Graphic of a brain with a circuitry design within it

A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance

By David Arney, Max Senges, Sara Gerke, Cansu Canca, Laura Haaber Ihle, Nathan Kaiser, Sujay Kakarmath, Annabel Kupke, Ashveena Gajeele, Stephen Lynch, Luis Melendez

A new working paper from participants in the AI-Health Working Group out of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Berkman Klein Center for Internet & Society at Harvard University sets forth a research agenda for stakeholders (researchers, practitioners, entrepreneurs, policy makers, etc.) to proactively collaborate and design AI technologies that work with users to improve their health and wellbeing.

Along with sections on Technology and a Healthy Good Life as well as Data, the authors focus a section on Nudging, a concept that “alters people’s behavior in a predictable way without forbidding any options,“ and tie nudging into AI technology in the healthcare context.     Read More

Graphic of sheets with algorithms shaped into a neuron

The Tricky Task of Defining AI in the Law

By Sara Gerke and Joshua Feldman

Walking her bike across an Arizona road, a woman stares into the headlights of an autonomous vehicle as it mistakenly speeds towards her. In a nearby health center, a computer program analyzes images of a diabetic man’s retina to detect damaged blood vessels and suggests that he be referred to a specialist for further evaluation – his clinician did not need to interpret the images. Meanwhile, an unmanned drone zips through Rwandan forests, delivering life-saving vaccines to an undersupplied hospital in a rural village.

From public safety to diagnostics to the global medical supply chain, artificial intelligence (AI) systems are increasingly making decisions about our health. Legislative action will be required to address these innovations and ensure they improve wellbeing safely and fairly.

In order to draft new national laws and international guidelines, we will first need a definition of what constitutes artificial intelligence. While the examples above underscore the need of such a definition, they also illustrate the difficulty of this task: What is uniquely common between self-driving cars, diagnostic tools, and drones? Read More

The German Stem Cell Network Has Compiled a Sample Text for Informed Consent

By Sara Gerke

Sara Gerke speaking
GSCN Conference in Jena in September, 2017

At the General Meeting of the German Stem Cell Network (GSCN) in Jena in September 2017, Tobias Cantz and I proposed the establishment of a new GSCN strategic working group.

This new working group, known as ELSA, focuses on the ethical, legal and social aspects of the modern life sciences. ELSA aims to serve as a country-wide interdisciplinary platform for the exchange of information and for the analysis and discussion of challenges facing basic and applied stem cell research in Germany.

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graphic of a keylock in front of a keyboard

The EU’s GDPR in the Health Care Context 

By Sara Gerke 

The EU’s General Data Protection Regulation, which came into force two years ago but became directly applicable in all EU Member States only last week, aims to establish an equal level of protection for the rights and freedoms of natural persons with regard to the processing of personal data in all EU Member States.

Each of us has been inundated with emails in the last few days and weeks, informing us about the GDPR and asking us, among other things, to review updated privacy policy. This flood of emails is, in particular, the consequence of the GDPR’s imposing administrative fines for infringements.

According to its territorial scope, the GDPR can also impact US companies that process personal data of data subjects who are in the EU. For example, this is the case for newspapers and affiliated websites, where the processing activities are related to the offering of services or goods, irrespective of whether payment is required. Some papers decided to simply block users in the EU, rather than abide by the GDPR’s provisions. 

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