§299b–21 Definitions

Summary

Defines key words for reporting and protecting patient safety information. HIPAA confidentiality regulations — the privacy rules made under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191; 110 Stat. 2033). Identifiable patient safety work product — patient safety material that lets someone identify a provider involved, contains individually identifiable health information under the HIPAA rules, or lets someone identify the person who reported the information. Nonidentifiable patient safety work product — patient safety material that is not identifiable in those ways. Patient safety organization — a public or private group listed by the Secretary to handle patient safety work. Patient safety activities — work to improve safety and care quality, collecting and analyzing safety information, making and sharing recommendations or best practices, using that information to promote a safety culture and give feedback, keeping confidentiality and security, using qualified staff, and running evaluation systems. Patient safety evaluation system — collecting, managing, or analyzing information for reporting to or by a patient safety organization. Patient safety work product — data, reports, records, analyses, or statements made by a provider for reporting to a patient safety organization or made by a patient safety organization for patient safety activities, showing the system’s deliberations, analysis, or the fact of reporting; it does not include a patient’s medical record, billing or discharge information, other original patient or provider records, or information kept separately from the evaluation system, and these exclusions do not stop legal discovery, required reporting to government agencies for public health or oversight, or a provider’s recordkeeping duties. Provider — an individual or group licensed or allowed by state law to give health care, including hospitals, nursing facilities, clinics, home health agencies, hospices, dialysis centers, pharmacies, physician and practitioner offices, laboratories, long‑term care and behavioral health facilities, and many kinds of clinicians (for example, physicians, physician assistants, nurse practitioners, nurses, midwives, psychologists, social workers, dietitians, therapists, and pharmacists), or others the Secretary names.