The Department of Health and Human Services’ Office for Civil Rights has released an announcement that certain legislative changes regarding individuals’ right of access to health records have been reversed. Here is that statement:
On January 25, 2013, HHS published a final rule entitled “Modifications to the HIPAA Privacy, Security, and Enforcement Rules Under the Health Information Technology for Economic and Clinical Health Act, and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules.” (2013 Omnibus Rule). A portion of that rule was challenged in federal court, specifically provisions within 45 C.F.R. §164.524, that cover an individual’s access to protected health information.
On January 23, 2020, a federal court vacated the “third-party directive” within the individual right of access “insofar as it expands the HITECH Act’s third-party directive beyond requests for a copy of an electronic health record with respect to [protected health information] of an individual . . . in an electronic format.” Additionally, the fee limitation set forth at 45 C.F.R. § 164.524(c)(4) will apply only to an individual’s request for access to their own records, and does not apply to an individual’s request to transmit records to a third party.
The right of individuals to access their own records and the fee limitations that apply when exercising this right are undisturbed and remain in effect. OCR will continue to enforce the right of access provisions in 45 C.F.R. § 164.524 that are not restricted by the court order. A copy of the court order in Ciox Health, LLC v. Azar, et al., No. 18-cv-0040 (D.D.C. January 23, 2020), may be found at https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2018cv0040-51.
The reversal follows the conclusion of legal action by the medical records provider, Ciox Health, who challenged the changes that were made in 2016. Ciox Health contracts with healthcare providers to maintain, retrieve, and produce individuals’ PHI and handles tens of millions of requests for PHI annually. The court has now declared the changes unlawful and vacated the 2016 expansion of fee limitations and the 2013 mandate broadening PHI delivery to third parties regardless of format.
To better understand how this reversal might affect your organization, please contact the HIPAA experts at PrivaPlan.