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.

Physician Revises Faxing Procedures to Safeguard PHI Covered Entity: Health Care Provider Issue: Safeguards A doctor's office disclosed a patient's HIV status when the office mistakenly faxed medical records to the patient's place of employment instead of to the patient's new health care provider. The employee responsible for the disclosure received a written disciplinary warning, and both the employee and the physician apologized to the patient. To resolve this matter, OCR also required the practice to revise the office's fax cover page to underscore a confidential communication for the intended recipient. The office informed all its employees of the ...read more

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 Any provision within this guidance that has been vacated by the Ciox Health decision is rescinded.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

National Pharmacy Chain Extends Protections for PHI on Insurance Cards Covered Entity: Pharmacies Issue: Impermissible Uses and Disclosures; Safeguards A pharmacy employee placed a customer's insurance card in another customer's prescription bag. The pharmacy did not consider the customer's insurance card to be protected health information (PHI). OCR clarified that an individual's health insurance card meets the statutory definition of PHI and, as such, needs to be safeguarded. Among other corrective actions to resolve the specific issues in the case, the pharmacy revised its policies regarding PHI and retrained its staff. The revised policies are applicable to all individual ...read more

SCOPE OF CRIMINAL ENFORCEMENT UNDER 42 U.S.C. § 1320d-6 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, and the knowingly element of the offense set forth in that provision requires only proof of knowledge of the facts that constitute the offense. MEMORANDUM OPINION FOR THE GENERAL COUNSEL DEPARTMENT OF HEALTH AND HUMAN SERVICES AND THE SENIOR COUNSEL TO THE DEPUTY ATTORNEY GENERAL You have asked jointly for our opinion concerning the scope of 42 U.S.C. § 1320d-6 (2000), the criminal enforcement provision of the ...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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