Digital Health

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

On December 5, 2023, the Spanish presidency of the Council of the EU issued a declaration to strengthen collaboration with Member States and the European Commission to develop a leading quantum technology ecosystem in Europe.

The declaration acknowledges the revolutionary potential of quantum computing, which uses quantum mechanics principles and quantum bits known as “qubits” to solve complex mathematical problems exponentially faster than classical computers.

The declaration was launched with eight Member State signatories (Denmark, Finland, Germany, Greece, Hungary, Italy, Slovenia, and Sweden), and invites other Member States to sign. By doing so, they agree to recognize the “strategic importance of quantum technologies for the scientific and industrial competitiveness of the EU” and commit to collaborating to make Europe the “’quantum valley’ of the world, the leading region globally for quantum excellence and innovation.Continue Reading Quantum Computing: Action in the EU and Potential Impacts

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 &

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

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) 2017/745 (the “MDR”) and removing the sell-off period in the MDR and Regulation (EU) 2017/746 (the “IVDR”).  The Commission has published a Q&A on the practical aspects of the latest changes (the “Q&A”).  We set out the top 10 questions to think about when assessing how the changes to the MDR and IVDR may impact you and your medical devices.
Continue Reading How do the recent changes to the MDR and IVDR impact you and your medical devices?  — Top 10 Questions