The Definition of Health Care Operations

This posting is one of several that outline the HITECH privacy provisions of the American Recovery and Reinvestment Act that President Obama signed into law on Tuesday, February 17, 2009, in Denver, CO. Here, we reproduce the definitions that appear in Subtitle D—Privacy, Section 13400. Definitions, that appear in the Conference Report on page H1345 of Congressional Record—House, February 12, 2009. These definitions are critical in understanding the content of the new HITECH privacy provisions and how they relate to existing HIPAA Administrative Simplification Privacy Rule standards.

HIPAA Privacy Definitions:

Breach Business Associate Covered Entity Disclosure Electronic Health Record Health Care Operations

Health Care Provider Health Plan National Coordinator Payment Personal Health Record Protected Health Information

Secretary Security State Treatment Use Vendor Of Personal Health Records

HEALTH CARE OPERATIONS

The term ‘health care operations’ has the meaning given such term in section 164.501 of title 45, Code of Federal Regulations.

Section 164.501—

Any of the following activities of the covered entity to the extent that the activities are related to covered functions:

(1) Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, provided that the obtaining of generalizable knowledge is not the primary purpose of any studies resulting from such activities; population-based activities relating to improving health or reducing health care costs, protocol development, case management and care coordination, contacting of health care providers and patients with information about treatment alternatives; and related functions that do not include treatment;

(2) Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities.

(3) Underwriting, premium rating, 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 claims for health care (including stop-loss insurance and excess of loss insurance), provided that the requirements of section 164.514(g)¹ are met, if applicable;

(4) Conducting or arranging for medical review, legal services, and auditing functions, including fraud and abuse detection and compliance programs;

(5) Business planning and development, such as conducting cost-management and planning-related analyses related to managing and operating the entity, including formulary development and administration, development or improvement of methods of payment or coverage policies; and

(6) Business management and general administrative activities of the entity, including, but not limited to,

(i) Management activities relating to implementation of an compliance with the requirements of this subchapter;

(ii) Customer service, including the provision of data analyses for policy holders, plan sponsors, or other customers, provided that protected health information is not disclosed to such policy holder, plan sponsor, or customer;

(iii) Resolution of internal grievances;

(iv) The sale, transfer, merger, or consolidation of all or part of the covered entity with another covered entity, or an entity that following such activity will become a covered entity and due diligence related to such activity; and

(v) Consistent with the applicable requirements of section 164.514², creating de-identified health information or a limited data set, and fundraising for the benefit of the covered entity.

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¹ Section 164.514(g) Standard: Uses and disclosures for underwriting and related purposes. If a health plan receives protected heath information for the purpose of underwriting, premium rating, or other activities relating to the creation, renewal, or replacement of a contract of health insurance or health benefits, and if such health insurance or health benefits are not placed with the health plan, such health plan may not use or disclose such protected health information for any other purpose, except as may be required by law.

² Section 164.514—Other requirements relating to uses and disclosures of protected health information: (a) Standard: de-identification of protected health information; (b) Implementation specifications: requirements for de-identification of protected health information; (e)(1) Standard: Limited data set; and (f)(1) Standard: Uses and disclosures for fundraising.