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Guideline for AI for medical products

Guideline for AI for medical products

The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the notified bodies are, to promote step-by-step implementation of safety of medical devices, that implement artificial intelligence methods, in particular machine learning, to compensate for the lack of a harmonized standard (in the interim) to the greatest extent possible.

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A Human-Centered Evaluation of a Deep Learning System Deployed in Clinics for the Detection of Diabetic Retinopathy

A Human-Centered Evaluation of a Deep Learning System Deployed in Clinics for the Detection of Diabetic Retinopathy

This paper contributes the first human-centered observational study of a deep learning system deployed directly in clinical care with patients. Through field observations and interviews at eleven clinics across Thailand, we explored the expectations and realities that nurses encounter in bringing a deep learning model into their clinical practices. First, we outline typical eye-screening workflows and challenges that nurses experience when screening hundreds of patients. Then, we explore the expectations nurses have for an AI-assisted eye screening process. Next, we present a human-centered, observational study of the deep learning system used in clinical care, examining nurses’ experiences with the system, and the socio-environmental factors that impacted system performance. Finally, we conclude with a discussion around applications of HCI methods to the evaluation of deep learning algorithms in clinical environments.

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A socio-technical framework for digital contact tracing

A socio-technical framework for digital contact tracing

In their efforts to tackle the COVID-19 crisis, decision makers are considering the development and use of smartphone applications for contact tracing. Even though these applications differ in technology and methods, there is an increasing concern about their implications for privacy and human rights. Here we propose a framework to evaluate their suitability in terms of impact on the users, employed technology and governance methods.

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The European Data Protection Supervisor, 2019 Annual Report a year of transition

The European Data Protection Supervisor, 2019 Annual Report a year of transition

With new legislation on data protection in the EU now in place, our greatest challenge moving into 2020 is to ensure that this legislation produces the promised results. This includes ensuring that new rules on ePrivacy remain firmly on the EU agenda. Awareness of the issues surrounding data protection and privacy and the importance of rotecting these fundamental rights is at an all time high and we cannot allow this momentum to decline.

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Artificial Intelligence and Machine Learning in Software as a Medical Device: discussion Paper and Request for Feedback

Artificial Intelligence and Machine Learning in Software as a Medical Device: discussion Paper and Request for Feedback

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day. Medical device manufacturers are using these technologies to innovate their products to better assist health care providers and improve patient care. The FDA is considering a total product lifecycle-based regulatory framework for these technologies.

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The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

The need for a system view to regulate artificial intelligence/machine learning-based software as medical device

FDA need to widen their scope from evaluating medical AI/ML-based products to assessing systems. This shift in perspective—from a product view to a system view—is central to maximizing the safety and efficacy of AI/ML in health care, but it also poses significant challenges for agencies like the FDA who are used to regulating products, not systems. We offer several suggestions for regulators to make this challenging but important transition

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When Autonomous Vehicles Are Hacked, Who Is Liable?

When Autonomous Vehicles Are Hacked, Who Is Liable?

Who might face civil liability if autonomous vehicles (AVs) are hacked to steal data or inflict mayhem, injuries, and damage? How will the civil justice and insurance systems adjust to handle such claims? RAND researchers addressed these questions to help those in the automotive, technology, legal, and insurance industries prepare for the shifting roles and responsibilities that the era of AVs may bring.

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