No Business Associate Agreement? $31K Mistake

The Center for Children’s Digestive Health (CCDH) has paid the U.S. Department of Health and Human Services (HHS) $31,000 to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule and agreed to implement a corrective action plan. CCDH is a small, for-profit health care provider with a pediatric subspecialty practice that operates its practice in seven clinic locations in Illinois.

In August 2015, the HHS Office for Civil Rights (OCR) initiated a compliance review of the Center for Children’s Digestive Health (CCDH) following an initiation of an investigation of a business associate, FileFax, Inc., which stored records containing protected health information (PHI) for CCDH. While CCDH began disclosing PHI to Filefax in 2003, neither party could produce a signed Business Associate Agreement (BAA) prior to Oct. 12, 2015.

TYLER, Texas — U.S. Attorney John M. Bales announced today that a former employee of an East Texas hospital has pleaded guilty to criminal HIPAA charges in the Eastern District of Texas. Joshua Hippler, 30, formerly of Longview, Texas, was indicted on March 26, 2014, on charges of Wrongful Disclosure of Individually Identifiable Health Information. Hippler pleaded guilty on August 28, 2014 during a hearing before United States Magistrate Judge John D. Love. The indictment alleged that from December 1, 2012, through January 14, 2013, Hippler, who was then an employee of a covered entity under HIPAA, obtained protected ...read more

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; ...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

Hospital Issues Guidelines Regarding Disclosures to Avert Threats to Health or Safety Covered Entity: General Hospital Issue: Safeguards; Impermissible Uses and Disclosures; Disclosures to Avert a Serious Threat to Health or Safety After treating a patient injured in a rather unusual sporting accident, the hospital released to the local media, without the patient’s authorization, copies of the patient’s skull x-ray as well as a description of the complainant’s medical condition. The local newspaper then featured on its front page the individual’s x-ray and an article that included the date of the accident, the location of the accident, the patient’s ...read more

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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?

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