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The Development, Implementation, and Oversight of Artificial Intelligence in Health Care image

The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues

Jenna Becker, Sara Gerke, and I. Glenn Cohen
Handbook of Bioethical Decisions

Artificial Intelligence (AI), especially of the machine learning (ML) variety, is used by health care organizations to assist with a number of tasks, including diagnosing patients and optimizing operational workflows.…

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The New European Medical Device Regulation: Balancing Innovation and Patient Safety

Michael Bretthauer and Sara Gerke
Annals of Internal Medicine

The European Union has introduced stricter provisions for medical devices under the new Medical Device Regulation (MDR). The MDR increases requirements for clinical trial testing for many devices before they…

The proposed EU Directives for AI Liability Leave Worrying Gaps Likely to Impact Medical AI image

The proposed EU Directives for AI Liability Leave Worrying Gaps Likely to Impact Medical AI

Mindy Nunez Duffourc and Sara Gerke
Nature NPJ Digital Medicine

Two newly proposed Directives impact liability for artificial intelligence in the EU: a Product Liability Directive (PLD) and an AI Liability Directive (AILD). While these proposed Directives provide some uniform…

Artificial intelligence tools in Clinical Neuroradiology image

Artificial intelligence tools in Clinical Neuroradiology: Essential Medico-Legal Aspects

Dennis M. Hedderich, Christian Weisstanner, Sofie Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke, et al.
Neuroradiology

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues…

Ethical perspectives on Surgical Video Recording for Patients, Surgeons and Society image

Ethical perspectives on Surgical Video Recording for Patients, Surgeons and Society: Systematic Review

Sara Gerke
British Journal of Surgery

For a surgical video to be a truly valuable resource, its potential benefits must be more fully weighed against its potential disadvantages, so that any derived instruments have a solid…

Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients image

Generative AI in Health Care and Liability Risks for Physicians and Safety Concerns for Patients

Mindy Duffourc, Sara Gerke, et al.
JAMA

Generative artificial intelligence (AI) is a quickly emerging subfield of AI that can be trained with large data sets to create realistic images, videos, text, sound, 3-dimensional models, virtual environments,…

German Pharmaceutical Pricing: Lessons for the United States image

German Pharmaceutical Pricing: Lessons for the United States

Marc A. Rodwin and Sara Gerke (Former Research Fellow in Medicine, Artificial Intelligence, and Law)
International Journal of Health Services

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell…

Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien image

Ethische und rechtliche Herausforderungen digitaler Medizin in Pandemien

Timo Minssen, Sara Gerke (Former Research Fellow in Medicine, Artificial Intelligence, and Law)
Pandemien und Ethik

Die Covid-19-Pandemie und die damit einhergehenden Mobilitäts-Begrenzungen, Kontaktverbote, Handy Überwachungs- Apps sowie weitere Strategien zur Eindämmung von Infektionsketten hat im letzten Jahr zu einem…

Beware explanations from AI in health care image

Beware explanations from AI in health care

Boris Babic, Sara Gerke (Former Research Felllow), Theodoros Evgeniou, and I. Glenn Cohen (Faculty Director)
Science

Artificial intelligence and machine learning (AI/ML) algorithms are increasingly developed in health care for diagnosis and treatment of a variety of medical conditions (1). However, despite the technical prowess of…

COVID-19 Antibody Testing as a Precondition for Employment image

COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations

Sara Gerke (Former Research Fellow), Gali Katznelson, Dorit Reiss, and Carmel Shachar (Executive Director)
Journal of Law, Medicine & Ethics

Employers and governments are interested in the use of serological (antibody) testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions…

Tech Companies Want AI to Fix the Disastrous Vaccine Rollout image

Tech Companies Want AI to Fix the Disastrous Vaccine Rollout

Todd Feathers, featuring Sara Gerker (Research Fellow, Medicine, Artificial Intelligence, and Law)
Vox

Across the US, the government’s early attempts to distribute the COVID-19 vaccine have been, at best, underwhelming. In Ohio, nearly 900 doses of Moderna’s COVID-19 vaccine went…

When Machine Learning Goes Off the Rails image

When Machine Learning Goes Off the Rails

Boris Babic, I. Glenn Cohen, Theodoros Evgeniou, and Sara Gerke
Harvard Business Review

What happens when machine learning—computer programs that absorb new information and then change how they make decisions—leads to investment losses, biased hiring or lending, or car…

Can AI Fairly Decide Who Gets an Organ Transplant? image

Can AI Fairly Decide Who Gets an Organ Transplant?

Boris Babic, I. Glenn Cohen (Faculty Director), Theodoros Evgeniou, Sara Gerke (Research Fellow), and Nikos Trichakis
Harvard Business Review

Health care organizations, like many other enterprises, face steep challenges in their attempt to maximize operational efficiency in the face of resource constraints. Whether it is a hospital’s…

How Much Can Potential Jurors Tell Us about Liability for Medical AI? image

How Much Can Potential Jurors Tell Us about Liability for Medical AI?

