No Business Associate Agreement? Big Mistake

No Business Associate Agreement? Big Mistake

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.



Health Plan Corrects Computer Flaw that Caused Mailing of EOBs to Wrong Persons Covered Entity: Health Plans Issue: Safeguards A national health maintenance organization sent explanation of benefits (EOB) by mail to a complainant's unauthorized family member. OCR's investigation determined that a flaw in the health plan's computer system put the protected health information of approximately 2,000 families at risk of disclosure in violation of the Rule. Among the corrective actions required to resolve this case, OCR required the insurer to correct the flaw in its computer system, review all transactions for a six month period and correct all ...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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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

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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?

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