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. Author manuscript; available in PMC: 2016 Jan 6.
Published in final edited form as: Clin Trials. 2015 Sep 15;12(5):520–529. doi: 10.1177/1740774515597677

Table 4.

Health care operations include certain administrative, financial, legal, and quality improvement activities and are defined in 45 CFR 164.501 as follows:

Conducting quality assessment and improvement activities, population-based activities relating to improving health or reducing health care costs, and case management and care coordination
Reviewing the competence or qualifications of health care professionals, evaluating provider and health plan performance, training health care and non-health care professionals, accreditation, certification, licensing, or credentialing activities
Underwriting and other activities relating to the creation, renewal, or replacement of a contract of health insurance or health benefits, and ceding, securing, or placing a contract for reinsurance of risk relating to health care claims
Conducting or arranging for medical review, legal, and auditing services, including fraud and abuse detection and compliance programs
Business planning and development, such as conducting cost-management and planning analyses related to managing and operating the entity; and
Business management and general administrative activities, including those related to implementing and complying with the Privacy Rule and other Administrative Simplification Rules, customer service, resolution of internal grievances, sale or transfer of assets, creating de-identified health information or a limited data set, and fundraising for the benefit of the covered entity