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.
| Must a covered entity inform individuals in advance of any fees that may be charged when the individuals request a copy of their PHI? This guidance remains in effect only to the extent that it is consistent with the court’s order in Ciox Health, LLC v. Azar, No. 18-cv-0040 (D.D.C. January 23, 2020), which may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51. More information about the order is available at https://www.hhs.gov/hipaa/court-order-right-of-access/index.html. Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded. Yes. When an individual requests access to her PHI and the covered entity intends to charge the ...read more |
| Direct Liability of Business Associates In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act,1 making business associates of covered entities directly liable for compliance with certain requirements of the HIPAA Rules. Consistent with the HITECH Act, the HHS Office for Civil Rights (OCR) issued a final rule in 2013 to modify the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules.2 Among other things, the final rule identifies provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable.3 As set forth in the HITECH ...read more |
| Private Practice Implements Safeguards for Waiting Rooms Covered Entity: Private Practice Issue: Safeguards; Impermissible Uses and Disclosures A staff member of a medical practice discussed HIV testing procedures with a patient in the waiting room, thereby disclosing PHI to several other individuals. Also, computer screens displaying patient information were easily visible to patients. Among other corrective actions to resolve the specific issues in the case, OCR required the provider to develop and implement policies and procedures regarding appropriate administrative and physical safeguards related to the communication of PHI. The practice trained all staff on the newly developed policies and ...read more |
| § 164.314 Organizational requirements. (a) (1) Standard: Business associate contracts or other arrangements. The contract or other arrangement required by § 164.308(b)(3) must meet the requirements of paragraph (a)(2)(i), (a)(2)(ii), or (a)(2)(iii) of this section, as applicable. (2) Implementation specifications (Required) - (i) Business associate contracts. The contract must provide that the business associate will - (A) Comply with the applicable requirements of this subpart; (B) In accordance with § 164.308(b)(2), ensure that any subcontractors that create, receive, maintain, or transmit electronic protected health information on behalf of the business associate agree to comply with the applicable requirements of ...read more |
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