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42 CFR § 401.722 - Qualified clinical data registries.

---
identifier: "/us/cfr/t42/s401.722"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 401.722 - Qualified clinical data registries."
title_number: 42
title_name: "Public Health"
section_number: "401.722"
section_name: "Qualified clinical data registries."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL PROVISIONS"
part_number: "401"
part_name: "GENERAL ADMINISTRATIVE REQUIREMENTS"
positive_law: false
currency: "2026-03-24"
last_updated: "2026-03-24"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1302, 1395hh, 1395w-5, and 1395kk-2."
cfr_part: "401"
---

# 401.722 Qualified clinical data registries.

(a) A qualified clinical data registry that agrees to meet all the requirements in this subpart, with the exception of § 401.707(d), may request access to Medicare data as a quasi qualified entity in accordance with such qualified entity program requirements.

(b) Notwithstanding § 401.703(q) (generally defining combined data), for purposes of qualified clinical data registries acting as quasi qualified entities under the qualified entity program requirements, combined data means, at a minimum, a set of CMS claims data provided under this subpart combined with clinical data or a subset of clinical data.

[81 FR 44482, July 7, 2016]