AI

Apr 12 2023

Emerging Technologies, Human Subject Research, and the Common Rule: High level overview of the 2023 OHRP Research Community Forum

Earlier this month, WPF attended a joint conference focused on the shifting dynamics of how the Common Rule that governs human subject research in the US will be interpreted amidst new technological shifts such as AI. The department of Health and Human Services is seeking to define what the next steps and new policy frameworks should be to ensure the Common Rule protects individuals in current and future research environments. Details on the presentations, conversations, and key takeaways in the post.

Jan 27 2023

NIST releases milestone AI Risk Management Framework to foster trustworthy AI ecosystems

This week has been an important one for U.S. policy regarding rights-preserving artificial intelligence and how to manage, define, and improve AI in practical implementations. There are two significant news items. First, the National Institute of Technology and Standards (NIST) has released its milestone AI Risk Management Framework (1.0) for voluntary use. The AI Risk

Aug 31 2022

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.

Jun 10 2022

Regulatory techniques and risk-based approaches in AI and machine learning

WPF has been invited to speak before the Brazilian Senate on the topic of the challenge of regulatory models for AI and machine learning systems. WPF Executive Director Pam Dixon will be testifying as an expert in this informational session; she was a delegate in creating the OECD AI Guidelines, and she currently co-leads the

May 16 2022

ISPI Forum on Digital Transformation, WPF speaker

The Italian Institute for International Political Studies (ISPI) will be holding a High Level Forum on Digital Transformation in connection with OECD. The event will be held 16 May 2022 in hybrid format. WPF will be speaking about what risks exists for consumers arising from illicit use of their personal data, and also approaches for

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.
COVID-19 and HIPAA: HHS’s Troubled Approach to Waiving Privacy and Security Rules for the Pandemic

The COVID-19 pandemic strained the U.S. health ecosystem in numerous ways, including putting pressure on the HIPAA privacy and security rules. The Department of Health and Human Services adjusted the privacy and security rules for the pandemic through the use of statutory and administrative HIPAA waivers. While some of the adjustments are appropriate for the emergency circumstances, there are also some meaningful and potentially unwelcome privacy and security consequences. At an appropriate time, the use of HIPAA waivers as a response to health care emergencies needs a thorough review. This report sets out the facts, identifies the issues, and proposes a roadmap for change.