Designated record set
Under HIPAA, the designated record set is the group of records a covered entity uses to make decisions about individuals — expressly including the medical records and the billing records a provider maintains, and the enrollment, payment, and claims-adjudication systems a health plan maintains. It is the set of information an individual has a right to inspect and obtain a copy of under the right of access.
Updated
A designated record set is a group of records maintained by or for a covered entity that is either the medical records and billing records about individuals maintained by or for a covered health care provider; the enrollment, payment, claims-adjudication, and case- or medical-management record systems maintained by or for a health plan; or any records used, in whole or in part, by or for the covered entity to make decisions about individuals (45 CFR 164.501).
A "record" within the set is any item, collection, or grouping of information that includes protected health information and is maintained, collected, used, or disseminated by or for the covered entity. The set is defined by function — the records used to make decisions about the individual — not by which department or system happens to store them.
In practice
For a billing operation, the definition matters because it names billing records and the payment and claims-adjudication systems outright. The individual's right of access (45 CFR 164.524) reaches into those records too — an itemized account, the claim data a practice holds, the remittances and explanations of benefits kept on file — not only the clinical chart.
The set is broader than the legal medical record and is not confined to one system. A practice identifying what an access request reaches should look across the records it uses to make decisions about the patient, wherever they live.
Commonly confused with
- Medical record: The medical record is the clinical documentation of a patient's care. The designated record set is broader: it also includes billing and payment records and any records the entity uses to make decisions about the individual.
- Psychotherapy notes: Psychotherapy notes are a mental-health professional's separately kept process notes; they are defined apart from the rest of the record and are outside the individual's right of access (45 CFR 164.524(a)(1)).