Internet of Things (IoT)

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 September 28, the governor of California signed into law AB 2089, which expands the scope of California’s Confidentiality of Medical Information Act (“CMIA”) to cover mental health services that are delivered through digital health solutions and the associated health information generated from these services. 

Continue Reading California Expands the Scope of the CMIA to Cover Certain Digital Mental Health Services and Information

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 ability to help streamline care

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 provisions related to digital health. 

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 designs.  This includes information from

On January 21, the Federal Trade Commission (“FTC”) announced new resources to help companies determine their obligations under the Health Breach Notification Rule (the “Rule”): the Health Breach Notification Rule: Basics for Business, which provides a quick introduction to the Rule, and Complying with FTC’s Health Breach Notification Rule (“Compliance Guidance”), a more in-depth compliance guidance.  These resources follow the FTC’s September 2021 Policy Statement, which expanded the Rule’s application to the developers of health apps, connected devices, and similar products, and similarly emphasize the FTC’s continued scrutiny of health technology.

Continue Reading FTC Releases New Health Breach Notification Rule Guidance, Targets Health Apps and Connected Devices

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 2022 related to FDA and

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”).

Purpose

AI

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 health, real-world data/evidence (RWD/E), and

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 Artificial Intelligence/Machine Learning (AI/ML)-Based Software