On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug manufacturing to seek public input
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 get the level of attention
On December 7, 2022, the Federal Trade Commission (“FTC”), along with the U.S. Department of Health and Human Services (“HHS”) and the U.S. Food and Drug Administration (“FDA”), announced updates to the Mobile Health App Interactive Tool—a questionnaire designed to help mobile health app developers identify federal laws and regulations that may apply to
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 machine learning (“AI/ML”).
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On July 28, 2020, FDA announced the publication of a final guidance on Multiple Function Device Products: Policy and Considerations that outlines FDA’s evolving approach to the regulation of multiple function device products, including software.
The concept of “multiple function” products was introduced by the 21st Century Cures Act (“Cures Act”) of 2016, which
On April 14, 2020, FDA issued a direct-to-final guidance outlining its “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” The guidance intends to “expand the availability of digital health therapeutic devices” – possibly the first time FDA has used such term in its written policies – to facilitate consumer and patient use and reduce potential exposure to COVID-19. The guidance applies to two groups of products: (1) computerized behavioral therapy devices and other digital health devices for psychiatric disorders; and (2) low-risk wellness and digital health products for mental health or psychiatric conditions. Like FDA’s many other COVID-19 enforcement policies, the policy will remain in effect “only for the duration of the public health emergency related to COVID-19.”
Continue Reading FDA Issues COVID-19 Policy for Certain Digital Health Solutions
This is the 11th, and final, of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: Why involve a lawyer?
This is the tenth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: What are the priorities for the solution?
This is the seventh of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: are healthcare providers involved, and what questions should be considered for collaborations?
This is the sixth of our video posts on 10 questions that can help lawyers contribute to the digital health ideation process. Today’s video explores the question: what are the limits on how the data can be used and disclosed?