York County Medicine Spring 2020 - 30

YO R K C O M E D S O C . O R G

IN THE NEWS:

Federal Court Vacates
Portions of Third-Party
Directive for Delivery of
PHI and Fee Limitations
for Third Party Requests

W

ith its recent decision in the case of Ciox Health
LLC v. Azar et al., the United States District Court
for the District of Columbia has invalidated two
administrative provisions regarding the transmittal of protected
health information (PHI) to third parties.
The Court vacated portions of the Omnibus Rule, a set of
federal regulations promulgated by the Department of Health and
Human Services (HHS) in 2013, insofar as the regulations expand
the Health Information Technology for Economic and Clinical
Health (HITECH) Act's third-party directive beyond requests for
a copy of an electronic health record (EHR) with respect to PHI
of an individual in an electronic format. Additionally, the Court
also declared guidance issued by HHS in 2016 that expanded the
application of regulatory fee limitations to an individual's request
to transmit PHI to a third party unlawful.
Following this decision, the HHS Office of Civil Rights
(OCR) issued an Important Notice Regarding Individuals' Right of
Access to Health Records, which can be accessed here https://www.
hhs.gov/hipaa/court-order-right-of-access/index.html. In this
Notice, OCR addresses the district court's order and reaffirms
its commitment to enforcing those rights not restricted by the
court order. The right of individuals to access their own records,
OCR declares, and the fee limitations that apply when individuals
exercise this right are undisturbed and remain in effect.

Background of the Case
In 2018, Ciox Health, a specialized medical records provider
that contracts with healthcare suppliers nationwide to maintain,
retrieve, and produce individual's PHI, brought suit against HHS
challenging the third-party directive of the Omnibus Rule as well
30

York County Medicine | SPRING 2020

as HHS guidance on fee limitations on the delivery of PHI to
third parties amongst other claims.

Third-Party Directive
The HITECH Act as well as the Health Insurance Portability
and Accountability Act of 1996 (HIPAA) and their accompanying
regulations set forth an array of individual rights with respect
to PHI. The HITECH Act was enacted in 2009 to promote the
adoption and meaningful use of health information technology
including the implementation of EHRs and other supporting
technologies.
Regarding an individual's right to receive a copy of electronic
PHI or request that such records be transmitted to a third party,
the HITECH Act provides, at 42 USC ยง17935(e)(1), that "in the
case that a covered entity uses or maintains an electronic health
record (EHR) with respect to" PHI, an individual has "a right to
obtain a copy of such information in an electronic format" and to
"transmit such copy" to a third party.
In 2013, HHS promulgated a set of regulations known as
the Omnibus Rule. These regulations directed covered entities
to transmit PHI maintained in any format to a third party, per a
patient's request, in the form and format requested by a patient if
readily producible in that form and format.
Ciox Health challenged the Omnibus Rule's expansion of
the third-party directive by arguing this expansion exceeded the
statutory authority endowed to HHS under the HITECH Act.
The Court agreed that HHS exceeded their statutory authority in
expanding the third-party directive to mandate delivery of PHI
regardless of whether such information is contained in an EHR.


http://www.YORKCOMEDSOC.ORG https://www.hhs.gov/hipaa/court-order-right-of-access/index.html https://www.hhs.gov/hipaa/court-order-right-of-access/index.html

York County Medicine Spring 2020

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