Background
Pursuant to Title 22 California Code of Regulations (CCR) section 79902, all health care facilities must report Medical Information Breach (MIB) incidents to the California Department of Public Health (CDPH). Title 22 CCR section 70972 for general acute care hospitals (GACHs) and Title 22 CCR section 71567 for acute psychiatric hospitals (APHs) require that GACHs and APHs also report Adverse Events (AEs) to CDPH. The regulations require health care facilities to report AEs through CDPH's online CalHEART portal. MIB incidents can also be reported through the CalHEART portal. CalHEART is now being updated to accommodate and collect additional information that is required to be reported based on regulatory changes for MIB incidents and AEs.
Updates to CalHEART
CDPH has updated the CalHEART online reporting application used by health care facilities to report AEs and MIB incidents. The new version of the portal is scheduled to be released on October 27, 2025, and contains several enhancements and new features to accommodate reporting requirements based on current regulations for reporting AE and MIB incidents. Please note that the CalHEART system will be unavailable for use between October 24, 2025, and October 27, 2025, to accommodate the rollout of the updated version.
Enhancements contained in this CalHEART version update to the AE and MIB incident reporting include:
- Allowing the attachment of supporting documentation
- A 15-business day timeframe to revise event/incident reports and/or upload additional attachments
- Allowing more involved individuals to be listed
- Adding additional mandated reporting elements
- Mobile Device Support
Facility Access Authorizers (New Role)
Facility Access Authorizers (FAAs) is a new role requirement that is part of the enhancements contained in the upcoming CalHEART release. Upon release of these updates, each facility is required to designate at least one but no more than two FAAs to maintain access to CalHEART. FAAs are responsible for approving, deleting, and modifying CalHEART user access for up to five total users for their respective facility.
Facility identified FAAs can locate additional information and instructions about requesting FAA status via the My Account page located in the CalHEART Healthcare Portal. A completed and signed FAA access request form must be attached when requesting FAA status access online through the CalHEART Healthcare Portal. Designated FAAs across multiple facilities must submit a completed and signed FAA access request form for each facility for which they are requesting access. The FAA access request form is available within the CalHEART Healthcare Portal and must be signed by an individual listed on the facility license. Eligible individuals with signing authority to approve FAAs at each facility are the:
- Administrator
- Administrator Designee
- Director of Nursing
- Director of Patient Care Services
- Facility Licensee
- Medical Director
- Program Director
To ensure that facilities maintain the ability to report AE and/or MIB via CalHEART, facilities should designate their FAA as soon as possible following the release of CalHEART version 2. Facilities requesting access to CalHEART for the first time must designate an FAA to use the system.
Please see the CalHEART Facility Access Request demonstration video on how to request access for the FAA role in the CalHEART Healthcare Portal.
Facility Access Approval Process
This update also includes a new registration process and enhancements to the facility access approval process. All existing users must apply to activate an account using the new platform. Facility staff that need access to submit AE and/or MIB incidents, will request access through the My Account page located in the CalHEART Healthcare Portal. These requests will then be routed to the designated FAA at each facility for approval. Individuals requesting access to a facility can view the facility's designated FAA contact information located on the FAA panel from the My Account page. While designated FAAs are being assigned and processed for each facility, new CalHEART user requests will not be able to be processed. Any new CalHEART user requests will be processed once the facility has approved the designated FAAs for the facility and their user account is activated.
Report Revisions and Attachments (New Features)
The report revision feature includes a 15-business day timeframe to revise event/incident reports, upload additional attachments which may be required to comply with regulatory requirements, and provides access to additional incident/event report data that is not currently available in CalHEART version 1. CalHEART version 2 users must request enhanced user access via the My Account page located in the CalHEART Healthcare Portal for access to the report revision feature. Additional information and instructions about enhanced user access can be found at the My Account page location. Enhanced user access requests are approved by the facility's FAA and are unable to be processed until an FAA is designated for that facility.
Online Webinar
An online webinar will be available to all new and existing CalHEART users and will cover the new CalHEART release application enhancements along with the updates for requesting facility access and the new FAA designation requirements. The online webinar will be held via Teams on October 20, 2025, from 1:30 p.m. to 2:30 p.m. Please use the Microsoft Teams Registration Link to register and access the webinar. Additionally, prerecorded CalHEART demonstration videos are available on the CalHEART Healthcare Portal which can be viewed at any time. These prerecorded videos provide demonstrations for user registration, FAA registration, and AE and MIB incident reporting submission processes.
For any questions about this AFL or required AE and MIB reporting requirements in CalHEART, please contact your local district office.
Sincerely,
Original signed by Mandi Posner
Mandi Posner
Deputy Director
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