FTC Adopts Policy Statement on Privacy Breaches by Health Apps and Connected...
On September 15, the Federal Trade Commission (“FTC”) adopted, on a 3-2 party-line vote, a policy statement that takes a broad view of which health apps and connected devices are subject to the FTC’s...
View ArticleCMS Proposal Would Impact Coverage of Innovative Digital Health Technologies
On September 15, 2021, CMS published a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary” Final Rule (“MCIT/RN Rule”), which was...
View ArticleU.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles”...
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”)...
View Article5 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,...
View ArticleFTC Releases New Health Breach Notification Rule Guidance, Targets Health...
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...
View ArticleFDA Webinar Provides New Insights on Use of Digital Health Technologies in...
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...
View Article3 Takeaways Digital Health Innovators Should Be Watching in the PREVENT...
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”...
View ArticleOIG Issues Advisory Opinion on Digital Program for the Treatment of Substance...
On March 2, 2022, the Office of Inspector General (“OIG”) for the Department of Health and Human Services (“HHS”) posted an advisory opinion concluding that a digital program for the treatment of...
View ArticleCalifornia AG Probes for Potential Bias in Healthcare Algorithms, Federal...
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...
View ArticleFTC, HHS, and FDA Update Tool to Help Mobile Health App Developers Understand...
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...
View ArticleHHS Proposes Rule to Improve Standards for Electronic Prior Authorizations...
On December 19, 2022, the U.S. Department of Health and Human Services (“HHS”) through the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule to adopt standards for certain...
View Article5 Reasons Digital Solutions for Women+ Health Will Grow in 2023
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...
View ArticleUK MHRA to recognize foreign regulatory approvals for medicines and medical...
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government...
View ArticleHow do the recent changes to the MDR and IVDR impact you and your medical...
To avoid a real and imminent risk of shortages of devices on the EU market, the European Commission recently adopted Regulation (EU) 2023/607, extending the transitional provisions in Regulation (EU)...
View ArticleFDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health...
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...
View ArticleFDA Releases Discussion Paper on AI in the Drug and Biological Product...
Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug...
View ArticleCMS Proposes Changes to Medicare Telehealth Policies, Including Increased...
On Thursday, July 13, 2023, the Centers for Medicaid & Medicaid Services (CMS) released the Calendar Year (CY) 2024 Physician Fee Schedule (PFS) Proposed Rule (CY 2024 PFS Proposed Rule), which...
View ArticleNHS Data Partnerships Guide – unlocking the benefits of data partnerships
Academic and commercial researchers using patient data are increasingly turning to real world data to gain broader insights into patient care and treatment. The UK is uniquely positioned to unlock the...
View ArticleFramework for the Future of AI: Senator Cassidy Issues White Paper, Seeks...
On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role...
View ArticleCalifornia Enacts Amendments to the CMIA
On September 27, 2023, Governor Newsom signed AB 254 and AB 352, which both amend the California Confidentiality of Medical Information Act (“CMIA”). Specifically, AB 254 expands the scope of the CMIA...
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