United States: Final HIPAA / HITECH Regulations Published: Revisions That Impact Research Activities

Last Updated: January 29 2013
Article by Jennifer J. Daniels


The long-awaited HIPAA/HITECH Final Rule is out! The Final Rule - titled Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules - includes several provisions that impact research activities, most of which are consistent with the proposed rule published on July 14, 2010. And, while in many ways the Final Rule makes things harder for Covered Entities and Business Associates, research involving the use of Protected Health Information just got a little easier.

Compound Authorizations

As those involved in human subject research know, from the beginning, the Privacy Rule created enormous headaches for researchers because it prohibited Covered Entities from combining an authorization for research that conditions research-related treatment upon the signing of the authorization (conditioned research) with another authorization for research that does not condition treatment upon the signing of an authorization (unconditioned research). So, for example, an authorization to participate in a clinical trial for a study drug could not be combined with an authorization to bank data and tissue samples or to participate in an optional sub-study.

The Final Rule adopts the proposal to amend 45 C.F.R. § 164.508(b)(3)(i) and (iii) to allow a Covered Entity to combine conditioned and unconditioned authorizations for research, provided that the compound authorization (1) clearly differentiates between the conditioned and unconditioned research components, and (2) clearly allows the individual the option to opt-in to the unconditioned research activities. The Final Rule permits the use of compound authorizations for any type of research activities, including optional sub-studies, and secondary future use of data (to the extent secondary future use is permitted by the Final Rule as discussed below), except where the research involves the use and/or disclosure of psychotherapy notes.

The Final Rule does not allow an authorization to include an option to opt-out of the unconditioned research activities. So, for example, the authorization cannot say "check here if you do not want your data provided to the biospecimens bank." In the commentary to the Final Rule, the Department of Health and Human Services (HHS) approves of three methods proposed by the Secretary's Advisory Committee on Human Research Protections (SACHRP) to obtain the necessary opt-in for unconditioned research activities: (1) a combined consent / authorization form for a clinical trial and optional banking component, with a check-box for the individual to have the choice to opt-in to the optional banking component, and one signature; (2) a combined consent / authorization form for a clinical trial and optional banking component, with one signature for the clinical trial and another signature to indicate the individual agrees to the optional banking component; and (3) a combined consent / authorization form for a clinical trial and optional banking component, with a check box to opt-in to the banking component, one signature, but with the detailed information about the banking presented in a separate brochure or information sheet referenced directly in the consent / authorization form. HHS clarifies that, for the third approach, the brochure or information sheet must be incorporated by reference into the authorization / consent form such that it is considered part of the form. In addition, if the brochure or information sheet includes any of the required elements of the authorization, and the authorization has not been altered by an IRB approved waiver, then the brochure / information sheet must be made available to potential research participants before they are asked to sign the authorization. Finally, in such cases, a Covered Entity must keep not only the signed authorization, but also a copy of the brochure or information sheet, in order to comply with documentation requirements under the Privacy Rule.

HHS explains in the preamble that Covered Entities are permitted but are not required to create compound authorizations for conditioned and unconditioned research activities. So, researchers may choose to use separate authorization forms. HHS makes clear that Covered Entities and researchers have flexibility in the methods used to distinguish the conditioned and unconditioned research activities and to provide the individual with a clear opportunity to opt-in to the unconditioned portions.

In response to a comment asking whether a portion of the compound authorization can be revoked without revoking the entire authorization, HHS clarifies that, where it is clear that an individual is revoking only part of a compound authorization, then the researchers can proceed accordingly. If it is not clear that only a specific part of the compound authorization is being revoked, then the researchers must either obtain written clarification from the participant or the entire authorization must be treated as revoked.

Authorization for Future Research Uses

Since its initial promulgation, HHS has interpreted Section 164.508(c)(1)(iv) of the Privacy Rule to require that authorizations for research be study specific. In other words, HHS took the position that a Covered Entity could not obtain an authorization from an individual that allowed PHI to be used for future, unspecified research, but rather each authorization had to specify the study for which PHI would be used and disclosed. As one scientist at a pharmaceutical company once put it to me, Ford Motor Company is allowed to take data it obtained from the last car it built to build a better car, but HIPAA prevents pharmaceutical manufacturers from using data collected in one study to build a better study the next time. So, to comply with the Privacy Rule, research sponsors jumped through hoops to be able to use PHI collected from one study for additional purposes, including forever tinkering with informed consent language to try to provide as specific a description as possible while still allowing for some flexibility to conduct additional research in the future, and adding broad data use language to clinical trial agreements to allow for the use of a limited data set in future research studies.

