Impact of 21st Century Cures Act interoperability rule on pediatric clinicians

The federal government has issued new regulations intended to promote secure access, exchange and use of electronic health information (EHI) and increase patients’ access to their own clinical data.

The requirements are outlined in the 21st Century Cures Act Interoperability Final Rule, which was finalized by the Office of the National Coordinator for Health Information Technology (ONC) in March 2020. Much of the final rule is technical and applies mostly to the health information technology (HIT) vendor/developer community. However, several sections have direct implications for clinicians and patients, including provisions to prevent information blocking that have raised concerns among pediatricians.

What pediatricians need to know

• Patients’ clinical data have always belonged to the patients. The final rule seeks to remove barriers to patients’ ability to access that information.
• The final rule established the United States Core Data for Interoperability (USCDI, http://bit.ly/3bYZI7B). USCDI is relevant to clinicians in two significant ways: It is the dataset subject to the information blocking provisions, and HIT systems are required to be able to exchange these data seamlessly.
• The information blocking provisions take effect in April. Initially, they apply only to USCDI. Eventually, all EHI will be subject to the information blocking provisions, including clinical data stored in electronic health records (EHRs), as well as electronic claims data or other sources outside the EHR. If the health information is collected and stored electronically, it must be shared electronically. This means the provisions impact almost every clinician and practice in the country.
• The final rule establishes a set of eight exceptions (https://bit.ly/2OkPFBL) to information blocking. The exceptions define the circumstances under which it is appropriate for an actor to withhold requested EHI or provide it in an alternate format.
• Enforcement rules for clinicians and health systems, including any penalties for information blocking, will be established later by the Office of the Inspector General (OIG). ONC has clarified that there will be no penalties for information blocking until the enforcement rules are finalized, and there will be no retroactive penalties for information blocking that occurs prior to the finalization of the enforcement rule. The OIG will have authority to determine whether information blocking occurred.

What this means for pediatric clinicians

For some, making the data in the USCDI available, especially in an automated fashion or in an accessible on-demand manner, will be a significant change. For example, practices may see that additional documents or clinical data will need to be made more readily available to patients via the patient portal. Practices may need to adjust policies and procedures to allow for open and transparent clinical data-sharing where required by the final rule.

The information-sharing aspects of the final rule can feel overwhelming, but pediatricians can embrace the chance to advocate for implementation that promotes safe and equitable patient access to their clinical data. Pediatricians can move toward compliance by:

• finding out how their practice, system and EHR vendor are approaching the rule;
• asking for and seeking out training at their practice or system, as well as on the ONC website;
• familiarizing themselves with the information blocking provisions and exceptions;
• reviewing and amending office policies for how information is shared with patients;
• updating processes to remove barriers to patients’ access to EHI;
• clarifying processes and policies about how the practice/health system will apply the information blocking exceptions (which EHI will the practice withhold and under what circumstances?); and
• addressing any workflows that could be interpreted as information blocking (i.e., charging fees for portal access, establishing long wait times for data that is not proactively pushed to the portal, blocking EHI that is not protected by state or federal law).

Throughout the development of the final rule, the AAP provided comments to reflect special considerations needed to protect the confidentiality of clinical data in pediatric health care.

The AAP continues to meet regularly with the ONC. Experts from the AAP Council on Clinical Information Technology, Section on Administration and Practice Management and Child Health Informatics Center continue to inform AAP responses and education for pediatricians.

Dr. Webber is chair of the AAP Council on Clinical Information Technology (COCIT) Executive Committee. Dr. Chung is a member of COCIT and the Committee on Child Health Financing.