; (2) include necessary elements, common and consistent definitions, and a standardized electronic interface for the entry and processing of the data by Program participants, as developed by the Director in consultation with patient safety organizations, health care providers, and the health information technology industry; (3) allow for the comprehensive collection and analysis of the patient safety data required to be submitted by all Program participants under section 945; and (4) include patient safety data required to be submitted by Program participants under section 945 as nonidentifiable patient safety work product and privileged and confidential in accordance with section 922. (b) Limitation Information submitted to the Database shall be confidential and protected from disclosure in accordance with the regulations promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. 1320d–2 note). (c) Access Access to the patient safety data contained within the Database shall only be provided through application to and approval by the Director. 945. National Healthcare Acquired Infection and Medical Error Reporting Program (a) Establishment The Secretary, acting through the Director of the Office, shall establish a National Healthcare Acquired Infection and Medical Error Reporting Program to provide for the confidential disclosure of medical errors and patient safety events in order to improve patient safety and health care quality, reduce preventable medical errors, ensure patient access to data and reports for medical injury due to medical error, negligence, or malpractice. (b) Eligible Participants To be eligible to participate in the Program an entity shall— (1) (A) be a healthcare provider; or (B) be any other entity determined to be eligible by the Director; (2) designate a patient safety officer to ensure that the conditions of participation described in subsection (c) are met