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
3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT Pandemics Act
On January 25, 2022, Senators Patty Murray and Richard Burr (Chair and Ranking Member of the Senate Health, Education, Labor, and Pensions (HELP) Committee, respectively) released a “discussion draft” of bipartisan legislation—the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (“PREVENT Pandemics Act”)—which contains notable
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FDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials
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
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5 Digital Health Issues to Watch at FDA in 2022
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
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U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
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
Reps. DeGette and Upton Release Highly-Anticipated “Cures 2.0” Draft
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
FDA Releases AI Action Plan
FDA has long recognized the significant potential of artificial intelligence- and machine learning- (AI/ML-) based software as a medical device (SaMD) to transform health care as well as the unique challenges presented by AI/ML-based software under the Agency’s traditional medical device regulatory framework. On January 12, 2021, FDA issued the
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