What if a HIPAA covered entity (or business associate) uses a CSP to maintain ePHI without first executing a business associate agreement with that CSP? What if a HIPAA covered entity (or business associate) uses a CSP to maintain ePHI without first executing a business associate agreement with that CSP?
Issued by: Office for Civil Rights (OCR)
What if a HIPAA covered
entity (or business associate) uses a CSP to maintain ePHI without
first executing a business associate agreement with that CSP?
Answer:
If a covered entity (or business associate) uses a CSP to maintain
(e.g., to process or store) electronic protected health information
(ePHI) without entering into a BAA with the CSP, the covered entity (or
business associate) is in violation of the HIPAA Rules. 45 C.F.R
§§164.308(b)(1) and §164.502(e). OCR has entered into a resolution agreement and corrective action plan
with a covered entity that OCR determined stored ePHI of over 3,000
individuals on a cloud-based server without entering into a BAA with the
CSP.[1]
Further, a CSP that meets the definition of a business associate –
that is a CSP that creates, receives, maintains, or transmits PHI on
behalf of a covered entity or another business associate – must comply
with all applicable provisions of the HIPAA Rules, regardless of whether
it has executed a BAA with the entity using its services. See 78 Fed.
Reg. 5565, 5598 (January 25, 2013). OCR recognizes that there may,
however, be circumstances where a CSP may not have actual or
constructive knowledge that a covered entity or another business
associate is using its services to create, receive, maintain, or
transmit ePHI. The HIPAA Rules provide an affirmative defense in cases
where a CSP takes action to correct any non-compliance within 30 days
(or such additional period as OCR may determine appropriate based on the
nature and extent of the non-compliance) of the time that it knew or
should have known of the violation (e.g., at the point the CSP knows or
should have known that a covered entity or business associate customer
is maintaining ePHI in its cloud). 45 CFR 160.410. This affirmative
defense does not, however, apply in cases where the CSP was not aware of
the violation due to its own willful neglect.
If a CSP becomes aware that it is maintaining ePHI, it must come into
compliance with the HIPAA Rules, or securely return the ePHI to the
customer or, if agreed to by the customer, securely destroy the ePHI.
Once the CSP securely returns or destroys the ePHI (subject to
arrangement with the customer), it is no longer a business associate.
We recommend CSPs document these actions.
While a CSP maintains ePHI, the HIPAA Rules prohibit the CSP from
using or disclosing the data in a manner that is inconsistent with the
Rules.
| 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 |
| HMO Revises Process to Obtain Valid Authorizations Covered Entity: Health Plans / HMOs Issue: Impermissible Uses and Disclosures; Authorizations A complaint alleged that an HMO impermissibly disclosed a member’s PHI, when it sent her entire medical record to a disability insurance company without her authorization. An OCR investigation indicated that the form the HMO relied on to make the disclosure was not a valid authorization under the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, the HMO created a new HIPAA-compliant authorization form and implemented a new policy that directs staff to obtain patient signatures ...read more |
| Radiologist Revises Process for Workers Compensation Disclosures Covered Entity: Health Care Provider Issue: Impermissible Uses and Disclosures A radiology practice that interpreted a hospital patient’s imaging tests submitted a worker’s compensation claim to the patient’s employer. The claim included the patient’s test results. However, the patient was not covered by worker’s compensation and had not identified worker’s compensation as responsible for payment. OCR’s investigation revealed that the radiology practice had relied upon incorrect billing information from the treating hospital in submitting the claim. Among other corrective actions to resolve the specific issues in the case, the practice apologized to ...read more |
| DOVER (Oct. 21, 2022) – The Delaware Division of Developmental Disabilities Services is announcing today that it is mailing letters to service recipients and legal guardians who were impacted by a recent data breach incident and is providing information to the public regarding the incident. On August 23, 2022, staff within the Division of Developmental Disabilities Services (DDDS) discovered that in the process of creating new user accounts in the division’s client database, DDDS staff inadvertently provided access to individual records of 7074 individuals. As a result of these actions, 159 new users had potential access to service recipients’ ...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
November 2022 (54)
January 2025 (1)
Blog Labels
Data Breach (1)
EHR Fraud (1)
Telehealth (1)
Covered Entity (40)
HIPAA Enforcement (3)
PPP Fraud (1)
ePHI (2)
HIPAA (2)
BAA (4)
|
