News, Resources, and Events Tagged "Sara Gerke"
The Development, Implementation, and Oversight of Artificial Intelligence in Health Care: Legal and Ethical Issues
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.…
The New European Medical Device Regulation: Balancing Innovation and Patient Safety
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
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: Essential Medico-Legal Aspects
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: Systematic Review
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
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
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
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
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…
To Spur Growth in AI, We Need a New Approach to Legal Liability
Artificial intelligence (AI) is sweeping through industries ranging from cybersecurity to environmental protection — and the Covid-19 pandemic has only accelerated this trend. AI may improve the lives of millions,…
COVID-19 Antibody Testing as a Precondition for Employment: Ethical and Legal Considerations
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
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
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?
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?
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…
Ethical and Legal Implications of Remote Monitoring of Medical Devices
Millions of life‐sustaining implantable devices collect and relay massive amounts of digital health data, increasingly by using user‐downloaded smartphone applications to facilitate data relay to clinicians via manufacturer…
Maximizing Use Of Claims Data To Address COVID-19: We Need To Revisit Gobeille v. Liberty Mutual
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
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: Ethical Implementation Imperatives
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
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: HLS scholars raise important legal and ethical questions about health care delivery and the enactment of extraordinary public health measures
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…
Ethical and Legal Aspects of Ambient Intelligence in Hospitals
Ambient intelligence in hospitals is an emerging form of technology characterized by a constant awareness of activity in designated physical spaces and of the use of that awareness to assist…
Harvard Law School researchers call for more regulation in medical AI
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
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
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?
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
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…
Ethical and legal issues of ingestible electronic sensors
From the abstract: Ingestible electronic sensors are a promising technology for improving health outcomes that may, for example, be useful in monitoring and promoting the taking of medication. However, these…
Sessions of the GSCN Working Groups
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…
Ethical and Legal Challenges of Artificial Intelligence in Cardiology
From the article: Artificial intelligence (AI) offers new opportunities to improve diagnosis and treatment across a wide spectrum of cardiovascular conditions. In theory, algorithms driven by AI can interpret the…
A User-Focused Transdisciplinary Research Agenda for AI-Enabled Health Tech Governance
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!
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…