Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment
Outpatient Surgical Facility Corrects Privacy Procedure in Research Recruitment
Covered Entity: Outpatient Facility
Issue: Impermissible Uses and Disclosures
An outpatient surgical facility disclosed a patient's protected
health information (PHI) to a research entity for recruitment purposes
without the patient's authorization or an Institutional Review Board
(IRB) or privacy-board-approved waiver of authorization. The outpatient
facility reportedly believed that such disclosures were permitted by the
Privacy Rule. OCR provided technical assistance to the covered entity
regarding the requirement that covered entities seeking to disclose PHI
for research recruitment purposes must obtain either a valid patient
authorization or an Institutional Review Board (IRB) or
privacy-board-approved alteration to or waiver of authorization. Among
other corrective actions to resolve the specific issues in the case, OCR
required the outpatient facility to: revise its written policies and
procedures regarding disclosures of PHI for research recruitment
purposes to require valid written authorizations; retrain its entire
staff on the new policies and procedures; log the disclosure of the
patient's PHI for accounting purposes; and send the patient a letter
apologizing for the impermissible disclosure.
| A Covered Entity is: A health plan. An individual or group plan that provides, or pays the cost of, medical care. Health plans include private entities (e.g., health insurers and managed care organizations) and government organizations (e.g., Medicaid, Medicare, and the Veterans Health Administration) A health care provider. A provider of health care services and any other person or organization that furnishes, bills, or is paid for health care in the normal course of business. Health care providers (e.g., physicians, hospitals, and clinics) are covered entities if they transmit health information in electronic form in connection with a transaction ...read more |
| Can a covered entity refuse to disclose ePHI to an app chosen by an individual because of concerns about how the app will use or disclose the ePHI it receives? No. The HIPAA Privacy Rule generally prohibits a covered entity from refusing to disclose ePHI to a third-party app designated by the individual if the ePHI is readily producible in the form and format used by the app. See 45 CFR 164.524(a)(1), (c)(2)(ii), (c)(3)(ii). The HIPAA Rules do not impose any restrictions on how an individual or the individual’s designee, such as an app, may use the health information ...read more |
| Mental Health Center Corrects Process for Providing Notice of Privacy Practices Covered Entity: Outpatient Facility Issue: Notice A mental health center did not provide a notice of privacy practices (notice) to a father or his minor daughter, a patient at the center. In response to OCR’s investigation, the mental health center acknowledged that it had not provided the complainant and his daughter with a notice prior to her mental health evaluation. To resolve this matter, the mental health center revised its intake assessment policy and procedures to specify that the notice will be provided and the clinician will attempt to ...read more |
| Enforcement Results as of September 30, 2022 Since the compliance date of the Privacy Rule in April 2003, OCR has received over 309,475 HIPAA complaints and has initiated over 1,053 compliance reviews. We have resolved ninety-seven percent of these cases (300,427). OCR has investigated and resolved over 29,779 cases by requiring changes in privacy practices and corrective actions by, or providing technical assistance to, HIPAA covered entities and their business associates. Corrective actions obtained by OCR from these entities have resulted in change that is systemic and that affects all the individuals they serve. OCR has successfully enforced the ...read more |
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