Human Subject Research Protection

WPF advises Secretary’s Advisory Committee on Human Research Protection regarding its proposed AI Framework

WPF recently reviewed and provided recommendations regarding a proposed AI Framework meant to apply to medical research involving human subjects. The issue of human subject research is a critically important one. In the US, The Common Rule (45 CFR subpart A) is a key regulation that protects people from unethical medical research. As research utilizing tools such as AI and SaMD — software as a medical device — grows in use, there is an urgent need to determine the proper ethical, legal, and regulatory framework for the use of these tools in the human subject research context. For this reason, WPF was pleased to review and provide recommendations to the Secretary’s Advisory Committee on Human Research Protections, SACHRP, on its proposed AI Framework.

WPF urges National Institutes of Health to expand privacy guidance for researchers

WPF is urging the National Institutes of Health to do more to properly advise the research community and to protect data subjects in its draft guidance on data management and sharing. WPF is asking for changes to the NIH guidance because in the US, much health research data in the hands of researchers is not subject to the privacy or security rules in HIPAA.

WPF to testify before NCVHS on emerging privacy concerns in health privacy — Beyond Digitization: Artificial Intelligence, APIs, and health privacy

WPF Executive Director Pam Dixon will testify before the full committee of the National Committee on Vital and Health Statistics (NCVHS) regarding emerging privacy concerns in the healthcare environment, including the role of artificial intelligence, patient authorizations, and automated access to patient health information.  The NCVHS is the statutory [42 U.S.C. 242k(k)] public advisory body

WPF files comments on US government proposal on confidentiality of drug/alcohol patient records, urges revisions

The World Privacy Forum commented on an important proposal to make changes to the existing rules regarding the confidentiality of alcohol and drug abuse patient records. The proposal is from the Substance Abuse and Mental Health Services Administration (SAMHSA), part of the US Department of Health and Human Services. These proposed rule changes are important, as the current

WPF Comments about Privacy and Big Data: Ethical Framework and Rights Essential

The World Privacy Forum filed comments with the U.S. Department of Commerce in response to its Request for Comments about big data, privacy, and the Consumer Privacy Bill of Rights. The White House Big Data report recognized that Big Data “raises considerable questions about how our framework for privacy protection applies in a big data ecosystem” and has the potential to “eclipse longstanding civil rights protections in how personal information is used in housing, credit, employment, health, education, and the marketplace.” This is among our concerns as well, and our comments focused on understanding big data’s benefits while drawing attention to where there are significant privacy risks that need to be addressed.