Now, HHS has modified the requirement that research authorizations be study specific. This modification does not make any changes to the authorization requirements in the regulations themselves - a HIPAA authorization for future research must still address each of the core elements required by § 164.508(c). But, in the preamble to the Final Rule, HHS says that it no longer interprets the "purpose" provision in § 164.508(c)(1)(iv) as requiring that an authorization be study specific. In order to satisfy the requirement that an authorization include a description of each purpose of the requested use or disclosure, HHS explains that an authorization for future research must adequately describe such purposes such that it would be reasonable for the individual to expect that his or her PHI could be used or disclosed for such future research. This could include specific statements with respect to sensitive research to the extent such research is contemplated. HHS clarifies that its intent is to give Covered Entities, researchers and IRBs flexibility in determining what adequately describes future research purposes.

It is important to note that HHS is not permitting authorizations to simply state that PHI may be used for future, unspecified research. HHS has aimed to bring the requirements for specificity under HIPAA in line with what is required by the Common Rule, which is to seek informed consent for future research so long as the future research uses are described in sufficient detail to allow an informed consent.

Also, HHS explains in the preamble to the Final Rule that there is no prohibition against the description of the information to be used or disclosed including PHI created after the end of the main study (e.g., allowing for disclosure of "your future medical records relating to a particular disease / condition").

Sale of PHI

Section 13405(d)(1) of the HITECH Act prohibits a Covered Entity or Business Associate from receiving direct or indirect remuneration in exchange for the disclosure of PHI unless the Covered Entity or Business Associate has obtained an individual's authorization pursuant to Section 164.508 that states whether the PHI can be further exchanged for remuneration by the entity receiving the information. The statute provides for several exceptions from the prohibition, which the Final Rule adopts, but HHS makes certain clarifications as to its scope. HHS creates a new defined term in the final rule for "sale of protected health information," which sale requires specific authorization. The defined term explicitly excludes disclosures for research purposes where the only remuneration received by the Covered Entity or Business Associate is a reasonable, cost-based fee to cover the cost to prepare and transmit the PHI for such purposes.

HHS does not consider a "sale of PHI" to encompass payments that a Covered Entity may receive in the form of grants, or contracts or other arrangements to perform research activities, because any provision of PHI to the payer is a byproduct of the service being provided to the payer by the Covered Entity. HHS explains, therefore, that the payment by a research sponsor to a Covered Entity to conduct a research study is not considered a "sale of PHI," even if the research results disclosed to the sponsor include PHI. Similarly, the receipt of a grant or funding from a government agency to conduct a research program is not a sale of PHI, even if some PHI is released to the government agency. But, a disclosure of PHI by a Covered Entity to an outside researcher, where the outside researcher is conducting research in exchange for remuneration and no services are being performed by the Covered Entity in exchange for the payment, would be considered a "sale of PHI," unless the only remuneration received by the Covered Entity is a reasonable, cost-based fee to cover the cost to prepare and transmit the data for such purposes. In determining whether the fee is reasonable, the Covered Entity can consider direct and indirect costs, including labor, materials and supplies for generating, storing, retrieving and transmitting PHI, related costs and overhead. However, HHS is clear that fees charged to incur a profit from the disclosure of PHI are not allowed without authorization.

HHS explains in the preamble to the Final Rule that ongoing research projects under existing authorizations, waivers of authorization or data use agreements are grandfathered such that the Covered Entity need not obtain a new authorization if there is a disclosure involved that amounts to a "sale of PHI." HHS goes on to say that the Covered Entity or Business Associate, not the IRB, is responsible for determining whether any fees paid to the Covered Entity or Business Associate in exchange for PHI cover only the Covered Entity's or Business Associate's costs to prepare and transmit PHI for research. Based on this discussion in the preamble - which indicates that an IRB is not in a position to determine whether a fee paid to a researcher is "a reasonable, cost-based fee to cover the cost to prepare and transmit the data" - it is unclear whether an IRB is able to waive the need for an authorization under § 164.512(i) for research where there is payment made for the disclosure of PHI. It may be that an IRB would grant a waiver of the need for an authorization if the Covered Entity certifies that any payment is a reasonable, cost based fee to cover the cost to prepare and transmit the data.

HHS refuses in the Final Rule to exclude a Limited Data Set from the prohibition on a sale of PHI. A Covered Entity may continue to use and/or disclose a Limited Data Set in accordance with an existing Data Use Agreement until the Data Use Agreement is renewed or is modified or until one (1) year from the compliance date of the Final Rule, whichever is earlier, even if the disclosure would otherwise require authorization because of remuneration paid for PHI.

Effective Date

The Final Rule is effective March 26, 2013. Covered Entities, Business Associates and Subcontractors will have 180 days beyond the effective date to come into compliance, which 180 days expire on September 23, 2013.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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Jennifer J. Daniels
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