Mike Saag, MD, HIVMA Chair, submitted comments on behalf of HIVMA to the U.S. Department of Health and Human Services Office for Civil Rights regarding proposed modifications to Health Insurance Portability and Accountability Act (HIPAA) rules.
HIVMA strongly supports efforts to minimize HIPAA regulatory and administrative burdens that can encumber clinical research, while also ensuring strong patient privacy protections.
We recommend that HHS conduct additional focused outreach to patients and clinical trial participants to more fully solicit their views regarding authorizations for future research and biospecimen use.
Such outreach could help improve clarity and comprehension of patient authorization content, while also providing a public education opportunity that could promote research literacy and support.
We [also] urge that HIV disease be given special protections similar to those provided for other potentially sensitive research activities, such as research involving genetic analyses or mental health information.
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