EHI is found in electronic health records (EHRs) as well as in sources such as practice management programs and electronic billing systems. A pediatrician must be prepared to electronically share the EHI they have.
- At this time, the Information Blocking provisions apply only to EHI that is contained within the US Core Data for Interoperability (USCDI). EHI that is not included in the USCDI (e.g., sexual orientation, gender identity) will be required to be shared electronically in October 2022.
- At this time, practices and health systems are not required to implement a patient portal. The Final Rule allows for secure electronic sharing of EHI in a variety of formats, including HIPAA-compliant emails and third-party applications of the patient’s choice. Regular email is not HIPAA compliant.
- Sharing of EHI is the priority. The preference and intention of the Final Rule is to facilitate electronic sharing, but the most important piece is getting the EHI to the requestor. In some instances, it is still ok to provide a printed copy.
- The Final Rule mandates EHI to be shared upon request. Many practices, hospitals and health systems are choosing to implement a proactive push of the covered EHI because it is a smoother, more efficient logistical approach to information-sharing, and can potentially free up staff time that would otherwise be used to monitor and respond to requests. The Rule itself does not mandate proactive pushing of EHI to the patient portal or proactive sharing by other means. Responses to requests for EHI need to be timely.
- The Final Rule prohibits charging fees for patient access to their own EHI. Pediatricians may not institute fees for patient portal access or patient access via third party apps.
- Patients have a long-established right to access their own health information and share it as they see fit. The Final Rule establishes new requirements for how some specific patient data elements are shared.
- The Final Rule does not make any changes to who has the right to access EHI. The Final Rule makes changes to how EHI is shared; it does not impact with whom the EHI can be shared.
- The Final Rule established eight Exceptions to account for circumstances under which it is appropriate to withhold requested EHI, delay providing it, or to provide it in alternative format:
- Preventing Harm Exception
- Privacy Exception
- Infeasibility Exception
- Health IT Performance Exception
- Content and Manner Exception
- Fees Exception
- Licensing Exception
- As of June 2021, there are no established enforcement rules or disincentives (i.e., fines) for Information Blocking by clinicians, practices, and health systems that do not run health information networks/health information exchanges (HIEs/HINs). Enforcement rules for these stakeholders will be established in a federal rule-making process, including a standard public comment period, in the future. Enforcement will be under the purview of the Office of the Inspector General (OIG). Per the Office of the National Coordinator for Health Information Technology (ONC), clinicians, practices, and health systems will not be fined (or otherwise punished) for Information Blocking that occurs prior to the finalization of the enforcement rule.
- Other important pieces of the 21st Century Cures Act Interoperability Final Rule include:
- Priority functionalities for certification of health IT for use in pediatric care
- Establishment of the USCDI
- Provisions for the use of third-party applications for sharing and exchanging EHI, including the establishment of secure application programming interfaces (APIs) for moving EHI from the EHR to the patients preferred app
- Establishment of security protocols for health care apps
Do you have questions or need assistance?
Contact AAP Cures Rule experts.
Additional AAP Resources for More Information
- AAP Guiding Principles for Information Sharing and Blocking
- Pediatric Information Blocking Use Cases
- EHRs for Pediatricians
Disclaimer: This information is general in scope and educational in nature. It is not intended as legal advice. If you require legal advice, contact an attorney.
The recommendations in this publication do not indicate an exclusive course of treatment or serve as a standard of medical care. Variations, taking into account individual circumstances, may be appropriate. This content is for informational purposes only. It is not intended to constitute financial or legal advice. A financial advisor or attorney should be consulted if financial or legal advice is desired.
American Academy of Pediatrics