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.

Can a covered entity use existing aspects of the HIPAA Privacy Rule to give individuals the right to decide whether sensitive information about them may be disclosed to or through a health information organization (HIO)? Yes. To the extent a covered entity is using a process either to obtain consent or act on an individual’s right to request restrictions under the Privacy Rule as a method for effectuating individual choice, policies can be developed for obtaining consent or honoring restrictions on a granular level, based on the type of information involved. For example, specific consent and restriction policies could ...read more

May a covered entity dispose of protected health information in dumpsters accessible by the public? For example, depending on the circumstances, proper disposal methods may include (but are not limited to): Shredding or otherwise destroying PHI in paper records so that the PHI is rendered essentially unreadable, indecipherable, and otherwise cannot be reconstructed prior to it being placed in a dumpster or other trash receptacle.Maintaining PHI for disposal in a secure area and using a disposal vendor as a business associate to pick up and shred or otherwise destroy the PHI.In justifiable cases, based on the size and the ...read more

State Hospital Sanctions Employees for Disclosing Patient's PHI Covered Entity: Health Care Provider / General Hospital Issue: Impermissible Disclosure A nurse and an orderly at a state hospital discussed the HIV/AIDS status of a patient and the patient's spouse within earshot of other patients without making reasonable efforts to prevent the disclosure. Upon learning of the incident, the hospital placed both employees on leave; the orderly resigned his employment shortly thereafter. Among other actions taken to satisfactorily resolve this matter, the hospital took further disciplinary action with the nurse, which included: documenting the employee record with a memo of ...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

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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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