On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog
Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices
UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
On May 21, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) published a statement of policy intent for UK recognition of international regulatory approvals of certain medical devices (the “Statement”). The Statement follows the Government response to the 2021 consultation on the future regulation of medical devices in the UK that details an intention to introduce alternative routes to market for medical devices, such as utilizing approvals from other countries and Medical Device Single Audit Program (“MDSAP”) certificates, in addition to the current UK Conformity Assessed (“UKCA”) marking process.
The MHRA has already taken similar steps in the medicines space, adopting a new International Recognition Procedure (“IRP”) in January 2024.
In relation to devices, the Statement applies to certain medical devices placed on the market in Great Britain. For relevant devices, the MHRA proposes to recognize foreign approvals from regulators in Australia, Canada, EU/EEA and USA (which is a smaller number of acceptable regulators than under the MHRA’s IRP for medicines). The Statement expressly excludes a number of medical devices from international recognition, including software as a medical device (“SaMD”) (including AI as a medical device (“AIaMD”)) and companion diagnostic products approved via US 510(k) (a route which relies on equivalence to a predicate).
The proposed framework is a draft and the final version is expected to come into force in 2025 at the same time as future core regulations. It also remains the government’s intention to introduce transitional arrangements for UKCA marked devices at the same time.Continue Reading UK MHRA Announces Intention To Recognize Certain International Approvals For Certain Medical Devices
MHRA Outlines New Strategic Approach to Artificial Intelligence
On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”). The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.
AI in Healthcare
AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment. AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence
EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines
In March 2024, the EU lawmakers reached agreement on the European Health Data Space (EHDS). Although the text has not yet been formally adopted by all the European institutions, a number of interesting points can already be highlighted. This article focuses on the governance and enforcement of the EHDS; for an overview of the EHDS generally, see our first post in this series.
The final text of the EHDS was adopted by the European Parliament on 24 April 2024 and is expected to be formally adopted by the European Council in the coming months.Continue Reading EHDS Series – 5: European Health Data Space Governance, Enforcement and Timelines
UK Government Outlines New Action to Tackle Biases in Medical Devices
On March 11, 2024, 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
FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process
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,
Continue Reading FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process