This is the fourth in our series on provisions of the Department of Health and Human Services (HHS) proposed rule implementing the HITECH Act that, if included in the final rule, are likely to have the greatest impact on the business operations of pharmaceutical and other life sciences companies. We previously covered HHS’s proposed treatment of communications about currently prescribed drugs, remunerated treatment communications, and authorizations for future research.
Today we will address how HHS may relax the current restrictions on “compound authorizations” for research purposes.
HHS is proposing to amend the compound authorization requirements under the HIPAA Privacy Rule, which currently prohibit combining an authorization that conditions treatment, payment, enrollment in a health plan, or eligibility for benefits with an authorization for another purpose for which treatment, payment, enrollment, or eligibility may not be condition. HHS recognized that the excess paperwork that results from this restriction has been found to be burdensome and potentially confusing to patients, as well as administratively burdensome for clinical researchers.
The proposed rule would permit a covered entity to combine conditioned and unconditioned authorizations for research, so long as the authorization:
- clearly differentiates between the conditioned and unconditioned components; and
- provides the individual with an opportunity to opt in to the research activities described in the unconditioned authorization.
Pharmaceutical companies will want to pay close attention to whether this change is included in the final rule. Like the potential modification to the rules on authorization for future research, this amendment could have a significant impact on the conduct of clinical trials. Adoption of the proposal holds the potential to alleviate administrative burdens on both clinical trial subjects and researchers and to facilitate more uniformity in the documentation of global trials (since the compound authorization prohibition is unique to the United States).