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.
| HHS Issues Guidance on HIPAA and Audio-Only Telehealth Today, the U.S. Department of Health and Human Services (HHS), through its Office for Civil Rights (OCR), is issuing guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules, including when OCR’s Notification of Enforcement Discretion for Telehealth - PDF is no longer in effect. This guidance will help individuals ...read more |
| 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 |
| Dentist Revises Process to Safeguard Medical Alert PHI Covered Entity: Health Care Provider Issue: Safeguards, Minimum Necessary An OCR investigation confirmed allegations that a dental practice flagged some of its medical records with a red sticker with the word "AIDS" on the outside cover, and that records were handled so that other patients and staff without need to know could read the sticker. When notified of the complaint filed with OCR, the dental practice immediately removed the red AIDS sticker from the complainant's file. To resolve this matter, OCR also required the practice to revise its policies and operating ...read more |
| Direct Liability of Business Associates In 2009, Congress enacted the Health Information Technology for Economic and Clinical Health (HITECH) Act,1 making business associates of covered entities directly liable for compliance with certain requirements of the HIPAA Rules. Consistent with the HITECH Act, the HHS Office for Civil Rights (OCR) issued a final rule in 2013 to modify the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules.2 Among other things, the final rule identifies provisions of the HIPAA Rules that apply directly to business associates and for which business associates are directly liable.3 As set forth in the HITECH ...read more |
|
July 2026
| 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
January 2025 (1)
November 2022 (54)
Blog Labels
EHR Fraud (1)
Telehealth (1)
Data Breach (1)
BAA (4)
PPP Fraud (1)
Covered Entity (40)
ePHI (2)
HIPAA Enforcement (3)
HIPAA (2)
|
