digital health

On March 15, 2024, FDA’s medical product centers – CBER, CDER, and CDRH – along with the Office of Combination Products (OCP) published a paper outlining their key areas of focus for the development and use of artificial intelligence (AI) across the medical product life cycle.  The paper, entitled “Artificial Intelligence & Medical Products:

On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, published on February 21, 2024, a white paper with various proposals to update privacy protections for health data. In Part 1 of this blog series (see here), we discussed the first section of Senator Cassidy’s February 21, 2024, white paper. Specifically, we summarized Senator Cassidy’s proposals on how to update the existing framework of the Health Insurance Portability and Accountability Act, as amended, and its implementing regulations (collectively, “HIPAA”) without disrupting decades of case law and precedent. In this blog post, we discuss the other sections of the white paper, namely proposals to protect other sources of health data not currently covered by HIPAA.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 2: Safeguarding Health Data Not Covered by HIPAA 

On February 21, 2024, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor, and Pensions (“HELP”) Committee, issued a white paper, “Strengthening Health Data Privacy for Americans: Addressing the Challenges of the Modern Era,” which proposes several updates to the privacy protections for health data. This follows Senator Cassidy’s September 2023 request for information from stakeholders about how to enhance health data privacy protections covered by the Health Insurance Portability and Accountability Act (“HIPAA”) framework and to consider privacy protections for other sources of health data not currently covered by HIPAA. The white paper notes that several entities, including trade associations, hospitals, health technology companies, and think tanks, responded to the RFI.Continue Reading Senator Cassidy Issues White Paper with Proposals to Update Health Data Privacy Framework – Part 1: Updates to the HIPAA Framework

Earlier today, the White House issued a Fact Sheet summarizing its Executive Order on a comprehensive strategy to support the development of safe and secure artificial intelligence (“AI”).  The Executive Order follows a number of actions by the Biden Administration on AI, including its Blueprint for an AI Bill of Rights and voluntary commitments from

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 to expressly cover reproductive or sexual health services that are delivered through digital health solutions and the associated health information generated from these services.  AB 352 imposes new requirements on how electronic health record (“EHR”) systems must store medical information related to gender affirming care, abortion and related services, and contraception and the ability of providers of health care, health care service plans, contractors, or employers to disclose such information.Continue Reading California Enacts Amendments to the CMIA

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 of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health and life sciences.  In the

The NHS has issued guidance on effective data partnerships, this blog summarises key terms for parties looking to collaborate on data driven projects with the NHS.
Continue Reading NHS Data Partnerships Guide – unlocking the benefits of data partnerships

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 proposes policy changes to the PFS and other Medicare Part B issues, effective on or after January 1, 2024.  As explained in our article

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 and biological products, this time focusing on the use of AI/ML in the drug and biologic development process, “Using Artificial Intelligence &