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Research Repositories, Databases, and the HIPAA Privacy Rule - health utah

Research Repositories, Databases, and the HIPAA Privacy Rule - health utah 2025

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The document discusses the implications of the HIPAA Privacy Rule on medical and health-related research, particularly regarding access to health information from various sources such as databases and repositories. It outlines the requirements for researchers to obtain authorization or waivers for using protected health information (PHI) and explains how the Privacy Rule affects the creation and use of research databases. The document also details exceptions to authorization requirements, including de-identified data sets and limited data sets, as well as the role of Institutional Review Boards (IRBs) in granting waivers. Overall, it emphasizes the need for researchers to understand and comply with the Privacy Rule to facilitate their access to health data while protecting individual privacy.

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Does HIPAA apply to research studies?

Research Health Information (RHI) is defined as data used in research that would be personally identifiable but not considered PHI and is therefore not subject to the HIPAA Privacy and security Rules.

What does the HIPAA privacy rule provides the right as research subjects to?

The Privacy Rule permits a covered entity to use and disclose protected health information for research purposes, without an individuals authorization, provided the covered entity obtains either: (1) documentation that an alteration or waiver of individuals authorization for the use or disclosure of protected health

What data is not protected by HIPAA?

Employee and education records: Any records regarding employee or student health, including known allergies, blood type, or disabilities, are not considered PHI. Wearable devices: Data collected by wearable devices including heart rate monitors or smartwatches is not PHI.

How do I make my database HIPAA compliant?

7 Steps to make your database HIPAA compliant Step 1: Identify vulnerabilities by implementing risk assessment. Step 2: Train Your Employees. Step 3: Protect Your PHI Database by Encrypting It. Step 4: Access Control. Step 5: Enforce BAA when working with vendors. Step 6: Implement backup and disaster recovery plan.

Does HIPAA apply to research data?

Answer: Under the HIPAA Privacy Rule you must meet certain requirements before using or disclosing individually identifiable health information for research. (These HIPAA requirements are in addition to IRB requirements under federal regulations for the protection of human subjects.)

What does HIPAA not apply to?

HIPAA does not apply to all healthcare providers or all insurance companies that cover the cost of medical care. For example, HIPAA does not apply to healthcare providers that only bill clients directly or to auto insurance companies that cover the cost of medical care if a plan member is injured in an auto accident.

Is there a database for HIPAA violations?

For the full list of HIPAA breaches and fines, you can visit OCRs Breach Portal, or Wall of Shame. This is where OCR lists the countless other small-scale HIPAA breaches and fines.

What patient protections are covered in a research study?

Human Subjects Protections Clinical research may involve risk to participants. Informed Consent. Data Safety and Monitoring. Institutional Review Board. Human Subjects Education.

Research Repositories, Databases, and the HIPAA Privacy Rule - health utah 2025

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Research Repositories, Databases, and the HIPAA Privacy Rule - health utah 2025

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Does HIPAA apply to research studies?

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How do I make my database HIPAA compliant?

Does HIPAA apply to research data?

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