Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research
Private Practice Revises Policies and Procedures Addressing Activities Preparatory to Research
Covered Entity: Private Practice
Issue: Impermissible Disclosure-Research
A private practice physician who was the principal investigator of a
clinical research study disclosed a list of patients and diagnostic
codes to a contract research organization to telephone patients for
recruitment purposes. The disclosure was not consistent with documents
approved by the Institutional Review Board (IRB). The private practice
maintained that the disclosure to the contract research organization was
permissible as a review preparatory to research. Activities considered
“preparatory to research” include: preparing a research protocol;
developing a research hypothesis; and identifying prospective research
participants. Contacting individuals to participate in a research study
is a use or disclosure of protected health information (PHI) for
recruitment, as it is part of the research and is not an activity
preparatory to research. To remedy this situation, the private practice
revised its policies and procedures regarding the disclosure of PHI and
trained all physicians and staff members on the new policies and
procedures. Under the revised policies and procedures, the practice may
use and disclose PHI for research purposes, including recruitment, only
if a valid authorization is obtained from each individual or if the
covered entity obtains documentation that an alteration to or a waiver
of the authorization requirement has been approved by an IRB or a
Privacy Board.
| § 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 |
| HHS Issues Guidance on HIPAA and Audio-Only Telehealth Today, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), is issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth - PDF is no longer in effect. This guidance will help individuals ...read more |
| Large Medicaid Plan Corrects Vulnerability that Resulted in Disclosure to Non-BA Vendors Covered Entity: Health Plans Issue: Impermissible Uses and Disclosures; Safeguards A municipal social service agency disclosed protected health information while processing Medicaid applications by sending consolidated data to computer vendors that were not business associates. Among other corrective actions to resolve the specific issues in the case, OCR required that the social service agency develop procedures for properly disclosing protected health information only to its valid business associates and to train its staff on the new processes. The new procedures were instituted in Medicaid offices and independent ...read more |
| Pharmacy Chain Institutes New Safeguards for PHI in Pseudoephedrine Log Books Covered Entity: Pharmacies Issue: Safeguards A grocery store based pharmacy chain maintained pseudoephedrine log books containing protected health information in a manner so that individual protected health information was visible to the public at the pharmacy counter. Initially, the pharmacy chain refused to acknowledge that the log books contained protected health information. OCR issued a written analysis and a demand for compliance. Among other corrective actions to resolve the specific issues in the case, OCR required that the pharmacy chain implement national policies and procedures to safeguard the ...read more |
|
December 2025
| Su | Mo | Tu | We | Th | Fr | Sa |
| 1 | 2 | 3 | 4 | 5 | 6 |
| 7 | 8 | 9 | 10 | 11 | 12 | 13 |
| 14 | 15 | 16 | 17 | 18 | 19 | 20 |
| 21 | 22 | 23 | 24 | 25 | 26 | 27 |
| 28 | 29 | 30 | 31 |
|
Blog Home
Newest Blog Entries
1/21/25 Understanding Business Associate Agreements
11/12/22 Modernizing Medicine Agrees to Pay $45 Million to Resolve Allegations of Accepting and Paying Illegal Kickbacks and Causing False Claims
11/12/22 Indian National Charged in $8 Million COVID-19 Relief Fraud Scheme
11/12/22 Former Hospital Employee Pleads Guilty To Criminal HIPPA Charges
11/12/22 Covered entities and those persons rendered accountable by general principles of corporate criminal liability may be prosecuted directly under 42 U.S.C. § 1320d-6
11/12/22 The Delaware Division of Developmental Disabilities Services Data Breach
11/12/22 OCR Settles Three Cases with Dental Practices for Patient Right of Access under HIPAA
11/12/22 HHS Issues Guidance on HIPAA and Audio-Only Telehealth
11/12/22 Five Former Methodist Hospital Employees Charged with HIPAA Violations
11/12/22 May a covered entity use or disclose protected health information for litigation?
11/12/22 When does the Privacy Rule allow covered entities to disclose protected health information to law enforcement officials?
Blog Archives
January 2025 (1)
November 2022 (54)
Blog Labels
ePHI (2)
PPP Fraud (1)
HIPAA (2)
HIPAA Enforcement (3)
BAA (4)
Telehealth (1)
Data Breach (1)
EHR Fraud (1)
Covered Entity (40)
|
