Important Notice Regarding Individuals’ Right of Access to Health

On January 28, the HHS Office for Civil Rights issued an important notice regarding an individuals’ right of access to health records and more specifically, when a request is made to transmit medical records to a third party.

Here is the full transcript of the notice:

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.

What Healthcare Providers Should Know

The HIPAA Privacy Rule permits a covered entity to impose a reasonable, cost-based fee to provide the individual (or the individual’s personal representative) with a copy of the individual’s PHI, or to direct the copy to a designated third party. The fee may include only the cost of certain labor, supplies, and postage:

  1. Labor for copying the PHI requested by the individual, whether in paper or electronic form.  Labor for copying includes only labor for creating and delivering the electronic or paper copy in the form and format requested or agreed upon by the individual, once the PHI that is responsive to the request has been identified, retrieved or collected, compiled and/or collated, and is ready to be copied.  Labor for copying does not include costs associated with reviewing the request for access; or searching for and retrieving the PHI, which includes locating and reviewing the PHI in the medical or other record, and segregating or otherwise preparing the PHI that is responsive to the request for copying.
  2. Supplies for creating the paper copy (e.g.,  paper, toner) or electronic media (e.g., CD or USB drive) if the  individual requests that the electronic copy be provided on portable media.  However, a covered entity may not require an  individual to purchase portable media; individuals have the right to have their  PHI e-mailed or mailed to them upon request.
  3. Labor to prepare an explanation or summary of the PHI, if the individual in advance both chooses to receive an explanation or summary and agrees to the fee that may be charged.
  4. Postage, when the individual requests that the copy, or the summary or explanation, be mailed.

Thus, costs associated with updates to or maintenance of systems and data, capital for data storage and maintenance, labor associated with ensuring compliance with HIPAA (and other applicable law) in fulfilling the access request (e.g., verification, ensuring only information about the correct individual is included, etc.) and other costs not included above, even if authorized by State law, are not permitted for purposes of calculating the fees that can be charged to individuals.  See 45 CFR 164.524(c)(4).

Further, while the Privacy Rule permits the limited fee described above, covered entities should provide individuals who request access to their information with copies of their PHI free of charge.  While covered entities should forgo fees for all individuals, not charging fees for access is particularly vital in cases where the financial situation of an individual requesting access would make it difficult or impossible for the individual to afford the fee.  Providing individuals with access to their health information is a necessary component of delivering and paying for health care. We will continue to monitor whether the fees that are being charged to individuals are creating barriers to this access, will take enforcement action where necessary, and will reassess as necessary the provisions in the Privacy Rule that permit these fees to be charged.

Need Help with Your HIPAA Compliance Program?

At Colington Consulting, we specialize in helping healthcare organizations and business associates build proactive compliance programs. Contact us at 844-740-7100 or schedule a free 30-minute HIPAA risk review to evaluate your current policies and protect your organization.