Do the HIPAA Rules allow a covered entity or business associate to use a CSP that stores ePHI on servers outside of the United States? Do the HIPAA Rules allow a covered entity or business associate to use a CSP that stores ePHI on servers outside of the United States?
Issued by: Office for Civil Rights (OCR)
Do the HIPAA Rules
allow a covered entity or business associate to use a CSP that stores
ePHI on servers outside of the United States?
Answer:
Yes, provided the covered entity (or business associate) enters into a
business associate agreement (BAA) with the CSP and otherwise complies
with the applicable requirements of the HIPAA Rules. However, while the
HIPAA Rules do not include requirements specific to protection of
electronic protected health information (ePHI) processed or stored by a
CSP or any other business associate outside of the United States, OCR
notes that the risks to such ePHI may vary greatly depending on its
geographic location. In particular, outsourcing storage or other
services for ePHI overseas may increase the risks and vulnerabilities to
the information or present special considerations with respect to
enforceability of privacy and security protections over the data.
Covered entities (and business associates, including the CSP) should
take these risks into account when conducting the risk analysis and risk
management required by the Security Rule. See 45 CFR §§
164.308(a)(1)(ii)(A) and (a)(1)(ii)(B). For example, if ePHI is
maintained in a country where there are documented increased attempts at
hacking or other malware attacks, such risks should be considered, and
entities must implement reasonable and appropriate technical safeguards
to address such threats.
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 ...read more |
Health Sciences Center Revises Process to Prevent Unauthorized Disclosures to Employers Covered Entity: General Hospitals Issue: Impermissible Uses and Disclosures; Authorizations A state health sciences center disclosed protected health information to a complainant's employer without authorization. Among other corrective actions to resolve the specific issues in the case, including mitigation of harm to the complainant, OCR required the Center to revise its procedures regarding patient authorization prior to release of protected health information to an employer. All staff was trained on the revised procedures. ...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 |
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 |
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