W. Nicholson Price II (Former Academic Fellow), Sara Gerke (Research Fellow), and I. Glenn Cohen (Faculty Director)
Journal of Nuclear Medicine

Artificial intelligence (AI) is rapidly entering medical practice, whether for risk prediction, diagnosis, or treatment recommendation. But a persistent question keeps arising: What happens when things go wrong? When patients…

Maximizing Use Of Claims Data To Address COVID-19 image

Maximizing Use Of Claims Data To Address COVID-19: We Need To Revisit Gobeille v. Liberty Mutual

Carmel Shachar (Executive Director), Sara Gerke (Postdoctoral Fellow), I. Glenn Cohen (Faculty Director)
Health Affairs Blog

To successfully manage our nation’s response to the COVID-19 pandemic, a robust health information infrastructure is essential. A national, organized system of health data would enable state health…

Applying the Proportionality Principle to COVID-19 Antibody Testing image

Applying the Proportionality Principle to COVID-19 Antibody Testing

Hrefna D Gunnarsdóttir, Michael S Sinha, Sara Gerke (Postdoctoral Fellow), and Timo Minsssen
Journal of Law and the Biosciences

As the COVID-19 pandemic continues to ravage the globe, many nations have started to relax stringent restrictions in an effort to restart the economy. While Member States of the European…

AI Surveillance during Pandemics image

AI Surveillance during Pandemics: Ethical Implementation Imperatives

By Carmel Shachar (Executive Director), Sara Gerke (Research Fellow), and Eli Y. Adashi
Hastings Center Report

From the article: “The health needs created by the pandemic put significant pressure on physicians, hospital leaders, public health officials, and other care providers to collaborate with developers to…

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

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

Sara Gerke (Research Fellow), Boris Babic, Theodoros Evgeniou, I. Glenn Cohen (Faculty Director)
nature: npj Digital Medicine

Abstract Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized…

Protecting rights in a global crisis image

Protecting rights in a global crisis: HLS scholars raise important legal and ethical questions about health care delivery and the enactment of extraordinary public health measures

Jonathan Chernoguz (Communications Intern)
Harvard Law Today

Fifty years from now, will emergency decisions made today to combat the spread of the COVID-19 pandemic be remembered as reprehensible human rights violations, comparable to the internment of Japanese…

Harvard Law School researchers call for more regulation in medical AI image

Harvard Law School researchers call for more regulation in medical AI

Andrea Park, referencing work by Sara Gerke (Research Fellow, Medicine, Artificial Intelligence, and Law) and I. Glenn Cohen (Faculty Director)
Becker's Health IT & CIO Report

From the article: Existing safeguards from the FDA and other regulatory bodies will require significant updates in order to maintain safety and ethics in healthcare's use of constantly "learning"…

Researchers call on regulators to reduce risks of AI in medicine image

Researchers call on regulators to reduce risks of AI in medicine

Greg Slabodkin, referencing work by Sara Gerke (Research Fellow, Medicine, Artificial Intelligence, and Law) and I. Glenn Cohen (Faculty Director)
Health Data Management

From the article: Continuous monitoring is critical if regulatory agencies such as the Food and Drug Administration are to reduce the risk in artificial and machine learning-based medical technology. That…

Algorithms on regulatory lockdown in medicine image

Algorithms on regulatory lockdown in medicine

Boris Babic, Sara Gerke (Research Fellow, Medicine, Artificial Intelligence, and Law), Theodoros Evgeniou, I. Glenn Cohen (Faculty Director)
Science

From the abstract: As use of artificial intelligence and machine learning (AI/ML) in medicine continues to grow, regulators face a fundamental problem: After evaluating a medical AI/ML technology…

How does emerging patent case law in the US and Europe affect precision medicine? image

How does emerging patent case law in the US and Europe affect precision medicine?

by Mateo Aboy (Visiting Scholar)...I. Glenn Cohen (Faculty Director)...Sara Gerke (Research Fellow)*
Nature Biotechnology

From the paper: No topic in medicine garners more interest today than precision medicine, with its goal of better tailoring treatment to patient needs. It is not only patients who…

That Pill Is Watching You - Privacy And Hackability Of Ingestible Electronic Sensors

By Elizabeth Fernandez, referencing work by Sara Gerke (Research Fellow, Medicine, Artificial Intelligence, and Law)
Forbes

From the article: These sensors can then give a medical care team direct information about their patient, from whether they are taking the medicines correctly to their physical or mental…

Sessions of the GSCN Working Groups

German Stem Cell Network
GSCN Annual Magazine

From the article: At the 6th GSCN Annual Conference, Tobias Cantz (Hannover) and Sara Gerke (Cambridge, USA) organized a Symposium on Ethical, Legal and Social Aspects (ELSA) of stem cell…

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

David Arney, Max Senges, Sara Gerke et al
AI-Health Working Group White Paper

From the abstract: AI-enabled health technology holds significant promise for improving health outcomes and clinical workflows. However, it also generates challenges for health data governance and security. More specifically, apps…

Petrie-Flom Welcomes New Precision Medicine Fellow!

Petrie-Flom Center

We are excited to announce that Sara Gerke is joining the Petrie-Flom Center's Project on Precision Medicine, Artificial Intelligence, and Law (PMAIL) as our Precision Medicine Fellow. As the…