Artificial Intelligence (AI)

Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus.  Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to

Continue Reading 5 Reasons Digital Solutions for Women+ Health Will Grow in 2023

The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”).  On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as

Continue Reading Change is Coming for Software and AI Medical Devices in the UK

Digital health technologies, including algorithms for use in health care, are being developed to aid healthcare providers and serve patients, from use with administrative tasks and workflow to diagnostic and decision support.  The use of artificial intelligence (“AI”) and machine learning algorithms in health care holds great promise, with the

Continue Reading California AG Probes for Potential Bias in Healthcare Algorithms, Federal Attention Continues

Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials.  DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study
Continue Reading FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials

As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities.  From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in
Continue Reading 5 Digital Health Issues to Watch at FDA in 2022

On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and
Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices

The Medicines & Healthcare products Regulatory Agency (“MHRA”) has published a “Consultation on the future regulation of medical devices in the United Kingdom” (the “Consultation”), which will run until 25 November 2021.  The consultation sets out proposed changes to the UK medical device regulatory framework with
Continue Reading Consultation on the Future Regulation of Medical Devices in the UK, including Work Programme for Software and AI Medical Devices

The International Coalition of Medicines Regulatory Authorities (“ICMRA”) has published a report on the use of artificial intelligence (“AI”) to develop medicines (the “AI Report”) that provides a series of recommendations on how regulators and stakeholders can address challenges posed by AI.  The ICMRA notes that there are numerous opportunities to apply AI to medicines development, but that AI poses a number of challenges to existing regulatory frameworks.  The AI Report discusses these opportunities and challenges in detail based on several case studies, and provides a set of recommendations for implementation by the ICMRA and its member authorities, which includes the European Medicines Agency (the “EMA”), the USA’s Food and Drug Administration, and the World Health Organisation.  Based on the AI report, we expect to see an increased focus on adapting regulatory frameworks to deal with AI products going forwards both on an international and national level.
Continue Reading ICMRA Publishes Report and Recommendations on AI and Medicinal Products

On June 22, 2021, Congressional leaders Diana DeGette (D-DO) and Fred Upton (R-MI) released a bipartisan follow-up to the 2016 21st Century Cures Act“Cures 2.0”—a “discussion draft” at this stage—is intended to build upon the Cures Act.  The draft lays out several notable policies related to digital
Continue Reading Reps. DeGette and Upton Release Highly-Anticipated “Cures 2.0” Draft

In April 2021, the European Commission released its proposed Regulation Laying Down Harmonized Rules on Artificial Intelligence (the “Regulation”), which would establish rules on the development, placing on the market, and use of artificial intelligence systems (“AI systems”) across the EU. The proposal, comprising 85 articles and nine annexes, is part of a wider package of Commission initiatives aimed at positioning the EU as a world leader in trustworthy and ethical AI and technological innovation.

The Commission’s objectives with the Regulation are twofold: to promote the development of AI technologies and harness their potential benefits, while also protecting individuals against potential threats to their health, safety, and fundamental rights posed by AI systems. To that end, the Commission proposal focuses primarily on AI systems identified as “high-risk,” but also prohibits three AI practices and imposes transparency obligations on providers of certain non-high-risk AI systems as well. Notably, it would impose significant administrative costs on high-risk AI systems of around 10 percent of the underlying value, based on compliance, oversight, and verification costs. This blog highlights several key aspects of the proposal.
Continue Reading European Commission Proposes New Artificial Intelligence Regulation