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When Is Clinical Research Governed by HIPAA?
Protected health information (PHI). HIPAA regulations apply only to PHI. PHI is defined as oral, written, typed, or electronic individually identifiable information related to (a) a person's past, present, or future physical or mental health; (b) provision of health care to the person; or (c) past, present, or future payment for health care. For health information to come under the definition of PHI, it must be created by an employer or by a covered entity. Research data derived from diagnostic or treatment information created by an investigator or acquired from existing health care records would be considered PHI.
Covered entity. A covered entity is defined as a health plan, a health care clearinghouse, or a health care provider that transmits any health information in electronic form in connection with financial or administrative activities related to health care. Investigators who are responsible for data collection involving mental health assessments or treatment that will be entered into a research participant's health care records or used for health care decisions is a covered entity. Health care organizations or independent practitioners from whom health care data may be obtained are also covered entities.
Definitions of treatment and research. HIPAA defines treatment as "the provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of health care by a health care provider with a third party; consultation between health care providers relating to a patient; or the referral of a patient for health care from one health care provider to another" (45 CFR 164.501). Research is defined as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (45 CF 164.501).
Research governed by HIPAA. Research in general is not considered a HIPAA-covered function. However, research activities that involve a covered entity or include treatment, payment, or the administration of health care operations must adhere to relevant HIPAA regulations. Psychologists conducting research involving direct delivery of services or assessments and diagnoses that will be used for a patient's treatment decisions should consider themselves covered entities under HIPAA. Psychologists who are not directly involved with patient care but are involved in the design or analysis of data for intervention or quality improvement research for a health care facility or other covered entity must use HIPAA-compliant procedures appropriate for that entity. Investigators who are not involved in direct delivery of services or intervention research but who provide consultation to or plan to use in their research PHI created by a covered entity must provide assurances of HIPAA compliance to the covered entity.
HIPAA permits institutions to segregate non-health care and health care related functions. However, constructing such institutional policies in ways that are HIPAA compliant are difficult. Thus investigators who work in academic settings affiliated with a medical institution or other health care facility must consult with their institution's legal counsel to determine whether, irrespective of their specific research activities, they are subsumed under the institution's HIPAA umbrella (Barnes & Kulynych, 2003).
Implications of HIPAA. HIPAA requires that if a person has legal authority to act on behalf of a minor in making health care decisions, a covered entity must treat such a person (called a personal representative) as the individual. Exceptions are permitted if there is reason to believe the patient or participant has been abused or is endangered by the personal representative or that treating the individual as a personal representative would not be in the best interests of the patient or participant (45 CFR 164.502g). This requirement refers to parents who are generally recognized as personal representatives of their minor children and court-appointed guardians or holders of relevant power of attorney.
HIPAA notice of privacy practices. When health care will be provided as part of a research protocol, HIPAA requires that prospective participants and their guardians receive a Notice of Privacy Practices that describes the psychologist's policies for use and disclosure of PHI, and the patient's and guardian's rights and investigator's obligations under the Privacy Rule (45 CFR 164.520). In most instances, the Notice will be given to prospective participants or their legal guardians at the same time as informed consent is obtained, because the Notice provides information relevant to the scope and limits of confidentiality (Fisher, 2003c). The Notice must be provided to participants and guardians in written form and separate from other informed consent procedures or documents.
HIPAA authorization to use PHI for research. To create, use, or disclose PHI for research purposes, a covered entity must receive a signed authorization from the prospective participant or a legal guardian limited to the specific research project (45 CFR 164.508[c]). Research is one of the few activities for which HIPAA permits authorization for the use or disclosure of PHI to be combined with informed-consent information and other types of written permission for the same research (45 CFR 164.508[b][i]). In addition, unlike nonresearch treatments, investigators who conduct clinical trials can condition provision of treatment within the research protocol based on authorization (45 CFR164.508[b][i]).
HIPAA authorization is also required for psychologists conducting records research on PHI collected by other persons or institutions that are covered entities. With few exceptions, when records contain identifiable health information, covered entities cannot give investigators access without a patient- or guardian-signed authorization that details the specific information that can be used and that states that its use is limited to the specific research purposes and to the specific investigative team for a specific period of time.
Reflection Exercise #6