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TITLE 26HEALTH AND HUMAN SERVICES
PART 1HEALTH AND HUMAN SERVICES COMMISSION
CHAPTER 925RESEARCH INVOLVING HEALTH AND HUMAN SERVICES COMMISSION SERVICES
RULE §925.3Definitions

      (i) health information that has been de-identified in accordance with 45 CFR §164.514(b); and

      (ii) employment records.

  (25) Research--Consistent with 45 CFR §46.102(l), a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this chapter, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this chapter, the following activities are not deemed as research.

    (A) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.

    (B) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters).

    (C) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.

    (D) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

  (26) Rights officer--A person who oversees the research site to protect and advocate for the rights of individuals receiving HHSC services.

  (27) State Hospital Central Administration--The HHSC office that is responsible for the management and oversight of the state hospital system.

  (28) Texas Health and Human Services Commission Privacy Division--The HHSC workforce responsible for creating and maintaining privacy policies and procedures and investigating potential unauthorized disclosures of protected health information, personally identifiable information, and sensitive personal information. The Privacy Division is responsible for declaring whether an incident is a breach of information and notifying or recommending notification to affected individuals. The Privacy Division acts as a resource and subject matter experts to HHSC.


Source Note: The provisions of this §925.3 adopted to be effective November 27, 2022, 47 TexReg 7731

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