National Institutes of Health (NIH)

Apr 30 2024

WPF advises FDA and HHS on informed consent guidance for medical research

The World Privacy Forum filed detailed comments regarding draft guidance on privacy and medical research to the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration. The proposed guidance, Facilitating Understanding in Informed Consent, is related to consent for human subject research (medical research) and is particularly important. Currently, models of consent are in the process of going digital, which has created a number of challenging problems to solve. In the comments, WPF had several recommendations to improve consent and privacy.

Aug 08 2007

World Privacy Forum responds to June 2007 NCVHS recommendations to the Secretary of HHS regarding health care information at non-HIPAA covered entities

Medical privacy | NCVHS | HIPAA — The World Privacy Forum has sent a letter to Dr. Simon P. Cohn, Chairman of the National Committee on Vital and Health Statistics, supporting the Committee’s formal conclusion that all entities that create, compile, store, transmit, or use personally identifiable health information should be covered by a federal privacy law. More needs to be done about health care data that is left unprotected by HIPAA. The Forum’s letter included a discussion of two HHS programs that operate outside of HIPAA: FDA RiskMAPS, and the National Institutes of Health, which is not a covered entity under HIPAA.

May 23 2007

Public Comments: May 2007 – NIH….World Privacy Forum files public comments and recommendations on pharmacogenomics privacy: all patient-specific PGx research should require certificates of confidentiality

The World Privacy Forum believes that the capability of identifying individuals from subsets of genetic information will expand greatly in the future. In public comments filed with the National Institutes of Health on pharmacogenomics (PGx) research, or research using genetic information to create highly personalized medicine, the World Privacy Forum recommended that all research activities that involve any type of patient-specific genetic information be required to have certificates of confidentiality, whether that information appears identifiable or not. The WPF also urged the NIH to require strong data use agreements to protect individuals’ privacy. The WPF also urged NIH and the Department of Health and Human Services to reinstate the position of “privacy advocate” so as to provide oversight in this area. Read the comments (PDF). For more information, see the genetic section of the WPF Medical Privacy Page.

Oct 31 2006

World Privacy Forum Comments on Proposed Policy for Genetic Database

Genetic privacy — Genome-wide association studies present complex and challenging privacy issues. The National Institutes of Health, in a published request for information, asked for public comment on its proposed policy regarding its support and management of a central genomic repository for genome-wide association studies. In comments filed with the National Institutes of Health, the World Privacy Forum raised concerns about the proposed NIH policy in the specific areas of genetic identifiability, secondary uses of the genetic data, oversight, legal protections, and informed consent.

Oct 29 2006

Public Comments: October 2006 Comments to National Institutes of Health regarding its Request for Information for Genome Wide Association Studies repository policy.

Genome-wide association studies present complex and challenging privacy issues. The National Institutes of Health, in a published request for information, asked for public comment on its proposed policy regarding its support and management of a central genomic repository for genome-wide association studies. In comments filed with the National Institutes of Health, the World Privacy Forum raised concerns about the proposed NIH policy in the specific areas of genetic identifiability, secondary uses of the genetic data, oversight, legal protections, and informed consent.

New Report: Risky Analysis: Assessing and Improving AI Governance Tools

We are pleased to announce the publication of a new WPF report, “Risky Analysis: Assessing and Improving AI Governance Tools.” This report sets out a definition of AI governance tools, documents why and how these tools are critically important for trustworthy AI, and where these tools are around the world. The report also documents problems in some AI governance tools themselves, and suggests pathways to improve AI governance tools and create an evaluative environment to measure their effectiveness. AI systems should not be deployed without simultaneously evaluating the potential adverse impacts of such systems and mitigating their risks, and most of the world agrees about the need to take precautions against the threats posed. The specific tools and techniques that exist to evaluate and measure AI systems for their inclusiveness, fairness, explainability, privacy, safety and other trustworthiness issues — called in the report collectively AI governance tools – can improve such issues. While some AI governance tools provide reassurance to the public and to regulators, the tools too often lack meaningful oversight and quality assessments. Incomplete or ineffective AI governance tools can create a false sense of confidence, cause unintended problems, and generally undermine the promise of AI systems. The report contains rich background details, use cases, potential solutions to the problems discussed in the report, and a global index of AI Governance Tools.
National IDs Around the World — Interactive map

About this Data Visualization: This interactive map displays the presence...
Report: From the Filing Cabinet to the Cloud: Updating the Privacy Act of 1974

This comprehensive report and proposed bill text is focused on the Privacy Act of 1974, an important and early Federal privacy law that applies to the government sector and some contractors. The Privacy Act was written for the 1970s information era -- an era that was characterized by the use of mainframe computers and filing cabinets. Today's digital information era looks much different than the '70s: smart phones are smarter than the old mainframes, and documents are now routinely digitized and stored and perhaps even analyzed in the cloud, among many other changes. The report focuses on why the Privacy Act needs an update that will bring it into this century, and how that could look and work. This work was written by Robert Gellman, and informed by a two-year multi-stakeholder process.